GLP‑1 news from 2026
1098 dated, sourced GLP-1 developments from 2026: approvals, trial results, prices, lawsuits, compounding and culture.
- Business
Eli Lilly raises 2026 outlook after Q3 revenue rises 39% to $24.4 billion
Eli Lilly reported third-quarter 2026 revenue of $24.40 billion on October 29, up 39% from a year earlier and above the $22.61 billion analysts expected, with adjusted earnings per share of $7.48 versus $6.26 expected. The company raised full-year revenue guidance to $91 billion–$92 billion from $85 billion–$87 billion. Mounjaro revenue rose 65% to $10.72 billion and Zepbound rose 49% to $5.35 billion, while the newly launched Foundayo brought in $184 million, below the $229 million estimate.
- Research and trials
Lilly's retatrutide tops Ozempic 2 mg on A1C and weight loss in Phase 3 trial
In a Phase 3 head-to-head trial reported on October 28, 2026, the highest dose of Eli Lilly's retatrutide lowered A1C by 2.2 percentage points after 80 weeks, compared with 1.8 points for Ozempic 2 mg. Patients on retatrutide lost 20.9% of body weight versus 9.4% on Ozempic, based on on-treatment analyses.
- Research and trials
Ascletis oral GLP-1 ASC30 cuts HbA1c 1.7% in Phase 2 diabetes trial
Ascletis said on October 28, 2026, that its oral small molecule GLP-1 receptor agonist ASC30 met the primary endpoint in a 13-week U.S. Phase 2 trial of 100 people with type 2 diabetes. Placebo-adjusted HbA1c reductions at 12 weeks were 1.7%, 1.6% and 1.7% at 40 mg, 60 mg and 80 mg, and placebo-adjusted weight loss at 13 weeks was 4.4%, 3.8% and 4.0%. The company reported no study discontinuations due to gastrointestinal adverse events and no hepatic safety signal.
- Research and trials
Vanda's tradipitant cut Wegovy-induced vomiting by 27% in Phase 3 trial
In Phase 3 Study 3601, announced October 27, 2026, tradipitant reduced the incidence of vomiting to 43% compared with 58.5% for placebo in patients given a single 1 mg dose of Wegovy. Severe nausea and vomiting occurred in 33.1% of tradipitant patients versus 50.6% on placebo. Vanda Pharmaceuticals said it plans a supplemental new drug application to expand the label.
- Prices
Employer coverage of Wegovy and Zepbound for weight loss falls to 53%, survey finds
A WTW survey dated October 27, 2026 found 53% of employers with more than 100 employees cover GLP-1 drugs for weight loss, down from 57% in 2025, and 16% are weighing dropping the benefit, up from 9%. A separate projection put employer health insurance costs at 8.2% higher per employee in 2027, with GLP-1 use accounting for a full percentage point of that increase.
- Competition
Judge denies Novo Nordisk request to block Lilly's Zepbound and Mounjaro ads
A U.S. federal judge on October 26, 2026 refused to grant Novo Nordisk a preliminary injunction against Eli Lilly's comparative advertising for Zepbound and Mounjaro, ruling that Novo had not shown irreparable harm. One Lilly commercial cited in the case said Zepbound users lost an average of 50 pounds compared with 33 pounds for Wegovy. Novo Nordisk said the ruling does not decide whether Lilly's advertising is false or misleading and that the litigation continues.
- Business
Oral GLP-1 developer Corxel to go public via SPAC merger
Corxel Pharmaceuticals plans to list on Nasdaq by merging with Amanat Acquisition Corp, a deal paired with a $300 million PIPE that is expected to raise about $377 million in total. The company's lead candidate, CX11, is an oral GLP-1 in late-stage development; Phase 2 data showed up to 11.5% body weight loss at 36 weeks. The transaction is expected to close in the first half of 2027.
- Safety
Case report ties tirzepatide to lithium toxicity in a bipolar patient
A case report dated October 26, 2026, describes a 50-year-old woman with bipolar disorder who developed tremor, slurred speech, and blurred vision three weeks after starting tirzepatide. Her serum lithium level rose from 0.7 to 1.2 mmol/L, and reducing her lithium dose resolved the symptoms. The report says this is the fourth reported case of tirzepatide-associated lithium toxicity.
- Research and trials
ACOG releases first GLP-1 pregnancy guidance, advises against use while pregnant
On October 23, 2026, the American College of Obstetricians and Gynecologists issued its first guidance on GLP-1 receptor agonists during pregnancy and breastfeeding. The guidance recommends stopping a GLP-1 weight-loss drug one to two months before trying to conceive and avoiding the drugs during pregnancy. It says the medications may be considered while breastfeeding after a baby's first month.
- Research and trials
Menopause hormone therapy linked to more weight loss on semaglutide and tirzepatide
A study of about 3,900 women, dated October 21, 2026, found that menopause hormone therapy was associated with greater weight loss from GLP-1 drugs. At one year, women taking hormone therapy plus semaglutide lost an average of 11% of body weight versus 9.5% on semaglutide alone, and 22% of combination users lost at least 20% versus 18% on semaglutide only. Tirzepatide plus hormone therapy showed smaller improvements, including 6.6% versus 5.9% weight loss at three months.
- Research and trials
Retatrutide cut sleep apnea severity by up to 24 AHI events per hour in Phase 3 trials
In two Phase 3 TRIUMPH trials reported October 20, 2026, retatrutide 9 mg and 12 mg lowered the apnea-hypopnea index by 24.4 and 21.9 events per hour more than placebo in adults with obstructive sleep apnea and obesity who did not have diabetes. Among participants with type 2 diabetes, the reductions versus placebo were 14.4 and 15.1 events per hour. Body weight fell 12.5% to 22.2% with retatrutide compared with 4.8% to 5.6% with placebo, and the most common adverse events were gastrointestinal.
- Research and trials
CagriSema linked to 25% average weight loss in women in REDEFINE 1 analysis
In post hoc analyses of the Phase 3 REDEFINE 1 trial presented October 20, 2026 at The Menopause Society, CagriSema 2.4 mg/2.4 mg produced an average 25.0% weight loss at 68 weeks in 2,309 women with obesity or overweight, versus 3.0% with placebo. Weight loss was 26.7% in premenopausal, 24.8% in perimenopausal and 23.1% in postmenopausal women. Novo Nordisk said the analyses are hypothesis-generating and require further study.
- Regulation
Apothecary Pharma recalls 22 lots of compounded tirzepatide over sterility concerns
Apothecary Pharma is voluntarily recalling 22 lots of 18 mg/mL, 4 mL sterile multi-dose vials of compounded tirzepatide, according to a notice dated October 20, 2026. The recall follows an FDA warning letter that found serious sterility deficiencies. The FDA classified the action as Class II, indicating a moderate risk of temporary or medically reversible adverse health consequences.
- Regulation
EMA panel recommends approval of Lilly's oral GLP-1 Foundayo
The European Medicines Agency's CHMP recommended on October 16, 2026, that Foundayo (orforglipron) be granted marketing authorization for weight management and type 2 diabetes in adults. The weight-management recommendation is based on two studies of more than 4,740 adults with obesity or overweight, in which participants lost about 5% to 11% of their body weight after 72 weeks, depending on dose. The once-daily tablet can be taken at any time of day, with or without food.
- Research and trials
Fractyl's Revita cuts weight regain after GLP-1 stop in REMAIN-1 trial
Fractyl Health reported six-month results from the REMAIN-1 pivotal cohort showing Revita-treated participants kept about 80% of their GLP-1-induced weight loss versus 67% with sham, a difference with p=0.0023. In a post hoc analysis, patients with a completed duodenal ablation of at least 20 cm regained 3.8% of total body weight compared with 8.2% for sham. Fractyl plans a De Novo marketing application to the FDA in late Q4 2026 and expects one-year data in Q1 2027.
- Compounding
FDA finds black mold and filth at two Chinese plants making compounded GLP-1 ingredients
FDA inspectors documented black mold on equipment, gross contamination on floors, and employees hiding paperwork or pouring out product samples at one Chinese plant that makes components for compounded semaglutide and tirzepatide. At a second plant, inspectors found evidence of bogus documentation, according to reports released under a Freedom of Information Act request and dated October 15, 2026.
- Compounding
Eli Lilly sues four compounding pharmacies over copycat weight-loss drugs
Eli Lilly filed four lawsuits on October 14, 2026, alleging that compounding pharmacies sold unauthorized copies of its GLP-1 weight-loss drugs. The suits name compounded versions of tirzepatide, the active ingredient in Mounjaro and Zepbound, and compounded semaglutide, the active ingredient in Ozempic and Wegovy.
- Research and trials
Orforglipron matches insulin glargine on cardiovascular safety in ACHIEVE-4
Daily orforglipron was noninferior to insulin glargine for major adverse cardiovascular events in the Phase 3 ACHIEVE-4 trial, results reported on October 14, 2026. In 2,749 adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk, the four-component MACE rate was 4.2% with orforglipron versus 5.0% with insulin glargine over a median two years (hazard ratio 0.84; 95% CI 0.59–1.20; p<0.0001 for noninferiority). Gastrointestinal adverse events were more common with orforglipron (62.1% vs 14.2%), while clinically significant or severe hypoglycemia (6.8% vs 19.2%) and death (1.4% vs 3.2%) were less common.
- Research and trials
GLP-1 drugs linked to 24% fewer schizophrenia hospital visits in study
A study of US health records published in Lancet Psychiatry on October 14, 2026 found that patients with schizophrenia who took GLP-1 drugs for diabetes had 24% fewer psychiatric hospital admissions. The same analysis reported 29% fewer emergency room visits for mental health crises among those patients. The researchers did not establish that the drugs caused the reduction.
- Research and trials
Viking Therapeutics starts Phase 3 trials of oral VK2735 for obesity
Viking Therapeutics announced on October 14, 2026 that it began the SUNRISE Phase 3 program for oral VK2735, its dual GLP-1/GIP receptor agonist. The program has two randomized, double-blind, placebo-controlled trials: SUNRISE-1 in adults with obesity or overweight without type 2 diabetes, and SUNRISE-2 in adults with type 2 diabetes. Each trial targets 560 participants taking once-daily doses of 27.5 mg, 35 mg, 55 mg, or placebo for 68 weeks, with percent change in body weight from baseline versus placebo as the primary endpoint.
- Research and trials
Verdiva Bio ends Phase 2 trial of oral GLP-1 VRB-101 for injectable switch patients
Verdiva Bio terminated a Phase 2 study of VRB-101, an experimental once-weekly oral GLP-1, that tested it as a maintenance option for patients who had lost weight on injectable GLP-1 drugs. The company cited market evolution when it announced the decision on October 14, 2026; the trial had enrolled eight participants before it ended. Verdiva said it will continue developing VRB-101 as a monotherapy.
- Safety
FDA received two death reports linked to counterfeit retatrutide
The FDA received reports of two recent deaths tied to counterfeit versions of retatrutide, an investigational weight-loss drug from Eli Lilly that is not approved for sale. The reports were described by CBS News via MedPage Today in a story dated October 13, 2026. Counterfeit products sold as retatrutide have no guaranteed ingredient, dose or sterility.
- Business
Walmart to cover Ozempic and Mounjaro at no cost for employees with Type 2 diabetes
Walmart said it will cover more than 250 prescriptions, including some insulin, inhalers and GLP-1s, at no cost to employees starting in 2027. Under the plan announced Oct. 13, 2026, Ozempic and Mounjaro will be free for employees with Type 2 diabetes after prior authorization. GLP-1s prescribed for weight loss are still not covered.
- Business
Roche licenses Rona's ALK7 RNAi obesity drug in deal worth up to $1.16B
On October 13, 2026, Roche agreed to license Rona Therapeutics' investigational ALK7-targeting RNAi candidate for obesity and metabolic diseases, gaining exclusive rights. Roche will pay up to $100 million upfront and in near-term milestones, plus up to $1.06 billion in longer-term milestones and royalties. The drug has not been approved, and the totals depend on hitting development and sales targets.
- Business
Zealand Pharma and Generate Biomedicines sign obesity drug deal worth up to $1.2 billion
Zealand Pharma and Generate Biomedicines announced on October 13, 2026 that they will partner to develop AI-designed obesity drugs, in a deal worth up to nearly $1.2 billion in milestone payments. Generate Biomedicines will receive $30 million upfront and up to $35 million in early preclinical milestones. Generate will lead research through candidate selection, while Zealand handles clinical development, regulatory submissions and worldwide commercialization of the multispecific protein therapies.
- Research and trials
Lilly says Taltz plus Zepbound shifted more biomarkers than Taltz alone in psoriasis-obesity trial
Exploratory Phase 3b data from the TOGETHER-PsO trial, presented October 9, 2026 at Fall Clinical, showed Taltz (ixekizumab) plus Zepbound (tirzepatide) changed 482 proteins and 467 genes by week 36, compared with 140 proteins and 16 genes for Taltz alone. Lilly reported that broader biomarker responses, including reduced inflammatory immune activity, appeared as early as week 12. The company did not present clinical symptom outcomes for the comparison.
- Research and trials
Petrelintide from Zealand and Roche shows up to 9.2% weight loss in Phase 2 trial
In a 220-patient Phase 2 trial reported October 7, 2026, once-weekly petrelintide produced 7.4% to 9.2% body weight reduction at 28 weeks in people with type 2 diabetes, compared with about 2% for placebo. HbA1c fell by up to 0.65 percentage points. Gastrointestinal side effects led 1.9% of patients on petrelintide to discontinue, versus 1.7% on placebo.
- Safety
GLP-1 users report more nail disorders, including detachment, in EADV study
A multinational cross-sectional study of 575 GLP-1 receptor agonist users and 1,329 controls, presented at EADV 2026 and dated October 7, 2026, found that 66.3% of users reported at least one nail disorder versus 52.8% of controls. Nail detachment, or onycholysis, had an odds ratio of 6.84, and hair loss was also more common in the GLP-1 group. The cross-sectional design cannot establish that the medications caused these conditions.
- Research and trials
Viking starts oral maintenance dosing study of VK2735 after injectable weight loss
Viking Therapeutics said it began Part 2 of a two-part trial testing whether about 195 adults with obesity can hold onto weight lost with weekly injections of VK2735 by switching to daily or weekly oral tablets, monthly or every-other-week injections, or placebo. All participants first receive weekly subcutaneous VK2735 or placebo for 21 weeks, then move to a maintenance regimen through Week 33, with safety, tolerability and pharmacokinetics as the main objectives. Results are expected in 2027.
- Research and trials
CVS Caremark adds Zepbound back to commercial formularies starting October 1
CVS Caremark began covering Zepbound (tirzepatide) again on its commercial template formularies on Oct. 1, 2026, as an additional preferred option alongside Wegovy (semaglutide). The change was announced May 28, 2026, and applies only to plan sponsors that adopt the template; tiers and copays are set by each sponsor and were not specified.
- Prices
Zepbound returns to CVS Caremark commercial formularies on Oct. 1
CVS Caremark added Zepbound (tirzepatide) back to its commercial formularies as an additional preferred weight-management option, effective Oct. 1, 2026, alongside Wegovy. For eligible commercially covered patients, Zepbound and the newly unblocked oral drug Foundayo are available for as little as $25 a month, while eligible Medicare Part D beneficiaries may pay $50 a month through a federal demonstration that runs through Dec. 31, 2027.
- Research and trials
Survodutide hits 13.1% weight loss in phase 3 diabetes trial as Zealand shares fall
Boehringer Ingelheim and Zealand Pharma reported that survodutide produced up to 13.1% average weight loss at 76 weeks in adults with obesity or overweight and type 2 diabetes, versus 3.1% on placebo, in the Phase 3 SYNCHRONIZE-2 trial. Under a second analysis in the New England Journal of Medicine, weight loss on the 6 mg dose was 9.8% versus 3.9% on placebo. Zealand shares fell as much as 13% in Copenhagen, and survodutide is not approved for any use.
- Prices
Rhode Island Medicaid ends weight-loss GLP-1 coverage on October 1
Rhode Island's enacted fiscal 2027 budget restricts Medicaid coverage of GLP-1 weight-management drugs to type 2 diabetes and other federally required indications starting October 1, 2026. Weight-management coverage, including Zepbound, runs through September 30. Rhode Island is one of 11 state Medicaid programs an independent tracker counted as covering GLP-1s for weight loss as of July 10, 2026.
- Research and trials
Lilly projects lower 10-year diabetes and heart risk with Foundayo in new analysis
Eli Lilly reported post hoc analyses of its ATTAIN-1 obesity trial on Oct. 1, 2026, projecting that Foundayo (orforglipron) cut estimated 10-year type 2 diabetes risk versus placebo by 45%, 50% and 57% at the 5.5 mg, 9 mg and 17.2 mg doses. The 17.2 mg dose was also linked to an estimated 18% reduction in predicted 10-year cardiovascular disease risk. The figures come from risk models using trial data, not from observed diabetes or heart disease outcomes.
- Research and trials
Digital-first tirzepatide program linked to 16.1 kg mean weight loss in UK women
An observational study published in Nature Medicine on October 1, 2026, followed 8,127 women in the UK who began GLP-1 therapy through a structured digital program, with 99.8% using tirzepatide. Mean weight loss was 16.1 kg, or 15.5% of baseline weight, and at six months 83.1% had lost at least 10% and 22.4% had lost at least 20%. Retention was 91.4%, glycated hemoglobin fell by 3.3 mmol/mol, and no serious treatment-related adverse events were reported.
- Research and trials
Novo reports liver fat fell sharply in 55-person Wegovy sub-study
Novo Nordisk said Oct. 1, 2026 that among 55 adults with obesity in its STEP UP trial, average liver fat measured by MRI dropped from 8.8% to 3.1% after 72 weeks on injectable Wegovy (semaglutide) at the pooled 7.2 mg and 2.4 mg doses. Of the 26 participants who started above 5% liver fat, 23 — 88.5% — finished below that mark. Novo described the analysis as post hoc and exploratory.
- Research and trials
Ribupatide shows up to 20.2% weight loss in Phase 2 trial of women with PMOS
Kailera Therapeutics and Jiangsu Hengrui Pharmaceuticals reported that their weekly injectable GLP-1/GIP dual agonist ribupatide produced up to 20.2% weight loss at 32 weeks in women with polyendocrine metabolic ovarian syndrome, compared with 2.6% on placebo. All three ribupatide dose groups also had more frequent menstrual cycles, while the placebo group's cycles became less frequent. No serious adverse events or adverse events leading to discontinuation were reported.
- Competition
Lilly's retatrutide hits Phase 3 goals, with FDA filing planned for early 2027
Eli Lilly reported that its investigational drug retatrutide met the main goal of two Phase 3 trials, with average weight loss of up to 55.8 pounds (22.6%) at 80 weeks in adults with severe obesity and cardiovascular disease, and up to 49.6 pounds (20.8%) in adults with type 2 diabetes. Lilly plans to file for U.S. approval in the first quarter of 2027. Amgen, which is developing the competing drug MariTide, has not reported Phase 3 results or a date for them.
- Research and trials
Lilly says eloralintide-tirzepatide combo beat tirzepatide alone in mid-stage trial
Eli Lilly reported that an experimental combination of eloralintide and tirzepatide produced up to 23.3% average weight loss and a 2.9-point average A1C drop over 48 weeks in adults with obesity or overweight and type 2 diabetes, compared with 14.8% weight loss and a 2.4-point A1C drop for tirzepatide 15 mg alone. Side-effect-related discontinuation rates were higher on the combination, ranging from 10.8% to 27.0%. Lilly plans to start Phase 3 trials of a single-injection version by the end of 2026.
- Research and trials
Wegovy pill tied to extra 8.8 pounds lost after switching from GLP-1 shots, Novo data show
Novo Nordisk presented real-world data on Sept. 30, 2026, showing that 194 adults with obesity or overweight who moved from a weekly GLP-1 injection to the Wegovy pill lost about 4% of their body weight, or roughly 8.8 pounds, over three months. The analysis, called OCTANE, had no control group, so it cannot show whether the switch caused the additional weight loss.
- Research and trials
Novo Nordisk data at EASD 2026 link CagriSema to brain and organ-fat changes
Novo Nordisk presented new CagriSema findings at the EASD 2026 annual meeting on September 30. In a 52-week brain-imaging study, adults with overweight or obesity on CagriSema showed altered brain responses to high-calorie food images and a 22.4% difference in body weight versus placebo. Separate analyses in type 2 diabetes found less fat around the liver and pancreas with a 14.3% body-weight reduction at week 40, and preliminary signs of balanced bone maintenance with a 14.2% reduction at week 68.
- Business
100 percent tariff on patented drug imports takes effect for all remaining importers
The 100 percent Section 232 tariff on imported patented pharmaceuticals and their ingredients took effect on September 29, 2026 for every importer not covered by an earlier deadline. The baseline rate is 100 percent, but companies with approved onshoring plans pay 20 percent, and companies with most-favored-nation pricing deals plus onshoring commitments pay zero through January 20, 2029. Generic drugs and biosimilars are not tariffed.
- Research and trials
Full TRIUMPH-2 data show retatrutide cut weight and A1C in type 2 diabetes
Eli Lilly released the complete Phase 3 TRIUMPH-2 results for its investigational triple-agonist retatrutide in 1,152 adults with type 2 diabetes and obesity or overweight. Over 80 weeks, the highest 12 mg dose produced average weight loss of 20.8%, against 4.0% for placebo, while A1C dropped 1.4 to 1.6 percentage points versus 0.2 points. The drug is not approved, and Lilly says it will seek FDA clearance in early 2027.
- Business
Novo Nordisk licenses weekly oral GLP-1 candidate HRS-1596 from Hengrui in deal worth up to $2.6 billion
Novo Nordisk signed an exclusive license for HRS-1596, a once-weekly oral GLP-1/GIP dual agonist from China's Hengrui Pharma, paying $300 million upfront with up to $2.6 billion more tied to milestones and royalties. The candidate is ready for a first phase 1 trial, which Hengrui is cleared to run in China in weight management and type 2 diabetes. US antitrust review must clear before the deal closes, which the companies target for late 2026.
- Research and trials
Lilly reports orforglipron 17.2 mg beat oral semaglutide 25 mg in an indirect comparison
Eli Lilly presented an indirect comparison on Sept. 29, 2026 finding that its once-daily pill Foundayo (orforglipron) 17.2 mg was associated with 1.5% more weight loss and a 0.3% larger A1C reduction than oral semaglutide 25 mg after 52 weeks in adults with type 2 diabetes. The two drugs were not tested against each other inside a single trial, and the 25 mg oral semaglutide dose is not approved in the United States. A separate Novo Nordisk-funded comparison in adults with obesity reached the opposite conclusion, favoring oral semaglutide 25 mg over orforglipron 36 mg on weight loss and discontinuations.
- Research and trials
Full Phase 2 petrelintide results published as Roche and Zealand begin Phase 3
Zealand Pharma and Roche published the full Phase 2 ZUPREME-1 results for petrelintide, an experimental once-weekly amylin analog for chronic weight management, in The Lancet Diabetes & Endocrinology, with data presented at EASD 2026. At week 28, the 1 mg and 2.5 mg doses produced about 7.9% mean weight loss and the 5 mg dose produced 9.8%, against 1.7% for placebo; the previously reported week-42 figure of up to 10.7% still stands. A global Phase 3 program has begun.
- Safety
Two men charged with smuggling counterfeit Ozempic from China into the US
Federal prosecutors announced charges on Sept. 29, 2026, against two Indian nationals accused of moving counterfeit Ozempic from China into the U.S. supply chain between July 2023 and April 2024. Court documents say one buyer, Assure Global LLC, ordered about 125,000 doses for a reported $18.8 million. Each man faces up to 71 years in prison if convicted.
- Research and trials
Lilly analysis links Zepbound to more weight loss than Wegovy HD in indirect comparison
Eli Lilly presented an indirect comparison at the EASD meeting in Milan showing Zepbound (tirzepatide) 15 mg was associated with 4.5% more body weight loss and the 10 mg dose with 3.2% more than Wegovy HD (semaglutide 7.2 mg) at 72 weeks. The analysis pooled data from the SURMOUNT-1 and STEP UP trials rather than randomly assigning patients, and the differences were smaller and not statistically significant under a second measure that counts only time on treatment.
- Research and trials
Novo-funded analysis links Ozempic 2 mg to lower cardiovascular risk than switching to Mounjaro
In a Novo Nordisk-sponsored retrospective analysis of U.S. claims data, adults with type 2 diabetes on semaglutide (Ozempic) 1 mg who escalated to 2 mg had a 6% lower risk of major cardiovascular events than those who switched to tirzepatide (Mounjaro). The analysis covered 636,525 adults and reported an adjusted hazard ratio of 1.06 (95% CI 1.04-1.08; P=0.005). It was presented September 29, 2026, at EASD 2026 and is not a randomized head-to-head trial.
- Research and trials
Lilly details ACHIEVE-4 cardiovascular data for Foundayo at EASD 2026
Eli Lilly presented the fuller ACHIEVE-4 dataset for its oral GLP-1 pill Foundayo (orforglipron) at the EASD 2026 meeting in Milan, elaborating on topline results first reported in April. In the trial of 2,749 adults with type 2 diabetes, Foundayo was non-inferior to insulin glargine on MACE-4 events, with a 16% lower risk, and showed a 23% lower risk of MACE-3 events. A1C and body weight improvements also favored Foundayo, and a pre-planned analysis found a 57% lower risk of all-cause death that was not adjusted for multiple comparisons.
- Regulation
FDA approves Lilly's once-weekly insulin Onswik for type 2 diabetes
The FDA approved Onswik (insulin efsitora alfa-gobe) on Sept. 24, 2026, a once-weekly basal insulin for adults with type 2 diabetes. It is the second once-weekly insulin cleared in the U.S. after Novo Nordisk's Awiqli, and Lilly says it is designed to cut more than 300 injections a year compared with daily basal insulin. In trials of over 3,400 adults, it lowered A1C about as much as once-daily insulin glargine or degludec.
- Regulation
Mylan sues Novo Nordisk over proposed generic Wegovy
Mylan Pharmaceuticals filed suit in Delaware federal court on September 24, 2026, asking for a ruling that its proposed generic version of Novo Nordisk's Wegovy does not infringe a Novo patent. The filing adds another case to a patent fight that dates to January 2023, when Novo sued Mylan's parent Viatris over its generic semaglutide application. Novo has accused Mylan of infringing five of its patents, and a July 2025 decision covered only one of them.
- Business
Novo Nordisk licenses Nanexa drug-delivery technology in deal worth up to $1.33 billion
Sweden's Nanexa AB said it signed a global licensing agreement giving Novo Nordisk exclusive rights to its PharmaShell delivery technology in up to five development programs for obesity, type 2 diabetes and other cardiometabolic conditions. The deal is worth as much as €1.165 billion ($1.3 billion), including an upfront payment of around $700 million, milestone payments and low single-digit royalties on future sales. Nanexa shares jumped more than 150% at the Stockholm open before settling to a gain of around 114%.
- Research and trials
Viking says VK2735 held most weight loss when dosing became less frequent
Viking Therapeutics reported topline results from a Phase 2 study of about 180 adults with obesity: after 21 weeks of weekly VK2735 injections, weight loss ranged from roughly 16% to 19%, compared with about 0% for placebo. When participants switched to less frequent maintenance dosing for 12 more weeks, every-other-week dosing retained up to 97% of that loss and monthly dosing retained up to 90%, compared with 61% for placebo. VK2735 is experimental and not an approved medicine.
- Research and trials
Roche says enicepatide lowered blood sugar and weight in Phase 2 diabetes trial
Roche and Genentech reported that the once-weekly injectable enicepatide met both primary endpoints in a 447-person Phase 2 trial of adults with type 2 diabetes and overweight or obesity. At the highest 24 mg dose, HbA1c fell an average of 2.65 percentage points and body weight fell 15.5% at 48 weeks, with 62% of patients reaching normal blood sugar. Roche did not release placebo-arm results, and the drug is not approved for any use.
- Research and trials
Lilly presents first public brenipatide data as Phase 3 trials target depression and alcohol use disorder
Eli Lilly presented early Phase 1 data on brenipatide, an investigational dual GIP/GLP-1 receptor agonist, at Psych Congress 2026 in New Orleans, the first time the company has spoken publicly about the drug at a conference. The candidate is already in Phase 3 trials for alcohol use disorder and major depressive disorder, with topline results expected in early 2028. In the Phase 1 study of 212 people, 57.6% of brenipatide-treated participants reported treatment-emergent adverse events versus 42.9% on placebo, while GI-related side effects occurred in 25% of both groups.
- Research and trials
Novo Nordisk says CagriSema beat lower-dose tirzepatide on weight loss in Phase 3 trial
Novo Nordisk reported that its investigational drug CagriSema 1.0 mg/1.0 mg produced 12.4% weight loss at week 60 in adults with type 2 diabetes, compared with 9.1% for tirzepatide 5 mg, meeting the trial's superiority goal for weight. Blood sugar reductions were similar between the two groups. A second trial in adults with overweight or obesity showed 21.0% weight loss on CagriSema versus 2.0% on placebo at week 68.
- Business
Novo Nordisk sets Capital Markets Day for September 21 in London
Novo Nordisk will hold its Capital Markets Day on 21 September 2026 in London from 09:00 to 15:30 BST, the company says, with Executive Management presenting on strategy, the R&D pipeline, business operations and performance. The sessions will be webcast live and available on demand. Novo Nordisk has not said which pipeline programs will be presented or whether financial targets will be updated.
- Research and trials
Novo Nordisk says CagriSema produced 21% weight loss in REDEFINE 9 trial
Novo Nordisk reported that CagriSema 1.0 mg/1.0 mg produced an average 21.0% weight loss at week 68 in about 300 adults with overweight or obesity, versus 2.0% for placebo, meeting the Phase 3 REDEFINE 9 primary endpoint. In a separate Phase 3 trial, REIMAGINE 5, the same dose beat tirzepatide 5 mg on weight loss in adults with type 2 diabetes. CagriSema is not approved; the FDA is expected to decide on Novo's application in late 2026.
- Business
Lilly says a third of new oral GLP-1 patients start on Foundayo as it breaks ground on Houston plant
Eli Lilly CEO Dave Ricks said Sept. 21, 2026, that about one-third of patients newly starting an oral GLP-1 in the US are beginning on the company's Foundayo (orforglipron), up from near one in four in early August. He also said roughly 700,000 seniors have started GLP-1 treatment for obesity since Medicare coverage began July 1, with about 70% of them on Lilly medicines. Lilly broke ground that day on a $6.5 billion Houston plant to make the pill's active ingredient, expected to be operating by 2030.
- Policy
Lilly CEO says 700,000 seniors have started GLP-1s under Medicare Bridge
Eli Lilly CEO David Ricks said about 700,000 Medicare beneficiaries have started GLP-1 treatment for obesity since Medicare's Bridge coverage began on July 1, 2026, and that roughly 7 in 10 of them are taking a Lilly medicine. The count is the first specific enrollment figure reported for the program; the Centers for Medicare & Medicaid Services has not published its own number.
- Business
Novo Nordisk sets $23 billion 2035 pipeline sales target and plans 10-fold oral scale-up
At a Capital Markets Day in London on Sept. 21, Novo Nordisk said it aims to launch more than five multi-blockbuster drugs by 2030 and generate more than $23 billion in annual pipeline sales by 2035, ahead of semaglutide patent expiries. The company said it will scale oral manufacturing to serve 10 times more patients, targeting 15 million people on oral obesity treatments by 2030. Shares fell, and analysts noted Novo's projected 3.53% growth rate fell short of the roughly 3.65% investors expected.
- Compounding
FDA faults Empower Pharmacy's Houston site and questions its compounded tirzepatide and semaglutide
The FDA sent Empower Clinic Services, which does business as Empower Pharmacy, a warning letter dated September 18, 2026, saying sterile drugs at its Houston site were prepared, packed or held under insanitary conditions and that its compounded tirzepatide and semaglutide appear to be essentially copies of FDA-approved products. The letter follows a November 2025 inspection and says the production volume makes differences from the approved drugs look "pretextual." Order counts for those products are redacted in the public copy of the letter.
- Regulation
Health Canada approves Sandoz generic semaglutide, the third copy of Ozempic cleared in Canada
Sandoz Canada said Sept. 18, 2026 that Health Canada authorized its generic semaglutide injection for adults with type 2 diabetes, covering three doses in two pen types. It is the third generic semaglutide cleared in Canada, after products from Dr. Reddy's and Apotex, and Sandoz has not disclosed a launch date or price.
- Business
Novo signs deal worth up to $1.4 billion with Orbis for oral macrocycle drugs
Novo Nordisk agreed on September 17, 2026, to work with Danish biotech Orbis Medicines on oral macrocycle drugs for heart and metabolic diseases, in a deal worth up to $1.4 billion in upfront and milestone payments plus royalties. Novo will also make a strategic investment in Orbis. The companies did not disclose how many drug programs the partnership covers or which targets it will pursue.
- Research and trials
Lilly and Novo Nordisk name GLP-1 and amylin drugs getting data at EASD 2026
Eli Lilly said it will present new data on Foundayo (orforglipron), retatrutide and eloraTZP at the EASD 2026 meeting, while Novo Nordisk said it will present 44 abstracts covering semaglutide, CagriSema and zenagamtide at the conference, which runs September 28 to October 2 in Milan. Lilly's release cites previously reported results, including up to 20.8% average weight loss with retatrutide at 80 weeks in TRIUMPH-2 and a 16% lower risk of MACE-4 events with Foundayo versus insulin glargine in ACHIEVE-4. Novo's release did not include efficacy figures for the new analyses it described.
- Prices
Starbucks to drop GLP-1 coverage for weight loss as employers trim benefits
Starbucks will stop covering GLP-1 drugs for weight loss starting in October 2026, joining PepsiCo, Cigna and other large employers that have cut or limited the benefit. Marsh's annual survey projects employer health benefit costs per employee will rise 8.2% on average in 2027, the largest increase since 2003, and Business Group on Health data show employer coverage of GLP-1s for obesity fell from 72% in 2025 to 60% in 2026.
- Business
Novo Nordisk says new strategy targets come Sept 21, not at Sept 15 staff meeting
Novo Nordisk has confirmed it expects to introduce new Strategic Aspirations at a Capital Markets Day on Sept 21, 2026, and that a Sept 15 internal employee townhall about the company's "next chapter" is a separate event held ahead of it. As of mid-September, the company had not disclosed the new strategy, financial targets or any fresh obesity-market commitments. The current strategy, introduced in 2019 and ending this year, produced 2025 sales of DKK 309.1 billion and obesity care sales of DKK 82.3 billion.
- Safety
Judge Marston opens Rule 702 hearing in Ozempic and GLP-1 stomach injury lawsuits
A federal judge in Philadelphia opened a five-day hearing on September 14, 2026, to decide whether the experts who say GLP-1 medications can cause lasting stomach injuries may testify. Defense lawyers are seeking to exclude eight of the plaintiffs' experts in MDL 3094, which covers about 3,848 pending cases. No ruling has been issued, and there is no deadline for one.
- Safety
Australia's drug regulator says a vial sold as retatrutide contained eight times the usual semaglutide dose
Australia's Therapeutic Goods Administration says laboratory testing of a vial sold as the experimental drug retatrutide found no retatrutide, only semaglutide at roughly eight times the strength of approved semaglutide products. The person who injected it vomited continuously, tore an esophagus and needed hospital care. The agency has not found where the vial came from.
- Safety
Court weighs expert testimony in GLP-1 stomach injury lawsuits
A federal judge in Philadelphia is set to hear arguments the week of September 14, 2026, on whether plaintiffs' scientific experts can testify in the GLP-1 stomach-injury lawsuits consolidated as MDL 3094. The MDL counted 3,928 pending cases as of an August 2026 report, with no settlements, no verdicts and no trial date.
- Research and trials
Milan diabetes meeting to feature mid-stage obesity drug data from Lilly, Roche and AstraZeneca
The 62nd annual meeting of the European Association for the Study of Diabetes runs Sept. 28 to Oct. 2 at the Milan Convention Centre, with the scientific program starting Sept. 29. Scheduled obesity and incretin presentations include Eli Lilly's eloralintide plus tirzepatide Phase 2 data and TRIUMPH-2 retatrutide results on Sept. 30, and Boehringer Ingelheim's survodutide SYNCHRONIZE-2 results on Oct. 1. AstraZeneca's AZD6234 amylin data and Roche's Pharma Day on Sept. 28 fall in the same window.
- Business
Generic liraglutide cash prices undercut weekly GLP-1 brands by as much as elevenfold
GoodRx cash listings on Sept. 14, 2026 put generic liraglutide at $112.19 for a two-pen diabetes carton and $372.45 for a five-pen weight-management carton, against chart listings above $1,200 for Ozempic and Mounjaro. The gap works out to roughly elevenfold for the smaller diabetes carton and about threefold for the weight-management carton.
- Research and trials
Zepbound label revised in August 2026 lays out starting, maintenance and maximum doses
The Zepbound prescribing information, revised 08/2026, gives one starting dose of 2.5 mg once weekly for four weeks, then maintenance doses of 5, 10 or 15 mg weekly for weight reduction and 10 or 15 mg for obstructive sleep apnea, with 15 mg the maximum. It lists four presentations, including a multi-dose vial and a single-patient-use KwikPen that each hold four doses of a single strength.
- Business
Novo Nordisk adopts 'Novo' name and a new culture framework before investor day
Novo Nordisk said on September 14, 2026 that it will use "Novo" as its name in day-to-day business and introduced the tagline "Lasting Health Starts Now" plus a four-part culture framework called "The Novo Way". The legal global name stays Novo Nordisk A/S, and the Apis bull logo remains in an updated form. Its Capital Markets Day, where the updated corporate strategy will be laid out in detail, is set for September 21, 2026, in London.
- Competition
Roche to report Phase 2 enicepatide data in obesity with type 2 diabetes at Sept. 28 Pharma Day
Roche is expected to release Phase 2 results for its experimental obesity drug enicepatide in people who have both obesity and type 2 diabetes, with the study carrying a Sept. 24 completion date and a company Pharma Day set for Sept. 28. A separate Phase 2 study of the same drug in people with obesity alone produced 22.5% placebo-adjusted weight loss at 48 weeks, with no sign of a plateau. Roche has said it wants to become a "top three player" in obesity but has no approved obesity medicine.
- Prices
Semaglutide cash prices settle between $149 and $499 a month as list prices stay above $1,000
As of mid-September 2026, branded semaglutide sold for cash ranges from $149 a month for the Wegovy or Ozempic pill to $499 a month for Ozempic 2 mg. Pens cost $199 a month for new patients for two fills, then $349. List prices listed by the federal TrumpRx site remain $1,349 for Wegovy and $1,028 for Ozempic.
- Competition
Sixteen obesity challengers sit in Phase 3 as Lilly and Novo keep the market into 2027
Sixteen experimental obesity treatments from companies other than Eli Lilly and Novo Nordisk are in Phase 3 testing, and none is scheduled to report results before 2027. The nearest exception is Amgen's MariTide, with primary completion dates in January 2027, while most other programs cluster in 2028. The branded market is expected to stay a two-company market through 2027.
- Science
FDA approves Scholar Rock's apitegromab for SMA as muscle-preservation race widens
The FDA approved Scholar Rock's apitegromab, sold as Isembyld, on September 11, 2026, for spinal muscular atrophy in patients already treated with existing therapies. It is the first approved drug that selectively blocks myostatin activation, a mechanism also being tested by several companies to limit lean-mass loss during GLP-1 weight loss, though no such combination is approved for that use.
- Prices
Aetna adds Zepbound to a standard formulary effective October 1, 2026
Aetna's formulary update document lists Zepbound (tirzepatide) as an addition to its Standard Control Formulary Choice in the Endocrine and Metabolic, Antiobesity class effective October 1, 2026, and moves Foundayo (orforglipron) from non-preferred to preferred in the same class. The posting follows CVS Caremark's May 28, 2026 announcement that it would add Zepbound back to its commercial formularies on October 1, 2026 and remove the new-to-market block on Foundayo as of June 1, 2026.
- Research and trials
Amgen's MariTide Phase 3 readouts move to early 2027
Amgen's MariTide will not report Phase 3 results in 2026. The primary readout for the MARITIME-1 obesity trial is guided to early 2027, and MARITIME-1 and MARITIME-2 both list primary completion dates of January 21, 2027. In Phase 2, MariTide produced up to about 20% average weight loss at 52 weeks on the efficacy estimand and 12.3% to 16.2% on the treatment-policy estimand.
- Research and trials
AstraZeneca to present AZD6234 data this fall as elecoglipron enters Phase 3
AstraZeneca is expected to present Phase 2 data for its amylin drug AZD6234 at the European Association for the Study of Diabetes meeting on Sept. 28 to Oct. 2, and analysts also expect results by the end of 2026 from a Phase 2 add-on trial in people on stable GLP-1 therapy and from the Phase 2b ASCEND study of AZD9550 plus AZD6234. The company has moved its oral GLP-1 elecoglipron into Phase 3 testing in obesity and type 2 diabetes, with William Blair expecting those readouts in 2027 or 2028. Detailed Phase 2 numbers for AZD6234 have not been released.
- Compounding
Compounded semaglutide and tirzepatide prices stay below brand self-pay in September index
A price index covering 14 telehealth providers recorded a median first-month price of $197 for compounded semaglutide and $299 for compounded tirzepatide as of September 3, 2026. Brand self-pay prices for the same period run $199 to $349 for the Wegovy pen and $299 to $449 for Zepbound before any membership fee. The gap persists even though the FDA resolved the semaglutide and tirzepatide shortages that compounded pharmacies had relied on.
- Regulation
China's semaglutide generics stay suspended under data exclusivity rules
China's core semaglutide patent has expired, but generic approvals from Hangzhou Jiuyuan Gene Engineering, Livzon Pharmaceutical Group and The United Laboratories are suspended rather than rejected. Regulators are working through a data exclusivity period tied to the China-Switzerland free trade agreement. Jiuyuan's generic Wegovy candidate, Jikeqin, was accepted for review on 25 February 2026.
- Business
Chinese obesity licensing leads 2026 deal table as Menarini licenses bofanglutide
AstraZeneca's collaboration with China's CSPC leads 2026 licensing at up to $18.5 billion with $1.2 billion up front, ahead of Bristol Myers Squibb with Hengrui at up to $15.2 billion and Pfizer with Innovent at up to $10.5 billion. In September, Italy's Menarini Group licensed European rights to Gan & Lee's once-every-two-weeks GLP-1 drug bofanglutide for EUR 62 million up front. More than 100 China-origin licensing deals have been signed with US or European companies since the start of 2025.
- Policy
CMS has not yet published 2027 Medicare Advantage and Part D plan details
CMS has finalized 2027 Medicare Advantage and Part D rules and payment policies but has not released the finalized plan landscape, average premiums or county-level plan details. The agency says those files will arrive in mid-to-late September 2026, ahead of annual enrollment from October 15 to December 7, 2026. The 2027 Part D out-of-pocket threshold is $2,400, and the standard-benefit deductible ceiling is $700.
- Research and trials
Corbus reports 5 percent weight loss for oral CB1 pill CRB-913 in Phase 1b trial
Corbus Pharmaceuticals said its once-daily oral pill CRB-913 produced a mean 5.0 percent weight loss at 12 weeks at the 60 mg dose, compared with 0.0 percent for placebo, in a Phase 1b obesity trial called CANYON-1. The drug is a peripherally restricted CB1 inverse agonist, a different mechanism from GLP-1 medicines, and 44.4 percent of participants who completed the 60 mg group lost at least 5 percent of their body weight.
- Prices
Dr. Reddy's launches generic semaglutide Obeda in India as prices tumble
Dr. Reddy's Laboratories launched Obeda, a generic injectable semaglutide for type 2 diabetes, in India at about ₹4,200 a month. It entered on the day semaglutide patent protections expired, alongside generics from more than a dozen other Indian companies, with some prices as low as ₹1,290 a month. Innovator product prices in India were roughly ₹8,800 to ₹10,850 a month.
- Regulation
Mazdutide remains China-only as Eli Lilly publishes a 179-person US phase 2 trial
Mazdutide is approved in China for chronic weight management and type 2 diabetes but is not approved or under FDA review in the United States. Eli Lilly published a 179-participant US phase 2 trial on August 21, 2026, showing 32-week weight loss of up to 18.1% at the 16 mg dose, with 20% of that group stopping for side effects. No US phase 3 program or FDA filing has been announced.
- Competition
Pfizer's obesity effort centers on monthly GLP-1 berobenatide with 2028 approval target
Pfizer's obesity program now centers on berobenatide, an ultra-long-acting GLP-1 designed for monthly injection that the company says could be the first monthly GLP-1 peptide approved for obesity. On its second-quarter 2026 earnings call, Pfizer said it expects to advance 10 Phase 3 studies this year and is targeting a first approval in 2028. Late-stage weight-loss results for the drug have not been reported.
- Research and trials
Survodutide heads to EASD 2026 with no US filing date disclosed
Boehringer Ingelheim is taking survodutide to the EASD 2026 congress in Milan without having disclosed a US filing date or expected launch, about four and a half months after the drug posted up to 16.6% average weight loss at 76 weeks in the Phase 3 SYNCHRONIZE-1 trial. Primary results from SYNCHRONIZE-2, which tested the drug in adults with type 2 diabetes, are scheduled for Oct. 1. Survodutide is a glucagon/GLP-1 dual agonist given as a weekly injection and has not been approved for any use.
- Research and trials
Viking guides VK2735 maintenance-dosing data to the third quarter of 2026
Viking Therapeutics expects data in the third quarter of 2026 from a Phase 1 study testing whether its experimental obesity drug VK2735 can hold weight loss with monthly injections or oral dosing after weekly treatment. Earlier trials showed up to 14.7% weight loss at 13 weeks for the subcutaneous form and up to 12.2% for the oral form. Viking ended the second quarter of 2026 with $502 million in cash, and the first Phase 3 readout, VANQUISH-1, is expected in late 2027.
- Culture
Penn AI study of 400,000 Reddit posts on Ozempic and other GLP-1s flags overlooked symptoms
A University of Pennsylvania study used artificial intelligence to analyze about 400,000 Reddit posts from nearly 70,000 users discussing GLP-1 drugs including Ozempic, Wegovy, Mounjaro and Zepbound. It surfaced menstrual changes, chills and hot flashes, and fatigue as patterns that appear less often in clinical trial safety data. The work shows associations, not causes, and researchers describe the patterns as leads for further study.
- Business
Analysts project $30 billion in retatrutide revenue by 2031 as Lilly plans early 2027 filing
Clarivate projections circulated in September 2026 estimate that retatrutide, Eli Lilly's experimental triple-hormone drug, could reach about $30 billion in annual revenue by 2031, split roughly $10 billion in obesity and $20 billion in diabetes. Lilly plans to file a Biologics License Application in the first quarter of 2027, with a 2028 launch window. The same analysis puts orforglipron, sold as Foundayo, at about $16 billion by 2031, and Lilly's capital spending reached $9.9 billion over the trailing twelve months, largely to build the manufacturing capacity those forecasts assume.
- Business
Citi raises Eli Lilly price target to $1,600 as weight-loss drug shares slide
Citi analyst Geoff Meacham raised his 12-month price target on Eli Lilly to $1,600 from $1,500 on September 14, 2026, keeping a Buy rating. The move followed an 8.44% drop in Lilly shares over the prior month, while the average Wall Street target sits at $1,318.66. Citi's bull case rests on tirzepatide's U.S. prescription share, Foundayo's prescriber growth and a planned retatrutide filing in early 2027.
- Business
Novo Nordisk CEO says obesity drug market will not have a single winner
Novo Nordisk chief executive Mike Doustdar said in an August 2026 Reuters interview and a September 7 Yahoo Finance interview that the obesity drug market will not go to one winner, because growth comes from treating more patients and from new pill forms rather than from taking share. Novo reported a 59.6% volume share of the global branded GLP-1 obesity market in its 2025 annual report, while in the US Zepbound has passed injectable Wegovy in weekly prescriptions. Novo's second-quarter 2026 update said the broader Wegovy franchise, including the pill, led branded obesity medicines in new patient starts.
- Science
Eli Lilly's eloralintide moves into Phase 3 alone and with tirzepatide
Eli Lilly's experimental amylin drug eloralintide is now in Phase 3 testing, both on its own and combined with tirzepatide. Its Phase 2 trial showed weight loss of up to 20 percent at the 9 mg dose, but nausea reached 64 percent in the highest-nausea dosing arm. Competing amylin programs from Novo Nordisk, Zealand Pharma and Roche are running on overlapping timelines.
- Business
Kailera shares sit near April IPO price as key obesity drug data stay years away
Kailera Therapeutics closed at $16.21 on August 28, 2026, down 12.5% and only 1.3% above its $16 IPO price, after closing at $18.51 ten days earlier. The company holds $1.172 billion in cash and marketable securities, which management says funds operations into mid-2028, while the first global Phase 3 results for its lead obesity drug ribupatide are not expected until 2028.
- Research and trials
Corbus reports 5% weight loss at 12 weeks for oral CRB-913, with full data due at ObesityWeek
Corbus Pharmaceuticals said Sept. 14, 2026 that CRB-913, an experimental once-daily oral obesity drug that is not a GLP-1, produced a mean 5% weight loss at 12 weeks at its highest dose in a Phase 1b trial of 254 adults. The company reported gastrointestinal side effects below published rates for oral semaglutide and orforglipron, though those comparisons come from separate trials, not head-to-head studies. Full CANYON-1 results are set for a late-breaking presentation at ObesityWeek 2026, Nov. 14–17.
- Culture
Zepbound and Mounjaro subreddits pass 233,000 and 204,000 members
The Reddit communities r/Zepbound and r/Mounjaro passed 233,000 and 204,000 members, respectively, on September 14, 2026. The two forums for the tirzepatide brands are now the largest peer-support spaces for the drug in the United States, with their own vocabulary of Zepaversaries, Onederland and forced switches.
- Compounding
U.S. News rates 20 GLP-1 telehealth platforms, leaving out compounded-only sellers
U.S. News & World Report released its first ratings of GLP-1 telehealth platforms on Aug. 12, scoring 20 providers that offer FDA-approved brand-name medications and excluding companies that sell only compounded versions. Amazon One Medical scored highest at 4.8, followed by Found at 4.6, Mochi Health and Ro at 4.4, and Noom at 4.3. Forbes Health's separate ranking, verified Sept. 14, lists Mochi Health and Remedy Meds among platforms that also offer compounded GLP-1s.
- Business
Eli Lilly set to face investors on Foundayo pricing and pipeline at Morgan Stanley conference
Eli Lilly was scheduled to address Morgan Stanley's 24th Annual Global Healthcare Conference in New York on Sept. 14, 2026, four days after starting private sales of its oral GLP-1 pill Foundayo (orforglipron) in the United Kingdom. Reuters has reported the company committed in November to offering Medicare beneficiaries Zepbound and orforglipron for no more than $50 a month, while Foundayo is listed at $149 a month and Zepbound at $299 a month through LillyDirect.
- Prices
Generic semaglutide lifts Canadian pharmacy volumes as prices fall
Canadian grocery chains say generic semaglutide is driving higher prescription volumes through their pharmacy units, with Loblaw reporting roughly 40 percent GLP-1 sales growth in each of its last two quarters. Metro's pharmacy same-store sales rose 4.8 percent even as generic price deflation pushed dollar sales down. Health Canada has approved three generic semaglutide products, making Canada the first G7 country to authorize them.
- Science
Swedish study links semaglutide and other GLP-1 drugs to fewer psychiatric hospitalizations in bipolar disorder
A nationwide Swedish study of nearly 15,000 people with bipolar disorder found significantly lower rates of psychiatric hospitalization during periods when they were taking GLP-1 medicines than during periods when they were not. The analysis is observational, and no GLP-1 medicine is approved for psychiatric conditions.
- Prices
Novo Nordisk cuts Ozempic price for uninsured Canadians as Apotex ships generic semaglutide
Novo Nordisk cut Ozempic's price for uninsured Canadians through a savings card as Apotex began shipping generic semaglutide and Dr. Reddy's expanded distribution, as reported September 13, 2026. Three of nine generic semaglutide products filed in Canada have been approved by Health Canada. Novo Nordisk has projected a 5% to 13% revenue decline for 2026.
- Competition
Novo's Wegovy pill keeps roughly four-to-one lead over Lilly's Foundayo in weekly prescriptions
In the latest reporting week, Novo Nordisk's Wegovy pill recorded about 183,000 U.S. prescriptions while Eli Lilly's Foundayo recorded 47,500, according to IQVIA data cited by Citi. Foundayo grew nearly 8% from the week before off a much smaller base, and Novo calls its pill the strongest U.S. GLP-1 volume launch to date.
- Safety
Ukraine charges 27 people over falsified tirzepatide drug sold as Biopatid
Prosecutors in Ukraine's Dnipropetrovsk region and the Security Service of Ukraine served notices of suspicion on 27 people over an organized ring that made and sold a falsified weight-loss drug called "Biopatid" containing tirzepatide, the molecule sold in the US as Mounjaro and Zepbound. Officials said more than 250 searches turned up underground lab equipment, packaging and about 15 million hryvnias in cash, and that products worth over $5 million were made this year.
- Culture
Large review finds no bone or joint effect from GLP-1 drugs, but lean mass falls
A meta-analysis in the journal Drugs pooled 60 studies covering 1,250,717 people and found no effect of GLP-1 receptor agonists on bone mineral density or fractures and no significant change in joint pain, function or stiffness. The same analysis found a consistent reduction in lean body mass and fat-free mass, but rated the certainty of that evidence as low and said the changes appeared largely related to weight loss.
- Research and trials
Review of 1.25 million people finds lean mass loss with GLP-1 drugs, no bone signal
A systematic review and meta-analysis published in the journal Drugs pooled 60 studies covering 1,250,717 people and found that GLP-1 receptor agonists consistently reduced lean body mass, with a standardized mean difference of −0.52. The same analysis found no effect on bone mineral density or fractures at any site. The authors rated the muscle evidence as low certainty and noted that almost no included study measured muscle strength or physical performance.
- Research and trials
Large analysis links GLP-1 drugs to lean mass loss but finds no bone effect
A systematic review and meta-analysis in the journal Drugs pooled 60 studies and 1,250,717 people and found no effect of GLP-1 receptor agonists on bone mineral density, fractures or osteoarthritis measures. It did find a consistent drop in lean body mass and fat-free mass, driven mainly by liraglutide and semaglutide, at low certainty of evidence.
- Culture
Penn AI study of 400,000 Reddit posts flags menstrual and temperature reports among GLP-1 users
University of Pennsylvania researchers used artificial intelligence to analyze more than 400,000 Reddit posts from nearly 70,000 users of semaglutide and tirzepatide, in a study published in Nature Health. About 44% of users described at least one side effect, with gastrointestinal problems most common, and nearly 4% of those reporting side effects described menstrual changes. The study cannot show the drugs caused any of the symptoms.
- Regulation
FDA has sent 32 warning letters on GLP-1 drugs and peptides since December 2024
A register of FDA warning letters involving GLP-1 medicines and research peptides counts 32 since December 2024, counted on 12 September 2026. Seventeen went to telehealth or compounding businesses, 12 to research-peptide sellers, and three to the companies that make the approved GLP-1 drugs. The five letters dated 24 August 2026 charge unapproved new drug violations rather than misleading promotion.
- Business
Hims & Hers margin squeeze a year after FDA removed semaglutide from shortage list
Hims & Hers reported second-quarter 2026 revenue of $753.2 million, up 38% from a year earlier, while gross margin fell to 64% from 76% and adjusted EBITDA margin slipped to 8% from 15%. The company raised full-year 2026 revenue guidance to $3.2 billion but cut its adjusted EBITDA forecast to $275 million to $325 million, and management still says it expects a return to net profitability in 2027.
- Research and trials
New reviews link semaglutide and liraglutide to psoriasis improvements
A narrative review in Frontiers in Immunology and a National Psoriasis Foundation primer in JAMA Dermatology both conclude that GLP-1 receptor agonists may reduce psoriasis severity in people who also have obesity or type 2 diabetes. Reported PASI reductions range from about 40% to 80%, but the primer says three randomized trials had conflicting results, including a placebo-controlled liraglutide trial that found no significant skin improvement.
- Regulation
FDA approves Isembyld, first muscle-targeted drug for spinal muscular atrophy
The FDA approved Scholar Rock's Isembyld (apitegromab-mstn) on September 11, 2026, for spinal muscular atrophy in adults and children aged 2 and older already receiving an SMN2-targeted treatment. In the Phase 3 SAPPHIRE trial, patients on Isembyld improved 2.2 points on a standard motor function scale versus placebo, and 34.2% gained at least 3 points compared with 13.5% on placebo. Scholar Rock shares rose more than 23% in after-market trading, and one analyst forecasts $2.1 billion in adjusted worldwide peak sales by 2035.
- Competition
Tirzepatide reaches nearly 57% of US GLP-1 prescriptions as oral drugs lift the market
IQVIA data cited by Citi show Eli Lilly's tirzepatide holding nearly 57% of total U.S. GLP-1 prescriptions, up from about 49.5% a year earlier, while Novo Nordisk's semaglutide stayed roughly flat at 37%. Total GLP-1 prescriptions grew 5.4% over four weeks, compared with a 6.8% decline a year earlier, a swing Citi attributed to the spread of oral GLP-1 drugs.
- Safety
Study links rare Wernicke encephalopathy cases to semaglutide and tirzepatide
Israeli researchers who reviewed 195,979 adverse event reports identified 15 cases of Wernicke encephalopathy, a brain disorder caused by severe vitamin B1 deficiency, and found it disproportionately associated with GLP-1 drugs. Most cases involved semaglutide (Ozempic, Wegovy, Rybelsus) or tirzepatide (Mounjaro, Zepbound). Only two of the 15 patients showed the classic diagnostic triad, and most had gastrointestinal problems, vomiting, appetite loss or malnutrition.
- Policy
Novo Nordisk and Eli Lilly hold tariff relief through 2029 under pricing deals, review finds
A review of trade filings and company disclosures found that drugmakers covering 89 percent of branded pharmaceuticals have most-favored-nation pricing agreements with the White House, and that nearly all of them also hold arrangements exempting their imports from Section 232 tariffs through Jan. 20, 2029. The relief covers Novo Nordisk and Eli Lilly, the two main makers of GLP-1 weight-loss and diabetes drugs, and leaves four of the 26 companies with pricing deals whose tariff treatment is not established in public disclosures.
- Prices
Medicare GLP-1 Bridge has saved $216 million, AARP tells members
AARP's weekly member briefing for the week of September 11, 2026 led with savings from the Medicare GLP-1 Bridge program. According to White House figures cited in the briefing, the program has saved about $216 million since July, with more than 500,000 enrollees paying $50 a month for drugs including Wegovy, Foundayo and Zepbound. KFF estimates the program's expanded access could affect about 3.8 million people who do not qualify for a GLP-1 under Part D.
- Business
Morgan Stanley downgrades Novo Nordisk over semaglutide patent cliff
Morgan Stanley cut Novo Nordisk to Underweight on September 11, 2026, citing slower mid-term growth and the coming loss of exclusivity for semaglutide, which the analysts said accounted for 75% of the company's 2026 sales. The bank kept a 250 Danish crown price target, implying more than 10% downside, and Novo shares fell 2.6% in early Copenhagen trading.
- Science
FDA approves Isembyld, the first myostatin inhibitor, for spinal muscular atrophy
The FDA approved Scholar Rock's Isembyld (apitegromab-mstn) on Sept. 11, 2026, for adults and children 2 and older with spinal muscular atrophy who are already receiving an SMN2-targeted treatment. It is the first muscle-targeted SMA therapy and the first myostatin inhibitor ever cleared in the United States. In the Phase 3 SAPPHIRE trial, treated patients improved by 2.2 points on the HFMSE motor scale after one year while those on placebo declined.
- Policy
Most states decline Novo Nordisk Medicaid pricing deal as coverage shrinks
Twenty-nine state Medicaid programs have told POLITICO they will not participate in the Trump administration's model for discounted GLP-1 prices, and only Indiana has publicly signed on. States are offered $245 per monthly dose of Novo Nordisk's Wegovy under the model, of which Indiana has said it will pay $85.16. Medicaid spending on GLP-1 drugs grew from $1 billion in 2019 to almost $9 billion in 2024, and five states ended weight-loss coverage over the past year.
- Competition
Wegovy pill and Foundayo both set weekly prescription highs, with Novo still ahead
Novo Nordisk's Wegovy pill and Eli Lilly's Foundayo each logged their highest weekly prescription totals so far in the latest tracking period, according to IQVIA data cited by Citi. The Wegovy pill reached about 183,000 total prescriptions, up from 181,000 the week before, while Foundayo rose nearly 8% to 47,500. Novo's oral semaglutide continues to hold the lead it built during a roughly three-month head start on the market.
- Competition
Wegovy pill and Foundayo both set weekly prescription records
Novo Nordisk's Wegovy pill reached about 183,000 weekly prescriptions and Eli Lilly's Foundayo rose nearly 8% to about 47,500, both the highest totals since their launches, according to IQVIA data cited by Citi. Over the last four weeks, total GLP-1 prescriptions rose 5.4%, swinging from a 6.8% decline a year earlier, a change Citi tied to oral GLP-1s drawing in new patients.
- Culture
Danone says yogurt sales are rising among US consumers taking GLP-1 drugs
Danone said demand for its North American yogurt brands has risen in part because of consumers using GLP-1 medications, with its high-protein Oikos line posting a 40% retail sales increase in 2024 based on Circana data the company provided. Danone's yogurt chief said yogurt consumption is nearly three times higher in US households where GLP-1s are used, a figure the company has not explained methodologically.
- Safety
Health Canada warns of counterfeit Ozempic and Mounjaro sold by retailers and online
Health Canada issued advisory RA-81518 on September 11, 2026, warning that unauthorized and counterfeit versions of Ozempic and Mounjaro are being sold by retailers and online, and said GLP-1 medications should be bought only from licensed pharmacies. The warning came as three of nine generic semaglutide products filed in Canada had been approved, with generic semaglutide from Dr. Reddy's and Apotex shipping to Canadian pharmacies and eight more submissions still under review.
- Business
Lilly starts selling Foundayo, its oral GLP-1 pill, in Israel
Eli Lilly has begun selling Foundayo, its once-daily oral GLP-1 pill, in Israel, the fourth country where the drug is marketed. Israeli pharmacies will stock it from September 15 at prices of 691 shekels for the lowest dose to 1,146 shekels for the highest, with subsidy levels not yet disclosed. The launch follows the UK, where Foundayo became available by private prescription in late August after regulators authorized it on August 10.
- Business
Lilly closes AtaiBeckley acquisition, adding an experimental depression therapy
Eli Lilly said on Sept. 11, 2026, that it completed its acquisition of AtaiBeckley Inc., a clinical-stage company whose lead program, BPL-003, targets treatment-resistant depression. Financial terms were not disclosed, and no clinical trial results for the program were released. Lilly said the deal is meant to advance therapies for treatment-resistant depression and other mental health conditions.
- Research and trials
Lilly's tirzepatide kidney disease trial in overweight and obesity marked completed
Eli Lilly's Phase 2 trial of tirzepatide in people with overweight or obesity and chronic kidney disease, with or without type 2 diabetes, changed to completed in a registry log dated September 11, 2026. The same entry shows the study's listed date moved up to July 6, 2026, from September 2026, and planned enrollment was reduced from 140 to 134 participants. No results, outcome measures or regulatory plans have been reported.
- Business
Novo Nordisk sets Sept. 15 staff town hall ahead of investor day
Novo Nordisk has scheduled a company town hall for Sept. 15, 2026, less than a week before its Sept. 21 capital markets day. Novo has warned that profit and sales could fall as much as 6% this year, even with demand for its new Wegovy pill, and its shares are down 14% for 2026. A cardiovascular-risk injection failed a large trial in July, and Morgan Stanley downgraded the stock on Friday.
- Business
Virginia regulators approve $98 million power project for Lilly's Goochland campus
The Virginia State Corporation Commission approved a $98 million project for Dominion Energy to build a 230-kilovolt substation and a 7-mile transmission line serving Eli Lilly's planned $5 billion manufacturing campus in Goochland County. The commission sided with Dominion over an objection from Asgard Broad Street Properties, which said the route undermines a nearly 500-unit neighborhood it wants to build. Lilly has not broken ground, and the power project is expected to be finished by summer 2028.
- Regulation
China approves Wegovy for MASH, a first for GLP-1 drugs there
Chinese regulators approved Wegovy (semaglutide) for metabolic dysfunction-associated steatohepatitis, or MASH, in non-cirrhotic adults with moderate to advanced fibrosis, staged F2 to F3, Novo Nordisk announced on Sept. 10, 2026. It is the first GLP-1 receptor agonist cleared for the liver disease in China. No Chinese launch date, price or reimbursement plan has been disclosed.
- Regulation
Seventh Circuit to hear Lilly appeal over retatrutide's regulatory status
The Seventh Circuit Court of Appeals will hear oral arguments on September 24 in Eli Lilly's fight with the FDA over whether its experimental obesity drug retatrutide is a biologic product or a conventional drug. Lilly argues a 60-day classification deadline restarted after a court remand and has run out; the FDA and a compounding trade group oppose the appeal. Retatrutide produced 28.3 percent average weight loss over 80 weeks in trials, and Lilly aims to seek approval in early 2027.
- Science
Modeling study estimates half of lost weight returns about 7.5 months after stopping semaglutide or tirzepatide
A Bayesian meta-analysis in Endocrinology, Diabetes, & Metabolism projected that people who stop semaglutide or tirzepatide take back about half their lost weight within 7.5 months and would reach their starting weight at about 15 months, an estimate the authors call an extrapolation past observed follow-up. A Cleveland Clinic cohort of 7,938 patients who stopped one of the drugs found much smaller regain a year later, which researchers attributed in part to switching or restarting treatment. A JAMA Network Open analysis found that most US adults with overweight or obesity discontinue GLP-1 medications within two years.
- Business
Lilly plans to steer GLP-1 profits into women's health, report says
Bloomberg reported on Sept. 10, 2026 that Eli Lilly is laying the groundwork for a broader push into women's health, funded by the windfall from its weight-loss and diabetes shots. The company has been assembling experts and looking for new medicines in areas that include bone health and endometriosis, according to people familiar with the matter. Lilly has not published specific targets, spending figures or a timeline, and it has not confirmed the plans.
- Science
Mouse study links weight regain after GLP-1 use to lasting change in fat cells
A Cleveland-led team reports in Cell Reports that obesity leaves a lasting change in fat cells that keeps the hunger hormone asprosin elevated after weight loss, a state it calls obesity memory. In mice, blocking the asprosin pathway prevented weight regain after dieting and prevented obesity risk from passing from mother to offspring. The findings are preclinical, and no human results are reported.
- Culture
Review names low engagement as the unsolved problem in digital obesity care
A review published September 10, 2026, in Current Obesity Reports says mobile apps, wearables, telehealth and AI have widened access to obesity care and reduced the burden of self-monitoring, but that low engagement remains a persistent problem with digitally delivered interventions. The review reports more than 3.6 billion diet-tracking app downloads in 2024 and a global weight loss app market worth $4.6 billion. It does not evaluate individual commercial apps or test any GLP-1 companion app.
- Business
Foundayo prescriber base grew from 8,000 to 36,000 in one quarter, analyst coverage says
Two September analyses of Eli Lilly's second-quarter disclosures report that the number of clinicians prescribing Foundayo, the company's oral GLP-1, rose from about 8,000 to roughly 36,000 in a single quarter. An international rollout is planned for 2027. Prescriber counts are a leading indicator; neither write-up reports how many prescriptions those clinicians actually wrote.
- Compounding
Lilly refers 200-plus retatrutide sellers to regulators as it sues six
Eli Lilly said it has referred more than 200 people and businesses to regulators and law enforcement over the sale or advertising of research-use-only retatrutide, its experimental weight-loss drug, alongside six lawsuits filed August 12, 2026. The company also reported more than 14,000 websites, ads and product listings it says unlawfully market the molecule in more than 100 countries.
- Science
Review suggests semaglutide eye risk is not shared by all GLP-1 drugs
A narrative review accepted September 10, 2026 in Frontiers in Medicine argues that the eye-related safety signals seen with GLP-1 medications are not a uniform class effect. The authors say longer-acting semaglutide has been repeatedly linked to non-arteritic anterior ischemic optic neuropathy (NAION) and to early worsening of diabetic retinopathy during rapid blood sugar correction, while shorter-acting liraglutide and exenatide show much weaker signals. The paper proposes a framework based on how long each drug engages its receptor, rather than a single shared mechanism.
- Research and trials
Review of GLP-1 drugs added to insulin in type 1 diabetes finds modest A1c and weight effects
An umbrella review published September 10, 2026, in Diabetes, Obesity and Metabolism pooled 18 meta-analyzes covering 56 unique studies of GLP-1 receptor agonists used alongside insulin in type 1 diabetes. It found average reductions of 0.23 percentage points in HbA1c and 3.93 kg in body weight, with high-certainty increases in nausea, vomiting and withdrawal because of side effects. The authors said the evidence does not support routine use.
- Research and trials
Beijing QL Biopharmaceutical registers 210-person semaglutide-to-zovaglutide switch trial
Beijing QL Biopharmaceutical has registered HORIZON-SWITCH-SZ, a Phase 2 trial that will test safety and tolerability when 210 adults with obesity switch from semaglutide to the company's experimental drug zovaglutide. The study is listed as not yet recruiting, with no start or completion date posted. Zovaglutide is a once-monthly GLP-1 peptide already in Phase 3 testing in China, and more than $72 million has been raised around the program.
- Business
Huntsville advances $230 million tax district for Eli Lilly's $6 billion Alabama plant
Huntsville held a public hearing on Sept. 10 on a tax increment financing district covering more than 9,000 acres in the Limestone County part of the city, tied to Eli Lilly's planned $6 billion Alabama manufacturing campus. The district would fund about $230 million in mostly infrastructure work across 11 projects, including road, sewer and school spending. The Limestone County Commission is scheduled to vote Oct. 5, and the Huntsville City Council on Oct. 8.
- Business
Novo Nordisk appoints global research head days before investor update
Novo Nordisk has appointed a new global head of research, a change at the top of its drug discovery organization that lands just before a Sept. 15 employee town hall and a Sept. 21 capital markets day. The company has not named the appointee. Novo has warned profit and sales could fall by as much as 6% this year, and its shares are down 14% for 2026.
- Research and trials
Novo Nordisk tests CagriSema for painful diabetic nerve damage
Novo Nordisk has disclosed a study of CagriSema, its weekly semaglutide-cagrilintide combination, in people with type 2 diabetes and painful diabetic peripheral neuropathy. The phase 2 trial compares the drug with placebo and asks participants to rate their pain intensity each week. One listing describes the study as completed as of September 2026, while another describes it as still recruiting, and no results have been reported.
- Research and trials
Review raises untested question about tirzepatide and oral progestogens
A hypothesis-generating review in Maturitas asks whether the gastric-emptying effect behind tirzepatide's labeled oral contraceptive warning could also change how the body handles oral progestogens prescribed for endometrial protection during menopausal hormone therapy or for gynecologic disease control. The review presents no new patient data: it restates the original contraceptive interaction findings and makes two cautions, that a fall in peak concentration is not the same as reduced efficacy, and that the effect is largest after the first dose and shrinks with continued treatment. No equivalent data exist for therapeutic progestogens.
- Research and trials
Weekly semaglutide-insulin combo outperforms daily insulin in type 2 diabetes trial
New results from the 40-week COMBINE 4 trial show a once-weekly combination of semaglutide and basal insulin icodec (IcoSema) lowered average A1c from 9.57% to 6.22% in adults with type 2 diabetes, compared with 9.50% to 7.10% for once-daily insulin glargine U100. The combination also produced a small average weight loss instead of a gain, and less hypoglycemia, but more gastrointestinal side effects. IcoSema is approved in several countries outside the US and has not been filed with the FDA.
- Regulation
China's regulator accepts Hengrui's ribupatide filing for type 2 diabetes
China's National Medical Products Administration has accepted a new drug application from Jiangsu Hengrui Pharmaceuticals for ribupatide injection, a dual GLP-1/GIP receptor agonist, for blood sugar control in adults with type 2 diabetes. Hengrui announced the acceptance on September 9, 2026, moving the drug into formal review. Kailera Therapeutics holds rights to ribupatide outside Greater China and is testing it globally in obesity, where the drug is called KAI-9531.
- Science
Endocrine Society sets six obesity research priorities and launches Center on Obesity
The Endocrine Society published a scientific statement on September 9, 2026 naming six priorities for obesity research in the era of GLP-1 medicines such as semaglutide and tirzepatide. The paper appeared in Endocrine Reviews and coincided with the launch of the society's Center on Obesity. A revised clinical practice guideline on obesity medications is expected in January 2027.
- Science
Mounjaro and Zepbound now bring in close to two-thirds of Eli Lilly's quarterly revenue, pipeline review says
A September 2026 review of Eli Lilly's pipeline says Mounjaro and Zepbound, both tirzepatide, together account for close to two-thirds of the company's quarterly revenue. That money is funding a broader metabolic medicine portfolio that includes the approved oral GLP-1 Foundayo (orforglipron) and retatrutide, which Lilly plans to file for US approval in the first quarter of 2027.
- Research and trials
Review finds tirzepatide produces more weight loss than semaglutide, with more serious adverse events
A meta-analysis of 10 head-to-head studies covering 41,381 adults with overweight or obesity found tirzepatide produced an average 4.28 percentage points more weight loss than semaglutide. Serious adverse events were reported in 5.7% of tirzepatide patients versus 2.9% of semaglutide patients, but rates of stopping treatment because of side effects did not differ significantly.
- Policy
Analysis says pharmacy benefit managers have escaped the administration's drug pricing push
A Forbes analysis published Sept. 9, 2026 argues the Trump administration has pressured drugmakers while taking comparatively little action against pharmacy benefit managers, which control about 80 percent of US prescriptions. It says the FTC settlements over insulin pricing include no monetary penalties, no admissions of misconduct and no restitution fund for patients. The piece came about three weeks after PBMs pledged to display TrumpRx cash prices in their benefit tools, a step that does not change rebate economics.
- Compounding
Fifth Circuit upholds FDA rulings that semaglutide and tirzepatide shortages have ended
The Fifth Circuit upheld the FDA's decisions removing semaglutide and tirzepatide injection drugs from the federal shortage list, in a tirzepatide opinion issued August 27, 2026 and a separate semaglutide ruling. The decisions mean compounding pharmacies can no longer rely on the former shortages to justify routine large-scale production of copies of Ozempic, Wegovy, Mounjaro and Zepbound. Patient-specific compounding under Section 503A survives on a narrower footing.
- Business
Morgan Stanley downgrades Novo Nordisk, citing semaglutide patent cliff
Morgan Stanley cut Novo Nordisk to Underweight from Equal-weight on Sept. 11, 2026, keeping a price target of 250 Danish crowns, about $40 per New York-listed share. The bank said semaglutide accounted for about 75% of Novo's 2026 sales and faces loss of exclusivity in the early-to-mid 2030s. It forecast a $10 billion oral obesity franchise by 2031 but said that will not offset pricing and competitive pressure.
- Business
Novo Nordisk halts two more ziltivekimab heart failure trials after futility finding
Novo Nordisk has ended the HERMES and ATHENA heart failure trials of its experimental drug ziltivekimab after an independent data monitoring committee recommended stopping them, the company told investigators on September 4. The halt follows the July 31 announcement that a separate ziltivekimab trial, ZEUS, found no reduction in major cardiovascular events, with a hazard ratio of 0.99 and a 95% confidence interval of 0.88 to 1.11, in more than 6,300 people. Novo Nordisk has said the setback will not change its adjusted operating profit outlook for 2026 because the cost is a non-cash impairment charge in the third quarter.
- Competition
Prescribers say Mounjaro heart indication could shift type 2 diabetes care
A survey of prescribers reported September 9, 2026 found that Mounjaro's cardiovascular indication is likely to shift prescribing in type 2 diabetes, because it removes the argument that only semaglutide had a proven heart benefit. Physicians surveyed said the approval mattered more than they had expected. The number of prescribers surveyed, the size of the expected shift and the terms of the approval itself have not been disclosed.
- Research and trials
Zealand's ZUPREME-2 petrelintide trial is marked completed
The registry entry for ZUPREME-2, Zealand Pharma's Phase 2 trial of petrelintide in people with overweight or obesity and type 2 diabetes, changed from active, not recruiting to completed on September 9, 2026. Petrelintide, an amylin analog, has shown up to 10.7% weight loss over 42 weeks in Phase 2 work with tolerability described as placebo-like. Results from ZUPREME-2 have not been released.
- Culture
Report describes a fake GLP-1 market on TikTok aimed at women
A report from the gender-equality group UltraViolet analyzed more than 200 TikTok accounts promoting unregulated GLP-1 weight-loss products and said TikTok removed only about 30% of the 202 accounts it flagged. A Texas woman who bought patches advertised as containing GLP-1 medication paid about $4 and later about $10, receiving the wrong product both times. Patches marketed for weight loss are not FDA approved and do not contain GLP-1 drugs.
- Compounding
Fifth Circuit upholds FDA decisions that ended GLP-1 shortages
A federal appeals court upheld two FDA decisions removing semaglutide and tirzepatide injection products from the national drug shortage list. The rulings cover Ozempic, Wegovy, Mounjaro and Zepbound and reject compounding industry challenges to the agency's supply data. The shortage determinations remain in place, and a law firm analysis says compounders can no longer rely on the former shortages to support routine large-scale production of copies.
- Business
MannKind and Rose Pharma sign deal to develop an inhaled GLP-1 for weight management
MannKind and Rose Pharma announced a worldwide licensing and collaboration agreement on Sept. 9, 2026 to develop ROSE-010 Technosphere, an inhaled, rapid-acting GLP-1 receptor agonist for weight management. MannKind will receive equity in Rose Pharma, a board seat and royalties on potential future sales, and will support formulation work through a Phase 1b study, while Rose Pharma keeps clinical development, regulatory strategy and commercialization. Financial terms were not disclosed.
- Research and trials
Novo Nordisk opens CagriSema trial in children and teens with type 2 diabetes
A Novo Nordisk Phase 3 trial testing CagriSema against placebo in children and adolescents with type 2 diabetes moved from "not yet recruiting" to "recruiting" on Sept. 9, 2026, according to a registry change record. CagriSema combines cagrilintide with semaglutide, the active ingredient in Wegovy. A regulatory decision on the combination in adults is expected in the fourth quarter of 2026.
- Business
Weight Watchers names Stephen Bye, a technology executive, as chief executive
WW International said on Sept. 9, 2026 that it appointed Stephen Bye as president and chief executive officer and a board member, effective this fall. Bye most recently ran Ookla, the company behind Speedtest and Downdetector, and has no disclosed pharmaceutical or telehealth operating background. He takes over as commercial weight loss companies lost 24% of group revenue in 2025 while spending on prescription obesity drugs grew 64%.
- Culture
Weight Watchers and Dear Media launch The Weigh In, a weekly GLP-1 podcast
Weight Watchers and the podcast network Dear Media announced on September 9, 2026 that they will launch The Weigh In, a weekly show about GLP-1 medications, with the first episodes available September 16. It is Weight Watchers' first podcast dedicated to GLP-1s. The show is hosted by Samhita Mukhopadhyay, a former executive editor of Teen Vogue who is now head of content and impact at Weight Watchers.
- Prices
GLP-1 prescriptions among seniors rose 19% after Medicare Bridge launch, Truveta says
New Truveta data show the share of adults 65 and older with a GLP-1 prescription rose 19 percent from June to July 2026, the largest month-to-month increase in seven years of the company's records. Tirzepatide prescriptions rose 80 percent on a relative basis and semaglutide 40.9 percent, while orforglipron volume was too small to measure. The increase followed the July 1 launch of Medicare's $50-a-month Bridge program, which CVS and Walgreens each say has produced roughly 100,000 prescriptions.
- Regulation
Structure Therapeutics reports 16.2% weight loss at 72 weeks for oral aleniglipron
Structure Therapeutics said its experimental oral GLP-1 pill aleniglipron produced up to 16.2% average weight loss at 72 weeks in an open-label extension, with fewer than 5% of participants stopping treatment because of side effects. Analysts at BMO Capital Markets called the result in line with Novo Nordisk's oral Wegovy and better than Eli Lilly's Foundayo, based on separate trials. The company also reported early data for a second oral candidate, ACCG-2671.
- Policy
CMS says most Medicare GLP-1 Bridge prior authorizations clear in under 12 hours
CMS officials told AARP that most prior authorization requests under the Medicare GLP-1 Bridge are decided in under 12 hours, beating the program's 72-hour target, and that most requests arrive electronically rather than by fax. The same officials confirmed there is no formal appeals process for a Bridge denial: a prescriber can correct and resubmit a request, but beneficiaries have appeal rights only for GLP-1 coverage decisions issued under the Part D benefit.
- Research and trials
Semaglutide tied to fewer asthma attacks in large UK records study
A study of UK electronic health records presented September 8, 2026 at the European Respiratory Society Congress in Barcelona found that people with asthma or COPD who started GLP-1 drugs had fewer flare-ups than similar patients who started sulfonylureas. Semaglutide (Ozempic, Wegovy) was linked to a 38% lower rate of asthma exacerbations and a 21% lower rate of COPD exacerbations. The investigators said the findings should not change treatment decisions on their own.
- Compounding
Judge trims Lilly's conspiracy claims against Mochi Health over compounded tirzepatide
On Sept. 8, 2026, a federal judge in California partially granted Mochi Health's motion to dismiss Eli Lilly's lawsuit over compounded tirzepatide, dismissing Lanham Act conspiracy claims against Mochi's medical entities and the supplying pharmacy while allowing California Unfair Competition Law conspiracy claims to proceed against Aequita Pharmacy and its parent. It is the third ruling in the case, after a full dismissal in 2025 and an April 2026 partial dismissal.
- Research and trials
Novo Nordisk halts two more heart failure trials of ziltivekimab
Novo Nordisk has ended two Phase 3 heart failure studies of ziltivekimab, HERMES and ATHENA, after a data monitoring committee saw a low likelihood of a different result from the failed ZEUS trial. ZEUS, reported July 31, 2026, found the drug did not significantly reduce major adverse cardiovascular events in more than 6,300 patients, and Novo's shares fell close to 9% as roughly $30 billion in market value was lost. A third trial, ARTEMIS, is still running, with data expected in the first half of next year.
- Research and trials
Novo Nordisk moves amycretin into phase 3 trials as a pill and a weekly injection
Novo Nordisk said it is advancing amycretin, a single molecule that targets the GLP-1 and amylin receptors, into phase 3 development for weight management in both a once-weekly injection and a once-daily pill. In a 125-person phase 1b/2a study, the highest 20 mg dose of the injection produced about 22% weight loss over 36 weeks, compared with a 2% weight gain on placebo. The company said it planned to begin the phase 3 program in adults with overweight or obesity in the first quarter of 2026.
- Business
Sandoz plans Canadian generic semaglutide launch this year but omits GLP-1s from 2035 goals
Sandoz said on September 8, 2026 that it wants to sell a generic version of semaglutide in Canada for patients with diabetes before the year is out, and that Brazil approved the same product in July. The company also told investors its net sales targets through 2035 assume no revenue from generic GLP-1 drugs, and that it plans to grow its biosimilars portfolio from 13 products to 100 by 2040.
- Business
Novo Nordisk's September 21 investor day puts strategy and semaglutide outlook on the table
Novo Nordisk holds a Capital Markets Day in London on September 21, its first under CEO Mike Doustdar, where it has said it will review strategy, operations and financial targets. Analysts want a credible growth plan after two cardiovascular trial setbacks for ziltivekimab and a stock trading near the bottom of its 52-week range.
- Business
Report projects obesity drug market growing about 27% a year through 2036
A market report published September 8, 2026 projects the obesity drug market will grow at a compound annual rate of about 27% from 2022 through 2036, helped by oral GLP-1 pills and new drugs in development. A separate IQVIA analysis put the anti-obesity category at nearly $42 billion in 2025, the fourth-largest therapeutic area, with about 190 products in development.
- Policy
CMS kept Bridge outreach limited while Lilly and Novo Nordisk advertised GLP-1s
Medicare's GLP-1 Bridge launched July 1, 2026, with a $50 monthly copay for eligible Part D beneficiaries, and is scheduled to run through December 31, 2027. A CMS official said the agency deliberately did limited public outreach before launch because beneficiaries act on information when they can actually use it, while Eli Lilly and Novo Nordisk ran their own promotions, including social video and television ads for Foundayo and Zepbound.
- Regulation
Health Canada reviewing eight more generic semaglutide files
Health Canada is reviewing eight additional generic semaglutide submissions as of September 8, 2026, after authorizing generic semaglutide injections from Dr. Reddy's Laboratories and Apotex. Under Canada's tiered generic pricing, the third approved generic would push the generic price to 35% of the brand price, and University of Toronto researcher Mina Tadrous has estimated out-of-pocket costs near C$100 a month at that point.
- Culture
Gallup revises 2026 estimates, reports 11% of US adults use GLP-1s for weight loss
Gallup updated its July 2026 report on Sept. 8, 2026, after changing its survey weighting criteria, and now puts current GLP-1 use for weight loss at 11% of U.S. adults, up from 3% in 2024. The revised figures also show 15% have ever used the drugs for weight loss, 90% awareness, and a 36.8% adult obesity rate.
- Culture
eMarketer analysis finds one GLP-1 user changes what the whole household eats
eMarketer reports that GLP-1 use reshapes purchasing for entire households, not just the person taking the drug, with spillover into shared meals, snacks and beverage choices. The firm ties the household effect to a user base that Gallup puts at 11% of US adults taking a GLP-1 for weight loss. The analysis comes from panel-based consumer data, not a controlled study.
- Business
Moonwalk raises $70 million to push fat-targeting RNAi obesity drug toward human trials
Moonwalk Biosciences raised $70 million in a Series B round co-led by Alpha Wave and YK Bioventures, with Eli Lilly, Gaorong Ventures, ARCH Venture Partners, Khosla Ventures and Future Ventures also participating. The money supports MW101, an adipose-targeted siRNA obesity drug licensed in part from Suzhou Siran Biotechnology, which the company plans to take into first-in-human testing in late 2027. In mice, MW101 produced weight and fat loss while maintaining muscle mass; no human data has been reported.
- Research and trials
Lilly-funded study finds lower health costs for Zepbound users over 55
A peer-reviewed, Lilly-funded matched-cohort study published August 24, 2026 found that adults over 55 taking Zepbound (tirzepatide) had monthly health care costs $145 lower than matched untreated peers at 6 to 12 months and $319 lower at 12 to 18 months, with costs drifting down slightly in the treated group while controls' costs rose. The analysis excluded the cost of Zepbound itself and could not observe its net price.
- Research and trials
Meta-analysis confirms weight regain after stopping GLP-1 drugs and easing of gut side effects
A PeerJ systematic review and meta-analysis pooled six studies of 8,993 adults with overweight or obesity and found a mean difference of 17.90 percentage points in weight change between people who stopped GLP-1 receptor agonists and those who continued. The review also found that overall and gastrointestinal side effects decreased after withdrawal, while the rate of cardiovascular events was not affected by stopping.
- Competition
Structure Therapeutics reports first clinical data for oral amylin drug ACCG-2671
Structure Therapeutics reported the first clinical data for an oral small-molecule amylin receptor agonist, ACCG-2671, on September 8, 2026. In a single-dose Phase 1/2a trial in 31 healthy adults without obesity, the drug had a half-life of about six days, no serious adverse events, and a 3.3% mean weight reduction at Day 24 after a 10 mg dose in six participants. The company also reported that its oral GLP-1 candidate aleniglipron produced up to 16.2% weight loss at 72 weeks in an open-label extension.
- Competition
Three obesity drug milestones still open as the third quarter nears its end
As of September 8, three company-guided third-quarter obesity milestones remained unannounced with 22 days left in the quarter: Structure Therapeutics' planned Phase 3 start for aleniglipron, Viking Therapeutics' VANQUISH-2 topline in people with type 2 diabetes, and the start of registrational Phase 3 trials of Zealand Pharma and Roche's petrelintide monotherapy. Ascletis, which dosed its first Phase 3 patient on August 30, was the only company in the group to hit its stated window.
- Research and trials
Novo Nordisk says semaglutide moved 40.4% of children aged 6 to 11 below the obesity threshold
Novo Nordisk reported first results from the phase 3 STEP Young trial on Sept. 7, 2026, saying 40.4% of children aged 6 to under 12 treated with once-weekly semaglutide were no longer classified as having obesity after 68 weeks, versus 0% on placebo. All children also received a reduced-calorie diet and increased physical activity. The company reported no new safety concerns, including for growth or pubertal development, but released only topline data.
- Business
Lilly passes $50 billion in US manufacturing commitments with four new plants
Eli Lilly said its U.S. manufacturing commitments since 2020 will pass $50 billion, more than double the $23 billion it committed from 2020 through 2024. The program centers on four new plants, three for active pharmaceutical ingredients and one to expand capacity for injectable medicines. Lilly says it will create more than 3,000 permanent jobs and nearly 10,000 construction jobs, but has not disclosed the plant locations or opening dates.
- Research and trials
Analysis finds semaglutide and tirzepatide match at some doses in type 2 diabetes
A pooled analysis of 23 phase III trials covering 16,524 people with type 2 diabetes found semaglutide and tirzepatide produce comparable weight loss at matched doses, with a 99.4% probability of equivalence between semaglutide 2.4 milligrams and tirzepatide 10 milligrams. Low-dose semaglutide did not match higher-dose tirzepatide, and the findings apply only to people with type 2 diabetes.
- Prices
North Carolina budget leaves state employees without GLP-1 weight-loss coverage
North Carolina's budget signed in July 2026 contained no provision restoring State Health Plan coverage of GLP-1 drugs for weight loss, and plan officials say current prices remain unaffordable. In June, NC Medicaid recorded $47,855,225 in weight-loss GLP-1 claims for 34,524 beneficiaries, an average of about $1,386 each before federal matching funds and manufacturer rebates.
- Safety
Case report describes four weekly semaglutide doses injected at once, with unusual symptoms
A case report published in 2026 describes a 50-year-old man who injected 9.6 mg of semaglutide — four times his prescribed 2.4 mg weekly dose — after mistaking a pen problem for a failed shot. Two days later he developed generalized burning skin sensations and marked weakness, but no nausea, vomiting or abdominal pain. The report covers one patient and cannot be generalized.
- Research and trials
GLP-1 drugs linked to fewer foot ulcers, more Charcot cases in diabetes study
An observational analysis of matched records from 19,770 pairs of U.S. adults with type 2 diabetes and existing diabetic neuropathy found those who started a GLP-1 receptor agonist had a 19 percent lower relative rate of diabetic foot ulcer at one year than those who started a DPP-4 inhibitor. The same analysis found nearly double the rate of Charcot neuroarthropathy, a rare collapse of foot bones and joints, in the GLP-1 group, while amputation and bone infection rates were similar.
- Research and trials
Tirzepatide and semaglutide show no difference in asthma exacerbation risk, study finds
In a retrospective study of US health records, adults with asthma and type 2 diabetes who started tirzepatide had a 12-month asthma exacerbation risk of 11.0 percent, compared with 11.1 percent for those who started semaglutide. The difference was not statistically meaningful (hazard ratio 1.00, 95% CI 0.91–1.10). Tirzepatide users had a slightly lower risk of rescue inhaler prescriptions.
- Business
Lilly reports 136% international growth and flags generic semaglutide supply limits in Canada
Eli Lilly said second-quarter 2026 Mounjaro sales rose 91% to US$9.94 billion and revenue outside the United States grew 136%, while U.S. revenue rose 48%. Lilly International president Patrik Jonsson said generic semaglutide sellers in Canada have had "significant supply constraints," and both Lilly tirzepatide products remain under patent there.
- Business
Novo Nordisk buyback reaches DKK 9.0 billion of DKK 15 billion program
Novo Nordisk reported on September 7, 2026 that it has repurchased DKK 9,021,774,283 of its own B shares, just over 60 percent of a DKK 15 billion program that began February 4, 2026. As of September 4, the company had bought 32,034,179 B shares at an average price of DKK 281.63. It now holds 46,074,876 B shares, equal to 1.0 percent of its share capital, as treasury shares.
- Business
Novo Nordisk says semaglutide helped 40% of children in trial leave obesity range, as shares slip
Novo Nordisk reported that 40.4% of children aged 6 to under 12 taking once-weekly semaglutide in the phase 3 STEP Young trial no longer met the study's obesity classification after 68 weeks, compared with 0% on placebo. Shares closed 1.92% lower at $46.60 the same day, and an analyst write-up said the pediatric opportunity alone is not a game changer for the company.
- Policy
Medicare sets $274 price for Ozempic, Wegovy and Rybelsus starting January 2027
Medicare has finalized a maximum fair price of $274 for a 30-day supply of Ozempic, Wegovy and Rybelsus, down from $959, effective January 1, 2027. The three semaglutide products are part of a second group of 15 drugs whose negotiated prices CMS estimates will save Part D enrollees about $685 million in out-of-pocket costs. What an individual pays still depends on their Part D plan's benefit design.
- Business
Lilly moved its employee pharmacy benefits to Rightway after Caremark dropped Zepbound
Eli Lilly replaced CVS Caremark with Rightway as the pharmacy benefit manager for employees in its medical plan, effective January 1, 2026, several months after Caremark removed Zepbound from its standard commercial formulary and kept Wegovy as preferred. Caremark announced in May 2026 that Zepbound returns to its commercial formularies as an additional preferred option on October 1, 2026. Lilly has not said the formulary decisions prompted the switch, or whether the October change will affect its Rightway arrangement.
- Regulation
Lilly seeks import ban on 11 online sellers of products labeled tirzepatide
Eli Lilly filed a complaint with the U.S. International Trade Commission against 11 online pharmacies, asking the agency to block imports of products marketed as containing tirzepatide, the active ingredient in its diabetes drug Mounjaro, Reuters reported on October 20, 2023. The named sellers are based in the United States, China, Britain, Spain and Poland, and Lilly said testing of one seller's product found it was "nothing more than sugar alcohol."
- Policy
Medicaid GLP-1 obesity coverage reaches 12 states, with Rhode Island dropping out October 1
Twelve state Medicaid fee-for-service programs covered GLP-1 drugs for obesity as of early September 2026, down from KFF's January count of 13 after Massachusetts stopped paying for obesity-only prescriptions on July 1. Rhode Island's elimination of weight-management coverage takes effect October 1, which would leave 11. Tirzepatide stays covered as Mounjaro for type 2 diabetes in every state, because federal law permits only the weight-loss exclusion.
- Prices
Hims & Hers opens $149 waitlist for branded Wegovy and Ozempic
Hims & Hers has opened a waitlist for branded Wegovy and Ozempic at $149 a month through its Novo Nordisk partnership, the lowest self-pay price the platform has offered for branded semaglutide. The offer extends a March 2026 shift from compounded to branded medication that the company says cut gross margin by about 12 points to 64 percent. Hims & Hers has reported filling more than 125,000 Wegovy shipments within six weeks of that launch.
- Prices
LillyDirect Zepbound self-pay prices confirmed at $299 to $449 with a 45-day refill condition
LillyDirect's 2026 self-pay prices for Zepbound are $299 for 2.5 mg, $399 for 5 mg and $449 for 7.5 mg to 15 mg when a patient refills within 45 days, according to a September 2026 pricing review that also corrected earlier figures. Miss that window and the regular price is $499 for 7.5 mg and $699 for 10 mg to 15 mg, a difference of up to $250 a month at maintenance doses.
- Business
WeightWatchers expands Med+ clinical program nationwide through LillyDirect partnership
WW International expanded its Med+ clinical program nationwide through a partnership with LillyDirect, Eli Lilly's direct-to-consumer pharmacy channel. Med+ membership is priced at $25 a month for the first two months on a 12-month plan, then $74 a month, with medication billed separately. The company's legacy behavioral business posted a 22.7 percent year-over-year revenue decline in the second quarter of 2026 while its clinical segment grew.
- Prices
Zepbound savings card keeps $25 copay in 2026 but pays less per fill
The 2026 Zepbound Savings Card keeps a $25 price for commercially insured patients whose plan covers the drug, but the card pays up to $100 per one-month fill and $1,300 a calendar year across 13 fills, down from $150 and $1,950 in 2025. Commercially insured patients whose plan does not cover Zepbound pay $499 for a one-month single-dose pen fill or $299 for the 2.5 mg KwikPen, down from $650. The card expires December 31, 2026.
- Business
WeightWatchers expands UK CheqUp partnership to pair medication access with coaching
WW International has expanded its UK partnership with CheqUp to offer integrated weight-health services that combine medication access with behavioral coaching. The company's clinical segment, built around GLP-1 medications, grew revenue 30.4% year over year in the second quarter of 2026 while total revenue fell 22.7%. Terms, pricing and a launch date for the expanded UK services were not disclosed.
- Research and trials
Novo Nordisk halts two ziltivekimab heart failure trials after futility finding
Novo Nordisk told trial investigators on September 4, 2026, that it is ending the Phase 3 HERMES and ATHENA studies of ziltivekimab early, after an independent data monitoring committee concluded the trials were unlikely to succeed. The halt follows the July 31, 2026, failure of the ZEUS trial, where the drug lowered inflammation markers but did not reduce major cardiovascular complications. ARTEMIS is now the only remaining Phase 3 study of the drug, with results expected in the first half of 2027.
- Business
Wegovy pill and Foundayo set weekly prescription records, IQVIA data show
Weekly prescriptions for Novo Nordisk's Wegovy pill reached about 181,000 in the latest IQVIA data cited by Citi, while Eli Lilly's Foundayo hit roughly 44,000, both record highs for the oral GLP-1 drugs. Citi said the oral launches helped swing total GLP-1 prescription growth from a 6.8% decline a year earlier to a 5.4% increase over four weeks.
- Safety
Report links three serious injuries to compounded GLP-1s from pharmacies tied to Mochi Health
A September 4, 2026 investigation describes three patients in three states who suffered severe medical emergencies after using compounded GLP-1 drugs made by pharmacies that supplied the telehealth company Mochi Health at various points. The cases include a Texas wrongful-death lawsuit over compounded semaglutide from Empower Pharmacy and a Kentucky lawsuit alleging liver failure and a transplant after compounded tirzepatide from Lexington Compounding Pharmacy. Each pharmacy denies that its product caused the harm, and Empower is asking a court to throw out the Texas case.
- Research and trials
GLP-1 prescribing to US children aged 8 to 11 rose 310-fold since 2019, study finds
A study published September 4 in the journal Pediatrics found that GLP-1 prescriptions for children aged 8 to 11 with obesity and without diabetes rose from 0.03% in 2019 to 9.3% by June 2026, a 310-fold increase. Over the study period, 20,282 children received Saxenda, Wegovy or Zepbound, and 93.7% of those prescribed had severe obesity. None of the drugs is FDA-approved for children under 12, though guidelines allow them to be considered from age 8 in some cases.
- Science
Lilly's retatrutide reaches 30.3% average weight loss in Phase 3 TRIUMPH-1 trial
Eli Lilly reported that retatrutide, an investigational triple GIP/GLP-1/glucagon agonist, met primary and key secondary endpoints in the Phase 3 TRIUMPH-1 trial of 2,339 adults. At 80 weeks, the 12 mg dose produced 28.3% average weight loss, and participants originally assigned to 12 mg averaged 30.3% at 104 weeks in a blinded extension. Nausea, diarrhea, constipation and vomiting were more common than with placebo, and 11.3% of the 12 mg group stopped treatment because of side effects.
- Compounding
Washington shuts down Aequita Pharmacy, the compounder behind Mochi Health's GLP-1 supply
Washington state health inspectors raided and shut down Aequita Pharmacy in Kirkland, Washington, the compounding facility that was Mochi Health's in-house source of compounded GLP-1 medications, describing what they found as a "serious risk" to patients. Inspectors reported questioning workers' licensing, finding expired medications and locating GLP-1 base powder that state officials said had been imported illegally from overseas. Mochi then contracted with Empower Pharmacy, which has received three FDA warning letters since 2022, been investigated by 15 state pharmacy boards and paid a $65,000 DEA fine in 2024.
- Compounding
Lilly says it referred 200-plus sellers to authorities over unapproved retatrutide
Eli Lilly says it has referred more than 200 people and businesses to the FDA, the Justice Department, state attorneys general and law enforcement over the black market for retatrutide, its experimental weight-loss drug. The company also says it has reported more than 14,000 websites, ads, social media posts and product listings marketing the drug in more than 100 countries, and filed its first six lawsuits on Aug. 12.
- Research and trials
Novo Nordisk starts recruiting phase 3 trial of two cagrilintide injection versions
A Novo Nordisk phase 3 study comparing two different injectable presentations of cagrilintide with placebo in people with excess body weight has moved from "not yet recruiting" to "recruiting". Cagrilintide is an investigational once-weekly amylin analog; in a sub-analysis of the phase 3 REDEFINE 1 trial, it produced 11.8% average weight loss versus 2.3% for placebo over 68 weeks. Novo Nordisk has not disclosed the new study's size, doses or expected completion date.
- Research and trials
Lilly registers phase 1 tirzepatide gastric emptying study in type 1 diabetes
Eli Lilly registered a phase 1, single-dose, blinded, randomized study (NCT07803744) that uses oral acetaminophen to track gastric emptying in adults with type 1 diabetes and overweight. The record was first posted on September 4, 2026, and is listed as not yet recruiting. Tirzepatide, sold as Mounjaro and Zepbound, is not approved for type 1 diabetes.
- Culture
Medscape commentary calls 'easy way out' GLP-1 stigma a clinical problem
A Medscape commentary published September 4, 2026, argues that the belief that GLP-1 drugs are an "easy way out" is a clinical problem that can suppress disclosure and push patients toward unsupervised sources. It cites figures showing that 25% of Americans have already tried a GLP-1 and that 100 million people would be eligible for a prescription. The article is commentary and review, not new data.
- Research and trials
Novo Nordisk cagrilintide injection enters Phase 3 obesity trial
Novo Nordisk has advanced a once-weekly cagrilintide injection for overweight and obesity into a Phase 3 trial that is now recruiting, with a study update filed Sept. 3, 2026. The trial compares cagrilintide with placebo and compares two injection devices, with participants followed for about nine months. Cagrilintide is also half of CagriSema, a combination product under FDA review with a decision expected in the fourth quarter of 2026.
- Safety
Pharmacists press state boards to act against unapproved retatrutide
A September 4, 2026 commentary in the pharmacy trade publication Pharmacy Times argues that state boards of pharmacy, not federal regulators alone, are the bodies able to discipline licensees tied to illegal retatrutide. The piece cites Ohio, which has collected more than $1 million in penalties from sellers of unapproved drugs including retatrutide, and Indiana, which denied renewal of a nonresident pharmacy license in a retatrutide matter.
- Compounding
Strive Pharmacy pre-sources peptide ingredients ahead of any FDA 503A bulks-list rule
Strive Pharmacy says it is pre-sourcing peptide active pharmaceutical ingredients and running stability, potency and sterility testing on a limited set of higher-demand products while the FDA decides whether to add peptides to the 503A Bulks List, co-founder and CEO Nate Hill told Pharmaceutical Executive in a Q&A published September 4, 2026. No proposed rule has been published, none of the six peptides a July FDA advisory panel recommended is on the list, and none is lawfully compoundable today.
- Research and trials
Veru's enobosarm muscle study closes enrollment in GLP-1 users
Veru Inc. says a study of its experimental drug enobosarm in people taking a GLP-1 receptor agonist for weight loss is now fully enrolled, and a registry tracker records the trial moving from "recruiting" to "active, not recruiting" on September 4, 2026. The company described 239 patients in the trial and said an earlier Phase IIb study found a 3-milligram dose of enobosarm preserved lean mass during semaglutide treatment.
- Business
California bill to lower GLP-1 prices through CalRx reaches governor
California's SB 1089, the Preventive Treatment Health Care Act, was enrolled and presented to the governor on Sept. 3, 2026, after clearing both chambers. It would let the state seek partners to make or distribute at least one FDA-approved GLP-1 obesity drug under CalRx, with a goal of pricing at or below what Medi-Cal beneficiaries paid in 2025. It follows California's decision to end Medi-Cal coverage of GLP-1s prescribed for weight loss alone.
- Research and trials
Novo Nordisk and United Laboratories report 19.7% weight loss for UBT251 in Chinese phase 2 trial
Novo Nordisk and The United Laboratories reported positive topline results from a 205-person phase 2 trial in China of UBT251, an experimental once-weekly injection that targets three hormone receptors. People on the 6 mg dose lost an average of 19.7 percent of body weight, about 17.5 kg, at 24 weeks, compared with 2.0 percent on placebo. The companies said side effects were mostly mild gastrointestinal events and are planning a phase 3 trial in China.
- Science
NYU Langone researchers report first genetic link between GLP-1 activity and male hair loss
An NYU Langone Health team treated inherited variation in the GLP1R gene as a stand-in for GLP-1 receptor activity and found a 7 percent higher risk of androgenetic alopecia in men with more predicted activity. The 7 percent figure held after the analysis accounted for high blood pressure, insulin resistance and low testosterone. The paper appeared online September 3 in the Journal of Investigative Dermatology, offers no explanation of how GLP-1 activity affects follicles, and covered men only.
- Research and trials
European obesity group says incretin drugs like semaglutide should not replace broader care
The European Association for the Study of Obesity published a position statement on September 3, 2026, in The Lancet Regional Health – Europe on integrating incretin-based obesity medicines into comprehensive care. The statement covers nutrition, physical activity, psychological support and long-term follow-up alongside pharmacotherapy. It is guidance for European practice and carries no regulatory force in the United States.
- Business
FDA still lists liraglutide as in shortage while two generic makers report supply available
The FDA's drug shortage database continued to list liraglutide injection as "Currently in Shortage" as of September 3, 2026, a status first posted July 18, 2023. Hikma reported both of its presentations available on September 3, 2026, and Meitheal reported both available on August 27, 2026, while Novo Nordisk's Victoza and Saxenda entries remained at Limited Availability.
- Business
Menarini licenses Gan & Lee's every-two-weeks GLP-1 bofanglutide for Europe
Italy's Menarini Group agreed to pay Gan & Lee Pharmaceuticals €62 million ($72 million) up front for European rights to bofanglutide, an experimental GLP-1 obesity drug injected once every two weeks. The deal includes up to €664 million ($771 million) in milestones and double-digit royalties, for a potential total of about €726 million, and covers 39 markets. Bofanglutide has finished a Phase 3 trial in China and a Phase 2 trial in the US, but is not approved in Europe.
- Compounding
LifeRxMD must disclose compounded drugs are not FDA-approved under Novo Nordisk settlement
Novo Nordisk and compounding pharmacy LifeRxMD Inc. settled a false-advertising lawsuit, and a Sept. 2, 2026 final judgment in the U.S. District Court for the District of New Jersey turned the deal into a permanent injunction. The order restricts how LifeRxMD may use Novo Nordisk's trademarks and requires the pharmacy, for 12 months, to tell customers that its compounded drugs are not FDA-approved or reviewed and that approved semaglutide medicines are available.
- Regulation
State boards warn licensees over research-use-only and unapproved GLP-1 peptides
State medical, nursing and pharmacy boards have issued a wave of warning notices about clinical use of peptides, most aimed at research-use-only products, according to a Sept. 3 legal analysis. The states listed as having issued warnings or taken a more restrictive posture are Alabama, California, Connecticut, Louisiana, Mississippi, New Jersey, Ohio and South Carolina, with licenses suspended in some cases. A separate analysis says pharmacists who use research-use-only peptides typically face an emergency suspension order.
- Research and trials
Ildong to report Phase 1 topline for oral GLP-1 ID110521156 on September 29
Ildong Pharmaceutical said it will present topline Phase 1 results for ID110521156, an oral GLP-1 receptor agonist from its affiliate Yunovia, at an investor briefing in Seoul on September 29. Interim data reported in June showed an average weight reduction of 6.9 percent and a maximum of 11.9 percent over four weeks in the 100 mg cohort. The topline will add high-dose weight-loss results along with safety and tolerability data.
- Business
Aspen forecasts more than $124 million in Mounjaro sales across Africa in 2027
Aspen Pharmacare, Lilly's distributor of Mounjaro in sub-Saharan Africa, said it expects regional sales of the tirzepatide drug to exceed 2 billion rand, or about $124 million, in its financial year ending June 2027. The company has submitted the drug for registration in Kenya and Nigeria, and its chief executive said both markets could contribute this year if approved.
- Science
Rutgers scientist describes GLP-1 as a brain circuit signal at Seoul conference
At the 2026 Good Brain Conference in Seoul on Sept. 3, Rutgers professor Fang Zhiping said GLP-1 works in the brain as a neuromodulator, not only as a metabolic hormone, and presented mouse experiments that traced GLP-1 circuits using genetically labeled cells, optogenetics and microelectrodes. He said circuit-level understanding could support drugs that target specific pathways and might later be turned to conditions such as depression, Alzheimer's disease and Parkinson's disease. No clinical candidate or human data was presented.
- Business
Superluminal raises $60 million to advance MC4R obesity drug into human testing
Superluminal Medicines closed an oversubscribed $60 million Series B financing on Sept. 3, 2026, led by BVF Partners. The money will fund a Phase 1 trial of the company's selective, biased MC4R agonist for rare genetic forms of obesity and hypothalamic obesity, expected to begin by the end of 2026. The company has now raised $213 million in venture financing to date.
- Research and trials
Case series reports tirzepatide eased hypoglycemia after gastric bypass
A case series in JCEM Case Reports described three patients with post-bariatric hypoglycemia after Roux-en-Y gastric bypass whose episodes had responded only partially to diet changes, acarbose and other drugs. On tirzepatide, all three spent more time in their glucose target range, had fewer and less severe hypoglycemic episodes and showed less glucose variability. The authors say the finding needs confirmation and that the optimal dose is unknown.
- Policy
Indiana alone in joining federal Medicaid GLP-1 pricing model as 29 states decline
Nine months after the Centers for Medicare and Medicaid Services opened the BALANCE model to states, the Public Sector Healthcare Roundtable reports that Indiana is the only state that has committed to participate, while 29 state Medicaid programs have declined, citing cost concerns, budget constraints and doubts about long-term finances. CMS's own model page still lists the number of participants as not applicable.
- Prices
Starbucks to stop covering GLP-1 drugs for weight loss in October
Starbucks will end employer coverage of GLP-1 medications when they are prescribed for weight loss, effective in October, while keeping coverage for diabetes and other approved uses. A 2026 Mercer survey found 6 percent of large employers dropped GLP-1 weight-loss coverage this year and another 5 percent expect to in 2027. GLP-1 drugs made up 11.4 percent of corporate employers' total annual health claims in 2024, up from 6.9 percent in 2023.
- Science
Semaglutide extends lifespan in older female mice, Nature study finds
A Nature paper published September 2, 2026 reports that daily semaglutide given to 20-month-old female mice raised median lifespan to 834 days from 742 days, about 12%. Treated animals also showed better muscle and cognitive function, improved glucose control and fewer signs of inflammation and other aging processes, and outperformed mice on a matched calorie-restricted diet on several measures. The National Institutes of Health, which funded the work, says the results do not imply that similar outcomes could be reached in people right away.
- Prices
Starbucks to end GLP-1 weight-loss coverage for employees in October 2026
Starbucks confirmed it will stop covering GLP-1 medications prescribed for weight loss, effective October 2026, while continuing coverage when the same drugs are prescribed for diabetes and other approved conditions. The change applies to benefits-eligible employees, which at Starbucks includes workers logging at least 20 hours a week. A 2026 Mercer survey found 6% of large employers dropped GLP-1 weight-loss coverage this year, and another 5% plan to do so in 2027.
- Policy
Analyst estimates up to $1.2 billion in annual Lilly sales from Medicare GLP-1 Bridge
The White House said on Aug. 31 that more than 500,000 seniors have used the Medicare GLP-1 Bridge since it opened July 1, saving $216 million, while CMS Administrator Mehmet Oz put sign-ups at about 600,000. Jefferies analyst Akash Tewari annualized that uptake to $1.5 billion to $1.8 billion in manufacturer revenue across the program, with $900 million to $1.2 billion of it going to Eli Lilly.
- Safety
FDA screens GLP-1 ingredients at the border and warns of vials tied to pharmacies that do not exist
The FDA added GLP-1 active ingredients to a green list import alert and warned that vials sold in the U.S. carry labels naming pharmacies that have no corresponding registration. California poison control centers separately report constant calls about unapproved GLP-1 products, including dosing errors from self-drawn vials. A safe-medicine group says it has tracked 50 state pharmacy board actions against unsafe compounders and 160 FDA warning letters.
- Culture
Obesity Action Coalition urges PepsiCo to keep GLP-1 coverage for employees
The Obesity Action Coalition on Sept. 2, 2026 called on PepsiCo to reverse a reported decision to end GLP-1 medication coverage for obesity for some employees beginning in October. The group said affected workers could be directed to manufacturer self-pay programs costing $300 to $500 a month, which it called no replacement for insurance. The OAC also pointed out that PepsiCo is developing products such as Propel Clear Protein aimed at GLP-1 users.
- Safety
Poison control centers report rise in calls tied to unapproved GLP-1 drugs
California's poison control system says it keeps getting calls from people who became sick, some of them hospitalized, after taking GLP-1 drugs, many of them compounded and unapproved. The FDA says unapproved versions do not go through the same federal review for safety, effectiveness and quality, and a safe-medicine group says it has tracked 50 state pharmacy board actions and 160 FDA warning letters since last year.
- Prices
LillyDirect self-pay prices for Zepbound pens and vials match at $299 to $449
A September 2, 2026 pricing review recorded that LillyDirect self-pay prices are now identical for Zepbound KwikPens and single-dose vials: $299 at 2.5 mg, $399 at 5 mg and $449 from 7.5 mg up when refilled within 45 days, against regular prices of $599 to $1,049. Foundayo self-pay runs $149 at 0.8 mg and, temporarily through December 31, 2026, at 2.5 mg, with $299 at the three top doses.
- Business
Lilly's Fogelsville plant wins final land approval in Upper Macungie
Upper Macungie Township supervisors voted unanimously on Sept. 2, 2026, to approve the final land development plan and sewage planning module for Eli Lilly's manufacturing campus in Fogelsville, Pennsylvania, with traffic mitigation made binding on the company. Lilly told the board that peak construction will run from the fourth quarter of 2027 into the first quarter of 2029, with as many as 1,500 workers on site.
- Culture
Zepbound ranked most effective pharma brand in 2025-26 NFL games, EDO says
Pharma ads that ran during 2025-26 NFL regular season games were about 104% more effective than average prime-time pharma ads on broadcast and cable, according to TV measurement firm EDO. Eli Lilly's Zepbound was the most effective brand, at 519% above the average pharma advertiser, and one 60-second Zepbound spot was the season's top individual commercial. In all, 332 pharma ads ran during the 18-week season, a 13% increase from the previous year.
- Business
Zepbound and Mounjaro labels updated, with new heart-risk indication for Mounjaro
Updated prescribing labels for the tirzepatide injections Zepbound (posted August 28, 2026) and Mounjaro (posted August 27, 2026) now cover the full range of approved presentations, from 2.5 mg/0.5 mL single-dose pens and vials to 60 mg/2.4 mL multi-dose vials and KwikPens. The Mounjaro label adds an indication to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high risk, listed as a change dated 08/2026. Both labels also show revised warnings about diabetic retinopathy complications dated 08/2026.
- Safety
FDA adds adverse event counts for compounded semaglutide and tirzepatide to safety page
The FDA's page on unapproved GLP-1 drugs now reports that, as of May 31, 2026, the agency had received 990 adverse event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. The agency says both counts are likely low because many state-licensed pharmacies are not required to report. The page also describes fraudulent compounded products whose labels name pharmacies that do not exist.
- Safety
GLP-1 lawsuits reach 4,238 pending cases across two federal dockets
The Judicial Panel on Multidistrict Litigation's report dated September 1, 2026 lists 4,022 actions pending in MDL 3094, the GLP-1 receptor agonist products liability litigation, and 216 pending in MDL 3163, a separate docket covering non-arteritic anterior ischemic optic neuropathy. Both are assigned to Judge Karen S. Marston in the Eastern District of Pennsylvania.
- Safety
FDA adds border screening for GLP-1 ingredients and warns of fake pharmacy names on compounded vials
The FDA's updated guidance on unapproved GLP-1 drugs adds a green list import alert, numbered 66-80, covering GLP-1 active pharmaceutical ingredients with potential quality concerns, while allowing imports from manufacturers that appear to meet its standards. The same update warns that some compounded semaglutide and tirzepatide products carry false label information, including pharmacy names that do not exist or belong to licensed pharmacies that did not make the drug, and cites one reported adverse event. As of May 31, 2026, the agency had received 990 adverse event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide.
- Compounding
FDA sends warning letters to five peptide sellers listing retatrutide and semaglutide
The FDA issued warning letters dated August 24, 2026 to five online peptide sellers whose websites listed retatrutide, semaglutide, tirzepatide, elamipretide, tesamorelin and bacteriostatic water. All five were cited for selling unapproved drugs, including companies that sold products labeled for research use. The five companies have not been named in reports of the letters.
- Regulation
Appeals court upholds delisting of Ozempic and Wegovy in compounding case
A Fifth Circuit panel ruled on September 1, 2026, that the FDA acted properly in removing the semaglutide drugs Ozempic and Wegovy from the national shortage list, and that any failure to use notice-and-comment procedures was harmless. The unpublished opinion in No. 25-10758 follows a companion tirzepatide decision issued August 27, 2026. The delisting had already closed off the compounding route that outsourcing facilities relied on.
- Safety
Ozempic and Mounjaro injury lawsuits top 4,000 cases as vision claims grow
As of September 2026, 4,022 cases were pending in the federal multidistrict litigation covering gastrointestinal injuries from GLP-1 drugs, and about 200 to 216 cases were pending in a separate docket for NAION vision loss. Both are before Judge Karen S. Marston in the Eastern District of Pennsylvania. No trial has been held and no settlement has been announced in either.
- Safety
GLP-1 injury lawsuits against Novo Nordisk and Eli Lilly reach 4,238 pending cases
The Judicial Panel on Multidistrict Litigation's monthly statistics report shows 4,022 pending actions in MDL 3094, the gastrointestinal-injury proceeding over GLP-1 medications, and 216 in MDL 3163, the vision-loss track. Both remain before Judge Karen S. Marston in the Eastern District of Pennsylvania, with Novo Nordisk and Eli Lilly as defendants. No settlement exists in either proceeding.
- Prices
KFF polling finds low awareness of TrumpRx and persistent GLP-1 cost concerns
KFF polling fielded Feb. 24 to Mar. 2, 2026 found that 35 percent of prescription drug users had heard of TrumpRx, the federal discount drug platform that launched in early 2026, and that 59 percent of adults doubt current policies will meaningfully lower drug costs. Seventy-two percent of adults said the government is not doing enough on drug pricing, and 43 percent of people taking medications said they had adjusted their use because of cost. About one in five adults say they have ever taken a GLP-1 medication, and most users say the drugs are difficult to afford.
- Business
Lilly cuts self-pay prices for two Foundayo doses through the end of 2026
Lilly has temporarily reduced the self-pay price of the 2.5 mg dose of Foundayo to $149 a month from $199, and the 5.5 mg dose to $199 a month from $299, with the lower prices running through December 31, 2026. The company has not published a start date or a reason for the change, and no 2027 pricing has been disclosed.
- Business
More than 20 drugmakers have now signed US drug-pricing deals, including Novo Nordisk and Eli Lilly
More than 20 drugmakers have announced U.S. drug-pricing agreements with the Trump administration, after a second wave in late August 2026 added nine companies offering medicines to state Medicaid programs at most-favored-nation prices. Among the disclosed terms, Novo Nordisk agreed to cut the monthly price of Ozempic from $1,000 to $350 and Wegovy from $1,350 to $350 when bought through TrumpRx, while Eli Lilly agreed to cap Zepbound and Foundayo at $50 a month for Medicare beneficiaries.
- Business
Novo Nordisk begins selling Wegovy pill in Germany, its first EU market
Novo Nordisk started selling the Wegovy pill, oral semaglutide 25 mg, in German pharmacies on September 1, 2026, making Germany the first of the 27 EU member states to stock the tablet. Retail prices vary by dose and sit roughly in line with the Wegovy pen, which runs about €170 to €280 in Germany. The tablet is approved for adults only in the EU, while the injectable is cleared from age 12.
- Business
Securities class action filed against Hims & Hers over privacy and billing disclosures
A securities fraud class action claims Hims & Hers Health misled investors about sharing consumer health information with advertising platforms and about charging customers for prescriptions almost immediately after they submit an intake form. The case covers investors who bought HIMS securities between August 4, 2025 and July 29, 2026, and the lead-plaintiff deadline is November 2, 2026. HIMS stock fell $4.32, or 14.73 percent, to $25.00 on July 29, 2026, the day a Federal Trade Commission privacy lawsuit against the company became public.
- Prices
UnitedHealthcare weight-loss drug coverage rules take effect with BMI 30 threshold
UnitedHealthcare's weight-loss prior authorization program, number 2026 P 1114-22, took effect Sept. 1, 2026. It covers medications including Wegovy, Zepbound and Foundayo, requires a BMI of 30 or higher, or 27 or higher with a related condition, and issues initial approvals of 5 months for Wegovy and 6 months for Zepbound and Foundayo. Renewals for most listed drugs require documented weight loss of at least 5 percent.
- Business
Mounjaro heart label helps diabetes coverage, not obesity coverage, analysts say
The FDA expanded Mounjaro's label on August 28, 2026, to include lowering the risk of cardiovascular death, heart attack and stroke in adults with type 2 diabetes at high cardiovascular risk. A 24/7 Wall St. analysis says that diabetes indication gives Eli Lilly medical-necessity language for cost reviews but does not touch Zepbound's obesity label, where employer coverage fell from 72% in 2025 to 60% in 2026.
- Regulation
Canada approves generic semaglutide after Novo Nordisk lets a C$250 patent fee lapse
Canada has cleared two generic injectable semaglutide products, from Dr Reddy's Laboratories and Apotex, after Novo Nordisk stopped paying a C$250 annual maintenance fee on its Canadian patent starting in 2018. Dr Reddy's version went on sale 15 May 2026, and seven more applications are still under review. Novo Nordisk says the situation is localized and that US exclusivity, which it holds until 2032, is unaffected.
- Research and trials
Tirzepatide 5 mg held cardiometabolic gains after dose step-down in SURMOUNT-MAINTAIN analysis
At the European Society of Cardiology's 2026 meeting, researchers presented a post-hoc analysis of the Phase IIIb SURMOUNT-MAINTAIN trial showing that people whose tirzepatide dose was reduced from the maximum tolerated dose to 5 mg kept improvements in blood pressure and other cardiometabolic markers while maintaining weight reduction. The number of participants, the size of the blood pressure changes and whether the findings were statistically significant have not been disclosed.
- Safety
Higher semaglutide doses linked to fewer new psychiatric diagnoses in large records study
A study published September 1 in npj Metabolic Health and Disease found that among 63,215 semaglutide patients with existing neurological or psychiatric conditions, a higher attained dose was associated with fewer new mood, anxiety and substance-use diagnoses over the following two years. Patients on 1.7 milligrams or more had a 29% lower relative risk of substance-related disorders and 18% lower risk of mood disorders than those on 0.25 to 1.0 milligrams. The pattern did not track with how much weight patients lost, and the observational design cannot show the drug caused the difference.
- Research and trials
Phase 3 liver outcomes trial of tirzepatide and other drugs starts recruiting
A phase 3 master protocol called SYNERGY-Outcomes is recruiting, with a target enrollment of 4,500 adults who have metabolic dysfunction-associated steatotic liver disease; tirzepatide is among the drugs being tested and major adverse liver outcomes is the primary endpoint. Estimated primary completion is August 2030. Which other agents the protocol includes has not been reported.
- Business
Novo Nordisk names Bayer's Andrea Haegebarth head of global research
Novo Nordisk announced on September 1, 2026 that Andrea Haegebarth, most recently Bayer's global head of research and early development for precision medicine, will become its senior vice president of global research effective October 1, 2026. Jacob Petersen, who held the research role, moves to a new position as head of R&D external innovation after more than 25 years at the company. Novo Nordisk spent DKK 52 billion, about US$8 billion, on research and development in 2025, or 16.8% of its sales, and lists 37 pipeline programs, 31 of them in obesity or diabetes.
- Research and trials
Pfizer opens berobenatide Phase 3 trials, starting with monthly-dose obesity study
Pfizer's Phase 3 study of berobenatide (PF-08653944) in adults with overweight or obesity is listed as recruiting on September 4, 2026. Two more Phase 3 trials in Japan list start dates of September 27, and a China trial lists August 31. Berobenatide is an experimental GLP-1 injection, and no approval date has been announced.
- Prices
Reuters details Ozempic, Wegovy and Zepbound prices inside Trump drug-pricing deals
Reuters published a company-by-company reference on September 1, 2026 covering the GLP-1 terms in the Trump administration's drug-pricing agreements. Novo Nordisk agreed to sell Ozempic and Wegovy at $350 a month through TrumpRx, down from list prices of about $1,000 and $1,350, while Eli Lilly agreed to offer Zepbound and Foundayo to Medicare beneficiaries at no more than $50 a month. TrumpRx.gov lists lower figures for some of the same drugs, including Ozempic at $199 a month.
- Prices
Medicaid most-favored-nation deals reach 26 drugmakers, with consumer savings in doubt
On Aug. 31, 2026, the Trump administration said nine more drugmakers agreed to most-favored-nation pricing for Medicaid, bringing the total to 26 companies. The deals apply mainly to Medicaid, cash sales on TrumpRx and certain GLP-1 drugs in Medicare or Medicaid, not to private insurance. A July JAMA research letter estimated $8.6 billion a year in Medicaid savings from the first 17 deals, while the White House says TrumpRx has saved patients more than $700 million.
- Culture
Virtual strength coaching tied to better body composition in Omada GLP-1 program, study finds
A 12-week virtual program that combined GLP-1 medication support with strength-focused activity coaching produced 6.0% average weight loss versus 3.3% with usual care in an evaluation of 245 adults. The program group also lost more body fat (-3.3% vs -1.6%) and showed a larger rise in muscle mass percentage (+0.6% vs +0.2%). The study was run by Omada Health, which sells the program, and all six authors are company employees.
- Competition
CSPC registers 240-person Phase 2 trial of its own diabetes candidate SYH2069
CSPC Ouyi Pharmaceutical has registered a 240-participant Phase 2 study of SYH2069, its own incretin drug candidate, in people with type 2 diabetes not controlled by diet and exercise alone or by metformin. The listing is marked not yet recruiting. The filing sits alongside CSPC's March 2026 obesity and diabetes collaboration with AstraZeneca, which included $1.2 billion upfront and potential payments of about $18.5 billion.
- Science
Lancet Diabetes & Endocrinology editorial questions pace of GLP-1 use
The Lancet Diabetes & Endocrinology published an editorial titled "Soaring GLP-1 receptor agonist use," raising concerns about equity of access, use outside regular monitoring and thin long-term safety data relative to the size of the population now taking the drugs. The piece is a journal position statement, not new trial evidence, and it does not give a count of users or a growth rate.
- Research and trials
Regeneron pushes back Phase 2 completion date for trevogrumab muscle study
Regeneron has moved the primary completion date for a Phase 2 trial of trevogrumab, alone or with garetosmab, added to semaglutide, from May 6, 2026 to June 16, 2026, according to a registry change logged by a trial tracker. Earlier COURAGE data found trevogrumab roughly halved semaglutide-related lean-mass loss, with the garetosmab combination cutting it to 7.4% of total weight lost. No drug in this category is FDA-approved for preserving lean mass.
- Business
Solera adds Noom weight, diabetes prevention and GLP-1 companion programs to its network
Solera Health added Noom to its weight management network effective Sept. 1, 2026, giving health plan and employer members access to Noom Weight, a CDC Full Plus-recognized diabetes prevention program and a GLP-1 Companion at no extra cost. Noom cites company data showing 82% of Noom Weight members lose at least 5% of body weight at one year and 64% of diabetes prevention participants avoid or delay type 2 diabetes. The programs reach members through benefits rather than direct subscriptions.
- Business
Novo Nordisk chief says investors overlook its pipeline beyond the Lilly rivalry
A New York Times profile published September 1, 2026, examines Novo Nordisk chief executive Mike Doustdar about a year into his turnaround effort, reporting that he argues investors are fixated on the company's rivalry with Eli Lilly and are underestimating the breadth of Novo's portfolio and pipeline. The piece frames pills as the company's likely second act after the Ozempic injection, and notes investor concern that the key US semaglutide patent expires early in the next decade.
- Safety
Judge weighs expert testimony on whether GLP-1 drugs cause gastroparesis
A federal judge in Philadelphia is deciding whether scientific experts may testify that Ozempic, Wegovy, Mounjaro and other GLP-1 drugs cause gastroparesis, the central question in about 4,000 pending lawsuits. The expert admissibility motions were fully briefed as of September 2026, and no ruling has been reported. Bellwether trials are expected in mid-to-late 2026 at the earliest.
- Science
Five semaglutide products share the US market with different doses and approved uses
US prescribing labels revised between January and June 2026 cover five semaglutide products: Ozempic injection, Ozempic tablets, Rybelsus tablets, Wegovy injection and Wegovy tablets. One molecule now reaches patients at strengths ranging from 0.25 mg to 25 mg, on daily or weekly schedules, under indications that differ by product.
- Business
Generic liraglutide's acquisition cost runs about 64 percent below brand Victoza
Federal pricing data put the national average acquisition cost for a generic liraglutide 3-pack at about $32.00 per mL effective Aug. 19, 2026, roughly 64 percent below brand Victoza at $87.81 per mL and far under Trulicity at about $487 per mL and the Ozempic pen at about $332 per mL. FDA drug listing records counted 62 liraglutide product records in September 2026, while liraglutide injection remains on the agency's shortage list.
- Science
Semaglutide's U.S. label now covers six approved uses across three brand families
Semaglutide is approved by the FDA for six separate uses in the United States, spread across the Ozempic, Wegovy and Rybelsus brands, according to the drugs' approval histories. The six are type 2 diabetes, cardiovascular risk reduction in type 2 diabetes, chronic kidney disease in type 2 diabetes, chronic weight management, cardiovascular risk reduction in obesity or overweight, and noncirrhotic MASH with moderate to advanced fibrosis.
- Prices
Novo Nordisk sets Wegovy self-pay prices at $349 for pens and $399 for the high dose
Novo Nordisk's published self-pay prices for Wegovy (semaglutide) are $349 a month for the 0.25 mg through 2.4 mg pens and $399 a month for the Wegovy HD 7.2 mg pen. Wegovy pills are listed at $149 to $299 a month depending on dose, and commercially insured patients can pay as little as $25 a month through the savings offer.
- Regulation
Seventh Circuit sets September 24 arguments in Lilly's retatrutide classification appeal
The Seventh Circuit will hear oral arguments on September 24, 2026 in Eli Lilly's appeal of an FDA finding that retatrutide is neither a protein nor a biological product. The ruling decides whether the drug would carry twelve years of market exclusivity as a biologic or five years as a new drug. Lilly has said it aims to file retatrutide with the FDA in the first quarter of 2027.
- Compounding
Compounded semaglutide prices still trail branded Wegovy in late 2026
Price trackers checking in September 2026 listed compounded semaglutide at about $178 to $299 a month, compared with $149 for the starter dose of the oral Wegovy pill and $349 for the Wegovy injection through NovoCare. The gap has kept compounding in business even after the FDA declared the semaglutide shortage resolved in February 2025 and began restricting large-scale production.
- Safety
Ozempic and Mounjaro injury lawsuits pass 4,000 cases with no trial date set
The federal court case combining gastrointestinal-injury lawsuits over GLP-1 drugs reached 4,022 pending cases in September 2026, up from 3,928 in the Judicial Panel on Multidistrict Litigation's August 1 report, with 4,056 actions filed in total. No bellwether trial date has been set, and selection of the first cases still depends on rulings about expert evidence. No settlements have been announced.
- Safety
Study links GLP-1 drugs to higher gallbladder risk in teens and young adults
A research letter in JAMA Pediatrics reports that people aged 12 to 21 with overweight or obesity who took GLP-1 receptor agonists had two- to threefold higher rates of biliary colic, cholecystitis and gallbladder removal in time-to-event analyses than matched nonusers. The analysis matched 18,759 treated patients to an equal number of nonusers using records from the TriNetX Research Network. The authors say the findings extend an established adult safety signal to younger patients and call for vigilance about biliary symptoms.
- Safety
GLP-1 injury liability could top $2 billion as federal lawsuits pass 4,000, analysts estimate
Legal analysts estimate combined liability across the two federal GLP-1 injury cases could exceed $2 billion, according to MDL Update, which tracks the litigation. About 4,022 cases were pending in the gastrointestinal MDL as of September 2026, with roughly 200 vision-loss cases in a separate MDL. No case has gone to trial and no settlements have been announced.
- Science
Wegovy remains the only GLP-1 approved for MASH as tirzepatide review continues
As of September 2026, Wegovy (semaglutide 2.4 mg weekly) is still the only GLP-1 medication with an FDA-approved MASH indication, covering adults with non-cirrhotic disease and moderate-to-advanced fibrosis. In the ESSENCE trial, 62.9% of patients on semaglutide had MASH resolution without worsening fibrosis versus 34.3% on placebo, and 36.8% had fibrosis improvement versus 22.4%. Tirzepatide has no MASH approval and its data remain under FDA review, so prescribing it for MASH is off-label.
- Regulation
Wegovy is under FDA review for a heart failure type tied to obesity
Wegovy (semaglutide) is under review at the FDA for heart failure with preserved ejection fraction, a condition for which no targeted therapy has been approved. In a 529-patient trial, weekly semaglutide 2.4 mg improved a heart failure symptom score by 7.8 points more than placebo and produced 10.7 percentage points more weight loss over 52 weeks. No FDA decision date has been reported.
- Research and trials
Amycretin is renamed zenagamtide as Novo Nordisk presents Phase 2 diabetes data at ADA 2026
Novo Nordisk's investigational GLP-1 and amylin drug, previously called amycretin, is now referred to as zenagamtide in the company's disclosures, which describe it as a single molecule under study for overweight or obesity and for type 2 diabetes. Phase 2b results in type 2 diabetes were listed on the ADA 2026 program alongside Phase 3 CagriSema data; the announcement did not include the zenagamtide trial's numbers. Zenagamtide is not approved in the United States, and no Phase 3 start date or filing plan has been disclosed.
- Competition
Corbus prepares to report Phase 1b results for its CB1 obesity drug CRB-913
Corbus Pharmaceuticals expects topline results in September 2026 from CANYON-1, a 240-participant Phase 1b trial of CRB-913, a drug aimed at the CB1 receptor. The study's final patient visit was completed in August 2026. The readout is an early test of whether CB1 can be pursued as an obesity target without central nervous system side effects.
- Culture
Novo Nordisk's daily Wegovy pill reaches patients as Eli Lilly's oral GLP-1 nears approval
The first once-daily GLP-1 pill for obesity is now in patients' hands in the U.S., with cash prices of $149 to $299 a month depending on dose. Eli Lilly's rival oral drug, orforglipron, is expected to win U.S. approval within months. The pills remove the need for refrigeration and needle disposal that comes with weekly injections.
- Safety
Medicaid cohort study compares GLP-1 use with new depression diagnoses
A multi-state Medicaid cohort study compared baseline use of five GLP-1 receptor agonists — dulaglutide, exenatide, liraglutide, semaglutide and tirzepatide — with newly documented depression diagnoses in adults with type 2 diabetes. It was published in September 2026 in the journal Healthcare. The cohort size, follow-up period and effect estimates have not been disclosed.
- Policy
UK review of obesity pill orforglipron stays open after NICE asks Lilly for more information
The UK's National Institute for Health and Care Excellence asked Eli Lilly for more information about orforglipron after its first committee meeting and has not set a date for a second review. The once-daily obesity pill, branded Foundayo, was authorised in the UK on 10 August 2026, but it is not available on the NHS while that evaluation is open. The appraisal listing carries an expected publication date of 18 November 2026.
- Safety
Optometry briefing tells clinicians to counsel GLP-1 patients on rare vision risk
A September 2026 clinical briefing for optometrists laid out how to counsel patients on GLP-1 medications about NAION, a rare cause of sudden vision loss, advising doctors to document optic-disc anatomy and warn patients rather than withhold treatment. The briefing cites a 2024 study in which NAION occurred in 17 of 194 semaglutide users with type 2 diabetes (8.9%) versus six of 516 matched controls (1.8%).
- Business
Oral GLP-1 weight loss market valued at $6.8 billion after two US pill approvals
Two GLP-1 pills for weight management — oral Wegovy (semaglutide) and Foundayo (orforglipron) — reached the US market roughly three months apart, and a market research report values the oral GLP-1 weight loss category at $6.8 billion in 2025. The report projects the category will reach $92.4 billion by 2034, a 38.2% compound annual growth rate.
- Research and trials
Orforglipron linked to weight loss in adults 65 and older in ATTAIN analysis
A post hoc subgroup analysis published in Obesity Pillars in September 2026 found that adults aged 65 and older taking once-daily oral orforglipron lost between 7.5% and 13.0% of their body weight at 72 weeks, depending on dose and trial, compared with 1.6% to 2.3% on placebo. The paper reports that results were comparable to participants under 65. Gastrointestinal side effects were the most common and generally mild to moderate.
- Business
CMS says about 600,000 Medicare beneficiaries have joined the GLP-1 Bridge program
CMS Administrator Dr. Mehmet Oz said about 600,000 Medicare beneficiaries have enrolled in the Medicare GLP-1 Bridge program in its first two months. Under the program, which opened July 1 and runs through December 31, 2027, eligible beneficiaries pay a flat $50 a month for covered drugs including Wegovy, Zepbound in its KwikPen form, and the oral GLP-1 Foundayo. Out-of-pocket costs for these drugs often exceeded $1,000 a month before the program, and CMS has not reported spending or savings figures.
- Prices
Brazil approves two more synthetic semaglutide pens as interchangeable with Ozivy
Brazil's regulator ANVISA has cleared two more synthetic semaglutide pens — an EMS generic and Germed's Semaclique — as interchangeable with Ozivy, the first such pen it authorized in May 2026. At least seven semaglutide products have now been registered in Brazil since the molecule's patent expired there in March 2026. Brazil generated 59.82% of South American GLP-1 revenue in 2025.
- Safety
People buy unapproved retatrutide online as Lilly presses payment processors
People in the US are buying vials of retatrutide, an experimental weight-loss drug approved by no regulator, from online sellers and mixing doses at home, according to reporting published Aug. 31. In an 80-week trial, patients with severe obesity and heart disease on the highest weekly doses lost an average 22% of body weight, or 55 pounds, according to Eli Lilly. Lilly says it has reported more than 14,000 listings across more than 100 countries and is pressing payment processors and platforms to cut off sales.
- Policy
Teva, Astellas among nine drugmakers joining White House lowest-price Medicaid deals
The White House said on August 31, 2026 that nine more manufacturers signed most-favored-nation pricing agreements, bringing the administration's count to 26 companies covering 89 percent of the branded drug market by its own tally. Alcon, Astellas, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva and UCB are on the list, though Reuters reported Teva said talks were still ongoing. The drugs covered and the size of the discounts have not been released.
- Research and trials
Blood sugar gains fade after stopping semaglutide in type 1 diabetes extension study
Adults with type 1 diabetes and obesity who stopped weekly semaglutide saw a greater decline in time in range over 12 weeks than people who had taken placebo, with a median change of -3.6 percentage points versus +1.5 percentage points. Glucose variability rose more in the semaglutide group, and measures of low blood sugar did not differ significantly between groups. The findings come from a 12-week extension of the ADJUST-T1D trial, published August 31, 2026.
- Safety
Brazil seizures of smuggled semaglutide and tirzepatide nearly triple in first half of 2026
Brazilian customs officers seized more than 76,000 pens, vials and other weight-loss products containing semaglutide or tirzepatide at the Paraguay border in the first half of 2026, nearly three times the total for all of 2025. Brazil's anti-counterfeiting association counted 60,787 units of illegal GLP-1 drugs seized nationwide in 2025, up from 609 in 2024. Officials are investigating 83 deaths and more than 3,600 complications linked to weight-loss drugs recorded since 2018.
- Business
Hims & Hers begins selling branded GLP-1 weight-loss drugs in Australia
Hims & Hers said on August 31, 2026 that it has begun offering branded GLP-1 weight-loss drugs and men's health treatments in Australia, its first Asia-Pacific market, following its acquisition of Australian digital health platform Eucalyptus and its Pilot brand. A company spokesperson said the weight-loss program may include access to branded GLP-1 medications but did not name which ones. Hims expects gross margins to remain below historical levels as it expands internationally, even as international growth lifted monthly revenue per subscriber by 21% from a year earlier.
- Business
Lilly to buy Merida Biosciences for up to $2.88 billion
Eli Lilly agreed on Aug. 31, 2026 to acquire privately held Merida Biosciences for up to $2.88 billion in cash. The deal brings Lilly an early-stage treatment, MER511, in Phase 1 testing for Graves' disease and thyroid eye disease. Lilly says closing is expected in the fourth quarter of 2026.
- Business
Lilly launches Foundayo ad campaign with Martha Stewart
Eli Lilly has begun its first broad consumer advertising campaign for Foundayo, its orforglipron brand, with Martha Stewart as the face of the ads. The campaign went wide in late August 2026 and drew criticism in consumer forums from people who objected to a spokesperson the discussion said does not take a GLP-1 medicine herself. Lilly reported $98 million in Foundayo revenue in the second quarter of 2026, the first quarter the drug appeared in the company's product table.
- Research and trials
Lilly registers 2,001-person Phase 3 trial of orforglipron in people with overweight
Eli Lilly has registered a Phase 3 trial of orforglipron, its oral GLP-1 pill, in 2,001 people who have overweight and are at risk of developing obesity-related complications or of progressing to class 1 obesity. The study is listed as not yet recruiting. Its stated population frames the drug around preventing weight-related disease rather than treating people who already have obesity.
- Research and trials
Lilly reports one-year results for Taltz plus Zepbound in psoriatic disease
In two Phase 3b trials, adults with psoriasis or psoriatic arthritis plus obesity who took Taltz (ixekizumab) and Zepbound (tirzepatide) together held or improved on their Week 36 results at one year. At Week 52, 30.6% of psoriasis patients on the combination hit complete skin clearance plus at least 10% weight loss versus 4.4% on Taltz alone, and 39.2% of psoriatic arthritis patients hit ACR50 plus at least 10% weight loss versus 1.7%. Lilly reported no new safety concerns.
- Safety
Penn study links GLP-1 diabetes drugs to more reported hair loss
A Penn Medicine analysis published in the BMJ found that adults with type 2 diabetes taking GLP-1 medications were 37% more likely to report hair loss than patients taking SGLT2 inhibitors such as Jardiance, and 68% more likely than patients taking DPP4 inhibitors such as Januvia. The study used electronic health records from more than 27,000 patients in one comparison and more than 23,000 in the other. The authors say weight loss is a known cause of hair shedding but that another mechanism is possible.
- Culture
Brazil seizures of smuggled Wegovy and Mounjaro surge as officials investigate deaths
Brazilian authorities seized more than 76,000 GLP-1 pens, vials and other products at the Paraguay border in the first half of 2026, nearly three times the 2025 total, according to the Federal Revenue Service. A separate agency tally counted 60,787 illegal GLP-1 units seized nationwide in 2025, up from 609 in 2024. Officials are investigating 83 deaths and more than 3,600 complications linked to weight-loss drugs since 2018.
- Research and trials
Study finds modest weight loss at starter doses of semaglutide and tirzepatide
Researchers analyzed 534 patients who stayed on the 0.25-milligram starter dose of injectable semaglutide and the same number who stayed on the 2.5-mg starter dose of tirzepatide for at least six months. At one year, average weight loss was 2.2% of body weight with semaglutide and 5.5% with tirzepatide, compared with 13.7% and 20.2% at higher doses in an earlier trial. Side effects were still common at the low doses, and the study was observational, so it cannot prove cause and effect.
- Research and trials
Sciwind begins Phase 3 trial of ecnoglutide in obesity with knee osteoarthritis
Hangzhou Sciwind Biosciences has moved a Phase 3 study of ecnoglutide in people with obesity and knee osteoarthritis from not yet recruiting to recruiting, according to a log that tracks changes to ClinicalTrials.gov. Ecnoglutide is already approved in China for type 2 diabetes and chronic weight management, and Pfizer holds Chinese commercialization rights under a deal worth up to $495 million. The trial's enrollment target, endpoints and completion date have not been reported.
- Policy
Sun Pharmaceutical wins tariff relief in new US drug pricing agreement
Sun Pharmaceutical said its agreement with the U.S. government carries more than two years of relief from Section 232 pharmaceutical tariffs, announced as part of a round of pricing deals President Donald Trump unveiled on Aug 31, 2026. The White House did not release how many medicines the deals cover or the size of the discounts, so the savings for the government and for patients remain unknown. The round follows agreements with 17 large drugmakers, including Eli Lilly and Novo Nordisk, whose weight-loss medicines have produced the largest savings so far.
- Regulation
Zepbound label keeps separate maintenance doses for weight loss and sleep apnea
The revised Zepbound prescribing information, dated August 2026, keeps two indications with different maintenance dose floors: 5 mg, 10 mg or 15 mg once weekly for weight reduction and long-term maintenance, and 10 mg or 15 mg once weekly for moderate to severe obstructive sleep apnea. The label restates that the 2.5 mg starting dose is for initiation only and is not approved as a maintenance dosage, and that safety and effectiveness have not been established in pediatric patients.
- Research and trials
Altimmune's pemvidutide MASH trial is registered as an 1,800-patient Phase 3
Altimmune's Phase 3 study of pemvidutide in MASH is now listed on the federal trial registry as PERFORMA, with an enrollment target of 1,800 participants and a status of recruiting. The size puts the liver program on a scale similar to other large metabolic trials. Altimmune's pemvidutide had already reported a positive Phase 2b in MASH, 15.6 percent weight loss at 48 weeks in obesity, and a Phase 2 win in alcohol use disorder in July 2026.
- Culture
Boston Globe reports pressure on people who take GLP-1s and those who skip them
A Boston Globe feature published Aug. 31 describes people who say they are criticized both for taking a GLP-1 medication and for not taking one, based on interviews rather than survey data. The piece quotes Boston-area residents, a weight-management doctor and a podcast host who studies weight discrimination, including a woman who says she delays medical care to avoid her doctor's repeated push to start a GLP-1. It cites TikTok views for #Ozempic-tagged videos rising from about 2 million in 2021 to 1.2 billion in 2023.
- Compounding
FDA sends 30 warning letters to telehealth firms over compounded GLP-1 ads
The FDA announced on March 3, 2026 that it sent 30 warning letters to telehealth companies over false or misleading claims about compounded GLP-1 products offered on their websites, the second such wave since September 2025. A compliance alert from the law firm Frier Levitt says the agency's enforcement focuses on claims that compounded products are equivalent to approved drugs, implied FDA approval and marketing that suggests the telehealth company made the medicine itself.
- Research and trials
Registry status of Innovent's mazdutide 9 mg obesity trial changes to unknown
The ClinicalTrials.gov record for Innovent Biologics' Phase 3 trial of mazdutide 9 mg in Chinese adults with obesity changed from 'active, not recruiting' to 'unknown,' a status meaning the sponsor has not verified the record within the registry's expected window. The same trial, GLORY-2, reported mean weight loss of 18.55% at 60 weeks for mazdutide 9 mg versus 3.02% for placebo, and 20.08% among participants without type 2 diabetes. Mazdutide is approved in China; no US approval or filing has been disclosed.
- Research and trials
Review finds newer GLP-1 agents outperform older drugs for weight loss in adults without diabetes
An updated systematic review reported August 31, 2026 found that newer GLP-1 receptor agonists and co-agonists produce substantially more weight loss than older agents in adults with overweight or obesity but not diabetes. Pooled trials showed dose-dependent reductions in weight, BMI and waist circumference, and in head-to-head trials tirzepatide and CagriSema each produced greater weight loss than semaglutide. Exact percentage weight-loss figures were not given.
- Safety
Penn study linking GLP-1 drugs to hair loss in diabetes patients draws national coverage
Penn Medicine publicized a study on Aug. 31, 2026, showing that people with type 2 diabetes taking GLP-1 medications were 37% more likely to report hair loss than those taking SGLT2 inhibitors and 68% more likely than those taking DPP4 inhibitors. The study was published in The BMJ on July 22, 2026, and its authors say weight loss is a known cause of hair shedding but that a different mechanism is possible.
- Research and trials
Analysis of 6,239 adults finds semaglutide cut weight, waist size and CRP
A systematic review and meta-analysis published August 31, 2026 pooled nine randomized trials covering 6,239 adults with overweight or obesity but no diabetes. Injected semaglutide was linked to a 12.04-percentage-point greater weight reduction than placebo, a 9.36 cm greater drop in waist circumference and a 40.90-percentage-point greater reduction in the inflammation marker C-reactive protein. Serious adverse events did not differ statistically overall, though one sensitivity analysis showed a higher risk ratio.
- Business
Wegovy 4 mg pill self-pay price rises to $199 as $149 intro offer ends
Novo Nordisk's $149-a-month self-pay price for the 4 mg Wegovy pill (semaglutide) ended on August 31, 2026, and the published price for that dose is now $199 a month. The 1.5 mg pill remains $149 a month, while the 9 mg and 25 mg pills are listed at $299 a month.
- Prices
White House announces pricing deals with nine more manufacturers for TrumpRx
The White House announced most-favored-nation pricing deals with nine additional drug manufacturers on August 31, 2026, expanding the list of medicines discounted through TrumpRx.gov. The nine companies and the drugs they cover have not been published. TrumpRx launched February 5, 2026 with 40 medicines from five manufacturers, including Ozempic at an average of $350 a month and Zepbound at an average of $346.
- Research and trials
Ascletis doses first patient in global Phase 3 trial of oral GLP-1 ASC30
Ascletis Pharma dosed the first participant in a global Phase 3 program for ASC30, a once-daily oral small-molecule GLP-1 receptor agonist, on August 30, 2026. The two trials, AURORA-1 and AURORA-2, together cover about 4,600 participants in the United States, Europe and Canada and will test 20 mg, 40 mg and 60 mg maintenance doses over 72 weeks. The company guides topline results to the third quarter of 2028 and an FDA submission by the end of 2028.
- Culture
Australian advocates say GLP-1 boom is reviving "skinny culture" pressure on women
Health advocates in Australia say the rise of GLP-1 drugs such as Ozempic and Mounjaro is reigniting "skinny culture" and body shame for women, according to an August 30, 2026 report. Advocate Yemi Penn says she has taken a low dose of a GLP-1 for 18 months; GP Angela Kwong says most of her female patients on these drugs take them for health reasons such as prediabetes, perimenopause or fertility. The report cites no study data on how common these experiences are.
- Research and trials
European cardiology group recommends semaglutide and tirzepatide for a type of heart failure
The European Society of Cardiology's updated heart failure guidelines recommend semaglutide and tirzepatide for patients with heart failure with preserved ejection fraction (HFpEF) and obesity, announced at its 2026 Congress in Munich. The same update backs mineralocorticoid receptor antagonists across the ejection fraction spectrum, removes the "mildly reduced" heart failure category, and introduces a new three-part classification for heart attacks.
- Research and trials
Semaglutide and tirzepatide compared with MRAs as fourth-line therapy in resistant hypertension
A retrospective cohort study in eClinicalMedicine used records from 67 US healthcare organizations to compare adults with overweight or obesity and resistant hypertension who started semaglutide or tirzepatide against those who started a mineralocorticoid receptor antagonist as fourth-line therapy. The analysis began with 213,309 eligible patients before propensity matching and measured major adverse cardiovascular events over two years. The two GLP-1 drugs were analyzed together, and the authors describe confounding by indication as the central limitation.
- Science
Novo Nordisk brings oral semaglutide heart data to ESC 2026, framing organ protection over weight loss
Novo Nordisk presented cardiovascular analyses of oral semaglutide at the European Society of Cardiology Congress in Munich, held Aug. 28–31, 2026, including a Sunday presentation on outcomes by baseline blood pressure control in people with type 2 diabetes at high cardiovascular risk. Company medical affairs framed the program around organ protection, and a vice president said mediation analyses suggest weight loss explains only part of semaglutide's cardiovascular benefit.
- Regulation
FDA adds heart risk claim to Mounjaro, a first for dual GIP/GLP-1 drugs
The FDA on Aug. 28, 2026 approved Mounjaro (tirzepatide) to lower the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with type 2 diabetes at high risk for those events, making it the first dual GIP and GLP-1 receptor agonist with a cardiovascular claim. In the SURPASS-CVOT trial, tirzepatide was non-inferior to dulaglutide, with an 8% lower rate of MACE-3 that did not reach statistical significance for superiority.
- Regulation
FDA adds heart risk reduction to Mounjaro's label for type 2 diabetes
The FDA approved Mounjaro (tirzepatide) to lower the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with type 2 diabetes at high risk for those events. The decision follows SURPASS-CVOT, which compared tirzepatide with dulaglutide in 13,299 adults over a median 210.1 weeks and produced a hazard ratio of 0.92 (95.3% CI 0.83 to 1.01). Non-inferiority was met; superiority was not established.
- Business
FDA approves Mounjaro to lower heart attack and stroke risk in type 2 diabetes
On August 28, 2026, the FDA approved Mounjaro (tirzepatide) to lower the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with type 2 diabetes at high risk for those events. The decision rests on SURPASS-CVOT, a 13,299-person trial that found an 8% lower rate of those events than dulaglutide (Trulicity), meeting non-inferiority but not superiority.
- Business
Foundayo passes 40,000 weekly US prescriptions 20 weeks into launch
Eli Lilly's oral GLP-1 Foundayo recorded 40,862 weekly US prescriptions in the week reported Aug. 28, its 20th week on the market and its first week above 40,000, according to IQVIA data cited by Citi. Novo Nordisk's Wegovy pill had reached roughly 57,000 weekly prescriptions by week 6 of its launch. Later weekly updates put Foundayo at about 44,000 and then 47,500 total prescriptions, while the Wegovy pill was near 183,000.
- Competition
India's cheap generic semaglutide sales lag far behind forecasts
Sales of copycat GLP-1 drugs in India reached only about 20% of the $261 million that Nomura had projected for all of 2026, according to Pharmarack data reported by Bloomberg. Generics launched after India's March patent expiry at prices up to 80% below Novo Nordisk's, yet distribution, pen supply and physician habits slowed adoption. Semaglutide remains patent-protected in the US until 2032.
- Prices
Canada's generic semaglutide prices to step down to 35% of brand with three sellers
Canada's pan-Canadian Pharmaceutical Alliance pricing framework ties generic semaglutide prices to the number of manufacturers on the market: the first entrant sells at 75% to 85% of the brand list price, the second at about 50%, and three or more at 35%. Applied to current Canadian brand prices of C$86.40 to C$663 for Ozempic and C$270 to C$550 for Wegovy, the final tier points to roughly C$100 a month out of pocket once three generics are selling.
- Culture
Essay asks what widespread Ozempic and GLP-1 use means for Jewish food traditions
Hadassah Magazine published an essay by Hilary Danailova on how GLP-1 drugs affect Jewish food culture, citing Gallup polling that found U.S. use of the medications quadrupled from 3 percent of Americans in 2024 to more than 11 percent in 2026. The piece also cites endocrinologists who say about 10 percent of patients do not respond to the drugs and that no good predictors of response exist.
- Regulation
FDA approves Mounjaro heart-risk indication and keeps 2.5 mg dose on the label
On Aug. 27, 2026, the FDA added an indication letting Mounjaro (tirzepatide) reduce the risk of cardiovascular death, heart attack or stroke in adults with type 2 diabetes who are at high risk for those events. The same action added language saying the 2.5 mg weekly dose can be used for ongoing blood sugar control. The heart indication rests on SURPASS-CVOT, which enrolled 13,299 adults and found Mounjaro non-inferior to Trulicity (dulaglutide), with an 8% lower rate of MACE-3.
- Compounding
Fifth Circuit upholds FDA removal of tirzepatide from shortage list
The Fifth Circuit affirmed the FDA's decisions removing tirzepatide injection products from the national drug shortage list, holding that any failure to use notice-and-comment rulemaking was harmless and that the shortage determination was not arbitrary or capricious. A companion opinion issued the same day upheld the FDA's removal of semaglutide injection products for the same reasons.
- Prices
Novo Nordisk confirms $675 US list price for Wegovy, Ozempic and Rybelsus in 2027
Novo Nordisk has confirmed that US list prices for its semaglutide medicines Wegovy, Ozempic and Rybelsus will fall to $675 per month for all doses on January 1, 2027, about 50% below the current Wegovy list price and roughly 35% below Ozempic's. List price is a health-system benchmark rather than what most patients pay, and the company says the change does not affect its self-pay pricing programs.
- Research and trials
Review proposes adaptive maintenance framework for weight loss care after GLP-1 drugs
A review published in Obesity Pillars proposes an "adaptive maintenance" framework for care after weight loss on GLP-1 and dual GLP-1/GIP medications, moving beyond a choice between indefinite maximum-dose treatment and stopping. The paper lists strategies for formal study, including monitored dose reduction with predefined re-escalation criteria, switching to an oral agent, reduced-frequency dosing and intermittent rescue therapy, and states that continued medication has the strongest direct evidence for limiting weight regain. The authors describe the framework as conceptual and say its monitoring thresholds need prospective validation.
- Competition
William Blair review maps obesity drug readouts through the end of 2026
A William Blair review circulated after second-quarter earnings lays out the remaining 2026 catalysts for companies chasing third place in obesity, including Roche's Sept. 28 Pharma Day, AstraZeneca amylin data at EASD, Pfizer's plan to advance ten berobenatide Phase 3 trials, Novo Nordisk's Phase 3 starts for zenagamtide and high-dose cagrilintide, and a fourth-quarter CagriSema decision. Obesity therapeutics reached $66 billion in sales in 2025, and IQVIA projects $105 billion to $200 billion by 2027 and beyond.
- Regulation
China begins review of Novo Nordisk's oral Wegovy
China's National Medical Products Administration has accepted Novo Nordisk's marketing application for the tablet form of Wegovy, the company said Aug. 27, 2026, opening a formal review. Acceptance does not mean approval, and Novo has not given a date for a decision. Eli Lilly filed for its own weight-loss pill, orforglipron, with the same regulator at the end of 2025 and has said a Chinese launch could come as soon as this year.
- Business
Study finds higher suicide-related reporting odds for semaglutide and liraglutide
An analysis of 42,941 European adverse-event reports filed from 2021 through 2025 counted 37 suicide- or self-injury-related cases for liraglutide, 141 for semaglutide and 47 for tirzepatide. Compared with tirzepatide, the reporting odds ratio was 2.54 for liraglutide and 2.69 for semaglutide. The authors say the findings do not establish causation and do not contradict regulators' conclusions.
- Regulation
Appeals court upholds FDA delisting of Mounjaro and Zepbound, citing $23 billion in Lilly capacity spending
The Fifth Circuit on August 27, 2026 affirmed the FDA's decision to remove Mounjaro and Zepbound from the national drug shortage list, rejecting compounding groups' challenge. The opinion records that Eli Lilly spent about $23 billion building and acquiring manufacturing capacity while the tirzepatide drugs were listed short, and that the FDA found supply would meet or exceed projected demand.
- Culture
Arla Foods Ingredients credits GLP-1 product demand for 19.3% revenue growth
Arla Foods Ingredients reported revenue growth of 19.3%, citing whey protein pricing and demand from products formulated for GLP-1 users as contributors. The figure is company-reported and was not broken out by end market, so how much of the gain came from GLP-1-related products has not been disclosed.
- Business
Deutsche Bank downgrades Novo Nordisk, sending shares down about 3%
Deutsche Bank cut its rating on Novo Nordisk and lowered its price target to 265 Danish kroner from 290 kroner, sending the stock down as much as 2.9% on Thursday. The bank cited doubts about a return to growth in 2027, a looming patent cliff, and the removal of ziltivekimab from the near-term earnings outlook after a late-stage trial failure. The downgrade landed about three weeks before Novo Nordisk's Capital Markets Day in London on September 21.
- Research and trials
Lilly registers 192-person Phase 3 trial of orforglipron in Chinese adults with obesity
Eli Lilly has registered a Phase 3 study of orforglipron, its oral GLP-1 pill sold in the U.S. as Foundayo, in 192 Chinese adults with obesity or overweight and weight-related health problems. The listing is marked not yet recruiting, and no start date has been disclosed. The move extends the pill's late-stage program into a market where Lilly and Novo Nordisk are competing hard for oral GLP-1 prescriptions.
- Research and trials
Novo Nordisk opens Korean Phase 3 trial of CagriSema in Asian adults
Novo Nordisk received Korean regulatory approval on August 26, 2026, for a Phase 3 trial of CagriSema in about 400 overweight or obese adults in Asia, with weight change at 80 weeks as the primary endpoint. CagriSema is an investigational weekly combination of cagrilintide and semaglutide that is not approved in the US or EU, and an FDA decision is expected in the fourth quarter of 2026 based on the REDEFINE 1 and REDEFINE 2 trials. In the REDEFINE 4 head-to-head trial, CagriSema did not show non-inferiority to tirzepatide 15 mg at 84 weeks.
- Safety
Mounjaro and Zepbound labels updated after cardiovascular trial
The FDA approved prescribing information changes for the two tirzepatide drugs, Mounjaro and Zepbound, based on the SURPASS-CVOT cardiovascular outcomes trial. Mounjaro gained an indication to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high risk, and both labels had their diabetic retinopathy warning revised. Zepbound's approval letter was signed Aug. 26, 2026, and Mounjaro's on Aug. 27, 2026.
- Prices
Judge lets Zepbound formulary lawsuit against CVS Caremark proceed
A federal judge in New York denied CVS Caremark's motion to compel arbitration and let part of a lawsuit proceed over the removal of Zepbound from its preferred drug lists, according to an August 26, 2026 order. The plaintiffs, who say their Zepbound coverage was denied on June 19 and July 1, 2025, have until September 25, 2026 to file an amended complaint.
- Prices
CVS and Walgreens say they have filled about 100,000 prescriptions each in Medicare's GLP-1 Bridge program
CVS and Walgreens each told NPR they have filled roughly 100,000 prescriptions through Medicare's GLP-1 Bridge program, which began July 1 and charges eligible beneficiaries $50 a month. Walmart did not provide a figure but said its Bridge fills have grown week over week. A USC Schaeffer Institute scholar estimated the visible volume is 5 to 10 percent of the roughly 4 million beneficiaries Medicare expected to qualify.
- Prices
KFF projects Medicare GLP-1 Bridge costs of $1.3 billion to $10 billion
KFF estimates the Medicare GLP-1 Bridge will cost between $1.3 billion and $10 billion over its 18 months, depending on participation among the roughly 4 million beneficiaries CMS expected might qualify. The program, which offers eligible beneficiaries obesity drugs for $50 a month, began July 1, 2026, and runs through 2027. CMS has not published a cost estimate or enrollment totals.
- Competition
Preprint links unapproved retatrutide to weaker weight loss and heart symptoms
A preprint analysis of electronic health records confirmed unapproved retatrutide use in 652 patients, with new use rising 1.8-fold per quarter from October 2023 through March 2026. Gray-market users lost 7.2% of body weight over 6 to 12 months, against 15.5% for trial participants and 7.7% for matched tirzepatide users, while showing a heart-rate rise and more cardiovascular symptoms. Retatrutide is not FDA approved and has no lawful route to purchase in the United States.
- Competition
AbbVie starts Phase 2 trial of amylin analog ABBV-295
AbbVie has begun a Phase 2 trial of ABBV-295, an experimental amylin analog for obesity, and partner Gubra said it received a milestone payment because that trial started. The move follows Phase 1 results reported in March 2026, in which weekly doses produced average weight loss of 7.75% to 9.79% at 12 weeks, compared with -0.26% for placebo. The size of the milestone payment was not disclosed.
- Culture
Researchers call for eating disorder screening as GLP-1 use grows
Researchers at Adelaide University say the rapid spread of GLP-1 medicines such as Ozempic and Mounjaro has collapsed the traditional separation between obesity treatment and eating disorder treatment, because the same patients now move between both. In a paper in the Journal of Eating Disorders, they call for eating disorder screening before and during GLP-1 therapy and for shared care pathways. No guideline body has been reported to require such screening.
- Business
Construction tracker puts Lilly's GLP-1 build-out above $13 billion at its Indiana site
A construction tracker published Aug. 27, 2026 reports that Eli Lilly is investing more than $13 billion at its Lebanon, Indiana complex and has $3.2 billion of international construction underway, with another $3.7 billion in planning. Oral GLP-1 projects include a Houston API campus, a Puerto Rico building addition expected to contribute to oral-dose production in 2029, and a $6 billion campus in Huntsville, Alabama. A separate report published Sept. 7, 2026 says Lilly's US manufacturing investment since 2020 will pass $50 billion, with four new sites planned.
- Culture
Higher digital platform engagement tied to staying on semaglutide in 48-week study
A 48-week observational study of 191 adults with severe obesity found that persistence with semaglutide rose with engagement in a digital assessment platform, from 59.5% among those who never used it to 79.5% among those who completed its questionnaires. Mean weight loss was 14.6% among people who stayed on treatment, and persistence explained about 69% of the link between engagement and weight loss.
- Regulation
FTC sues Hims & Hers over health data sent to advertising platforms
The FTC, Utah and Los Angeles County on behalf of California sued Hims & Hers on July 29, 2026, alleging the telehealth company sent customers' health information to advertising platforms while promising a private process, and separately billed people before any provider consultation. Tracking code from at least fifteen ad platforms ran on the Hims site, according to a review of the complaint. Hims & Hers has recorded a roughly $60 million legal accrual and says it will vigorously defend itself.
- Research and trials
JAMA Psychiatry study links semaglutide and tirzepatide to lower mortality in serious mental illness
A target trial emulation in JAMA Psychiatry matched more than 1.5 million adults and found that starting a GLP-1 receptor agonist was associated with lower four-year mortality than starting an SGLT2 inhibitor, with a larger absolute difference in people with serious mental illness (4.91% vs 6.45% of deaths). The mortality gap was already visible at one year, and the paper says the benefits were driven by semaglutide and tirzepatide.
- Science
Lilly study links Zepbound to lower medical costs in adults over 55
Eli Lilly said Aug. 26, 2026 that a company-funded real-world study found adults over 55 with overweight or obesity who stayed on Zepbound had lower medical costs than similar untreated adults, with differences of up to $181 per patient per month at six months and up to $607 at 12 months. The analysis excluded the cost of Zepbound itself, so the figures reflect potential savings that could offset the drug's price rather than net treatment costs. The study was published in Diabetes, Obesity and Metabolism.
- Research and trials
Meta-analysis: liraglutide and semaglutide yield about 9% weight loss after bariatric surgery
A systematic review and meta-analysis published August 25, 2026 found that adults who started an incretin receptor agonist at least one year after metabolic bariatric surgery lost an additional 9.22% of body weight at 12 months with liraglutide and 9.02% with semaglutide, measured from the start of drug treatment. At six months, tirzepatide produced 4.23 percentage points more total weight loss than semaglutide. No serious adverse events were reported, but the authors caution that the studies were highly varied.
- Policy
Obesity Action Coalition calls Medicare GLP-1 Bridge a step forward, not a fix
The Obesity Action Coalition published its first assessment of the Medicare GLP-1 Bridge on August 26, 2026, calling the July 1 launch an important policy step that still leaves access barriers and does not amount to comprehensive obesity care. The Bridge gives eligible Medicare Part D beneficiaries certain GLP-1 medications for chronic weight management for a $50 monthly copay through December 31, 2027. The group also reported that the Treat and Reduce Obesity Act has reached 51 House and 19 Senate cosponsors.
- Prices
Walgreens says about half of its Medicare Bridge patients had never taken a GLP-1
Walgreens' chief pharmacy officer Rick Gates told NPR that roughly half of the patients the chain has served through Medicare's GLP-1 Bridge program had never taken a GLP-1 before, and that demand exceeded the company's expectations. CVS and Walgreens say they have each filled about 100,000 Bridge prescriptions since the $50-a-month program began July 1, and Walgreens reports no supply problems so far.
- Policy
White House plans new round of Medicaid drug-pricing deals with midsize biotechs
The White House plans to announce a new round of drug-pricing agreements with several midsize biotech companies on Monday, Bloomberg News reported. Under the voluntary deals, the companies would discount outpatient drugs for state Medicaid programs so state prices align with what they charge in foreign countries, and participation by states would remain optional. The administration has projected $64.3 billion in combined federal and state Medicaid savings over 10 years from the framework.
- Research and trials
Pfizer files Phase 3 trial of once-monthly berobenatide in Japan
Pfizer has submitted VESPER-JM, a Phase 3 randomized, double-blind, placebo-controlled study of once-monthly berobenatide in about 197 Japanese adults with obesity disease, with a listed start date of Sept. 27, 2026. A companion Japanese trial, VESPER-JW, tests a once-weekly version in about 180 adults. Participants stay on treatment and follow-up for roughly 21 to 22 months, which puts topline results years away.
- Business
Novo Nordisk tells FDA it will discontinue Saxenda in January 2027
Novo Nordisk has notified the FDA that it will stop making Saxenda, its liraglutide injection for weight loss, and that the product will be available until a January 2027 discontinuation. The FDA posting, dated Aug. 25, 2026, gives the reason as discontinuation of the manufacture of the drug. The same FDA update lists both package sizes of Victoza, a liraglutide product for type 2 diabetes, as having limited availability because of a shipping delay.
- Prices
Medicare's $50 GLP-1 discount skips an estimated 5.9 million enrollees with treatable conditions
A KFF Health News investigation published Aug. 25, 2026 estimates that 5.9 million Medicare enrollees cannot get the Medicare GLP-1 Bridge program's $50 monthly price because they already have a diagnosis that FDA-approved GLP-1s are cleared to treat, such as type 2 diabetes or moderate-to-severe obstructive sleep apnea. Those beneficiaries are sent back to their Part D drug plan, where copays for the drugs can run $200 to $600 a month. Juliette Cubanski of KFF estimates 3.8 million people qualify for the discount and that Medicare would spend about $3.3 billion if a quarter of them stay enrolled for the full 18 months, or about $10 billion if three-quarters do.
- Prices
Employer survey finds 14 percent have dropped or plan to drop GLP-1 coverage for 2027
A Business Group on Health survey released August 25 found that about 14 percent of US employers have already ended or plan to end GLP-1 drug coverage in 2027. The share of employers covering the medicines for weight loss fell from 72 percent in 2025 to 60 percent in 2026, and employers project a 9.2 percent rise in healthcare costs for 2027 without new cost controls.
- Culture
Chipotle, Shake Shack and Smoothie King add menus aimed at GLP-1 users
Three fast-casual chains — Chipotle, Smoothie King and Shake Shack — are now flagging some menu items as "GLP-1 friendly," ABC News reported on Aug. 25, 2026. Gallup data cited in the report show 11% to 12% of U.S. adults took GLP-1 medications in 2026, up from 3% two years earlier. A 2026 restaurant industry survey found that people on the drugs buy restaurant food about 7.6 times a week, compared with 5.1 times for other diners.
- Regulation
Prime Therapeutics lists four GLP-1 FDA decisions due by December
A pharmacy benefit manager's August 2026 pipeline update lists four pending FDA decisions for GLP-1 drugs in late 2026: a cardiovascular indication for Mounjaro in the third quarter, Foundayo (orforglipron) for type 2 diabetes and an Ozempic 25 mg tablet in the fourth quarter, and CagriSema for weight management in December. Prime Therapeutics called the CagriSema decision the largest single catalyst left in the year.
- Culture
Large employer GLP-1 weight loss coverage falls to 60% from 72%, survey finds
The share of large U.S. employers covering GLP-1 drugs for weight management fell to 60% in 2026 from 72% in 2025, according to the Business Group on Health's 2027 Employer Healthcare Strategy Survey. Fourteen percent of employers said they have already ended that coverage or plan to end it in 2027. The survey was released Aug. 25, 2026, and drew on 127 large employers representing about 11 million covered lives.
- Prices
PepsiCo to drop weight-loss drug coverage for some employees in October
PepsiCo told some employees that its health insurance will stop covering prescription weight-loss drugs in October 2026, Bloomberg reported, citing an internal email that called the medications a fast-rising cost. Eli Lilly chief executive David Ricks said on Aug. 31 that employer coverage changes are roughly balanced overall and that companies pay for obesity whether or not the drugs are covered.
- Research and trials
VA/DoD obesity guideline discourages stopping effective GLP-1 weight-loss drugs
Annals of Internal Medicine published a synopsis of the 2025 VA/DoD clinical practice guideline on adult overweight and obesity management, which discourages discontinuing effective medications to prevent weight regain. The guideline, based on evidence published from April 1, 2019, through January 6, 2025, found insufficient evidence to recommend delaying pharmacotherapy until a lifestyle program is completed. It contains 23 recommendations, including 8 new ones.
- Competition
Genentech licenses Hanmi obesity candidate in deal worth up to $2.3 billion
Genentech has licensed an obesity drug candidate from Hanmi Pharmaceutical in a deal worth up to $2.3 billion, announced in August 2026. The candidate is based on UCN2 and is not a GLP-1 drug, setting it apart from semaglutide, the molecule in Ozempic, Wegovy and Rybelsus. Neither company has disclosed the upfront payment, the milestone schedule or how far along the candidate is in testing.
- Regulation
Prime Therapeutics puts a fourth-quarter 2026 window on a Foundayo diabetes decision
Prime Therapeutics' August 2026 GLP-1 pipeline update says Eli Lilly submitted orforglipron, sold under the brand name Foundayo, for type 2 diabetes in the second quarter of 2026 under the Commissioner's National Priority Voucher pilot, making an approval possible in the fourth quarter of 2026. The same update placed the Mounjaro cardiovascular indication in the third quarter, and the FDA granted that indication on August 27. Prime notes that voucher-based timelines are estimates, not published PDUFA dates.
- Business
Business Post tallies Novo Nordisk's written-off deals as ziltivekimab setback lingers
Business Post reported on August 25, 2026 that Novo Nordisk has spent billions of dollars on acquisitions that were later impaired or written down, and that it is pursuing legal action against KBP Biosciences. The report puts that record against the July 31 failure of ziltivekimab, which missed its primary endpoint in the ZEUS trial in more than 6,300 patients and helped send Novo shares down nearly 9 percent, wiping out roughly $30 billion in market value in a day.
- Research and trials
Commentary calls for pediatric safety research on tirzepatide in youth type 2 diabetes
A commentary published August 25, 2026 in AME Clinical Trials Review reviews the SURPASS-PEDS trial and reports that tirzepatide lowered HbA1c by 2.23 percentage points on average over 30 weeks in children and adolescents with type 2 diabetes, compared with a 0.05-point rise on placebo. The authors say the drug was effective and safe in the short term, but that questions about growth, puberty, bone accrual and long-term adherence remain open. They call for dedicated safety follow-up in children rather than extrapolation from adult trials.
- Culture
Nestlé and supplement makers push companion nutrition products for GLP-1 users
Food, supplement and drug companies are competing for a "companion nutrition" market aimed at people taking GLP-1 medications, targeting protein shortfalls, digestive discomfort and nutrient gaps. A Gallup web survey of 5,065 U.S. adults, conducted May 28 to June 5, 2026, found 11% of U.S. adults were currently taking the medications for weight loss. No randomized trial results showing these products change GLP-1 outcomes have been reported.
- Culture
Guardian asks eating disorder experts how to talk about bodies in the Ozempic era
The Guardian published an advice feature on August 25, 2026 in which eating disorder specialists said people should stop commenting on other people's bodies, including compliments, now that GLP-1 drugs have made visible weight change common. Dr. Ulrike Schmidt of King's College London cited a 2023 Butterfly Foundation report finding that 57% of young people were dissatisfied with how they look and that 49% said this had sometimes stopped them from attending school.
- Compounding
FDA warning letters name tirzepatide sold by three online peptide sellers
The FDA posted warning letters dated Aug. 24, 2026 to NuScience Peptides, Royal Peptides and TXP Innovations, which does business as Tex Peptides, listing tirzepatide, semaglutide and retatrutide among products the agency calls unapproved new drugs. Each letter gives the company 15 business days to answer in writing. The violations stem from FDA reviews of the three websites in July 2026.
- Compounding
FDA tally of adverse event reports for compounded GLP-1s passes 1,700
The FDA had received 990 reports naming compounded semaglutide and more than 730 naming compounded tirzepatide as of May 31, 2026, a combined total above 1,700. A report does not prove the drug caused the problem, and the agency says the real number is probably larger because many state-licensed pharmacies are not required to file reports.
- Compounding
Lilly and Novo file 10 advertising challenges against compounded GLP-1 sellers
Eli Lilly and Novo Nordisk have filed 10 cases in the past year with BBB National Programs' National Advertising Division against compounders and telehealth companies selling unapproved GLP-1 drugs. Novo says it has filed 130 federal lawsuits and five NAD challenges, while Lilly has filed dozens of federal suits and at least five NAD cases. Challenged advertisers have voluntarily dropped or modified claims, and the NAD can refer companies that do not take part to the FTC and state attorneys general.
- Research and trials
Novo Nordisk begins first Phase 3 trial of zenagamtide and registers two more
Novo Nordisk has begun enrolling AMBITION 7, a 1,778-person Phase 3 trial comparing the experimental drug zenagamtide with insulin glargine in people with type 2 diabetes. Two more Phase 3 studies were registered: AMAZE 7, which compares zenagamtide with semaglutide in people with excess body weight, and AMAZE 9, which tests zenagamtide tablets. Both are listed with planned September 2026 start dates.
- Research and trials
Amgen opens enrollment in MARITIME-2 extension testing less frequent MariTide dosing
Amgen's MARITIME-2 long-term extension, a Phase 3 study testing monthly and every-eight-week MariTide dosing for maintaining weight loss in adults with obesity or overweight and type 2 diabetes, moved from not yet recruiting to recruiting on Aug. 24, 2026. A parallel extension of MARITIME-1 is testing monthly, every-eight-week and quarterly maintenance dosing in people without diabetes. The two extensions are where Amgen's stated goal of four to six doses a year for maintenance will be tested; enrollment targets and completion dates have not been reported.
- Regulation
FDA sends warning letters to five peptide sellers over unapproved drugs
The FDA issued warning letters dated Aug. 24, 2026, to five peptide sellers: Royal Peptides LLC, NuScience Peptides LLC, Peak Performance Peptides, Peptide Partners LLC, and TXP Innovations LLC, which does business as Tex Peptides. Each letter is listed under the subject "Unapproved New Drugs/Misbranded" and was posted publicly on Sept. 1, 2026. The specific peptides involved have not been disclosed.
- Competition
Eli Lilly launches Foundayo weight-loss pill in the UK at about £100 to £120 a month
Eli Lilly began selling Foundayo, its once-daily orforglipron tablet, in the UK on 24 August by private prescription, at a likely price of £100 to £120 (about $136 to $164) a month. The MHRA authorised the drug on 10 August for weight management and type 2 diabetes, but NHS coverage depends on a NICE appraisal that has no date set for a second committee meeting.
- Compounding
Lilly and Novo take GLP-1 copycat fight to advertising review board
Eli Lilly and Novo Nordisk have filed 10 combined cases in the past year with BBB National Programs' National Advertising Division, a self-regulatory body that resolves advertising disputes faster than litigation. Novo has filed 130 federal lawsuits and five NAD challenges; Lilly has filed dozens of federal lawsuits and at least five NAD challenges. Compounding companies have voluntarily dropped or changed challenged claims in the cases decided so far.
- Compounding
Lilly and Novo widen compounding fight as court lets 503B ad claim proceed
Eli Lilly and Novo Nordisk have filed 10 cases in the past year with the advertising industry's self-regulatory National Advertising Division against compounders and telehealth companies selling copies of their GLP-1 drugs. Separately, a South Carolina federal court on Aug. 6, 2026 let a Lanham Act false-advertising claim proceed over a compounder's statements that it complied with Section 503B, a route that attacks marketing claims rather than whether a compounded drug is lawful.
- Compounding
Noom and Willow Health drop challenged compounded GLP-1 claims after NAD rulings
Noom agreed in May 2026 to modify or discontinue its "A Smaller Dose. A Smarter Start. Microdose GLP-1Rx Starts at $119" claim after the National Advertising Division found it conveyed an unsupported message that a smaller dose itself delivered a health benefit, and it separately dropped other dosing, efficacy and side-effect claims. Willow Health Services, which had been referred to the FTC and state attorneys general after a December 2025 decision, returned to NAD and in July 2026 permanently discontinued all challenged claims for its compounded semaglutide. Lilly and Novo Nordisk have filed 10 cases against compounders and telehealth companies with NAD over the past year.
- Regulation
UK watchdog seeks more data on Lilly's Foundayo as the weight-loss pill goes on private sale
NICE has asked Eli Lilly for more information on its oral weight-loss pill Foundayo after a first appraisal committee meeting, with no date set for a second review. The drug, known chemically as orforglipron, launched in the UK on August 24 through private prescription at roughly £100 to £120 a month, below the £330 monthly private price of Lilly's Mounjaro injection. NHS coverage depends on the outcome of the NICE assessment, and the pill is still under review in the European Union.
- Research and trials
Novo Nordisk wins Korean approval for three phase 3 zenagamtide trials
South Korea's drug regulator cleared three phase 3 studies of zenagamtide, Novo Nordisk's single-molecule GLP-1 and amylin drug formerly called amycretin. One of them, AMBITION 4, compares a low dose of zenagamtide with semaglutide in 1,060 people with type 2 diabetes. The Korean trials are due to begin in October.
- Competition
Novo, Lilly and Innovent use obesity awareness campaigns to work around China's prescription drug ad ban
A Reuters investigation published on Aug. 24, 2026, found that Novo Nordisk, Eli Lilly, Pfizer and China's Innovent Biologics promote weight-loss medicines in China through disease-awareness ads, subway billboards and social-media posts that never name the products, which Chinese rules bar them from advertising directly to consumers. Hospital staff in Shanghai and Guangzhou said patients who once asked for Novo's semaglutide (Wegovy) now more often request Lilly's tirzepatide (Mounjaro) and Innovent's mazdutide (Xinermei). Analysts at JP Morgan estimate GLP-1 weight-management sales in China could reach 30 billion yuan within five to seven years, up from about 3 billion to 4 billion yuan now.
- Regulation
UK court grants Novo Nordisk dynamic order to block counterfeit semaglutide sites
The English High Court issued a dynamic website-blocking order requiring internet service providers to block sites selling counterfeit and unlicensed medicines, after an earlier order covered four target websites plus mirror sites. Novo Nordisk, the UK marketing authorisation holder for Ozempic and Wegovy, can now self-certify new sites for blocking without returning to court.
- Research and trials
Orforglipron linked to about 13% weight loss in adults 65 and older in trial analysis
A post hoc analysis of the ATTAIN-1 and ATTAIN-2 trials found that adults 65 and older taking orforglipron lost an average of 12.2% to 13% of body weight at the 17.2 mg dose over 72 weeks, compared with about 2% with placebo. Results in the older subgroup were broadly consistent with those in younger participants, and gastrointestinal side effects were the most common. The analysis was not designed as an independent test of efficacy.
- Research and trials
Tirzepatide linked to lower one-year cardiovascular event rate than sitagliptin in real-world analysis
A population-based cohort study in The BMJ of 52,971 US adults with type 2 diabetes and established cardiovascular disease found a one-year rate of major adverse cardiovascular events of 2.9% among those who started tirzepatide, compared with 4.4% among those who started sitagliptin. Tirzepatide was also associated with fewer infections requiring hospital admission (hazard ratio 0.64) and fewer infection-related deaths. The analysis was observational, and the authors said the mortality findings may be especially susceptible to residual confounding.
- Culture
Reuters feature describes how Lilly and Novo promote weight-loss drugs in China despite ad ban
A Reuters feature by Andrew Silver, published Aug. 24 by The Japan Times and Aug. 26 by Kyodo News, described obesity-awareness banners, stadium ads and gym events used in China by Eli Lilly, Novo Nordisk, Pfizer and Innovent Biologics, where prescription medicines cannot be advertised directly to consumers. Jefferies data cited in the piece put Lilly first in second-quarter weekly GLP-1 sales on Alibaba's Tmall and JD.com, in a market J.P. Morgan estimates could grow to 30 billion yuan, about $4 billion, within five to seven years from roughly 3 billion to 4 billion yuan now. No regulator has taken action tied to the campaigns.
- Culture
Clinicians say hiding GLP-1 use from children can model shame about weight
A WDBJ7 health report aired Aug. 20, 2026, examined what happens when parents hide their GLP-1 use from their children, with clinicians saying secrecy can contribute to shame and stigma about medication. The report cited a recent study finding that half of parents taking GLP-1 drugs for weight loss talk openly with their children about the medication. The guidance offered was expert opinion rather than new research.
- Culture
Class action says Ledisa's GLP-1 patches contain no GLP-1
A proposed class action filed Aug. 13, 2026 in the U.S. District Court for the Eastern District of California alleges that Ledisa LLC sold adhesive patches marketed as "GLP-1 Patches" that contain no GLP-1 and no GLP-1 receptor agonist, listing berberine, apple cider vinegar, cinnamon, pomegranate, resveratrol and folic acid instead. The case, Cathey v. Ledisa LLC, No. 1:26-cv-06456-EPG, seeks to represent U.S. purchasers and California purchasers of the patches, which the complaint says were sold in 30-packs starting in 2025. Ledisa has not responded in court, no class has been certified, and there is no settlement, fund or claim form.
- Policy
Most state Medicaid programs decline White House deal offering Wegovy at $245 a month
Twenty-nine state Medicaid programs told POLITICO they will not take part in the Trump administration's model for discounted obesity drugs, and Indiana is the only state publicly enrolled. Novo Nordisk offers Wegovy at $245 per monthly dose under the model, and Indiana has said it would pay $85.16 of that. Seven states are still undecided and 14 did not answer questions.
- Safety
BMJ fact-check says UK semaglutide death headlines rest on suspected-reaction reports
The BMJ has fact-checked UK press coverage that linked GLP-1 drugs to hundreds of deaths, saying the totals come from Yellow Card reports of suspected reactions rather than confirmed harms. In the figures it reviewed, semaglutide accounted for 3,454 serious reports in women and 1,216 in men, while fatal outcomes were nearly even at 28 in women and 29 in men and clustered among people aged 60 to 69.
- Research and trials
Tirzepatide linked to lower stroke risk than other GLP-1 drugs in atrial fibrillation study
A retrospective analysis published August 22 in Nature Communications compared 14,118 matched pairs of adults with atrial fibrillation and type 2 diabetes who started tirzepatide or another GLP-1 receptor agonist. Tirzepatide use was associated with lower risks of any stroke, ischemic stroke, hemorrhagic stroke and death, with an absolute stroke difference of 2.1 percentage points at one year and a mortality difference of 6.2 percentage points. The authors said randomized trials are required before recommendations change.
- Prices
Medicare sets a $274 negotiated price for Ozempic, Wegovy and Rybelsus starting in 2027
Medicare's maximum fair price for semaglutide, the ingredient in Ozempic, Wegovy and Rybelsus, is $274 for a 30-day supply beginning January 1, 2027, down from a list price of about $959. The figure sets what Medicare pays, not what a beneficiary pays, because Part D plan design still determines copays and coinsurance. CMS calculated a separate price of $276.78 for one commonly used Ozempic pen.
- Business
Lilly starts construction on $6.5 billion Houston manufacturing campus
Eli Lilly has begun building a $6.5 billion pharmaceutical manufacturing campus on 236 acres at Generation Park northeast of Houston. The company says the site will eventually add 615 permanent jobs and generate about 4,000 construction jobs, with overall completion estimated around 2030. Local reports on the groundbreaking gave different figures, including 3,500 total jobs and a 2027 completion target.
- Competition
Regeneron adds two olatorepatide Phase 2 obesity trials after Chinese Phase 3 reports 19.3% weight loss
Two Regeneron Phase 2 studies of olatorepatide, a dual GLP-1/GIP drug licensed from Hansoh Pharma, are now listed on the US trial registry, one recruiting and one active but not recruiting. The listings follow a Hansoh-run Phase 3 in mainland China that reported up to 19.3% mean weight loss at 48 weeks, with nausea below 10% and vomiting below 5%. Olatorepatide has not been reviewed by any regulatory authority.
- Regulation
Scholar Rock's apitegromab approved for SMA, not for GLP-1 muscle loss
The FDA approved ISEMBYLD (apitegromab-mstn) on September 11, 2026 for spinal muscular atrophy in adults and children 2 and older already on an SMN2-targeted treatment, after a September 2025 Complete Response Letter and a previously listed US action date of September 30, 2026. The same drug's obesity-related data come from the Phase 2 EMBRAZE trial, which combined apitegromab with tirzepatide in 102 people over 24 weeks and reported 54.9 percent greater relative lean-mass retention than tirzepatide plus placebo.
- Research and trials
Apitegromab plus tirzepatide preserved 54.9% more lean mass in 24-week trial
In the phase 2 EMBRAZE trial, adding Scholar Rock's apitegromab to tirzepatide preserved 54.9% more relative lean mass over 24 weeks than tirzepatide plus placebo, while total weight loss was similar, according to results published in Nature Medicine. The trial enrolled 102 participants. The combination is investigational and is not approved for weight management.
- Research and trials
Structure's oral GLP-1 aleniglipron trials show as recruiting, with topline data due in 2028
Structure Therapeutics' two Phase 3 trials of its oral GLP-1 pill aleniglipron are listed as recruiting: ACCOMPLISH-1, for up to 3,600 adults with obesity or overweight and a weight-related condition, and ACCOMPLISH-2, for up to 1,100 adults with obesity or overweight and type 2 diabetes. The company says the program began in August 2026 and that topline results are expected in the second half of 2028. A 72-week extension study reported up to 16.2% average weight loss at the 180 mg dose.
- Prices
UnitedHealthcare sets monthly GLP-1 quantity limits starting September 1
UnitedHealthcare has published an updated quantity-limit list for commercial plans that takes effect September 1, 2026. It caps monthly fills at 4 Wegovy pens, 1 Ozempic pen, 4 Zepbound autoinjectors or vials, 1 Zepbound KwikPen, 4 Mounjaro pens and 5 Saxenda pens, and requires two one-month fills before a three-month fill is available.
- Culture
Lilly and Novo Nordisk GLP-1 contest may hinge on cost and prescriber habits
An analysis published Aug. 21, 2026 concludes that affordability and prescribing habits, rather than further weight loss, could decide which GLP-1 captures market share as Eli Lilly and Novo Nordisk compete. It cites KFF polling in which 55% of insured current or former users said paying for their prescription was difficult, and a Spherix Global Insights poll of 185 prescribers in which 80% were highly satisfied with Zepbound versus 47% for Lilly's Foundayo.
- Regulation
Delhi court tells Sun Pharma to seek approval before launching semaglutide tablets
The Delhi High Court ordered Sun Pharma Laboratories on 11 August 2026 to get court approval before commercially manufacturing or launching semaglutide tablets in 3 mg, 7 mg and 14 mg doses, in a patent suit filed by Novo Nordisk. The court declined an interim injunction for now and will weigh Novo Nordisk's request for relief after Sun Pharma applies for approval. The next hearing is before the Joint Registrar on 4 November 2026.
- Business
Rexall and Novo Nordisk Canada launch home delivery for Ozempic, Wegovy and Rybelsus
Rexall and Novo Nordisk Canada launched Novo Nordisk Care Rx, a home delivery service for the semaglutide brands Ozempic, Wegovy and Rybelsus, on August 21, 2026. The service covers every province and territory except Quebec, which also sits outside Novo Nordisk's Ozempic savings card. It arrives as Health Canada has approved three of nine generic semaglutide products and Novo Nordisk projects a 5 to 13 percent revenue decline for 2026.
- Prices
Aon projects 9.5% rise in US employer health costs for 2027, citing GLP-1 drugs
Aon said on August 20 that it expects U.S. employer healthcare costs to rise 9.5 percent in 2027, pushing average spending above $19,000 per employee and marking a fourth consecutive year of near double-digit growth. The firm listed specialty medicines and GLP-1 treatments for diabetes, obesity and other conditions among the pressure points on prescription drug spending. Starbucks separately confirmed it will stop covering GLP-1 drugs prescribed for weight loss in October, while keeping coverage for diabetes and other approved uses.
- Prices
PBMs commit to showing TrumpRx cash prices alongside insurance prices in prescribing tools
The Pharmaceutical Care Management Association and ten pharmacy benefit managers pledged to display TrumpRx cash prices next to a patient's benefit price inside real-time benefit tools used by doctors, an effort coordinated with CMS. TrumpRx lists Ozempic at $199 a month against $1,028 and Zepbound at $299 a month against $1,087. No start date, and no list of the ten PBMs, was disclosed.
- Culture
H&M drops 3XL and 4XL dresses as GLP-1 use rises
H&M discontinued its 3XL and 4XL dresses for spring/summer 2026, after those sizes made up 2% of its new dress inventory in 2025, according to an analysis by the research firm Edited reported by The Guardian. Mango cut new dresses in sizes 16 to 20 from 6.6% of inventory in spring/summer 2025 to 0.5% a year later, and plus-size models made up 0.3% of runway looks across the fall/winter 2026/2027 fashion weeks. Mintel research says 18% of US adults reported using GLP-1 drugs as of June 2025, up from 12% in 2024.
- Culture
Wegovy and Zepbound are reshaping health care spending, new research finds
New Wells Fargo research reported by USA TODAY on Aug. 20, 2026, finds GLP-1 drugs such as Wegovy and Zepbound are shifting health care spending away from late-stage treatment. A May 2026 JAMA study cited in the article found bariatric surgeries fell 34% from 2022 to 2024 while GLP-1 use rose 140%. Another study found semaglutide cut major cardiovascular events by 20% in overweight or obese adults without diabetes.
- Competition
Gubra says Boehringer has started Phase 2 testing of triple agonist BI 3034701
Gubra's half-year report says Boehringer Ingelheim began Phase 2 development of BI 3034701, a GLP-1/GIP/NPY2 triple agonist for obesity and overweight, triggering a EUR 10 million milestone payment to Gubra. Gubra also said partner AbbVie reported 12- and 13-week Phase 1 results for the amylin analog ABBV-295 ahead of a planned Phase 2 start in the third quarter of 2026, and that its own candidate GUB-UCN2 entered a Phase 1/2a trial.
- Research and trials
Review links GLP-1 drugs to less papilledema in intracranial hypertension
A systematic review and meta-analysis of eight studies covering 13,243 patients found GLP-1 receptor agonists were linked to lower papilledema risk at 3 months (risk ratio 0.430) and at 24 months (risk ratio 0.469) in people with idiopathic intracranial hypertension. Headache frequency, visual disturbances and refractory disease were also lower. The authors called the evidence low-certainty because it comes mostly from observational studies.
- Research and trials
Novo Nordisk starts late-stage trial of lower-dose oral Wegovy
Novo Nordisk has begun a 60-week Phase 3 trial called OASIS-5 that will test two lower doses of oral semaglutide, sold as Wegovy, against placebo in 450 adults with obesity. The specific doses have not been disclosed, and the trial is expected to finish in 2028.
- Culture
Brazilian survey finds 23.8% of GLP-1 users took semaglutide or liraglutide without a prescription
A web-based survey of 860 adults in Brazil who used GLP-1 receptor agonists for weight loss found that 23.8% reported using the drugs without a medical prescription. Higher rates were associated with not having obesity, not attending fitness centers, and working in healthcare. Because participants volunteered online, the figure is not a national prevalence estimate.
- Business
Lilly marks Kenosha expansion for Zepbound and Mounjaro production
Eli Lilly is marking an expansion at its Kenosha County, Wisconsin plant, which makes injectable medicines including Zepbound and Mounjaro. Lilly announced a $3 billion Wisconsin investment and says the site went from acquisition in 2024 to FDA approval and medicine production in 18 months. The company has not published how much additional output the expansion adds.
- Business
Upper Macungie planners back Eli Lilly's $3.5 billion injectable medicine plant
The Upper Macungie Planning Commission recommended approval of Eli Lilly's final subdivision and land development plan for a $3.5 billion injectable-medicine campus near Fogelsville, Pennsylvania. The 797,432-square-foot plant on about 150 acres is expected to handle final assembly and packaging of injectable medicines and to support about 2,000 construction jobs, with manufacturing operations projected to begin in 2031.
- Research and trials
AstraZeneca opens three SELENE Phase 3 trials of AZD6234, one for people already on an incretin
AstraZeneca has opened three Phase 3 trials of its experimental amylin analog AZD6234, named SELENE 1, SELENE 2 and SELENE 3, with planned enrollments of 2,500, 1,500 and 500 people. SELENE 3 is the notable one: it tests the drug as an add-on for people who are already taking an incretin medicine such as semaglutide or tirzepatide. No Phase 3 results, doses, comparison arms or completion dates have been reported.
- Compounding
Mississippi boards bar licensees from research-grade and non-FDA-approved peptides
Mississippi's medical licensure, nursing and pharmacy boards issued a joint statement prohibiting licensees from compounding, administering, dispensing, recommending or prescribing non-FDA-approved or research-grade peptides, and from delegating those acts. When the statement takes effect and what penalties it carries have not been reported. The action adds a state layer on top of federal compounding rules, which states may tighten but cannot loosen.
- Regulation
Novo Nordisk again asks FDA to bar compounding of semaglutide
Novo Nordisk has renewed its request that the FDA place semaglutide on the Demonstrable Difficulties for Compounding lists, which would block pharmacies from compounding the drug even during a future shortage. The nomination was first filed in October 2024 under docket FDA-2017-N-2562. It remains pending alongside a separate proposal to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list.
- Research and trials
Tirzepatide weight loss holds up in women with PCOS, large UK study finds
A retrospective study of 54,114 women prescribed tirzepatide through a UK digital weight-management service found that those who reported having PCOS lost about the same amount of weight as those who did not. At 10 months, average weight change was -19.40 percent in the PCOS group and -18.74 percent in the non-PCOS group, a difference reported as not significant. Only 40 women with PCOS reached the 10-month timepoint, and PCOS status was self-reported.
- Business
Generic liraglutide acquisition benchmark falls about a third in six months
National Average Drug Acquisition Cost data effective August 19, 2026 priced the generic liraglutide two-pen carton at $33.8176 per mL, down from $48.7442 per mL in the file effective February 18, 2026. The five-pen weight-management carton fell to $47.6947 per mL from $73.7391 in January. Brand Victoza and Saxenda stayed near $87 per mL.
- Research and trials
VA begins enrolling 622 veterans in trial of semaglutide for alcohol use disorder
The Department of Veterans Affairs has opened recruitment for a 622-participant trial testing semaglutide against placebo for moderate or severe alcohol use disorder at 18 sites nationwide. Half of participants will receive the drug for six months, and enrollment is expected to take about two years. Semaglutide is not approved for alcohol use disorder.
- Research and trials
Orforglipron plus basal insulin cut A1C and weight in ACHIEVE-5 Phase 3 trial
In the Phase 3 ACHIEVE-5 trial, adding once-daily oral orforglipron to titrated insulin glargine lowered A1C by 1.58% to 1.88% over 40 weeks in adults with type 2 diabetes, compared with 0.79% for placebo, and reduced body weight by 2.6% to 5.4% while the placebo group gained 0.2%. The 546-participant study, published in JAMA, found no increase in clinically significant hypoglycemia, with gastrointestinal side effects the most common. Orforglipron is an oral GLP-1 receptor agonist described in the report as investigational for type 2 diabetes.
- Competition
Lilly's eloralintide readout nears as amylin design debate sharpens
Eli Lilly is approaching a mid-stage weight-loss readout for its amylin candidate eloralintide, while Novo Nordisk's CagriSema is expected to become the first approved drug combining an amylin analog with a GLP-1 agonist later this year. Reported Phase 2 results for eloralintide reached up to 20% weight loss at 9 mg over 48 weeks, with nausea rates as high as 64% in one arm. Lilly is testing eloralintide in Phase 3 both alone and with tirzepatide.
- Regulation
FTC, California and Utah sue Hims & Hers over health data sharing
On July 29, 2026, the FTC plus California and Utah sued Hims & Hers Health, Inc., alleging the telehealth company sent users' health information to advertising platforms through tracking pixels and used deceptive billing and cancellation practices. It is the current FTC's first enforcement action aimed at tracking pixels and unauthorized health-data sharing with ad platforms. The agencies seek an injunction, monetary relief and civil penalties.
- Competition
Lilly's obesity pill Foundayo posts $98 million in first full quarter
Eli Lilly's oral obesity drug Foundayo (orforglipron) recorded $98 million in second-quarter sales, its first full quarter on the market, below the $104 million analysts expected. Novo Nordisk's Wegovy pill, which launched in January 2026, generated about $494 million in the same period, also short of estimates. Lilly's injectable drugs Mounjaro and Zepbound carried the company, lifting total quarterly revenue 48%.
- Science
Two brain regions may explain the GIP weight-loss paradox, review says
A research highlight published August 19, 2026 in Nature Reviews Endocrinology summarizes a Nature Metabolism study that identified two distinct brain regions behind the appetite-suppressing effects of GIP receptor agonism and antagonism. In mice, removing GIP receptors in the area postrema blocked the food-intake and weight-loss effects of acyl-GIP, while control mice responded. The region responsible for the effects of GIP receptor antagonism is not identified in the published summary.
- Policy
Trump nominates Heidi Overton to lead FDA as GLP-1 and peptide compounding decisions wait
President Trump nominated Dr. Heidi Overton, deputy director of the White House Domestic Policy Council, to lead the FDA on Aug. 19, 2026 — his third choice for the job after two others declined. She has made no public statements on peptide compounding, the 503A or 503B bulks lists, or GLP-1 policy, and no Senate hearing date has been set.
- Culture
Northeastern clinicians say GLP-1 weight loss culture may raise eating disorder risk
Two Northeastern University clinicians argue that the normalization of GLP-1 weight loss has pulled explicit diet culture back into mainstream conversation and raised the risk of disordered eating. The Aug. 19, 2026 commentary cites National Eating Disorders Association figures showing 9 percent of Americans — nearly 31 million people — have had an eating disorder, with one death linked directly to the condition every 52 minutes. It presents no new data, and NEDA says the full effect of drugs like Ozempic on eating disorders is still unknown.
- Culture
Commentary describes tension over unapproved retatrutide as Lilly sues sellers
A Medscape commentary published August 19, 2026 says the expanded access pathway for retatrutide, a weight-loss drug not approved anywhere, can pit doctors against patients and can stretch to the better part of a year before a single dose is authorized. Eli Lilly filed six lawsuits on August 12 against peptide sellers, a compounding pharmacy and a medical spa it says marketed retatrutide products for human use. Lilly is expected to file for FDA approval of retatrutide in the first quarter of 2027.
- Research and trials
REMODEL data point to inflammation and vessel pathways in semaglutide kidney effects
Investigators presented mechanistic findings from the REMODEL trial at the World Congress of Nephrology 2026, reporting that semaglutide reduced albuminuria by roughly 40% and lowered perirenal and hilar fat in people with type 2 diabetes and chronic kidney disease. The trial found no effect on its primary endpoint, MRI-derived kidney oxygenation, but showed improvements in markers of fibrosis and inflammation and changes in endothelial cell biology. The investigators said these pathways may extend to non-diabetic kidney disease, though that has not been tested.
- Business
Resilience and Eli Lilly add $750 million for Ohio drug manufacturing
Resilience and Eli Lilly have expanded their manufacturing partnership with $750 million in combined investment to increase the supply of medicines made in the United States, including new production of Lilly's KwikPen device at Resilience's Cincinnati-area sites. The expansion is expected to create at least 400 jobs, bringing Resilience's Ohio workforce to more than 1,400. Neither company said how much of the capacity is intended for GLP-1 or incretin medicines.
- Regulation
South Korea says no causal link confirmed in reported Mounjaro pancreatitis cases
South Korea's Ministry of Food and Drug Safety said no causal relationship has been confirmed between tirzepatide or semaglutide products and reported pancreatitis cases, including three tirzepatide cases and four semaglutide cases reported in the country through March. The ministry said pancreatitis and gallbladder disease already appear in Korean prescribing information and that it will keep tracking overseas safety decisions and domestic reports.
- Competition
Wegovy pill keeps early lead over Foundayo in oral obesity market
Novo Nordisk's oral Wegovy recorded about 183,000 weekly prescriptions in the most recent reporting period, roughly four times the 47,500 for Eli Lilly's Foundayo, according to IQVIA data cited by Citi. The gap reflects a launch head start and earlier insurance coverage for the Wegovy pill, which had full commercial coverage from its first week while Foundayo did not gain CVS Caremark coverage until June 1, 2026.
- Science
Semaglutide linked to 37.8% drop in inflammation marker in SELECT analysis
A prespecified secondary analysis of the SELECT trial reports that semaglutide lowered high-sensitivity C-reactive protein, a blood marker of inflammation, by 37.8% at 104 weeks. Reductions were visible by weeks 4 and 8 and appeared even among participants who lost little weight, though the authors stopped short of claiming a weight-independent mechanism.
- Competition
Canada warns on illegal retatrutide sales as US seizures of illicit GLP-1s climb
A warning about unapproved and illegal sales of retatrutide was issued in Canada on August 18, 2026, extending the gray market for Eli Lilly's experimental drug beyond the United States. An Axios report on August 24 said US Customs and Border Protection intercepted more than 690 shipments of illicit GLP-1 drugs in all of fiscal 2025, but more than 1,400 in July 2026 alone. Retatrutide has not been submitted for approval anywhere, and its Phase 3 trials are still running.
- Competition
Enveda completes Phase 1 of ENV-308, an exercise-mimetic aimed at weight maintenance
Enveda Biosciences finished a Phase 1 study of ENV-308 in 88 healthy adults, reporting no serious adverse events and no discontinuations or dose interruptions, and said it is moving the drug into Phase 2. ENV-308 is designed to mimic Lac-Phe, a hormone released during intense exercise and after meals, and is positioned as a maintenance therapy against weight regain after stopping a GLP-1. The Phase 1 measured safety and tolerability, not weight loss, and the lean-mass claims attached to the drug come from preclinical work.
- Prices
Trump credits TrumpRx and drug deals for falling prices, while experts point to other causes
U.S. prescription drug prices fell 0.8% in July and 3.1% over the past year, the steepest one-year drop since 1963, according to Bureau of Labor Statistics data. The White House credits its "most favored nation" deals with drugmakers and the TrumpRx discount site, while drug pricing experts say Medicare negotiation, generic competition and market pressure on GLP-1 drugs likely explain more of the decline.
- Compounding
Analysis finds no lawful compounding path for Lilly's retatrutide
Eli Lilly filed six federal lawsuits on August 12, 2026 against businesses it says sold retatrutide, its experimental obesity drug that is not approved anywhere. A Frier Levitt analysis published August 18, 2026 concluded retatrutide cannot lawfully be compounded under Section 503A because it is not a component of an FDA-approved drug, is absent from the FDA's bulk drug substances list and has no USP or NF monograph.
- Compounding
Lilly sues six companies over unapproved retatrutide sales
Eli Lilly filed six federal lawsuits on Aug. 12, 2026, accusing four research-use-only peptide sellers, one medical spa and one compounding pharmacy of illegally selling retatrutide, its experimental obesity drug. Retatrutide has never been approved by any regulator worldwide, and the FDA has said it cannot be used in compounding under federal law. Lilly also says it has referred more than 200 individuals and entities to regulators and flagged more than 14,000 online listings for the drug.
- Research and trials
Lilly trial finds oral orforglipron helped maintain weight loss after injectable GLP-1s
In a Phase 3b trial, 376 adults who had already lost weight on injectable tirzepatide or semaglutide were switched to once-daily oral orforglipron or a placebo for one year. Those taking orforglipron maintained about 75% of their earlier weight loss after tirzepatide and about 79% after semaglutide, compared with about 49% and 38% for placebo.
- Science
Mouse study ties GLP-1 brain signaling to reduced defensive aggression
A preclinical study published in Translational Psychiatry reports that activating GLP-1 receptors in a midbrain area called the dorsomedial periaqueductal gray suppressed pathological defensive aggression in mice. The report, dated August 18, 2026, describes the effect as a brake on an overactive threat circuit rather than a removal of defensive behavior. No effect sizes, drug doses or human data were included.
- Business
Hims CEO says FTC wanted a headline as shares recover past pre-lawsuit level
Hims & Hers chief executive Andrew Dudum told CNBC on August 18 that the Federal Trade Commission "wanted more of a headline than a real agreement here" after settlement talks in a nearly three-year investigation failed. The company's shares, which fell about 15 percent to $25.00 on July 29 when the FTC and two states sued, closed at $31.10 on August 19, above where they traded before the complaint existed.
- Prices
White House credits GLP-1 price cuts and TrumpRx for record drop in drug prices
The White House said on Aug. 17 that prescription drug prices have posted their largest annual decline in more than 60 years, attributing it to most-favored-nation pricing deals and the TrumpRx discount platform. The release says TrumpRx has produced $700 million in patient savings since its February launch and that GLP-1 drugs that once cost over $1,000 a month now start at $149. Consumer Price Index data show prescription drug prices fell 0.8% in July and are down 3.1% over 12 months, and Axios reports TrumpRx likely explains only part of the decline.
- Prices
US drug prices post steepest annual decline in decades as GLP-1 competition adds pressure
Prescription drug prices fell 0.8% in July 2026 and are down 3.1% from a year earlier, the steepest annual decline in more than six decades, according to Consumer Price Index data. An analysis of the July figures concluded the TrumpRx discount site likely explains only part of the drop, pointing also to Medicare price negotiations, generic competition and price cutting in the GLP-1 market.
- Compounding
Novo Nordisk has sued 132 companies over compounded semaglutide, Danish report says
Novo Nordisk has sued 132 companies over products marketed as semaglutide, according to the Danish business newspaper Børsen, which said the damages sought run into the billions. The cases span roughly 40 US states and target compounding pharmacies, telehealth providers and clinics, with 55 of the 132 already decided at the first-instance level. Courts have granted 44 permanent injunctions in the campaign.
- Culture
Journal review calls GLP-1 stigma a distinct problem from weight stigma
A review published in the International Journal of Obesity argues that stigma tied to GLP-1 medications should be treated as its own construct, separate from weight stigma aimed at body size. The authors say narratives that frame GLP-1-assisted weight loss as a "shortcut" may add health and treatment-engagement harms beyond those of weight stigma alone, and they call for work to define and measure it.
- Culture
Nestlé plans food and supplement products aimed at GLP-1 side effects
Nestlé is developing food, supplement and skincare-adjacent products for people taking GLP-1 weight-loss drugs, targeting muscle loss, facial fat loss and nutrient gaps, chief technology officer Stefan Palzer told Reuters. The report cites Boston Consulting Group's estimate that about 16 million Americans take GLP-1 medicines, a figure expected to rise sharply by the end of the decade. No launch dates, prices or markets for the new lines have been disclosed.
- Safety
Vision loss lawsuits against Novo Nordisk and Eli Lilly press FDA on NAION warnings
Local television reports from Boston and Atlanta in August 2026 featured plaintiffs who say they lost vision after taking semaglutide, part of a federal multi-district lawsuit involving more than 130 cases. European and UK labels warn about NAION, and Canada and Australia updated their safety information, but the FDA has not added a NAION warning to US labels. Novo Nordisk and Eli Lilly dispute that the drugs cause the condition.
- Prices
Novo Nordisk Canada launches Ozempic savings card aimed at generic price levels
Novo Nordisk Canada has introduced a savings card intended to bring brand-name Ozempic to roughly generic price levels for uninsured Canadians, available through Rexall pharmacies and excluding Quebec. The move follows Dr. Reddy's generic semaglutide reaching Canadian pharmacies on May 15, 2026, and a Health Canada authorization for a second generic from Apotex. Novo Nordisk has forecast a 5% to 13% sales decline for 2026.
- Regulation
Mexico clears Wegovy oral tablet, a first for Latin America
Mexico's health regulator approved the Wegovy oral tablet, a 25 mg once-daily semaglutide pill, for weight management, making the country the first in Latin America to authorize it. The approval covers adults with obesity, or with overweight plus at least one weight-related condition, and includes an indication to reduce major adverse cardiovascular events in people with established cardiovascular disease. Novo Nordisk has not disclosed a Mexican launch date, price or distribution plan.
- Science
Prolonged GLP-1 exposure remodels about 1,000 genes in pancreatic beta cells, preclinical work finds
Researchers report that sustained GLP-1 receptor signaling changes the activity of roughly 1,000 genes in pancreatic beta cells, a shift the authors describe as flipping a molecular switch. The work suggests long-term treatment may leave beta cells in a different, potentially more resilient state instead of only triggering bursts of insulin release. The findings are preclinical and have not been confirmed in humans.
- Culture
Study finds Ozempic users judged more harshly than diet-and-exercise users
A randomized study of 297 participants published in Social Science & Medicine found that a woman described as losing weight with the drug Ozempic was viewed more negatively and assumed to be less healthy than one who lost weight through diet and exercise alone. Ratings for a version describing bariatric surgery did not differ significantly from either of the other two methods. Participants also sharply underestimated how common weight regain is.
- Compounding
One year after the semaglutide shortage ended, compounding enforcement narrows the market
An analysis published Aug. 16, 2026 marks roughly twelve months since the FDA determined the national semaglutide shortage was resolved, the decision that started enforcement deadlines for pharmacies compounding copies of Ozempic and Wegovy. The FDA has issued more than 135 warning letters to GLP-1 compounders since September 2025, and a proposal to keep semaglutide, tirzepatide and liraglutide off the 503B Bulks List is still not final.
- Policy
State legislatures and pharmacy boards build their own rules for compounded GLP-1s
A regulatory analysis published August 16, 2026 says state legislatures and pharmacy boards are adding prescribing limits, telehealth standards, sourcing rules and advertising restrictions for compounded GLP-1 drugs and peptides on top of federal requirements. A September 3, 2026 article by attorney Martha Rumore reports warning notices from state licensing boards on peptides, with licenses suspended in some cases, and lists eight states as restrictive. That article also says an FDA advisory panel recommended six peptides be added to the 503A Bulks List.
- Business
Lilly says more than 80% of Foundayo prescriptions went to first-time GLP-1 patients
Eli Lilly says more than 80% of prescriptions for its oral obesity drug Foundayo (orforglipron) have gone to patients who had never taken a GLP-1 medicine before. The company points to the figure as evidence the pill is widening the treated population rather than taking patients away from its injectable Zepbound (tirzepatide). The number comes from Lilly and has not been independently verified.
- Competition
Novo Nordisk asks court to pause Eli Lilly's GLP-1 advertising
Novo Nordisk filed a motion on August 14, 2026 asking a federal court in New Jersey to stop Eli Lilly's current GLP-1 advertising while its false-advertising lawsuit proceeds; the court set the motion for consideration on August 17. The July 21 suit says Lilly's ads compare Zepbound and Mounjaro at their top doses against lower Wegovy and Ozempic doses, omitting a 7.2 mg Wegovy dose approved in March 2026. Lilly denies wrongdoing and says its claims come from the SURMOUNT-5 head-to-head trial, which reported about 20.2% weight loss with tirzepatide versus 13.7% with semaglutide over 72 weeks.
- Business
Anti-obesity drugs become fourth-largest therapy class, IQVIA says
IQVIA told the Academy of Managed Care Pharmacy annual meeting that anti-obesity drugs are now the fourth-largest therapy class, with a 4.6% market share and nearly $42 billion in value. GLP-1 sales reached about $132 billion in 2025, up 33.5%, led by Mounjaro (tirzepatide) at $39.1 billion and Zepbound (tirzepatide) at $22.9 billion. About 190 obesity-related products are in the pipeline, and IQVIA projects $100 billion in added sales growth from obesity therapies by 2029.
- Culture
Lilly sues 14 companies over generic Mounjaro and Zepbound
Eli Lilly has sued 14 companies in the U.S. District Court for the District of Delaware over generic versions of its tirzepatide drugs Mounjaro and Zepbound, its first U.S. patent suits against copies of the two products. The filings were reported on August 14, 2026 as part of what the report calls a wave of Hatch-Waxman cases, arriving as global patent disputes over GLP-1 drugs continue to multiply.
- Culture
Survey of 1,226 patients finds skin, hair and muscle concerns more common among GLP-1 users
A survey of 1,226 people receiving medical weight management found 61.9% reported at least one skin, hair, facial or muscle concern, led by skin sagging at 37.7%, facial volume loss at 29.2% and hair loss at 28.9%. Concerns were more common with greater weight loss and among GLP-1 users; among those who lost 10% to 20% of body weight, 76.6% of GLP-1 users reported a concern versus 52.1% of non-users. The authors say these effects can undermine treatment adherence and propose nutrition and strength preservation as the first response.
- Science
Cambridge study explains how opposite approaches to the same GIP receptor both aid weight loss in mice
Researchers at the University of Cambridge report in Nature Metabolism that the GIP receptor can drive weight loss in two opposite ways, depending on the brain region involved: activating it in the brainstem cut appetite in mice, while blocking it in the hypothalamus released a brake on fullness signals. The work is preclinical and has not been tested in people. More than a billion people worldwide live with obesity, and GIP-targeting drugs such as Mounjaro and Zepbound activate the receptor while MariTide blocks it.
- Regulation
Label for oral GLP-1 Foundayo sets 30-day dose steps and no food timing rules
The US prescribing information for Foundayo (orforglipron) has been published on DailyMed, covering adults with obesity or with overweight plus a weight-related condition. It sets a 0.8 mg starting dose that increases at 30-day intervals to a 17.2 mg maximum. The tablet is taken once daily with or without food, and the administration instructions include no water limit or waiting period.
- Prices
KFF brief reports 2025 denial rates of 12% to 18% across three insurance markets
A KFF analysis of newly posted insurer data found Medicare Advantage plans denied 12% of standard prior authorization requests in 2025, Medicaid managed care plans denied 14% and ACA Marketplace plans denied 18%. Appeals overturned 67%, 47% and 43% of challenged denials in those markets. The reports cover medical items and services but exclude prescription drugs.
- Compounding
Lilly sues six US retatrutide sellers and asks platforms and payment firms to cut them off
Eli Lilly filed six new lawsuits on Aug. 12, 2026 against U.S. sellers of black-market retatrutide and asked online platforms, payment companies and shippers to stop handling the drug. Lilly said it has flagged more than 200 people and businesses to regulators and law enforcement, and reported more than 14,000 listings pushing retatrutide in over 100 countries. No medicine containing retatrutide has been approved by any regulatory agency in the world.
- Research and trials
Zealand Pharma sets second-half 2026 deadlines for petrelintide Phase 3 and ZUPREME-2
Zealand Pharma confirmed in its half-year 2026 report that topline results from the Phase 2 ZUPREME-2 trial of petrelintide in people with overweight or obesity and type 2 diabetes are due in the second half of 2026, and that it and Roche expect to start registrational Phase 3 trials of petrelintide monotherapy in the same window. A Phase 2 combination trial, ZYNERGY, is also planned. Petrelintide is an investigational amylin analog that has shown up to 10.7% weight loss at 42 weeks with tolerability close to placebo.
- Competition
Lilly sues six US sellers over black-market retatrutide
Eli Lilly filed six federal lawsuits on Aug. 12, 2026 against U.S. businesses it accuses of selling unapproved, black-market versions of retatrutide, its experimental weight-loss drug. The defendants include four "research use only" peptide sellers, a medical spa and a compounding pharmacy, and Lilly says it has referred more than 200 people and companies to regulators and law enforcement. Retatrutide has not been approved by any regulator worldwide and cannot be lawfully compounded, according to the FDA.
- Research and trials
Preoperative GLP-1 use shows no extra aspiration risk and lower 14-day mortality in records analysis
An observational analysis of surgical records from June 2013 to June 2023 found no increased aspiration risk among patients taking GLP-1 receptor agonists before surgery compared with metformin, SGLT2 inhibitors or DPP-4 inhibitors. GLP-1 users had lower 14-day mortality than metformin users (0.98% vs. 2.20%; risk ratio 0.44) and lower mortality and bacterial pneumonia than DPP-4 inhibitor users. The authors say prospective studies are still needed.
- Prices
US prescription drug prices fall 3.1%, steepest annual drop since 1963
The prescription drug component of the Consumer Price Index fell 0.8% from June to July 2026 and was 3.1% lower than a year earlier, the largest 12-month decline since March 1963. The index has not posted a monthly increase at any point in 2026 through July. Economists disagree over how much of the drop reflects Medicare price negotiations, generic and biosimilar competition, or recent GLP-1 discount deals.
- Research and trials
Kailera says oral ribupatide IND is active, with Phase 3 obesity trials planned for 2027
Kailera Therapeutics says its US investigational new drug application for oral ribupatide is active, with global Phase 3 obesity trials planned for the first half of 2027. The company also says its US Phase 2b trial of high-dose injectable ribupatide is fully enrolled, with data expected in mid-2027, and its Phase 3 KaiNETIC program is on track for more than 4,700 participants, with data expected in 2028.
- Culture
Novo Nordisk CEO defends Lilly lawsuit over weight-loss drug ads and acknowledges Lilly's lead
Novo Nordisk CEO Mike Doustdar on Aug. 12 defended his company's July lawsuit accusing Eli Lilly of misleading advertising for its injectable GLP-1 drugs, saying "competition has to be fair." He acknowledged Lilly has gained more volume and market share in injectables, while pointing to more than 5 million U.S. prescriptions for Novo's Wegovy pill. Lilly says its ads are truthful and that no head-to-head trial supports Novo's claim that higher-dose Wegovy matches Zepbound.
- Business
Altimmune says $519 million in cash funds pemvidutide through 2029 MASH readout
Altimmune reported $519 million in cash, equivalents and investments at the end of the second quarter and said the balance funds the company through the 52-week PERFORMA Phase 3 readout in MASH, expected in 2029. The company also completed enrollment in the RESTORE Phase 2 trial of pemvidutide in alcohol-associated liver disease, a third indication alongside MASH and alcohol use disorder.
- Regulation
UK approves Eli Lilly's Foundayo, Europe's second GLP-1 weight-loss pill
Eli Lilly won its first European approval for Foundayo, an orforglipron pill, when the U.K. regulator cleared it for weight management and type 2 diabetes by prescription. It is the second GLP-1 weight-loss pill in Europe, arriving about two months after Novo Nordisk's Wegovy pill launched there. In the U.S., Foundayo launched in April and recorded $98 million in second-quarter sales.
- Science
GLP-1 craving effects may trace to a brain region called the lateral septum
An analysis published in August 2026 traces the reduced cravings reported by some people taking GLP-1 drugs such as Ozempic and Wegovy to the lateral septum, a brain region packed with GLP-1 receptors that has long been studied for emotion rather than reward. The region receives memory and location signals from the hippocampus and passes them to dopamine-producing reward areas that have few GLP-1 receptors themselves. The evidence cited is mostly from mice, including studies showing that activating GLP-1 receptors in the lateral septum reduced food and alcohol consumption.
- Culture
Chrissy Metz discloses GLP-1 use and becomes an ambassador for Ro
Actress Chrissy Metz, 45, told People she began taking a GLP-1 medication after years of doubt, pointing to perimenopause and obesity in her family as reasons she decided to try one. She is now an ambassador for Ro, a telehealth company. The reporting does not name the drug she takes, her dose or how long she has been on it, though a photo caption says she has lost 100 pounds.
- Business
Hims & Hers sets aside about $60 million for the FTC case
Hims & Hers disclosed in its second-quarter filing, dated August 10, that it recorded an approximately $60 million legal contingency accrual as of June 30, 2026, for the Federal Trade Commission matter, with total accrued legal contingencies of $62.5 million against $0 at the end of 2025. The filing confirms an October 2023 FTC civil investigative demand, says settlement talks failed, and discloses a consumer class action brought under the federal wiretap statute and two California privacy laws.
- Competition
UK authorizes orforglipron for weight management and type 2 diabetes, first in Europe
Britain's Medicines and Healthcare products Regulatory Agency licensed orforglipron (Foundayo) on August 10, 2026, for weight management and type 2 diabetes, the first European approval of the once-daily GLP-1 tablet. The weight-management license covers adults with a BMI of 30 or higher, or 27 to 30 with at least one weight-related condition. Lilly started UK supply on August 24 by private prescription, with private pricing indicated at £100 to £120 a month, and the drug is not available through the NHS while NICE reviews it.
- Business
UK regulator authorizes Eli Lilly's orforglipron (Foundayo) for weight management and type 2 diabetes
The UK's Medicines and Healthcare products Regulatory Agency authorized orforglipron (Foundayo) on August 10, 2026, for weight management and type 2 diabetes in adults, making the UK the first country in Europe to clear the once-daily GLP-1 tablet for both uses. The dose climbs from 0.8 mg to 17.2 mg in six steps, with at least a month at each level, and the pill can be taken at any time of day without food or water restrictions. It is not yet available through the NHS, pending a NICE evaluation.
- Research and trials
Tirzepatide plus testosterone and training tied to muscle and grip gains in 93-man case series
A retrospective case series of 93 men with obesity and low morning testosterone found that those given weekly tirzepatide along with testosterone cypionate and coaching on resistance exercise and protein intake lost 20.9 to 22.6 kilograms over 12 months while gaining 1.6 to 3.7 kilograms of estimated skeletal muscle mass and 5.7 to 7.1 kilograms of grip strength. Total lean body mass still fell by 4.0 to 6.1 kilograms. The authors say the combined, uncontrolled design means no single component can be credited with the muscle results.
- Compounding
Hims & Hers revenue rises 38% to $753 million as gross margin falls and net loss reaches $86 million
Hims & Hers Health reported second-quarter 2026 revenue of about $753 million, up 38% from a year earlier, with subscribers up 19% to 2.891 million. Gross margin fell to 64% from 76%, and the company swung to a net loss of $86.3 million from net income of $42.5 million a year earlier. The quarterly release did not break out revenue from GLP-1 medications or explain the margin decline.
- Culture
Review finds no evidence for a best day of the week to take semaglutide or tirzepatide
A systematic review published August 10, 2026, in the journal Medicina screened 1,471 records and found only three studies relevant to the timing of weekly semaglutide or tirzepatide dosing. None of them directly compared one day of the week with another, and the authors concluded that current evidence does not support a specific optimal day.
- Business
Novo Nordisk and AWS sign partnership on AI drug discovery
Novo Nordisk announced a strategic partnership with Amazon Web Services to accelerate drug discovery using artificial intelligence, in a press release dated Aug. 10, 2026. The announcement gives no financial terms, no timeline and no detail on which research programs the partnership covers.
- Research and trials
Second Obesity commentary flags evidence gaps in microdosing tirzepatide from multi-dose pens
A second commentary on microdosing tirzepatide was published online in the journal Obesity on August 9, 2026, three months after the manuscript was received. The new letter, by endocrinologist Fernando Vidal-Ostos De Lara, is a letter to the editor with no abstract and no new patient data, and it extends an earlier, three-page Obesity commentary on the same practice in multi-dose pens.
- Policy
UK gets reduced Section 232 pharma tariff treatment, but reports differ on the rate
The United Kingdom has secured reduced Section 232 tariff treatment for pharmaceutical exports to the United States, according to an advisory dated Aug. 4, 2026. Reports differ on the size of the reduction: a 0 percent rate on pharmaceuticals as of July 31, 2026, a 10 percent rate under tariff heading 9903.04.63, or a 10 percentage-point addition to the general 100 percent duty. Japan, the EU, Korea, Switzerland and Liechtenstein carry a 15 percent rate under the framework, which took effect July 31, 2026 for most companies.
- Business
Novo Nordisk CEO calls oral Wegovy a must-win as Canadian generics ship
Novo Nordisk chief executive Mike Doustdar described the launch of an oral Wegovy pill as the company's must-win battle of 2026, comments that came as generic semaglutide from Dr. Reddy's and Apotex reached Canadian pharmacies. Novo Nordisk has guided to a 5% to 13% revenue decline for 2026, and its Ozempic savings card for uninsured Canadians excludes Quebec. The pill competes in the United States with Eli Lilly's oral orforglipron while generic injectable semaglutide spreads in markets where patents have lapsed.
- Business
Federal judge dismisses compounded GLP-1 antitrust suit against Lilly and Novo
A federal judge in San Antonio dismissed Strive Specialties' antitrust lawsuit against Eli Lilly and Novo Nordisk, finding that compounded GLP-1 medicines are not reasonably interchangeable with branded products such as Ozempic, Wegovy, Mounjaro and Zepbound. The dismissal, dated Aug. 5, 2026, was with prejudice, and the court separately found Strive did not adequately allege harm to competition. Strive says it is weighing an appeal.
- Prices
CMS extends Medicare GLP-1 Bridge through 2027 as BALANCE model stalls
CMS has extended the Medicare GLP-1 Bridge through December 31, 2027, a year past its original end date, after the BALANCE model was indefinitely delayed in Medicare Part D. The program covers Foundayo, Wegovy and Zepbound's KwikPen for weight management at a $50 monthly copay for eligible beneficiaries.
- Research and trials
Network meta-analysis ranks tirzepatide 15 mg first, liraglutide 3.0 mg last for weight loss
A network meta-analysis of 24 randomized trials found that tirzepatide 15 mg ranked highest for weight and waist reduction among three GLP-1-based obesity drugs, while liraglutide 3.0 mg produced the smallest weight loss. Liraglutide 3.0 mg also carried higher risks of any adverse event and of discontinuing treatment because of one. No significant differences between the drugs were found for serious adverse events.
- Compounding
Judge throws out compounding pharmacy's antitrust suit against Lilly and Novo over GLP-1 drugs
A federal judge in San Antonio dismissed an antitrust lawsuit filed by compounding pharmacy Strive Specialties against Eli Lilly and Novo Nordisk on August 6, 2026, finding that Strive did not plausibly allege a product market or adequately show how it was harmed. Strive said it is disappointed and is weighing an appeal.
- Regulation
Health Canada generic backlog tops 500 files, with seven semaglutide submissions waiting
The Canadian Generic Pharmaceutical Association said more than 500 generic submissions are sitting at Health Canada, with over 100 formally backlogged and seven generic semaglutide files still awaiting decisions. Two generic semaglutide injections, from Dr. Reddy's and Apotex, were already authorized at that point. Canadian generic prices fall step by step as more manufacturers reach the market, from 75% of the brand list price with one generic to 35% with three or more.
- Policy
CMS tells Part D plans the Medicare GLP-1 Bridge sits outside their benefit
CMS published implementation guidance for Part D plans in the Medicare GLP-1 Bridge, a demonstration that runs from July 1, 2026 through December 31, 2027 and operates outside the Part D benefit's coverage and payment flow. The program covers Foundayo, Wegovy and the Zepbound KwikPen at a $245 net price per monthly supply from manufacturers, with a $50 copay for eligible beneficiaries.
- Business
Lilly raises 2026 outlook as Mounjaro and Zepbound sales climb 48%
Eli Lilly reported second-quarter 2026 revenue of $23.0 billion, up 48% from a year earlier, and lifted its full-year revenue guidance to $85 billion to $87 billion. Mounjaro brought in $9.9 billion, Zepbound $4.9 billion, and the new obesity pill Foundayo $98 million in its first quarter of sales.
- Competition
Lilly raises 2026 outlook as Mounjaro and Zepbound surge while Foundayo lags
Eli Lilly reported second-quarter 2026 revenue of $23.0 billion, up 48%, driven by its injectable GLP-1 drugs Mounjaro and Zepbound. Sales of its new obesity pill Foundayo came in at $98 million, below analyst expectations, while Novo Nordisk's rival oral Wegovy reached $497 million.
- Prices
Lilly says most new Zepbound prescriptions in the U.S. are now self-pay
On Lilly's second-quarter 2026 earnings call, management said self-pay accounted for 55% of new Zepbound prescriptions and 45% of all Zepbound prescriptions in the U.S. during the quarter. U.S. Zepbound revenue rose 44% to $4.9 billion, a gain Lilly attributed to demand but partly offset by lower realized prices, including cuts to cash-pay prices. Company revenue overall rose 48% to $23.0 billion.
- Culture
Lilly raises full-year outlook as Mounjaro and Zepbound sales reach $14.9 billion in a quarter
Eli Lilly reported $23.0 billion in second-quarter 2026 revenue, up 48% from a year earlier. Mounjaro brought in $9.943 billion and Zepbound $4.928 billion — about 65% of the total — and the company raised its full-year 2026 revenue guidance to $85.0 billion to $87.0 billion.
- Business
Lilly's Foundayo posts $98 million in first partial quarter, below expectations
Eli Lilly reported $98 million in worldwide Foundayo sales for the second quarter of 2026, the oral GLP-1 pill's first partial quarter on the market, including $67 million in the U.S. That was short of a Wall Street consensus near $130 million. Lilly added the drug to its Key Products list and confirmed it has filed for U.S. approval of orforglipron for type 2 diabetes, while executives pointed to June pharmacy benefit manager coverage and the July 1 Medicare Bridge program as the start of an inflection.
- Competition
Lilly's Mounjaro and Zepbound sales climb while Novo Nordisk's GLP-1 growth stalls
Eli Lilly's tirzepatide medicines Mounjaro and Zepbound generated about $14.9 billion combined in the second quarter of 2026, with Mounjaro sales up 91% and Zepbound up 46%. Novo Nordisk's Ozempic and injectable Wegovy sales were essentially flat, and both its oral Wegovy pill and Lilly's Foundayo fell short of analyst estimates. Novo shares fell 6% after its report, while Lilly raised its full-year revenue outlook.
- Competition
Lilly says retatrutide data package is complete, targets early 2027 FDA filing
Eli Lilly said on Aug. 5, 2026 that the clinical data package for retatrutide, its investigational triple agonist, is complete, and that it plans to submit the drug to the FDA in the first quarter of 2027 for obesity, obstructive sleep apnea and knee osteoarthritis pain. In Phase 3 trials, participants lost up to 22.6% of body weight at 80 weeks in one study and up to 20.8% in another. Lilly intends to file retatrutide as a biologic, a classification the FDA has disputed and one that carries 12 years of market exclusivity instead of five.
- Prices
Lilly's Mounjaro and Zepbound sales jump as realized prices fall 13%
Eli Lilly reported second-quarter 2026 revenue of $22.974 billion, up 48%, with worldwide Mounjaro sales of $9.943 billion and U.S. Zepbound sales of $4.928 billion. The two tirzepatide drugs made up 64.7% of company revenue, while realized prices fell 13% worldwide. Lilly raised its full-year 2026 revenue guidance to $85 billion to $87 billion.
- Research and trials
Amgen reports nine Phase 3 MariTide trials and one remaining obesity asset
Amgen's second-quarter report, released August 4, 2026, described nine global Phase 3 MariTide trials running across obesity, type 2 diabetes, cardiovascular disease, heart failure and obstructive sleep apnea, with three more Phase 3 diabetes trials to start in 2026 and a Phase 2b liver-fat study enrolling. The company also discontinued an early-stage obesity candidate, leaving MariTide as its only obesity asset. MARITIME-1 and MARITIME-2, the lead obesity trials, list primary completion dates of January 2027.
- Regulation
Lilly and FDA head toward decision on whether retatrutide is a biologic
Eli Lilly and the FDA are still litigating whether retatrutide, an experimental obesity drug, should be regulated as a biologic or as a conventional drug. The answer decides whether Lilly gets 12 years of market exclusivity under a biologics license application or five years under a new drug application. Lilly now plans to file the medicine for approval in the first quarter of 2027.
- Research and trials
Testosterone plus lifestyle outperforms GLP-1 therapy in obesity-linked hypogonadism analysis
A network meta-analysis in The Journal of Sexual Medicine pooled 23 randomized trials with 1,899 men who had obesity-related functional hypogonadism. Testosterone replacement plus structured lifestyle therapy produced the largest increase in total testosterone (mean difference 7.19, 95% CI 1.18 to 13.21) and was the only intervention that significantly improved erectile function scores (mean difference 1.29, 95% CI 0.07 to 2.50). GLP-1 receptor agonist-based therapy was among the five strategies compared but did not lead the network, and no intervention significantly reduced glycated hemoglobin.
- Science
Lilly pipeline update lists brenipatide, macupatide and a long-acting GIP receptor agonist
Eli Lilly's clinical development pipeline, current as of August 5, 2026, lists eloralintide in Phase 3 for obesity, obstructive sleep apnea, osteoarthritis pain and as an incretin add-on for obesity. The same table lists brenipatide in two Phase 3 and seven Phase 2 programs, macupatide in Phase 2 for obesity, and a long-acting GIP receptor agonist in Phase 2 for chemotherapy-induced nausea and vomiting. No results, doses or timelines are included.
- Compounding
Novo Nordisk wins Dutch injunction against compounded semaglutide nasal spray
Novo Nordisk obtained a preliminary court injunction in the Netherlands on Aug. 5, 2026, against a compounded semaglutide nasal spray. The action extends the company's enforcement campaign against unapproved semaglutide formulations into a new country and a new route of administration. Nasal and sublingual semaglutide products have no approved dosing or bioavailability data anywhere in the world.
- Business
Novo Nordisk raises 2026 outlook as Wegovy pill prescriptions top 5 million
Novo Nordisk reported adjusted operating profit of DKK 33,389 million for the second quarter of 2026 and raised its full-year outlook to adjusted sales growth of 0% to -6% at constant exchange rates, up from -4% to -12%. The company said the Wegovy pill has passed 5 million prescriptions in the US since its January launch, with more than 265,000 weekly prescriptions in the week ending July 17.
- Business
Novo Nordisk says the Wegovy pill, not the injection, is driving semaglutide growth
Novo Nordisk's second-quarter 2026 report shows Ozempic sales up 3% to DKK 31.375 billion and Wegovy injection sales up 1% to DKK 19.484 billion, while the Wegovy pill added DKK 3.218 billion in its second full quarter. Adjusted group sales rose 7% and adjusted operating profit rose 11% at constant exchange rates, and the company raised its 2026 outlook.
- Research and trials
CagriSema misses blood sugar goal in head-to-head trial against tirzepatide
Novo Nordisk's experimental CagriSema produced 15.2% weight loss and a 1.9 percentage point HbA1c reduction at 68 weeks in the REIMAGINE 4 trial, while tirzepatide 15 mg produced 15.8% weight loss and a 2.2 point reduction. The trial met non-inferiority on weight but missed it on blood sugar, so it did not succeed on its dual primary endpoint.
- Business
Novo Nordisk raises 2026 outlook as write-downs pull reported profit down 16%
Novo Nordisk reported second-quarter 2026 adjusted sales of DKK 78,488 million, up 7% at constant exchange rates, and adjusted operating profit of DKK 33,389 million, up 11%. Reported operating profit fell 16% at constant exchange rates, hurt by DKK 6.3 billion in non-cash impairment charges on pipeline assets, including about DKK 4.0 billion tied to monlunabant. The company raised its 2026 adjusted sales and adjusted operating profit outlook to 0% to -6% at constant exchange rates, from -4% to -12%.
- Competition
Pfizer drops two more obesity drugs and narrows its pipeline to berobenatide
Pfizer removed two clinical-stage obesity programs from its pipeline on Aug. 4, 2026: MET-224o, an oral ultra-long-acting GLP-1 in Phase 1 that came with the $10 billion Metsera acquisition, and PF-07976016, a Phase 2 GIP receptor antagonist. Pfizer's only remaining oral GLP-1 candidate is PF-08642534, its name for YP05002, licensed from China's YaoPharma for $150 million upfront. The company's lead obesity asset is now the Phase 3 injectable berobenatide.
- Science
Yale study in mice says semaglutide needs brain hunger neurons to sustain fat loss
A Yale-led team reported in the Proceedings of the National Academy of Sciences that semaglutide activated, rather than silenced, AgRP hunger neurons in female mice, and that mice without those neurons did not sustain weight loss on GLP-1 drugs. The paper was published August 4, 2026, and used mice, so whether the same mechanism operates in people is not yet known.
- Competition
Amgen discontinues Phase 1 obesity drug AMG 513, leaving MariTide as its only late-stage asset
Amgen stopped development of AMG 513, an obesity candidate in Phase 1 testing, the company said in its August 4, 2026 second-quarter results. One Phase 1 study will continue so that enrolled participants can be followed to completion. MariTide is now Amgen's only obesity asset in late-stage development.
- Research and trials
Altimmune begins Phase 3 trial of pemvidutide in MASH
Altimmune said on August 3, 2026 that it has started PERFORMA, a global registrational Phase 3 trial of pemvidutide in MASH, testing fibrosis improvement and MASH resolution. The trial follows positive Phase 2b results for the same drug in the same liver disease. Altimmune's obesity program for pemvidutide remains in Phase 2, where the drug has been reported to produce about 15.6% weight loss at 48 weeks.
- Research and trials
Danish study finds 52% of semaglutide users for weight loss stopped within a year
A peer-reviewed cohort study of 77,310 Danish adults without diabetes who started semaglutide for weight management found that 18% had stopped by three months and 52% by one year. Dropout was highest among adults aged 18 to 30. The study measured who stopped and when, and does not explain why.
- Safety
Ozempic and GLP-1 stomach injury lawsuits reach 3,928 in federal court
The federal multidistrict litigation over alleged gastrointestinal injuries from GLP-1 medications grew to 3,928 pending cases as of August 3, 2026, up 80 cases in a month. No case in the litigation has settled or gone to trial, and a hearing on the plaintiffs' expert evidence in the stomach-injury track is set for September 14-18, 2026.
- Policy
Lilly opens broader early-access program for unapproved obesity drug retatrutide
Eli Lilly said on Aug. 3, 2026 that more patients can apply for early access to retatrutide, its experimental obesity drug, after the company gave the medicine to a single 79-year-old patient in June. Patients must be 18 or older, have obesity that has not responded to the highest approved dose of an obesity therapy, and have at least two serious or life-threatening obesity-related complications. Lilly plans to file for FDA approval of retatrutide in the first quarter of 2027.
- Prices
Canadian drug plans brace for 65% semaglutide price cut when third generic arrives
Canadian benefits analysts are telling plan sponsors to expect semaglutide list prices to fall to 35% of the brand price, a 65% cut, as soon as a third generic version reaches the market. Sandoz is targeting the third quarter of 2026 for that entry, and Aspen Pharmacare is going Canada-first. Under Canada's pCPA pricing tiers, the third generic — not the first approval — is what resets drug-plan budgets.
- Regulation
Eli Lilly sues sellers of unapproved retatrutide in first such lawsuits
Eli Lilly filed its first lawsuits over unauthorized sales of retatrutide, an investigational triple-agonist drug that is not approved, Endpoints News reported on August 1, 2026. The filings target entities accused of selling the drug without authorization.
- Research and trials
Tirzepatide tied to weight loss and metabolic gains in partial lipodystrophy study
A single-center retrospective study of 40 patients with partial lipodystrophy found that tirzepatide was linked to a median weight drop from 91.0 kg to 82.8 kg over a median 9.5 months. The study also reported significant improvements in blood sugar control, triglycerides, and daily insulin needs. There was no control group, and metreleptin remains the only approved treatment specific to lipodystrophy.
- Business
Lilly holds about 60% of US obesity market as Zepbound and Foundayo outpace Wegovy
Eli Lilly's obesity drugs held roughly 60% of the US branded obesity market through the summer of 2026, with Novo Nordisk's Wegovy franchise at about 40%, according to IQVIA prescription data cited by Citi and Jefferies. In the week reported Sept. 11, Novo's Wegovy pill recorded about 183,000 total prescriptions while Lilly's Foundayo reached about 47,500, up nearly 8%.
- Competition
Structure Therapeutics begins Phase 3 testing of oral GLP-1 pill aleniglipron
Structure Therapeutics said it has started a Phase 3 program, called ACCOMPLISH, for its once-daily oral GLP-1 pill aleniglipron, with two trials enrolling up to 3,600 and 1,100 adults and results expected in the second half of 2028. The company also reported 72-week data from an extension study in which participants who reached the 180 mg dose lost up to 16.2% of body weight and fewer than 5% stopped treatment because of side effects.
- Competition
Mazdutide and ecnoglutide join the GLP-1 watchlist as Chinese candidates draw attention
Mazdutide and ecnoglutide now appear on a monthly obesity drug watchlist as China-origin GLP-1 candidates, tracked for approvals and data alongside US and European programs. In the 60-week GLORY-2 trial, a 9 mg dose of mazdutide produced placebo-subtracted weight loss of 15.1% in 461 adults in China with overweight or obesity, 16% of whom had type 2 diabetes. Neither drug is approved in the United States, and no US filing for either has been reported.
- Prices
CVS Caremark's Zepbound exclusion carries into 2026 as oral GLP-1s advance
CVS Caremark removed Zepbound (tirzepatide) from its Standard, Advanced Control and Value formularies on July 1, 2025, and the exclusion continues through 2026, with Wegovy (semaglutide) named the preferred weight-loss GLP-1. Two class action lawsuits filed in September 2025 allege the change affected about 200,000 patients and favored rebate revenue; CVS Caremark says the suits are without merit. Lilly said the decision hurt Zepbound prescriptions in July 2025 and could challenge third-quarter sales growth.
- Science
ADA 2026 panel puts lean mass loss at the center of GLP-1 obesity treatment
Experts at the American Diabetes Association 2026 Scientific Sessions said roughly 25% of total weight lost through any intervention comes from lean body mass, and that share can reach 40% or more with higher-dose GLP-1 drugs. In a phase 2 trial, adding the myostatin inhibitor bimagrumab to semaglutide cut the lean-mass fraction of weight loss from about 21% to 7%. No head-to-head comparison of lean mass across different GLP-1 drugs has been reported.
- Business
Novo Nordisk reported to be preparing US launch of four-dose Wegovy FlexTouch pen
Novo Nordisk is preparing to launch a multi-dose Wegovy FlexTouch pen in the United States, according to trade reporting that cited multiple sources and said FDA records show the device is already cleared. The pen holds 9.6 mg of semaglutide in 3 mL and delivers four labeled 2.4 mg doses, replacing four single-use pens with one device for about a month. No launch date or price has been announced.
- Competition
Obesity drug pipeline widens beyond GLP-1 as elecoglipron, aleniglipron and petrelintide advance
AstraZeneca has moved its oral drug elecoglipron into Phase 3, Structure Therapeutics has begun dosing patients in a Phase 3 trial of oral aleniglipron, and Zealand Pharma and Roche are advancing the amylin analog petrelintide, which produced up to 10.7% average weight loss at 42 weeks in Phase 2. A tracker counts more than 150 active obesity programs across mechanisms including amylin, glucagon and RNAi.
- Regulation
Novo Nordisk seeks FDA approval of a 25 mg Ozempic tablet for type 2 diabetes
Novo Nordisk has filed a supplemental application with the FDA for a 25 mg tablet strength of Ozempic (semaglutide) for adults with type 2 diabetes, and a decision is expected in 2026. Oral Ozempic strengths currently top out at 9 mg. No specific decision date or pricing has been disclosed.
- Competition
Pfizer advances monthly GLP-1 obesity injection from its Metsera purchase
Pfizer completed its roughly $10 billion acquisition of obesity biotech Metsera on Nov. 13, 2025, gaining MET-097i, a weekly and monthly injectable GLP-1 that Pfizer said was about to begin Phase 3. Pfizer has not reported Phase 2b results for a monthly candidate identified as PF-08653944 or disclosed how many obesity trials it plans for 2026. Monthly dosing is the pitch against weekly Wegovy and Zepbound.
- Regulation
Zepbound label update revises diabetic retinopathy warning for type 2 diabetes
The Zepbound prescribing information carries a revision date of 8/2026, and its change log lists an update to the section on diabetic retinopathy complications in patients with type 2 diabetes. The same table shows the suicidal behavior and ideation warning was removed in 02/2026. The label keeps its instruction for patients using oral hormonal contraceptives to switch to a non-oral method or add a barrier method for four weeks after starting and after each dose escalation.
- Business
Novo Nordisk's ziltivekimab fails ZEUS heart trial, erasing $30 billion in market value
Novo Nordisk said July 31 that ziltivekimab, an investigational anti-inflammatory antibody, did not reduce major cardiovascular events in the phase 3 ZEUS trial of more than 6,300 people with atherosclerotic cardiovascular disease, chronic kidney disease and inflammation. The hazard ratio was 0.99, with a 95% confidence interval of 0.88 to 1.11, compared with placebo. Novo Nordisk shares fell 9.3% and the company lost $30.7 billion in market value the same day.
- Research and trials
Novo Nordisk's ziltivekimab fails phase 3 ZEUS trial; shares fall about 9%
Novo Nordisk said its phase 3 ZEUS trial of ziltivekimab did not meet its primary endpoint in people with atherosclerotic cardiovascular disease, chronic kidney disease and inflammation, in a company announcement dated July 31, 2026. The drugmaker's shares fell about 9% that day, and a non-cash impairment is expected in the third quarter of 2026.
- Business
U.S. tariffs of up to 100% on patented drugs begin for Eli Lilly and 16 other companies
Section 232 tariffs on imported patented pharmaceuticals took effect July 31, 2026, for the 17 drugmakers named in Annex III of an April 2 proclamation, a list that includes Eli Lilly. Importers of patented drugs from all other companies have until September 29, 2026. Companies with approved onshoring plans and most-favored-nation pricing agreements pay reduced rates, or zero.
- Research and trials
Cleveland Clinic guidance advises against microdosing GLP-1 medications
Cleveland Clinic published consumer guidance on July 31, 2026 telling patients not to microdose GLP-1 drugs such as semaglutide and tirzepatide, citing dosing-error risk and a lack of evidence for meaningful or sustained benefit. FDA has separately reported overdoses from compounded injectable semaglutide in which patients took five to 20 times the intended dose, some requiring hospitalization.
- Prices
Medicaid GLP-1 discount program deadline passes with no participating state named
The July 31, 2026 deadline for state Medicaid agencies to apply to the BALANCE Model has passed, and as of mid-August 2026 CMS listed no participating state and reported its participant count as not applicable. The model lets CMS negotiate GLP-1 prices for states, but participation is voluntary. Medicaid enrollment in the model began in May 2026 and runs through December 31, 2031.
- Research and trials
FDA comment period closes on plan to bar bulk compounding of semaglutide, tirzepatide and liraglutide
The deadline for public comments on the FDA's proposal to keep semaglutide, tirzepatide and liraglutide off the 503B bulks list passed on July 30, 2026. The FDA extended the original deadline by 30 days after industry groups asked for 60. No date for a final decision has been announced.
- Prices
Brazil approves Sun Pharma's generic semaglutide injection for type 2 diabetes
Brazil's health regulator ANVISA approved Sun Pharmaceutical Industries to make and market semaglutide injections for adults with inadequately controlled type 2 diabetes, and the company plans to launch within days through Brazil-based Hypera Pharma. The product is a once-weekly pre-filled pen sold in two strengths, 2 mg/1.5 mL and 4 mg/3 mL. Sun cited IQVIA data valuing Brazil's semaglutide injectable market at about $413 million for the 12 months ended June 2026.
- Business
Lilly and Resilience to invest $750 million in Ohio injectable manufacturing
Eli Lilly and contract manufacturer Resilience will invest $750 million to expand U.S. pharmaceutical manufacturing, adding production of Lilly's KwikPen injectable device at Resilience's Cincinnati-area site. The project is expected to create at least 400 jobs and bring Resilience's Ohio headcount above 1,400, with full operations from the upgrade expected in 2027.
- Regulation
Two more generic semaglutide products approved in Canada but not yet on shelves
Health Canada's Drug Product Database lists Aspen-Semaglutide and Sevmia as approved with no market date as of July 28, 2026, so neither could be bought at a pharmacy counter. Three of nine generic semaglutide products have been approved in Canada, while Dr. Reddy's generic reached Canadian pharmacies in 2026. Canadian pricing tiers run from 75% to 85% of the brand price for the first generic and fall to 35% once three generics are on the market.
- Compounding
FTC sues Hims & Hers over subscription billing and health data sharing
The Federal Trade Commission, joined by Utah and Los Angeles County, sued Hims & Hers Health on July 29, 2026, alleging the telehealth company shared customers' health information with advertising platforms including Meta and Snap and used deceptive billing and cancellation practices for prescription subscriptions. Hims & Hers denied the allegations and said it will defend itself; its shares fell 10%. The FTC's investigation dates to October 2023, and the company recorded a $15 million probable-loss accrual in May 2026.
- Research and trials
Trial finds daily oral semaglutide lowered heavy drinking but missed craving goal
In a phase 2 randomized trial, 50 adults with moderate to severe alcohol use disorder took oral semaglutide or placebo for eight weeks. The drug failed to significantly reduce laboratory-measured alcohol craving, the primary endpoint, and did not significantly cut drinks per day, but it did significantly reduce heavy drinking days, drinks on drinking days, naturalistic craving, alcohol-related consequences and cannabis use days. By week eight, 81% of the semaglutide group had dropped at least one World Health Organization risk drinking category, versus about 54% on placebo.
- Regulation
Patent expert says Novo Nordisk let an Ozempic patent extension lapse in Canada
Tahir Amin, chief executive of the Initiative for Medicines, Access & Knowledge, told the BBC that Novo Nordisk's Canadian semaglutide patent could have run until 2028 but was not renewed, saying "somebody dropped the ball." Canada became the first G7 country to authorize a generic version of semaglutide after a separate regulatory requirement expired on January 5, 2026, and Dr Reddy's began selling its generic there on May 15, 2026.
- Research and trials
Viking pushes oral VK2735 into late-2026 Phase 3 as injectable trials stay on track
Viking Therapeutics said July 29 that it expects to start Phase 3 trials of an oral tablet form of VK2735 in the fourth quarter of 2026, and that maintenance-dosing results are expected later this quarter. The company's two Phase 3 injection trials, VANQUISH-1 and VANQUISH-2, are fully enrolled, and Viking reported $502 million in cash as of June 30.
- Research and trials
Study finds similar six-month weight loss on 2.5 mg and 5 mg tirzepatide
A multicenter, non-randomized cohort of 112 non-diabetic Japanese adults with obesity found that participants who stayed on 2.5 mg of tirzepatide weekly lost 15.3 percent of their body weight at six months, versus 16.1 percent for those who moved up to 5 mg, a difference the authors report as not statistically significant. Adverse events were reported by 35 percent of the 2.5 mg group and 50 percent of the 5 mg group, mostly gastrointestinal symptoms. The study was published July 28, 2026, in Diabetes, Obesity and Metabolism.
- Competition
Altimmune says pemvidutide cut heavy drinking in Phase 2 alcohol use disorder trial
Altimmune reported on July 28, 2026 that pemvidutide, an investigational dual glucagon/GLP-1 drug, met the main goal of its RECLAIM Phase 2 trial in moderate to severe alcohol use disorder. Heavy drinking days per week fell by 4.20 with pemvidutide versus 2.75 with placebo (p=0.0014), and 64.4% of treated patients had a two-level drop in WHO risk drinking levels versus 34.8% on placebo. The company says it will ask the FDA for an End-of-Phase 2 meeting.
- Competition
Gubra begins human trial of GUB-UCN2, an obesity drug aimed at preserving muscle
Gubra has begun a Phase 1/2a trial of GUB-UCN2, an experimental urocortin-2 obesity drug designed to reduce fat while preserving muscle, with the study listed as starting July 27, 2026. The company disclosed the start in its half-year report on Aug 20, 2026 and says first data from the single-ascending-dose portion is expected in the first half of 2027. Weeks later, Roche agreed to pay $190 million upfront for rights outside South Korea to a competing UCN2 analog from Hanmi Pharmaceutical, in a deal worth up to about $2.5 billion in total.
- Business
Judge lets part of CagriSema fraud lawsuit against Novo Nordisk proceed
A federal judge in New Jersey ruled on July 28 that Novo Nordisk must face part of a shareholder lawsuit over statements it made before reporting CagriSema trial results. Most claims were dismissed, but a narrower set tied to the drug's tolerability and dosing can move into discovery. Investors sued after the company's American depositary receipts fell 17.8% on December 20, 2024, when CagriSema produced 20.4% weight loss against a 25% target.
- Research and trials
Semaglutide taper trial protocol published in PLoS One
PLoS One published the protocol for the REST trial on July 27, 2026. The randomized study will compare a 16-week gradual semaglutide dose reduction, cut by 25% every four weeks, with immediate discontinuation in adults who have lost at least 10% of their body weight. The primary outcome is the difference in body weight change between the two groups. No results are reported in the protocol.
- Competition
Novo Nordisk seeks court order to stop Lilly's Zepbound and Mounjaro ads
Novo Nordisk said July 24 it is asking a federal court to block Eli Lilly's advertising for Zepbound and Mounjaro, three days after filing a false-advertising suit over those campaigns. Novo plans to file the injunction motion Aug. 17, targeting ads that say Zepbound produces "significantly more" weight loss than Wegovy and that Mounjaro lowers A1C "significantly more" than Ozempic. Lilly denies wrongdoing and says it will fight the motion.
- Science
Mouse study links GIP receptor effects to two brain regions, offering clues for tirzepatide
A Nature Metabolism study in mice found that the area postrema drives the appetite-suppressing effect of GIP receptor agonists, while GIP receptors in the hypothalamus drive the extra weight loss seen when a GIP receptor blocker is added to a GLP-1 or amylin receptor agonist. The two knockout models responded differently to the GLP-1 drug liraglutide, which the authors say helps explain why both turning the GIP receptor on and blocking it can add weight loss alongside GLP-1 medicines.
- Competition
Lilly says retatrutide met goals in two more Phase 3 trials, with FDA filing set for early 2027
Eli Lilly reported on July 23, 2026 that retatrutide met the primary endpoint in two more Phase 3 trials: TRIUMPH-2 in adults with type 2 diabetes and obesity, with average weight loss of up to 20.8% at 80 weeks, and TRIUMPH-3 in adults with severe obesity and cardiovascular disease, at up to 22.6%. Lilly said it now plans to submit a Biologics License Application to the FDA in the first quarter of 2027, while it completes manufacturing and quality-control data.
- Regulation
Australia adds rare vision disorder warning to all GLP-1 labels, including Ozempic and Mounjaro
Australia's Therapeutic Goods Administration issued a class-wide safety update on July 23, 2026, adding the rare eye condition NAION to the product information for every GLP-1 receptor agonist sold in the country: semaglutide, tirzepatide, liraglutide and dulaglutide. The agency's adverse event database lists 36 cases of optic ischemic neuropathy — 23 involving semaglutide, 10 involving tirzepatide and three involving liraglutide, and none for dulaglutide. The TGA said the label changes reflect class-level awareness and should not imply the drugs caused the cases.
- Compounding
FDA compounding panel recommends six peptides, including BPC-157, over staff objections
The FDA's Pharmacy Compounding Advisory Committee voted on July 23 and 24, 2026, to recommend BPC-157, KPV, TB-500, MOTS-c, semax and epitalon for the 503A Bulks List, despite FDA staff advice against all seven substances on the agenda. Emideltide was rejected 7-6 with one abstention. The votes are advisory and do not change what pharmacies may legally compound.
- Research and trials
Lilly says retatrutide is ready to file, with US submission planned for early 2027
Eli Lilly says its investigational drug retatrutide has produced five positive phase 3 trials and is ready to be filed for approval in obesity, obstructive sleep apnea and knee osteoarthritis pain, with a US filing targeted for the first quarter of 2027. The TRIUMPH-3 trial, in people with severe obesity and established cardiovascular disease, showed 22.6 percent weight loss. Retatrutide is not approved, and the company has not disclosed pricing or a review timeline.
- Research and trials
Review finds GLP-1 drugs raise testosterone mainly in men with metabolic conditions
A systematic review published July 23 in the journal Cells examined eight studies of GLP-1 receptor agonists and male reproductive health. In men with obesity, type 2 diabetes or functional hypogonadism, the drugs were linked to modest testosterone increases and better erectile function or selected semen measures, while a placebo-controlled trial in healthy men with normal testosterone found no significant effect. The authors say the response depends on a man's baseline metabolic status.
- Safety
BMJ study finds higher hair loss risk with GLP-1 drugs including semaglutide and tirzepatide
A target trial emulation published July 22 in The BMJ found that adults with type 2 diabetes who started a GLP-1 receptor agonist had a higher risk of hair loss than those who started an SGLT-2 inhibitor or a DPP-4 inhibitor. Hazard ratios were 1.37 against SGLT-2 inhibitors and 1.68 against DPP-4 inhibitors, and the signal was specific to non-scarring alopecia. The authors say the absolute risk is low and note the FDA has indicated it is evaluating the signal.
- Competition
Novo Nordisk sues Eli Lilly over Zepbound and Mounjaro advertising
Novo Nordisk sued Eli Lilly on July 21, 2026, in New Jersey federal court, saying national ads for Zepbound and Mounjaro mislead viewers by comparing Lilly's top doses with lower doses of Wegovy and Ozempic and by leaving out the 7.2 mg Wegovy dose approved in March. Novo says the ads reached consumers more than 700 million times after an April cease-and-desist letter. Lilly says its advertising rests on the SURMOUNT-5 head-to-head trial and will defend the case.
- Business
Trump announces two-year pause on generic drug tariffs, then 100% and 200% rates
President Donald Trump said imported generic drugs will keep a 0% US tariff for two years starting August 1, 2026, then face a 100% rate for one year and 200% after that. He said the schedule is meant to force generic manufacturing into the United States, and that policy on branded drugs stays unchanged. No implementation guidance has been released.
- Research and trials
Review finds thin evidence for off-label semaglutide and tirzepatide uses
A review published July 21, 2026 in Biomedicines surveyed unconventional uses of semaglutide and tirzepatide across oncology, psychiatry and addiction medicine, orthopedics, aesthetic medicine and human reproduction. It reports signals in all five areas but concludes the evidence comes mainly from preclinical models, observational cohorts and pharmacoepidemiologic studies, with randomized trials remaining limited. The review reports no effect sizes or patient counts.
- Competition
Hengrui reports positive Phase 3 diabetes results for ribupatide in China
Hengrui Pharma said its once-weekly injectable ribupatide met the primary endpoint and all key secondary endpoints in a Phase 3 trial of 218 treatment-naive Chinese adults with type 2 diabetes. Average HbA1c fell by up to 2.67 percentage points at 36 weeks, and up to 94.5% of participants on the 4 mg dose reached HbA1c below 7%. Hengrui plans to file for approval in China, and the drug is not approved in the United States.
- Culture
Rebel Wilson becomes Noom's chief wellness officer, leading campaign pairing GLP-1s with habit change
Rebel Wilson, who has said she used Ozempic to maintain a 77-pound weight loss, is now chief wellness officer at the telehealth company Noom. She is leading a Noom campaign that argues GLP-1 medications and healthy lifestyle habits work better together. The role puts a celebrity who has spoken openly about using a GLP-1 at the center of a weight-loss company's marketing rather than in opposition to the drugs.
- Business
Lilly completes $2.8 billion purchase of AtaiBeckley and its depression drug BPL-003
Eli Lilly agreed on July 16, 2026, to acquire AtaiBeckley Inc. for about $2.8 billion in upfront cash, plus up to $1 billion in contingent payments tied to future milestones, and completed the deal on September 11, 2026. The acquisition adds BPL-003, an investigational nasal spray for treatment-resistant depression that holds FDA Breakthrough Therapy Designation and has begun Phase 3 work, along with two other mental health programs.
- Competition
Boehringer Ingelheim starts Phase 2 trial of Gubra-originated triple agonist for obesity
Boehringer Ingelheim has begun a Phase 2 clinical trial of a triple receptor agonist in people living with overweight and obesity, the drug's originator Gubra said on July 16, 2026. The compound's name, dose, enrollment size and timeline have not been disclosed. Separately, Gubra reported in March 2026 that a different partnered drug, the amylin analog ABBV-295, produced average weight reductions of roughly 8% to 10% over 12 to 13 weeks in a Phase 1 study.
- Business
European Commission approves Wegovy pill, first oral GLP-1 for weight management in the EU
The European Commission approved the Wegovy pill, once-daily oral semaglutide 25 mg, for weight management in adults with a BMI of at least 30, or at least 27 with a weight-related condition. It is the first oral GLP-1 cleared for weight management across the European Union. The same decision approved a single-dose, ready-to-use pen for the higher-dose Wegovy 7.2 mg injection.
- Culture
Expert panel sets protein, fluid and fiber targets for people on GLP-1 drugs
A 13-member panel of India-based endocrinologists published a consensus statement on nutrition for people taking GLP-1-based therapies, recommending protein at 20 to 30 percent of energy rising to 1.2 to 1.5 g/kg/day or higher, fluid above 2 liters a day and fiber at 20 to 30 g a day. The panel also called for four to five small eating occasions daily instead of large portions, slower eating and no large evening meals. Of 44 statements, 43 reached high or moderate agreement.
- Regulation
European Commission approves oral Wegovy, the pill's fifth regulatory clearance
The European Commission approved the Wegovy pill, a once-daily oral semaglutide for weight management in adults, making it the first GLP-1 receptor agonist available in tablet form for weight management across all EU member states. It is the fifth regulatory approval for the pill, after the United States, the U.K., the United Arab Emirates and Bahrain. In the OASIS 4 trial, participants on oral semaglutide 25 mg lost about 17% of their body weight versus about 3% on placebo.
- Culture
Sam's Club bundles Weight Watchers benefit as Costco expands GLP-1 access
Sam's Club Plus members will get a free three-month Weight Watchers Core membership, valued at $54, plus discounts of up to 50% on Weight Watchers' Core+ and Med+ plans under a partnership the companies announced in July 2026. Rival Costco offers the oral Wegovy tablet at $149 a month through its pharmacies and a 50% discount on Wegovy and Ozempic injections.
- Research and trials
Case series links high-dose tirzepatide to flat mood and lost motivation
Three women with obesity taking tirzepatide at 15 mg weekly reported reduced motivation, emotional flatness and loss of interest in activities they previously enjoyed, according to a three-case series in Obesity Pillars. All three had their dose cut to 10 mg weekly or lower; two improved markedly on dose reduction alone, and one also received bupropion. Re-escalating the dose in one patient brought the symptoms back without added weight loss.
- Prices
Zepbound coverage gap grows to 114 million people, GoodRx tracker shows
GoodRx Research reports that 60% of commercially insured Americans had no coverage for Zepbound as of July 2026, up from 51% in 2025, leaving more than 114 million people without coverage for the weight-loss drug. Unrestricted coverage fell from 5% to 4%, and 88% of people with coverage for a weight-loss GLP-1 still face prior authorization, step therapy or both.
- Safety
Tirzepatide safety study finds medication errors top FDA report signal list
An analysis of 123,145 reports to the FDA Adverse Event Reporting System found medication errors and injection-site reactions were the strongest safety signals for tirzepatide, the drug in Mounjaro and Zepbound. Among reports with valid timing data, half of the events occurred within 13 days of starting the drug, and 67.1% within 30 days.
- Research and trials
Structure Therapeutics begins enrolling two Phase 3 trials of oral GLP-1 pill aleniglipron
Structure Therapeutics has started enrolling participants in two Phase 3 trials of aleniglipron, an experimental oral GLP-1 medicine, under a program called ACCOMPLISH. ACCOMPLISH-1 is planned for about 3,600 participants and ACCOMPLISH-2 for about 1,100, with enrollment in the two studies starting within days of each other. Topline results are expected in the second half of 2028.
- Policy
CMS posts beneficiary guidance for the Medicare GLP-1 Bridge and its $50 copay
The Centers for Medicare & Medicaid Services has published beneficiary-facing guidance for the Medicare GLP-1 Bridge, a demonstration running July 1, 2026 through December 31, 2027 that gives eligible Part D enrollees access to certain GLP-1 drugs for a flat $50 copay. The program runs outside normal Part D rules, so the copay does not count toward the deductible or the annual out-of-pocket cap, and low-income subsidies do not apply. A single central processor handles prior authorization, claims and pharmacy payment in 2026.
- Research and trials
Meta-analyzes find no clear rise in birth defects after GLP-1 exposure in pregnancy
Two meta-analyzes published in July 2026 found no statistically significant increase in major congenital malformations among pregnancies exposed to GLP-1 receptor agonists. One reported an odds ratio of 1.11 (95% CI 0.82–1.51) for any congenital malformation; the other reported a relative risk of 1.02 (95% CI 0.96–1.08). Both sets of authors said the evidence is low-certainty and does not prove the drugs are safe in pregnancy.
- Research and trials
Tirzepatide shows higher one-year persistence than semaglutide in military cohort
In a Military Health System cohort of 10,649 active-duty service members starting weight-management therapy, 81.9% of those on tirzepatide (Zepbound) were still persistent at one year, compared with 70.7% on semaglutide (Wegovy) and 34.2% on liraglutide (Saxenda). The adjusted hazard of discontinuation was 33% lower for tirzepatide than semaglutide. All patients had guaranteed coverage through the military system, so the rates may not reflect other US populations.
- Culture
Survey of 518 employed adults starting tirzepatide finds 32.4% work impairment
A baseline survey of 518 full-time employed US adults starting tirzepatide for obesity or overweight found 32.4% average overall work impairment, driven mainly by presenteeism. Most had employer-provided insurance, but only 55.9% of that group reported coverage for obesity medications, and 52.3% said they would consider changing jobs to get it.
- Research and trials
BMJ review links the biggest fat loss among obesity drugs to the biggest lean mass loss
A network meta-analysis of 262 trials and 99,791 people found tirzepatide cut fat mass by 25.7%, more than any other obesity drug, and also cut lean mass the most at 8.3%. Injectable semaglutide was the only drug tied to fewer deaths and fewer heart attacks. Across 43 trials, no drug moved quality-of-life scores past the threshold researchers call meaningful.
- Prices
Employer coverage of GLP-1s for weight loss holds steady as drug share of claims rises
A June 2026 survey of almost 300 U.S. employer health plans found that 36% cover GLP-1 medications for weight loss as well as diabetes, the same share as a year earlier, while 60% cover them for diabetes only. Spending on the drug class rose from 6.9% of annual claims in 2023 to 11.4% in 2026.
- Prices
FDA accepts second generic tirzepatide application, from Amneal and Adalvo
On July 8, 2026, Amneal Pharmaceuticals and its partner Adalvo said the FDA accepted two abbreviated new drug applications for a generic tirzepatide autoinjector, nine days after the FDA accepted two Sandoz ANDAs covering the Mounjaro and Zepbound indications. Acceptance puts the applications in the review queue but is not approval, and Eli Lilly's core tirzepatide patent runs to about January 2036.
- Regulation
Novo Nordisk updates Singapore Wegovy label with higher-dose STEP UP data
Novo Nordisk said Singapore updated the Wegovy (semaglutide) label to include STEP UP trial results for a higher 7.2 mg dose. In the 72-week trial, mean weight loss was 20.7% and 31.2% of patients on that dose lost at least 25% of their body weight. The company also reported that up to 84% of the weight lost came from fat mass.
- Regulation
Wegovy pill reaches UK patients as doctors debate prescribing and demand
The semaglutide (Wegovy) tablet is now available to UK patients for weight loss, weeks after the MHRA authorized it on 11 June 2026. It can be bought privately from pharmacies but is not yet available on the NHS, which first requires an evaluation by NICE. The BMJ reports the launch has raised questions among doctors about prescribing, monitoring and demand.
- Culture
Gallup: 11 percent of U.S. adults now take a GLP-1 for weight loss, up from 3 percent in 2024
A Gallup survey released July 7, 2026 found that 11 percent of U.S. adults currently take a GLP-1 medication for weight loss, up from 3 percent in 2024, and 15 percent have used one at some point. The same poll put the U.S. adult obesity rate at 36.8 percent, down from a record 39.9 percent in 2022.
- Research and trials
Tirzepatide tied to bigger daytime-function gains in sleep apnea patients who felt worst at baseline
Post-hoc analyses of the SURMOUNT-OSA trial grouped participants by how severe their self-reported fatigue, sleepiness, snoring and sleep quality were at the start, then compared changes on tirzepatide with placebo. Tirzepatide was associated with greater improvement than placebo in every subgroup, and vitality gains were numerically larger among people who began the trial reporting fatigue. Detailed effect sizes and participant counts for each subgroup have not been reported.
- Research and trials
Two migraine patients had fewer attacks on tirzepatide, but weight loss confounds the finding
A case series published July 6, 2026, in the journal Headache reports that two patients with migraine had fewer migraine headaches after starting tirzepatide. The authors call the finding preliminary and say the improvement cannot be credited to the drug itself because both patients also lost weight.
- Prices
MassHealth ends weight-loss coverage for Wegovy, Zepbound and other obesity drugs
Massachusetts' Medicaid program stopped covering anti-obesity medications prescribed only for weight loss on July 3, 2026, cutting off roughly 22,000 members. The state expects the change to save about $15 million. Coverage continues for members with diabetes or another medically accepted indication, but a new prior authorization is required.
- Regulation
UK regulator approves Wegovy (semaglutide) to treat a form of liver disease
On July 3, 2026, the UK's Medicines and Healthcare products Regulatory Agency approved the semaglutide injection Wegovy to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis. The approval is conditional, pending further results from an ongoing study, and access through the NHS depends on a separate cost-effectiveness review that has not concluded.
- Research and trials
Audit finds compounded semaglutide and tirzepatide still sold after shortages ended
A JAMA Health Forum audit of 75 weight-loss clinics and medical spas in West Virginia and Oklahoma found compounded semaglutide and tirzepatide still being offered after the federal shortages of those drugs ended. More than half of the businesses combined the products with B vitamins, and 4 of 21 supplier facilities lacked licenses for sterile compounding. Three of 22 facilities had faced state disciplinary action since 2023 and one had received multiple FDA warning letters.
- Safety
Judge authorizes early causation and preemption motions in GLP-1 vision-loss MDL
A case management order issued July 2, 2026 in MDL 3163, the federal consolidation of NAION vision-loss claims, opened the first substantive motion practice on general causation and federal preemption. The same two questions are already being litigated in the larger stomach-injury MDL, which has 3,928 pending cases to MDL 3163's 200. No rulings, settlements or verdicts have been reported in either track.
- Compounding
Medicare GLP-1 Bridge begins with a $50 copay for Wegovy, Zepbound KwikPen and Foundayo
Medicare's GLP-1 Bridge demonstration started July 1, 2026, giving eligible Part D beneficiaries a flat $50 copay for a one-month supply of three GLP-1 products. The covered list names Foundayo (orforglipron) tablets, Wegovy (semaglutide) injection or tablets, and the Zepbound (tirzepatide) KwikPen only. The program runs through December 31, 2027.
- Policy
Medicare's GLP-1 Bridge begins, offering Foundayo, Wegovy and Zepbound for $50 a month
Medicare started its GLP-1 Bridge demonstration on July 1, 2026, giving eligible Part D beneficiaries Foundayo, Wegovy or the Zepbound KwikPen for a flat $50 monthly copay through December 31, 2027. To qualify, beneficiaries must be 18 or older and meet specific BMI thresholds tied to conditions such as prediabetes, uncontrolled hypertension or chronic kidney disease. People already getting a GLP-1 through Part D, or who have type 2 diabetes, moderate-to-severe sleep apnea or fatty liver disease, are excluded.
- Prices
Massachusetts GIC drops obesity-only GLP-1 coverage for non-Medicare members
Massachusetts' Group Insurance Commission ended coverage of GLP-1 medicines prescribed solely for obesity for non-Medicare members on June 30, 2026, and ended the Vida Health prescribing arrangement the same day. Starting July 1, members need prior authorization through CVS Caremark, and coverage can be approved only when the prescription is tied to a qualifying condition such as cardiovascular disease, sleep apnea or MASH/NASH. Medicare GIC members keep obesity coverage through December 31, 2026.
- Policy
Medicare GLP-1 Bridge launches July 1 with Wegovy prescriptions flat
The Medicare GLP-1 Bridge program, a CMS initiative for weight-loss drugs, began July 1, 2026, according to Jefferies analysts. Wegovy (semaglutide injection 2.4 mg) prescriptions have been relatively flat since the program started, Fierce Pharma reported. Novo Nordisk makes Wegovy.
- Regulation
FDA picks Eli Lilly for PreCheck pilot on new US manufacturing plants
The FDA selected Eli Lilly and six other companies on June 29, 2026, for a pilot program meant to speed technical review of new U.S. drug manufacturing sites. Lilly's designated site is a plant in Lebanon, Indiana, that will make active pharmaceutical ingredients for existing and future medicines. Lilly recently committed $4.5 billion to two Lebanon sites, including one focused on ingredients for its obesity medicines.
- Compounding
Apollo Care pulls roughly 162,000 compounded semaglutide vials after particles found
Apollo Care, a 503B compounding facility in Columbia, Missouri, recalled 156,611 vials of compounded semaglutide plus 5,500 vials of a semaglutide-and-glycine product on July 29, 2026. Particulate matter identified as nylon, polyamide and proteinaceous material was found in the vials. The Class II recall covers multiple strengths distributed nationwide.
- Compounding
Compounded semaglutide and tirzepatide still sold after shortages ended, study finds
A secret-shopper study published in JAMA Health Forum found 75 weight-loss clinics and medical spas in West Virginia and Oklahoma selling compounded GLP-1 drugs between August and October 2025, months after the semaglutide and tirzepatide shortages ended and the FDA stopped allowing compounded copies. Of the 75 businesses, 92.0% offered compounded semaglutide, 86.7% offered compounded tirzepatide and 9.3% offered oral or sublingual forms. Researchers identified 23 supplier pharmacies for analysis and found that 4 of 21 state-licensed ones were not licensed to do sterile compounding.
- Safety
Novo Nordisk and Eli Lilly GLP-1 injury MDL tops 4,000 cases as briefing closes
Summary judgment briefing in the federal GLP-1 injury litigation ran through July 2026, with about 4,022 cases now pending against Novo Nordisk and Eli Lilly. Expert depositions finished in April 2026 and the Daubert motions that decide which expert testimony a jury may hear are fully briefed, but no hearing date has been reported.
- Research and trials
Large US study finds tirzepatide beat semaglutide on one-year weight loss after bariatric surgery
A retrospective cohort of 208,155 US patients who had metabolic and bariatric surgery found that those still on tirzepatide after a year had lost 17.2 percent of their body weight, versus 12.0 percent on semaglutide. Pooled incretin-based therapy was not linked to major adverse cardiovascular events (hazard ratio 0.91, 95% CI 0.80-1.05). The design is observational, and the authors say it cannot establish cause and effect.
- Business
Amazon Pharmacy adds Lilly's oral GLP-1 Foundayo with same-day delivery
Amazon Pharmacy began offering Foundayo (orforglipron), Eli Lilly's oral GLP-1 pill, with same-day delivery, and the pill also became available through GoodRx. Pricing, insurance acceptance and delivery areas were not disclosed. The move follows CVS Caremark's selection of Wegovy as the preferred GLP-1 on its largest commercial formularies, with cash-pay prices of $499 to $699 a month for competing products.
- Safety
Australia adds class-wide GLP-1 eye warnings as US Ozempic label stays unchanged
Australia's Therapeutic Goods Administration issued a July 23, 2026 safety update adding class-wide warnings about rare severe eye disorders to marketed GLP-1 receptor agonist labels, and advised prompt medical attention for sudden vision changes. The European Medicines Agency estimated about one additional NAION case per 10,000 person-years of semaglutide treatment. The US Ozempic prescribing information, revised in May 2026, still does not carry a NAION warning.
- Research and trials
Tirzepatide alone lowered A1c by about 2 points in Chinese adults with early type 2 diabetes
The phase 3 SURPASS-CN-MONO trial assigned 206 adults in China with early type 2 diabetes to once-weekly tirzepatide at 5, 10 or 15 mg or to placebo for 40 weeks. A1c fell 1.93 to 2.04 percentage points more with tirzepatide than with placebo, and weight loss ranged from 6.0 to 9.7 kg. No clinically significant or severe hypoglycemia occurred in the tirzepatide groups.
- Regulation
Lilly reissues Foundayo medication guide with a seven-day missed-dose restart rule
Eli Lilly has reissued the patient Medication Guide for Foundayo (orforglipron), its once-daily oral GLP-1 tablet, carrying document number OFG-0002-MG-20260729. The updated guide tells patients to take a missed dose as soon as possible, never to take two doses in the same day, and to call a healthcare provider about restarting treatment after missing seven or more days in a row. The guide does not describe what a restart involves.
- Business
Foundayo prescribing information revised in July 2026
The U.S. prescribing information for Foundayo (orforglipron) was revised in July 2026, and the current label carries the revision date 7/2026. A supplement label, numbered 220934s003, was posted alongside the original approval label. Foundayo is an oral GLP-1 tablet with an initial U.S. approval listed as 2026.
- Regulation
Wegovy prescribing information now covers both the weekly injection and the daily tablet
The Wegovy label on DailyMed, updated June 18, 2026, now covers the once-weekly injection and the once-daily tablet in one prescribing information document. Each form keeps its own dosing table: the injection starts at 0.25 mg weekly and the tablet starts at 1.5 mg daily. The tablet lacks the pediatric obesity and MASH indications that the injection carries.
- Compounding
FDA scientists flag evidence gaps in peptides ahead of July compounding panel
FDA scientists say there is not enough evidence to support loosening compounding restrictions on seven peptides, including BPC-157, TB-500 and MOTs-C. The agency posted documents on June 29, 2026, about three weeks before a Pharmacy Compounding Advisory Committee meeting on July 23 and 24. Health Secretary Robert F. Kennedy Jr. wants compounding pharmacies to be able to offer the peptides again.
- Business
Sandoz asks European patent court to revoke Novo Nordisk semaglutide patent
Sandoz has filed a case at the Unified Patent Court seeking revocation of Novo Nordisk unitary patent 3 689 365, which covers the 1 mg dose of semaglutide for diabetes in 18 European Union countries. The action was filed in the court's Milan Central Division on 30 June 2026. If Sandoz succeeds, the patent would no longer block competing versions of that dose in those countries.
- Prices
Loophole in Trump GLP-1 pricing deal with Lilly and Novo Nordisk, STAT reports
STAT reported on June 30 that the White House's GLP-1 pricing deal with Eli Lilly and Novo Nordisk left the companies room to keep list prices high in parts of the market the agreement does not cover. The deal, announced in November 2025, set a $245 monthly price in Medicare and Medicaid, but that price was contingent on private Medicare insurers covering the drugs for all uses with a $50 copay — a condition the administration did not publicly mention.
- Prices
Health Canada approves Sevmia, its first generic semaglutide for weight loss
Health Canada authorized Sevmia, an Apotex generic version of Wegovy, for chronic weight management on June 29, 2026. It is the first generic semaglutide approved in Canada for weight loss and the third generic semaglutide the regulator has cleared. Six other generic semaglutide submissions remain under review.
- Research and trials
AstraZeneca opens 4,500-person obesity trial for elecoglipron
AstraZeneca has opened enrollment in a Phase 3 master protocol for elecoglipron, its experimental obesity drug, with a planned 4,500 participants who have obesity or overweight, with or without type 2 diabetes. The study anchors a broader program that includes five Eluminate diabetes trials and the Elevate-HF and Elevate-CKD outcomes trials, with roughly 25,000 participants planned in total.
- Prices
FDA accepts first generic tirzepatide application, from Sandoz
On June 29, 2026, the FDA accepted two abbreviated new drug applications from Sandoz for generic tirzepatide, covering the Mounjaro (type 2 diabetes) and Zepbound (obesity) indications. It is the first generic tirzepatide filing accepted for review, but acceptance is not approval, and Eli Lilly's core patent on the molecule runs to about January 2036. Estimated availability ranges from a possible 2028 to 2030 launch if patent challenges or a settlement go Sandoz's way, to 2036 to 2038 under the patent timeline.
- Policy
UK and Eli Lilly launch £85 million obesity care program
The UK government and Eli Lilly launched the Obesity Pathway Innovation Programme on 29 June 2026, backed by £85 million — £50 million from the government and £35 million from Lilly. The program funds about a dozen projects that test AI triage, virtual advice and local hubs to widen access to obesity care, including weight-loss medication "where clinically appropriate."
- Research and trials
FDA gives the public until July 30, 2026 to comment on 503B compounding of semaglutide and tirzepatide
The FDA extended the comment deadline on its proposal to leave semaglutide, tirzepatide and liraglutide off the 503B Bulks List, moving the cutoff to July 30, 2026. A requester asked for 60 more days and the agency granted 30. No final determination has been announced, so large-scale compounding of the three ingredients remains legally unchanged.
- Regulation
EU regulators move to add SURPASS-CVOT heart data to Mounjaro label
The European Medicines Agency's procedural record shows a type II variation (EMA/VR/0000310637) for Mounjaro (tirzepatide) with an opinion issued on 25 June 2026, updating SmPC sections 4.1, 4.4, 4.8 and 5.1 and the package leaflet based on final results from the SURPASS-CVOT trial. SURPASS-CVOT compared tirzepatide with dulaglutide on major adverse cardiovascular events in people with type 2 diabetes; the procedural record does not include the trial's numerical results.
- Business
CMS data show Victoza and Saxenda spending fell sharply in the first year of generic liraglutide
CMS drug spending files show Medicare Part D spending on the brand-name liraglutide drug Victoza fell to about $281 million in 2024 from about $1.32 billion in 2023, while generic liraglutide recorded about $48 million in its first year. In Medicaid, spending on Saxenda fell to about $38.4 million from about $129.5 million, and generic liraglutide recorded about $31 million.
- Business
Lilly launches UK version of LillyDirect delivery service, starting with Mounjaro
Eli Lilly launched LillyDirect in the United Kingdom on June 25, 2026, a post-prescription dispensing and delivery service that starts with Mounjaro (tirzepatide). Two dispensing partners, Blueco Healthcare's Onescript service and Pharmacy2U, will handle delivery to patients' homes. Lilly says it may later add other medicines, including orforglipron (Foundayo), if UK regulators approve it.
- Business
LillyDirect and ŌURA partner to link wearable data with obesity treatment
Eli Lilly's telehealth platform LillyDirect and Finnish health technology company ŌURA announced a collaboration that pairs Oura Ring tracking with obesity care, starting with a free sizing kit for LillyDirect customers. ŌURA says more than half of its users consider themselves overweight or obese, and tens of thousands log their use of GLP-1 receptor agonist drugs in its app.
- Business
Lilly closes Centessa acquisition, adding narcolepsy program to neuroscience unit
Eli Lilly and Company said on June 24, 2026 that it completed its acquisition of Centessa Pharmaceuticals plc, a clinical-stage company developing orexin receptor 2 agonists for narcolepsy and potentially other sleep-wake disorders. Financial terms were not disclosed in the announcement. Carole Ho, Lilly's executive vice president and president of Lilly Neuroscience, said Lilly intends to pursue the program's potential "with urgency."
- Research and trials
Hypothesis paper proposes tirzepatide for refractory endometriosis without human data
A paper published June 24, 2026, in the International Journal of Molecular Sciences proposes tirzepatide as a possible add-on treatment for treatment-refractory endometriosis. The journal classifies the article as a Hypothesis, and the authors state that the underlying concept rests on a single non-replicated case-control study and that direct experimental or clinical validation is absent. No patient outcomes, doses, or safety data in endometriosis are reported.
- Policy
Lilly gave one patient compassionate access to retatrutide, and Congress wants to know who
Eli Lilly and the FDA allowed one 79-year-old man to receive the experimental obesity drug retatrutide through the FDA's compassionate use program, with the request made in April 2026, according to STAT. On June 25, Sen. Maggie Hassan asked HHS Secretary Kennedy for documents about the case and asked whether the patient was President Trump. The patient's identity has not been disclosed.
- Research and trials
Microdosing semaglutide and tirzepatide spreads as doctors say evidence is missing
A Los Angeles Times report published June 23 documents how far microdosing of GLP-1 drugs has spread. Dr. Sara Siavoshi, who treats about 5,000 patients, estimates that 30 to 40 percent of them are microdosing semaglutide or tirzepatide, and Dr. Shauna Levy says no scientific studies have looked at the practice's efficacy or safety.
- Business
NHS England opens tirzepatide access to a second, lower-BMI patient group
On June 23, 2026, NHS England expanded primary care eligibility for tirzepatide, sold as Mounjaro, to a second cohort: adults with a BMI of 35 to 39.9, or 32.5 to 37.4 with an ethnic adjustment, who also have at least four qualifying long-term conditions. The first cohort, active since June 2025, was limited to a BMI of 40 or above with four or more conditions, and a third cohort is scheduled for April 1, 2027.
- Culture
PwC says 21% of US households now include a GLP-1 user, up from 9% in January 2025
PwC reported on June 22, 2026 that 21% of US households include a current GLP-1 user, more than double the 9% it reported for January 2025. The firm also tied GLP-1 use to household spending shifts: grocery spending down 5.5%, quick-service restaurant spending down 8.7% after six to eight months, and apparel spending up 9.9%.
- Research and trials
Lancet issues expression of concern on exenatide Parkinson's trial
The Lancet has published an Expression of Concern about its 2025 phase 3 trial of exenatide once a week as a possible disease-modifying treatment for Parkinson's disease. The paper ran on Feb. 22, 2025 (volume 405, issue 10479, pages 627–636) and remains listed in PubMed with no retraction reported. The notice record does not state the journal's reasons and does not restate the trial's results.
- Regulation
Japan approves Wegovy for MASH, the country's first treatment for the liver disease
Japan's Ministry of Health, Labour and Welfare approved Wegovy (semaglutide) for metabolic dysfunction-associated steatohepatitis without cirrhosis in patients with moderate to advanced fibrosis on June 19, 2026, making it the first approved MASH treatment in Japan. In Part 1 of the Phase 3 ESSENCE study, at week 72, 36.8% of patients on semaglutide 2.4 mg had improved liver fibrosis without worsening MASH versus 22.4% on placebo, and 62.9% had MASH resolution without worsening fibrosis versus 34.3%. In the United States, Novo Nordisk filed oral semaglutide 25 mg for MASH in the second quarter of 2026, and no FDA decision date had been announced.
- Regulation
Wegovy label consolidates four injection formats and tablets into one document
The Wegovy prescribing information updated June 18, 2026 now covers four injection presentations — a five-strength single-dose pen, a 7.2 mg Wegovy HD pen, a five-strength prefilled syringe and the FlexTouch multi-dose pen — plus the 1.5 mg, 4 mg, 9 mg and 25 mg tablets in one document. Each format carries its own strengths, storage rules and instructions, including a new June 2026 warning not to share FlexTouch between patients.
- Culture
Survey of 518 US adults finds insurance and cost top barriers to starting tirzepatide
A real-world survey of 518 US adults who began tirzepatide found the leading reasons for starting were improving overall health and well-being (83.8%) and physical functioning (58.3%). The most common barriers were concerns about health insurance coverage (90%) and treatment cost (57.7%). Participants also reported substantial problems with physical functioning and psychosocial well-being, and high internalized weight bias, before starting the drug.
- Research and trials
ACP guideline names semaglutide and tirzepatide first-line for obesity
The American College of Physicians published a living clinical guideline conditionally recommending that clinicians start pharmacologic treatment alongside lifestyle changes in nonpregnant adults with obesity, listing semaglutide and tirzepatide as first-line options backed by moderate-certainty evidence. The guideline also covers adults with overweight plus conditions such as type 2 diabetes or cardiovascular disease, and places phentermine–topiramate, liraglutide and naltrexone–bupropion in lower tiers.
- Business
FDA sends 25 warning letters to telehealth firms over compounded semaglutide and tirzepatide marketing
The FDA issued 25 warning letters to telehealth companies over false or misleading marketing of compounded semaglutide and tirzepatide, the drugs sold as Ozempic, Wegovy, Mounjaro and Zepbound. The letters were posted on the agency's website on June 16, 2026, and were sent earlier in the month to companies including Medica Weight Loss, Ready Med and Clover Meds. The action follows a March 2026 round of 30 warning letters and an April 2026 proposal to remove the weight-loss drugs from a key compounding list.
- Research and trials
Tirzepatide benefits similar in adults 65 and older, pooled trial analysis finds
A post hoc analysis pooling seven Phase 3 tirzepatide trials found clinically meaningful weight reduction and favorable cardiometabolic and quality-of-life results in adults 65 and older, broadly comparable to younger adults. Older adults showed no clinically meaningful differences from placebo in gastrointestinal tolerability, falls, fractures, depression, pancreatitis or kidney, liver and gallbladder-related adverse events. The analysis was published June 16, 2026 in Diabetes, Obesity and Metabolism.
- Safety
FDA sends 25 warning letters to telehealth companies over compounded GLP-1 marketing
During the week of June 15, 2026, the FDA issued 25 warning letters to telehealth companies over allegedly false or misleading claims about compounded GLP-1 products, saying the marketing violated the misbranding provisions of the Federal Food, Drug, and Cosmetic Act. It is the third large batch of its kind in less than a year, after about 80 warning letters and 40 untitled letters in September 2025 and 30 warning letters in March 2026. The agency also published new webpages on promoting compounded drugs and on its concerns about compounded GLP-1s.
- Research and trials
FDA names five compounded GLP-1 marketing claims it considers deceptive
The FDA has published a page listing five categories of marketing claims it treats as deceptive when telehealth companies sell compounded drugs, compounded GLP-1s included. The categories cover implying the seller is the compounder, calling a product generic or the same as an approved drug, claiming FDA approval or safety review, saying it is clinically proven to match an approved drug, and claiming the source is FDA-approved or FDA-licensed. The agency says such marketing breaks federal law and points readers to a warning letter database where the term "telehealth" returns past letters.
- Compounding
FDA lists marketing claims it calls deceptive for compounded drugs, including GLP-1s
FDA has refreshed its guidance page for telehealth companies that advertise compounded drugs, spelling out five kinds of marketing claims the agency considers misleading. The list includes calling a compounded product a generic version of an FDA-approved drug, saying a compounded drug is FDA-approved, and describing a pharmacy as FDA-approved or FDA-licensed. FDA says compounded drugs are not reviewed for safety, effectiveness or quality before marketing, and that it does not approve or license any facility.
- Research and trials
Study finds 11.9 percent of women with PCOS in Polish network had incretin prescriptions
A retrospective study of 38,263 women with polycystic ovary syndrome in a Polish private healthcare network found that 11.9 percent had a recorded prescription for a GLP-1 receptor agonist or tirzepatide, while 42.8 percent received metformin. Only 11.5 percent of the incretin users had a coded type 2 diabetes diagnosis. New starts within a year of PCOS diagnosis rose from 0.14 percent in 2018 to 5.97 percent in 2024.
- Research and trials
Semaglutide tied to 15 percent fewer fractures in type 2 diabetes study
A Stanford-led analysis of nearly 60,000 adults with type 2 diabetes found semaglutide users had 794 bone fractures versus 1,045 in a comparison group taking other weight-loss and diabetes medicines, a 15 percent lower fracture incidence. The findings were presented June 14, 2026 at ENDO 2026 in Chicago, and the authors say prospective studies are needed to confirm them.
- Research and trials
ENDO 2026 reviews find GLP-1 drugs do not harm male fertility and may improve testosterone
Two reviews presented at ENDO 2026, the Endocrine Society's annual meeting in Chicago, found no evidence that GLP-1 drugs harm male hormones or sperm and some signs they may help. A UK team's review of five randomized trials described a 24-week semaglutide study that improved sperm shape while testosterone stayed stable, and a 16-week liraglutide study that raised testosterone in men with obesity. A separate published review of 16 clinical studies reached a similar but more cautious conclusion.
- Competition
Lilly presents retatrutide Phase 3 data at ADA 2026 as obesity competition sharpens
Eli Lilly presented Phase 3 results for retatrutide at the American Diabetes Association's 2026 meeting, including 28.3% average weight loss over 80 weeks in the TRIUMPH-1 obesity trial. That is well above the roughly 21% and 15% seen with approved tirzepatide and semaglutide in their trials. A dysesthesia signal that rose with dose also drew attention.
- Prices
Federal employee program sets new Zepbound coverage rules effective July 1
The FEP Pharmacy and Medical Policy Committee approved policy 5.99.031 on June 11, 2026, effective July 1, 2026, setting prior-approval criteria for Zepbound. Members must show inadequate response, intolerance or contraindication to at least two oral weight-management drugs and documented participation in a weight-management program. Approved requests are limited to 12 single-dose pens per 84 days for six months, with 12-month renewals requiring at least 5 percent weight loss.
- Regulation
UK approves Wegovy tablet, the country's first oral GLP-1 for weight loss
The UK's Medicines and Healthcare products Regulatory Agency approved an oral semaglutide (Wegovy) tablet for weight loss and weight management in adults on 11 June 2026. The approved schedule starts at 1.5 mg once daily and rises to 4 mg, 9 mg and 25 mg, with at least a month at each level. The tablet is not yet available through the National Health Service.
- Business
Some US employers plan to drop GLP-1 weight-loss coverage in 2027
Two surveys of large US employers found that a small share of those that cover GLP-1 drugs for weight loss plan to drop the coverage in 2027, with Business Group on Health putting the figure at about 10% and Mercer at 5%. The surveys also differ on current coverage: Business Group on Health data show 67% of large employers cover GLP-1s in 2026, while Mercer says 44% of companies with more than 500 workers cover the drugs for obesity. Insurer Cigna stopped covering the weight-loss treatments for its own employees effective in July.
- Regulation
UK regulator clears Novo Nordisk's Wegovy tablet for weight loss
The UK's Medicines and Healthcare products Regulatory Agency authorised the semaglutide (Wegovy) tablet for weight loss on June 11, 2026, for adults with a BMI of 30 or above, or a BMI of 27 to 30 with at least one weight-related condition, alongside diet and exercise. Dosing starts at 1.5 mg once daily and rises to 25 mg. The tablet is not yet available through the National Health Service, which requires a separate evaluation.
- Business
Novo Nordisk discloses IT security incident but gives no details
Novo Nordisk posted a press release dated June 11, 2026 titled "Novo Nordisk A/S: IT Security incident at Novo Nordisk," according to the company's news archive. The listing gives no information on what systems or data were involved. The disclosure came as the company reported second-quarter adjusted operating profit of DKK 33,389 million, up 11% at constant exchange rates, while reported operating profit fell 16%.
- Business
Novo Nordisk says its Wegovy pill has passed 3 million US prescriptions
Novo Nordisk said its oral Wegovy pill has topped 3 million US prescriptions since launching Jan. 5, and that more than 80% of those prescriptions went to people new to the GLP-1 drug class. CEO Mike Doustdar told Fierce Pharma he is "a lot more optimistic" than when he took the job in August 2025 and said the company's manufacturing scale-up is now "second to none."
- Culture
Lilly taps Shaquille O'Neal for national Zepbound sleep apnea campaign
Eli Lilly said on June 10, 2026 that Shaquille O'Neal is fronting a national campaign called Watch This about his moderate obstructive sleep apnea and his treatment with Zepbound (tirzepatide). The company says about 24 million US adults have moderate-to-severe OSA and that 85% of cases go undiagnosed. The ads focus on the sleep condition rather than weight loss, and O'Neal said the prescription made a difference for him.
- Research and trials
Pfizer starts 954-person Phase 3 trial of obesity drug berobenatide
Pfizer has begun enrolling a 954-participant Phase 3 trial of the experimental obesity drug berobenatide (PF-08653944) in US adults with overweight or obesity, with a primary completion date of May 4, 2028. Pfizer also registered Phase 3 programs in Japan, including a once-monthly study in adults with obesity listed as VESPER-JM. Berobenatide is not approved by the FDA, and no results from the late-stage trials have been reported.
- Business
Novo Nordisk says 80% of Wegovy pill users are new to GLP-1 drugs
Novo Nordisk CEO Mike Doustdar said about 80% of people filling prescriptions for the new Wegovy pill had never taken a GLP-1 medicine before, and that the launch reached 1 million U.S. prescriptions in 12 weeks and 3 million by week 22. Novo says the oral semaglutide product is bringing in new patients rather than pulling them away from injectable versions.
- Competition
Goldman Sachs lifts 2030 obesity drug forecast to $114 billion on oral GLP-1 demand
Goldman Sachs raised its estimate for the global obesity drug market in 2030 to $114 billion from $101 billion, citing faster adoption of oral obesity pills, stronger demand outside the US and lower prices. The bank now expects oral medicines to make up 40% of that market, worth $46 billion, and forecasts a larger role for Novo Nordisk's Wegovy pill.
- Business
Lilly reports Foundayo beat oral semaglutide on blood sugar and weight in three type 2 diabetes trials
Eli Lilly released detailed results on June 8, 2026, from three Phase 3 trials of its oral GLP-1 pill Foundayo (orforglipron) in adults with type 2 diabetes. In ACHIEVE-3, Foundayo 17.2 mg lowered A1C by an average of 2.2% at 52 weeks versus 1.4% for oral semaglutide 14 mg, and average weight loss was 19.7 pounds versus 11.0 pounds. Lilly said it plans to file with the FDA for type 2 diabetes by the end of the second quarter.
- Competition
AstraZeneca's oral GLP-1 elecoglipron moves to Phase 3 after 11.8% weight loss
AstraZeneca said on June 8, 2026 that it is advancing elecoglipron, an experimental once-daily oral GLP-1 pill, into an extensive Phase 3 program in obesity and type 2 diabetes. In the Phase 2b VISTA trial, the 75 mg dose produced 11.8% average weight loss at 36 weeks versus 0.3% for placebo, and in SOLSTICE it lowered HbA1c by 1.9 percentage points at 26 weeks versus 0.2. Side effects were mostly gastrointestinal and consistent with the GLP-1 drug class.
- Safety
CBS News finds doctors and nurses promoting unapproved retatrutide
A CBS News investigation reported on June 8, 2026, that some U.S. doctors and nurses are promoting and prescribing retatrutide, a weight-loss drug that has not been approved by the FDA. The investigation identified more than 120 websites and over 50 clinics selling or promoting the drug, and reports of retatrutide exposures to U.S. poison centers rose 265% in the first four months of 2026 compared with the end of 2025.
- Safety
FAERS analysis finds semaglutide optic neuropathy signal far above tirzepatide's
A comparative analysis of FDA adverse event reports found 355 reports of optic ischemic neuropathy with semaglutide, giving a reporting odds ratio of 94.45, compared with 49 reports and a ratio of 2.94 for tirzepatide and 13 reports and a ratio of 4.58 for liraglutide. No signal appeared for dulaglutide, exenatide or lixisenatide, which the authors say argues against a uniform class effect. The study cannot establish cause or absolute risk.
- Compounding
FDA cites 25 companies over claims about compounded semaglutide and tirzepatide
FDA warning letters dated June 8, 2026, went to 25 telehealth and compounding companies that market compounded semaglutide and tirzepatide. The agency says their websites made false or misleading claims, and gave each company 15 business days to answer in writing. The letters were posted on June 16, 2026.
- Science
ADA revises diabetes standards as orforglipron and retatrutide data close 2026 sessions
The American Diabetes Association ended its 86th Scientific Sessions in New Orleans on June 8, 2026, with revised Standards of Care that make cardiovascular and kidney risk reduction a co-primary goal alongside blood sugar control. The meeting featured Phase 3 results for orforglipron, retatrutide, CagriSema, survodutide and evolocumab, including 28.3% average weight loss on retatrutide at 80 weeks and A1C reductions of 1.54% to 2.05% with orforglipron added to insulin.
- Competition
Lilly says oral Foundayo beat comparators on blood sugar in three type 2 diabetes trials
Eli Lilly reported that its once-daily oral GLP-1 pill Foundayo (orforglipron) produced larger HbA1c reductions than dapagliflozin, oral semaglutide and placebo across three phase 3 ACHIEVE trials in adults with type 2 diabetes. In ACHIEVE-3, orforglipron 36 mg lowered HbA1c by 20.9 mmol/mol versus 16.0 mmol/mol with oral semaglutide 14 mg, and in ACHIEVE-5 it lowered HbA1c by 17.2-20.5 mmol/mol versus 8.6 mmol/mol with placebo. Foundayo is FDA-approved for weight loss, not for type 2 diabetes.
- Business
Novo Nordisk says Wegovy pill topped 3 million US prescriptions in five months
Novo Nordisk said June 7, 2026, that its Wegovy (semaglutide) pill has passed 3 million US prescriptions since its January 5 launch, a pace of roughly one fill every five seconds. The company said more than 80% of new pill prescriptions went to people who had not previously used a GLP-1 medicine.
- Research and trials
GLP-1 drugs linked to 41% lower obesity-related cancer risk in large study
A target trial emulation published in Annals of Oncology found that adults with obesity and no diabetes who took GLP-1 receptor agonists had a 41% lower incidence of obesity-associated cancers over a median two years than matched adults who received diet or exercise counseling. The reduction was nearly 70% in men and 58% for endometrial cancer. Tirzepatide users saw a larger reduction than semaglutide users, and the researchers say the findings do not prove the drugs prevent cancer.
- Research and trials
Novo Nordisk presents full REIMAGINE results for CagriSema in type 2 diabetes
Novo Nordisk presented complete phase 3 results from the REIMAGINE 1, 2 and 3 trials of CagriSema in adults with type 2 diabetes at ADA 2026 on June 7, with simultaneous publication in The Lancet Diabetes & Endocrinology and The Lancet. In the largest trial, REIMAGINE 2, CagriSema 2.4 mg/2.4 mg lowered HbA1c by 1.91 percentage points versus 1.75 for semaglutide 2.4 mg — statistically superior, but a margin of only 0.16 points. Weight loss was 14.2% versus 10.2%. CagriSema is not approved in the United States.
- Research and trials
Novo Nordisk presents CagriSema and zenagamtide data at ADA 2026
Novo Nordisk presented phase 3 REIMAGINE 1–3 results for CagriSema in type 2 diabetes and phase 2b results for zenagamtide, formerly amycretin, at the American Diabetes Association's 2026 Scientific Sessions in New Orleans. In the zenagamtide trial, 448 adults on metformin had A1C reductions of up to 1.8 percentage points with weekly injections and up to 14.5% body weight loss at week 36. Neither drug is approved in the United States.
- Competition
Boehringer Ingelheim reports survodutide cut visceral and liver fat in two Phase 3 trials
Boehringer Ingelheim said its investigational drug survodutide reduced visceral fat by up to 34% and liver fat by up to 63.1% over 76 weeks in the Phase 3 SYNCHRONIZE-1 trial, with weight loss of up to 16.6% under the efficacy estimand. In the 48-week SYNCHRONIZE-MASLD trial in adults with fatty liver disease, 61% of treated participants reached normal liver fat, versus 5.7% on placebo. The data were presented at ADA 2026 and published in the New England Journal of Medicine and Nature Medicine.
- Business
Lilly reports Foundayo weight loss across menopause stages in ATTAIN analyses
Eli Lilly presented post-hoc analyses on June 7, 2026, showing that women taking the highest dose of Foundayo (orforglipron) in the ATTAIN-1 and ATTAIN-2 trials lost weight at every stage of menopause. In ATTAIN-1, perimenopausal women lost up to 30.4 pounds (14.4%) and postmenopausal women up to 28.2 pounds (14.1%) over 72 weeks, with waist circumference down as much as 4.9 inches.
- Science
Boehringer's survodutide beat placebo on weight loss in Phase 3 trial, NEJM reports
A Phase 3 trial published June 7 in the New England Journal of Medicine found that once-weekly survodutide, an investigational dual GLP-1 and glucagon receptor agonist, produced mean weight loss of 12.2% at 3.6 mg and 13.0% at 6.0 mg over 76 weeks in adults with obesity and without diabetes, compared with 5.4% on placebo. Gastrointestinal symptoms were the most common side effects and were more frequent at the higher dose. The drug is not approved for any use.
- Safety
Study finds hair-loss signals for semaglutide and tirzepatide in FDA reports
A disproportionality analysis of FDA Adverse Event Reporting System data from 2016 through 2025 found reporting signals for alopecia with semaglutide in 2022 and 2024 and with tirzepatide in 2024 and 2025, but none for five other GLP-1 receptor agonists. The study counted 1,941 alopecia-related reports across 1,929 cases, 697 of them involving semaglutide. Its authors stress that FAERS cannot estimate how often a side effect occurs or adjust for other causes.
- Competition
Pfizer details monthly berobenatide data and plans 10 Phase 3 trials in 2026
Pfizer said its investigational weight-loss drug berobenatide delivered continuous weight loss as patients moved from weekly to monthly dosing, with 15.9% weight loss at 32 weeks on the top weekly dose in a Phase 2b extension. The company plans 10 Phase 3 trials of the drug in 2026 as part of more than 20 obesity trials this year.
- Research and trials
Lilly says retatrutide cut sleep apnea severity by about 60 percent in a Phase 3 trial
Eli Lilly reported on June 6, 2026 that retatrutide, its investigational triple-hormone drug, reduced moderate-to-severe obstructive sleep apnea severity by up to 36.1 events per hour on the apnea-hypopnea index, a 60.6 percent drop from a baseline of 58.6. The same Phase 3 program reduced knee osteoarthritis pain by up to 4.3 points, or 73.1 percent, on a 0-to-10 scale, and produced average weight loss of up to 70.3 pounds at 80 weeks. Retatrutide is not approved and is legally available only to clinical trial participants.
- Research and trials
Lilly's retatrutide shows weight, A1C, knee pain and sleep apnea benefits in late-stage trials
Eli Lilly reported that retatrutide, its investigational triple-hormone drug, cut body weight by an average of 28.3% at 80 weeks in adults with obesity, reduced knee osteoarthritis pain by up to 73.1% and sleep apnea severity by up to 60.6%, and lowered A1C by up to 2.0 points at 40 weeks in adults with type 2 diabetes. The results from the TRIUMPH-1 and TRANSCEND-T2D-1 Phase 3 trials were presented June 6, 2026, at the American Diabetes Association meeting. Retatrutide is not approved and is available only to clinical trial participants.
- Science
Lilly lays out four-molecule obesity pipeline at ADA, led by tirzepatide and orforglipron
At the American Diabetes Association's 86th Scientific Sessions on June 6, 2026, Eli Lilly executives described tirzepatide, orforglipron, retatrutide and eloralintide as complementary options for obesity and diabetes. The company pointed to new orforglipron trial data, including up to 9.2% weight loss in people with type 2 diabetes and about 95% maintenance of prior injectable weight loss after switching.
- Science
Novo Nordisk presents semaglutide analyses on sleep apnea, asthma and liver health
Novo Nordisk presented post hoc analyses from the SELECT, STEP, ESSENCE and OASIS trials at ADA 2026, reporting fewer new obstructive sleep apnea cases and fewer asthma-related adverse events with semaglutide 2.4 mg than with placebo, along with blood pressure and liver-related improvements. The company said the analyses are exploratory and hypothesis-generating, and that semaglutide is not approved to treat sleep apnea, asthma, hypertension or MASLD.
- Research and trials
SURMOUNT-MAINTAIN tirzepatide maintenance trial appears in print in The Lancet
The SURMOUNT-MAINTAIN trial of tirzepatide for maintaining bodyweight reduction in people with obesity in the USA has been published in print in The Lancet. The print version sets out the modified treatment-regimen estimand used for the primary analysis and the rescue-therapy rules that began at week 84, both of which affect how the placebo arm's -9.9% figure is read.
- Science
ADA 2026 closes with retatrutide, orforglipron and CagriSema data
The American Diabetes Association's 86th Scientific Sessions ran June 5 to 8, 2026, in New Orleans, where phase 3 results were presented for retatrutide, orforglipron, CagriSema and survodutide. Retatrutide produced 28.3% average weight loss at 80 weeks in the TRIUMPH-1 trial, and orforglipron cut A1C by 1.54% to 2.05% when added to insulin glargine. The 2026 ADA Standards of Care made cardiovascular and kidney risk reduction a co-primary treatment goal alongside blood sugar control.
- Research and trials
Consensus report outlines safety guidance for semaglutide and tirzepatide in type 1 diabetes
Diabetes Technology & Therapeutics published a consensus report on GLP-1 and dual GLP-1/GIP receptor agonist use in type 1 diabetes. The report says no drug in these classes is approved for type 1 diabetes and names hypoglycemia and hyperglycemia-related ketosis as the main safety risks. Six professional organizations endorsed it, including the American Association of Clinical Endocrinologists, Breakthrough T1D and the International Society for Pediatric and Adolescent Diabetes.
- Competition
Structure Therapeutics publishes aleniglipron phase 2b obesity data in Nature Medicine
Structure Therapeutics said on June 5, 2026, that Phase 2b trial results for its experimental oral GLP-1 drug aleniglipron were published in Nature Medicine. The company reported an overall discontinuation rate of 10.4% and weight loss of up to 16.2% in an open-label extension, where participants kept losing weight beyond 36 weeks.
- Research and trials
Small study finds 18 percent weight loss with tirzepatide after bariatric surgery
A prospective study of 34 adults who regained weight after bariatric surgery or an endoscopic weight-loss procedure found an average 18.1 percent total body weight loss after 24 weeks on weekly tirzepatide at doses of 2.5 to 10 mg. Side effects were limited to mild gastrointestinal symptoms, and no one stopped treatment. The study was small, had no control group, and followed patients for six months.
- Research and trials
Telehealth survey finds most tirzepatide users with sleep apnea reported better sleep
A survey funded by telehealth company Roman Health Ventures found that 86.7 percent of 181 tirzepatide users with a history of obstructive sleep apnea reported improvement in at least one sleep-related outcome, and 77.3 percent reported improvement in more than one. Only 199 of 5,372 patients who were sent the survey responded, and the results rest on patient reports rather than sleep studies. The abstract was published June 5, 2026 in the journal Diabetes as part of the American Diabetes Association's scientific sessions abstracts.
- Safety
Large study quantifies gut motility risk from GLP-1 drugs, including tirzepatide
A cohort study of 313,342 matched pairs of US adults with type 2 diabetes found that initiators of GLP-1 based therapies had higher rates of severe constipation, gastroparesis and gastrointestinal obstruction than initiators of SGLT-2 inhibitors — 1.02 versus 0.75 events per 100 person-years, a hazard ratio of 1.37. The absolute risk was 1% or less per year, and the relative increase held across agents and patient subgroups, the authors reported in Diabetes, Obesity and Metabolism on June 4, 2026.
- Policy
Medicare Rights Center flags cost-sharing limits in the GLP-1 Bridge Program
The Medicare Rights Center says the Medicare GLP-1 Bridge Program's flat $50 monthly copay sits outside normal Part D cost sharing: it does not count toward the Part D deductible or the annual out-of-pocket limit, and Extra Help cannot be used to lower it. The program starts July 1, 2026, runs through December 31, 2027, and covers Wegovy, Zepbound and Foundayo for eligible Medicare beneficiaries.
- Research and trials
Obesity journal commentary asks whether multi-dose tirzepatide pens will drive microdosing
A commentary in the journal Obesity argues that multi-dose tirzepatide pens make it physically easier to split doses, turning the missing evidence on microdosing from an academic question into an urgent one. It follows a 2025 Diabetes Care article that made the same case for semaglutide multidose pens, which deliver about 72 unnumbered clicks per device and carry a 56-day beyond-use date.
- Business
FDA database lists Rybelsus 14 mg tablet as to be discontinued
The FDA's drug shortage database lists Rybelsus 14 mg tablets (NDC 0169-4314-30) with a status of "To Be Discontinued" and a discontinuation date of June 4, 2026. The posting states the products will be replaced by Ozempic (semaglutide) tablets. A semaglutide search returns three results in total, and the record that names a strength identifies the 14 mg tablet.
- Research and trials
Tirzepatide plus metformin tied to weight loss and menstrual gains in small PCOS trial
In a 16-week randomized trial, 60 overweight or obese Chinese women with polycystic ovary syndrome who took metformin plus low-dose tirzepatide lost an average of 10.4 kg, compared with 1.7 kg for those on metformin alone. The combination group also had larger reductions in visceral fat and higher rates of menstrual cycle recovery and pregnancy. The trial was open-label, small and short.
- Business
Wegovy pill is the most-chosen new weight-loss medicine of 2026, Novo Nordisk says
Novo Nordisk said that in 2026 more patients starting a new weight-management medicine chose Wegovy than any other option, helped by its new pill and a higher-dose injection. The company said the Wegovy pill, oral semaglutide, has passed 3 million US prescriptions since its January 5 launch, and that more than 80% of pill prescriptions are going to patients who had not previously used a GLP-1.
- Business
Cigna to end GLP-1 weight-loss coverage for its own employees on July 1
Cigna will stop covering GLP-1 drugs prescribed for weight loss, including Wegovy and Zepbound, in its own employee health plan beginning July 1, 2026, the company told staff on June 1. Workers whose prescriptions were approved will be offered older generic weight-loss pills instead, and anyone now taking a GLP-1 can refill through June 30. Cigna had 67,700 employees at the end of 2025, 88% of them in the U.S.
- Science
Macupatide trial separates GIP and GLP-1 effects on insulin in type 2 diabetes
In a 12-week phase 1b trial, the experimental GIP drug macupatide raised insulin sensitivity by 33.1% in adults with type 2 diabetes, while the GLP-1 drug dulaglutide raised insulin secretion by 163.6%. The two drugs given together produced larger changes in both measures, with a 321.5% rise in the clamp disposition index. The results were published June 2, 2026, in Diabetes, Obesity and Metabolism.
- Safety
Judge Marston hears competing science on GLP-1 vision-loss claims in MDL 3163
Judge Karen S. Marston held a Science Day on June 2, 2026 in MDL 3163, the federal litigation over whether GLP-1 drugs cause non-arteritic anterior ischemic optic neuropathy (NAION). The session was educational, not a ruling, and nothing was decided. MDL 3163 had 110 pending cases as of the June 1, 2026 JPML report, against Novo Nordisk and Eli Lilly.
- Business
CVS Caremark ends new-to-market block and covers Foundayo
CVS Caremark began covering Foundayo (orforglipron) on June 1, 2026, after removing the new-to-market block on the oral GLP-1 for its commercial template plans. CVS Health also said it will add Zepbound (tirzepatide) back to those formularies as an additional preferred option on October 1, 2026. Eligible patients with commercial coverage may pay as little as $25 a month, and Medicare Part D beneficiaries may pay $50 a month through the Medicare GLP-1 Bridge program starting July 1.
- Regulation
Eli Lilly opens single-patient expanded access for retatrutide
Eli Lilly has registered a single-patient expanded access program for retatrutide, an investigational obesity drug, on ClinicalTrials.gov under record NCT07629401. The listing, dated June 1, 2026, covers adults with a body mass index of 35 or higher who have two or more serious obesity-related complications and cannot get into a trial. A physician must request the drug from Lilly and then from the FDA.
- Research and trials
Survodutide heart-safety trial finishes its main measurement period
The cardiovascular safety trial for survodutide, an investigational drug for people with overweight or obesity, has completed its main measurement period. The trial, called SYNCHRONIZE-CVOT, enrolled 5,531 participants and lists a primary completion date of June 1, 2026. Results had not been published as of September 14, 2026.
- Regulation
Ozempic injection label updated with three type 2 diabetes indications
The prescribing information for Ozempic (semaglutide) injection was updated on the DailyMed drug labeling site on June 1, 2026. The label lists three approved uses in adults with type 2 diabetes: improving blood sugar, reducing the risk of major cardiovascular events, and reducing the risk of kidney function decline, end-stage kidney disease and cardiovascular death. The weekly dose steps run from 0.25 mg up to 2 mg.
- Regulation
Novo Nordisk says FDA decision on CagriSema expected by late 2026
Novo Nordisk expects the FDA to decide on CagriSema, its once-weekly combination of cagrilintide and semaglutide, by late 2026, and one pharmacy benefit manager's pipeline update names December as the month to watch. The company filed for weight management in December 2025 based on the REDEFINE 1 and REDEFINE 2 trials. In February 2026 it also reported that the REDEFINE 4 trial missed its primary goal, with CagriSema producing 23.0% weight loss over 84 weeks versus 25.5% for tirzepatide 15 mg.
- Research and trials
Two-year trial finds tirzepatide outperforms intensified care in early type 2 diabetes
In the SURPASS-EARLY trial, 794 adults diagnosed with type 2 diabetes within the past four years and not at goal on metformin were randomly assigned to tirzepatide or intensified conventional care. Over two years, tirzepatide lowered A1c by 0.68 percentage points more and weight by 8.0 kg more, and 60.2 percent of the tirzepatide group reached normoglycemia versus 24.0 percent of the comparison group.
- Science
Experts at ADA 2026 focus on muscle loss and nutrition for people taking semaglutide and tirzepatide
At the American Diabetes Association 2026 Scientific Sessions, four clinicians said GLP-1 care is expanding beyond weight and blood sugar into lean muscle preservation, nutrition targets and joint outcomes. They reported that lean mass can account for 25% of weight lost on any treatment and 40% or more with higher-dose GLP-1 compounds, and cited protein intake of roughly 1.2 to 1.6 grams per kilogram per day plus resistance training as the main tools studied so far.
- Research and trials
Commentary questions long-term bone and reproductive effects of GLP-1 drugs in adolescents
A commentary in the Journal of Pediatric and Adolescent Gynecology says long-term skeletal, reproductive and psychological outcomes of GLP-1 receptor agonist use in adolescents remain uncertain, even though trials of liraglutide and semaglutide showed significant weight reduction without short-term effects on growth or puberty. The authors note that adolescence is the critical window for peak bone mass and that no long-term skeletal data or reproductive outcome data after adolescent exposure exist. They call for bone health monitoring, resistance exercise, contraceptive counseling and screening for disordered eating.
- Science
Apitegromab plus tirzepatide limits muscle loss in Phase 2 EMBRAZE trial
Phase 2 results from the EMBRAZE trial, published in Nature Medicine, found that apitegromab combined with tirzepatide produced the clearest evidence yet that muscle loss during GLP-1 treatment can be limited with a drug. Tirzepatide is the molecule sold as Mounjaro and Zepbound. Across GLP-1 trials, lean mass has accounted for roughly 25% to 40% of total weight lost.
- Competition
Eli Lilly files orforglipron for type 2 diabetes in the U.S. under priority voucher pilot
Eli Lilly submitted orforglipron, sold as Foundayo, for type 2 diabetes in the United States during the second quarter of 2026 under the FDA's Commissioner's National Priority Voucher pilot, with a decision possible in the fourth quarter of 2026. The FDA approved the oral GLP-1 tablet for obesity in April 2026. Orforglipron is a small molecule taken once daily with no food or water restrictions, unlike injected semaglutide and tirzepatide.
- Science
Study maps how semaglutide signals in brainstem neurons to drive weight loss
A paper published in Nature Metabolism in June 2026 reports that semaglutide raises cyclic AMP in GLP-1 receptor-expressing neurons of the brain's area postrema through a Gs-dependent pathway, and that disrupting Gs or cAMP signaling in those neurons eliminates semaglutide-induced weight loss in the models studied. The work also ties a separate set of hindbrain neurons to semaglutide-induced conditioned taste aversion.
- Regulation
Wegovy prescribing information revised in June 2026 with two contraindications
The Wegovy prescribing information was revised as of June 2026 and now carries two contraindications and 11 warnings and precautions, including pulmonary aspiration during general anesthesia or deep sedation. The label directs patients to discontinue at least two months before a planned pregnancy and states that breastfeeding is not recommended during treatment with Wegovy tablets.
- Competition
Viking completes enrollment in phase 3 trial of injectable VK2735
Viking Therapeutics has completed enrollment in VANQUISH-2, a phase 3 trial of its injectable obesity drug VK2735 in adults with obesity and type 2 diabetes. The companion trial, VANQUISH-1, is also fully enrolled. No phase 3 results have been reported, and the oral version of VK2735 is not due to enter phase 3 until the second half of 2026.
- Regulation
FDA logs 990 adverse event reports for compounded semaglutide
As of May 31, 2026, the FDA has received 990 reports of adverse events associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. The agency said the real totals are likely higher because most state-licensed compounding pharmacies are not required to report adverse events to the FDA.
- Research and trials
Nutrition review proposes calorie floors during GLP-1 and dual incretin therapy
A review published in the journal Nutrients outlines a nutrition-first framework for people using GLP-1 and dual incretin therapy for obesity. It proposes energy floors of roughly 1,200 calories a day for most women and 1,500 a day for most men, individualized to body size and activity. The article covers dietary management, symptom tolerability and long-term weight maintenance.
- Research and trials
Weight-loss doctor says GLP-1 microdosing lacks evidence and any agreed definition
In a STAT First Opinion piece published May 29, 2026, Harvard endocrinologist Jody Dushay writes that GLP-1 microdosing is popular but unsupported, with no legitimate long-term data behind it. She also says there is no single definition of what counts as a microdose for weight loss or any other condition.
- Research and trials
Weight-loss doctor says GLP-1 microdosing has no evidence or agreed definition
In a STAT First Opinion column published May 29, 2026, Harvard endocrinologist Jody Dushay writes that microdosing GLP-1 drugs such as Wegovy and Zepbound is not backed by legitimate long-term data and has no single agreed definition. She states that the FDA-approved doses of semaglutide and tirzepatide are the only ones studied for safety and effectiveness.
- Prices
CVS Caremark to restore Zepbound coverage Oct. 1 and lift Foundayo block June 1
CVS Health said on May 28, 2026 that CVS Caremark will put Zepbound back on its standard commercial formularies as an additional preferred option effective Oct. 1, 2026, and will remove its new-to-market block on Foundayo effective June 1, 2026. Wegovy keeps preferred status on the same lists. Eligible patients with commercial coverage are cited at as little as $25 a month, and Medicare Part D beneficiaries may pay $50 a month through a federal demonstration that starts July 1, 2026.
- Business
CVS Caremark to cover Foundayo from June 1, completing PBM coverage
Eli Lilly said May 28, 2026 that CVS Caremark will cover Foundayo (orforglipron) on its commercial template starting June 1, and will return Zepbound (tirzepatide) to those templates by October 1. With that, all three of the largest US pharmacy benefit managers cover Lilly's obesity medicines, and eligible commercially insured patients could pay as little as $25 a month.
- Prices
North Carolina treasurer says budget is unlikely to restore GLP-1 weight-loss coverage for state workers
State Treasurer Brad Briner said he does not expect North Carolina lawmakers to fund a return of State Health Plan coverage of GLP-1 drugs for weight loss, after he asked for about $100 million for it. A 2025 Senate budget proposal set aside $25 million for the benefit, while the House version included nothing. The plan, which covers more than 700,000 people, is negotiating prices with drugmakers and could restart coverage without legislation if those talks succeed.
- Competition
Novo Nordisk renames amycretin as zenagamtide ahead of ADA 2026 data
Novo Nordisk said on May 27, 2026 that its experimental drug amycretin is now called zenagamtide, a unimolecular long-acting GLP-1 and amylin receptor agonist being studied in both oral and subcutaneous forms for type 2 diabetes and obesity. Phase 2b results in type 2 diabetes are scheduled for presentation June 7 at the American Diabetes Association's 2026 Scientific Sessions, part of 40 abstracts the company will present. The drug is not approved in the United States, and no zenagamtide results have been released yet.
- Business
Patients report trouble filling generic liraglutide 3 mg five-pen cartons
Patients in an online liraglutide community say they have been unable to fill prescriptions for generic liraglutide 3 mg, the weight-management dose, in five-pen cartons, describing a supply gap through late May and into June 2026. Two-pen and three-pen cartons, the package sizes used for the diabetes version, were still available, and several members said they eventually received Cipla-labeled cartons after transferring their prescriptions between pharmacy chains.
- Prices
Brazil approves EMS's Ozivy, its first generic semaglutide pen
Brazil's health regulator Anvisa approved Ozivy, an injector pen made by Brazilian drugmaker EMS that uses semaglutide, the same active ingredient as Novo Nordisk's Ozempic. It is described as Brazil's first generic semaglutide injector pen, cleared after Ozempic's patent expired in the country in March. EMS plans capacity for up to 40 million pens a year in São Paulo state, but the product can't be sold until Brazil's medicine pricing chamber sets a price cap.
- Business
Lilly to buy three infectious disease companies for up to about $3.8 billion
Eli Lilly said on May 26, 2026 that it has agreements to acquire Curevo, LimmaTech Biologics and Vaccine Company, with maximum cash payouts of $1.5 billion, $780 million and $1.55 billion. The deals bring vaccine candidates against shingles, drug-resistant bacteria and Epstein-Barr virus, all of which are still investigational.
- Research and trials
Nurse practitioner commentary ties GLP-1 microdosing to cost barriers and weight bias
A commentary published May 26, 2026, in the Journal of the American Association of Nurse Practitioners argues that affordability barriers keep driving patients toward unsupervised "microdosing" of GLP-1 drugs and unapproved "research-grade" peptides sold online, despite recent federal pricing agreements. It names gastrointestinal tolerability and "vanity weight" as the two drivers of deliberately subtherapeutic dosing, and cites provider weight bias as a reason patients seek unregulated alternatives. The abstract reports no prevalence figures or specific doses.
- Research and trials
Analysis links GLP-1 receptor agonists to lower macular degeneration risk in older adults
A target trial emulation of 157,880 matched patients aged 60 and over with obesity and no diabetes found that starting a GLP-1 receptor agonist was associated with a lower risk of age-related macular degeneration than starting another weight-loss medication (HR 0.82; 95% CI 0.68–0.98). Follow-up was much shorter in the GLP-1 group, median 1.11 years versus 2.56 years, and the drugs were analyzed as one class rather than by molecule. The authors say whether the finding reflects a direct retinal effect, greater weight loss, or both is not yet known.
- Culture
Penn study uses AI to scan 400,000 Reddit posts for GLP-1 side effects
Researchers at the University of Pennsylvania used large language models to analyze more than 400,000 Reddit posts from nearly 70,000 users about semaglutide and tirzepatide. About 44% of users mentioned at least one side effect, mostly gastrointestinal, and the study flagged less-documented reports such as menstrual irregularities and temperature-related symptoms. The authors say the findings are signals to investigate, not proof the drugs caused the symptoms.
- Research and trials
Semaglutide produced 18 percent weight loss after bariatric surgery in small trial
In a double-blind, placebo-controlled trial called BARI-STEP, 70 adults with a poor response to bariatric surgery were assigned to weekly semaglutide 2.4 mg or placebo. Mean weight change at 68 weeks was −18.0 percent with semaglutide versus +0.4 percent with placebo, an adjusted difference of −19.18 percentage points. Adverse events matched semaglutide's known safety profile, with no new concerns reported for the post-surgical group.
- Competition
Appeals panel upholds order for Tru Niagen to drop 'clinically proven' claims
An appeals board at BBB National Programs upheld a finding that Niagen Bioscience should stop advertising Tru Niagen as "clinically proven" and drop immune, brain and heart health claims. The panel agreed with the National Advertising Division that a supplement's status under the 1994 Dietary Supplement Health and Education Act does not decide whether an ad claim is misleading.
- Business
Analysis links orforglipron to up to 13% weight loss in adults 65 and older
A post-hoc subgroup analysis of the ATTAIN-1 and ATTAIN-2 trials reported that once-daily oral orforglipron (Foundayo) was associated with average weight loss of roughly 8% to 13% at 72 weeks in adults 65 and older, compared with about 2% with placebo, in people with or without type 2 diabetes. Results were similar to those seen in younger participants, and side effects were mostly mild to moderate gastrointestinal events. The analysis was published in Obesity Pillars.
- Competition
Lilly says retatrutide delivered 28.3% average weight loss in phase 3 obesity trial
Eli Lilly reported that retatrutide, an investigational triple hormone drug, produced an average 28.3% body weight loss — about 70.3 pounds — over 80 weeks in the phase 3 TRIUMPH-1 trial. The 12 mg dose also led 45.3% of participants to lose at least 30% of their body weight, and a 104-week extension in people with a baseline BMI of 35 or higher reached 30.3%. Retatrutide is not approved and is available only in clinical trials.
- Research and trials
Lilly's retatrutide produced 28.3% average weight loss at highest dose in Phase 3 trial
Eli Lilly said on May 21, 2026 that its investigational drug retatrutide helped adults with obesity lose an average of 28.3% of their body weight over 80 weeks at the 12 mg dose in the Phase 3 TRIUMPH-1 trial. Nearly half of that group, 45.3%, lost at least 30% of their body weight. Discontinuation because of side effects was 11.3% at 12 mg, higher than the 4.9% seen with placebo.
- Regulation
European panel backs oral Wegovy and a 7.2 mg pen for weight loss
A European Medicines Agency committee recommended approving Wegovy (semaglutide) as a once-daily tablet in four strengths for weight management in the EU, which would make it the first oral GLP-1 weight-loss medicine in Europe. The same panel also backed a 7.2 mg single-pen version of the Wegovy injection. One study in the regulator's summary reported average weight loss of 13.61% with the tablets versus 2.18% with placebo over 64 weeks.
- Safety
FDA logs more than 1,700 adverse event reports tied to compounded GLP-1 drugs
FDA's page on unapproved GLP-1 drugs lists more than 1,700 adverse event reports involving compounded semaglutide and tirzepatide as of May 21, 2026. The same page cites import alerts, dosing concerns and counterfeit versions of brand-name products. FDA has not published a breakdown of the reports by product, severity or outcome.
- Science
Hims & Hers starts selling Apotex generic semaglutide in Canada
Hims & Hers Health began offering generic semaglutide to patients in Canada on May 21, 2026, supplied by Apotex Inc, which Health Canada approved earlier this month for type 2 diabetes. Hims said personalized plans start at C$149 a month, while branded Ozempic in Canada runs C$200 to C$400 a month. Dr Reddy's also holds Canadian approval and has launched a generic there.
- Competition
Advertising review board upholds ruling against Tru Niagen's "clinically proven" claims
The National Advertising Review Board upheld a March 16, 2026 National Advertising Division recommendation that Niagen Bioscience stop claiming Tru Niagen is "clinically proven" to raise NAD+ levels and drop certain health-benefit claims. The panel rejected Niagen's argument that a claim's structure/function status under DSHEA lowers the evidence needed to support it.
- Safety
Pooled analysis estimates about one extra NAION case per 7,000 semaglutide patients a year
A systematic review and meta-analysis published May 21 in PLOS Medicine found semaglutide use was associated with a higher relative risk of the rare eye condition NAION in people with type 2 diabetes, with a hazard ratio of 2.17 compared with other glucose-lowering regimens. In absolute terms, the researchers estimated about one additional case per 7,000 patients treated for a year, an absolute risk difference of 0.014%. The authors graded the certainty of the evidence as low to very low.
- Compounding
Lower-priced Wegovy and Foundayo pills pull some patients off compounded GLP-1s, doctors say
Nine U.S. doctors told Reuters that cheaper branded weight-loss pills are moving some patients off compounded GLP-1 drugs. The lowest doses of oral Wegovy and Foundayo cost about $149 a month, roughly matching compounded prices, while injectable versions start at $199 or more. Doctors said insurance denials remain the biggest obstacle even as the pills draw in patients who previously declined treatment.
- Culture
National Restaurant Association survey finds GLP-1 users buy restaurant food more often
A National Restaurant Association survey of 1,400 US adults found that current GLP-1 users bought a meal, snack or beverage from a restaurant 7.6 times in the prior week, compared with 5.1 times for non-users. The survey, fielded March 6–11, 2026, also found that nearly half of GLP-1 users said they dine out less often since starting the medication, while about one in four said they dine out more.
- Prices
TrumpRx GLP-1 prices settle near $285 for Ozempic and $349 for Wegovy
As of May 2026, the federal drug portal TrumpRx.gov listed Ozempic at about $285 a month and Wegovy at about $349 a month under most-favored-nation pricing, according to GLP-1 Cost Calculator. The White House describes the same injections as averaging $350 a month and falling as low as $199 depending on dose. The portal launched February 5, 2026, and was expanded May 18, 2026.
- Safety
Eli Lilly asks judge to end all injury claims over Trulicity, Mounjaro and Zepbound
Eli Lilly filed a May 19, 2026 brief in the federal GLP-1 litigation, MDL No. 3094, setting out 11 motions to disqualify plaintiffs' expert witnesses and to win summary judgment on gastroparesis, ileus and obstruction, gallbladder and other injury claims. Lilly also argues that the FDA considered and rejected extra gastroparesis warnings, which it says blocks those claims. No allegation has been decided on the merits.
- Business
Supreme Court declines to hear Novo Nordisk's Inflation Reduction Act challenge
The US Supreme Court denied Novo Nordisk's petition for review of its challenge to the Inflation Reduction Act's drug pricing provisions, ending the case after a Third Circuit dismissal. Novo Nordisk separately reported second-quarter 2026 adjusted sales up 7% at constant exchange rates and adjusted operating profit of DKK 33,389 million, and raised its full-year outlook on stronger GLP-1 sales. The company has not said whether the end of the litigation will change US prices or rebates.
- Prices
TrumpRx expands to everyday medicines and generic price comparisons
On May 18, 2026, the Trump administration widened TrumpRx.gov beyond the brand-name most-favored-nation deals it launched in February, adding everyday medicines and retail generic price comparisons. The site now says it offers "hundreds of generics" and displays a running total of more than $700,000,000 saved for Americans. Brand-name GLP-1 prices already listed on the site include Ozempic at $199 a month, the Wegovy pen at $199, the Wegovy pill at $149 and Zepbound at $299.
- Science
Lilly starts Phase 2 obesity trial of GIP drug macupatide
Eli Lilly has begun a Phase 2 trial of macupatide (LY 3532226), an experimental GIP receptor agonist, in people with obesity, testing it alone and in combination. The study, registered as NCT07589608, started May 15, 2026, in the United States and is given by subcutaneous injection. Macupatide's highest development phase is listed as Phase 2 for both obesity and type 2 diabetes.
- Safety
Eye doctors' group says tirzepatide's NAION risk needs more study
A joint consensus statement from the American Academy of Ophthalmology and the North American Neuro-Ophthalmology Society says the evidence suggests a possible but unproven link between semaglutide and a rare vision condition called NAION, with hazard ratios around two-fold in several large database studies and no increased risk in others. The groups say the absolute risk remains small and that the link for other GLP-1 drugs, especially tirzepatide, has been studied less and needs more research.
- Science
Apotex puts a generic version of Ozempic on the Canadian market
Apotex said on May 14, 2026 that it has begun commercial sales in Canada of Apo-Semaglutide Injection, a generic equivalent of Ozempic, in 2 mg and 4 mg prefilled pens covering 0.25 mg, 0.5 mg and 1 mg doses. The first inventory is moving to wholesalers, with pharmacy availability expected in the weeks ahead, under a Canadian indication limited to type 2 diabetes in adults. No price was given, and the announcement did not address the United States.
- Business
Teva reports discontinuation of its generic Saxenda five-pen carton
Teva Pharmaceuticals posted a discontinuation notice dated May 14, 2026 for its generic liraglutide five-pen carton, NDC 0480-7250-46, according to the FDA's drug shortage database. FDA records conflict on timing: the same package carries a marketing end date of Sept. 30, 2027 in the agency's NDC directory. Novo Nordisk separately told FDA that brand Saxenda will be available until a January 2027 discontinuation.
- Business
Lilly commits $50 million to UNICEF child health program over six years
Eli Lilly committed $50 million to UNICEF USA on May 14, 2026, for a six-year program to prevent and treat non-communicable diseases in children across 21 low- and middle-income countries. The effort aims to reach more than 30 million young people and caregivers from 2026 through 2032. It builds on $20.9 million Lilly has given since 2022, work UNICEF says has reached nearly 16 million children and caregivers.
- Research and trials
Switching from injectable GLP-1s to oral orforglipron held most weight loss in phase 3b trial
A phase 3b trial called ATTAIN-MAINTAIN found that people who had lost weight on injectable tirzepatide or semaglutide kept most of that reduction after switching to once-daily oral orforglipron instead of stopping treatment. At week 52, the tirzepatide group on orforglipron maintained 74.7% of its prior weight reduction versus 49.2% on placebo, and the semaglutide group maintained 79.3% versus 37.6% on placebo. Orforglipron remains investigational.
- Culture
Adding a GLP-1 to a behavioral weight program cut food noise more than behavioral treatment alone
Research presented May 13, 2026 at the European Congress on Obesity found that 417 adults in a digital behavioral weight-management program who also started a GLP-1 medication reported a 4.05-point drop in food noise after one month, compared with 1.15 points for those who did behavioral treatment alone. That is a between-group difference of 3.0 points on a 20-point scale, adjusted for baseline scores. It is the first controlled look at whether GLP-1 drugs reduce food noise beyond behavioral treatment by itself.
- Prices
Tirzepatide hits NCE-1 date, opening the door to generic patent challenges
On May 13, 2026, tirzepatide reached its NCE-1 date, the first day generic manufacturers can ask the FDA to accept an abbreviated new drug application with a Paragraph IV challenge to Eli Lilly's patents on Mounjaro and Zepbound. Lilly's New Chemical Entity exclusivity itself still runs to May 13, 2027, and the core compound patent is listed as expiring in 2036.
- Research and trials
Novo data show 21.6% weight loss with Wegovy pill in early responders
Novo Nordisk reported that its Wegovy pill produced 21.6% weight loss among people who responded early to treatment and doubled improvement in mobility measures, in analyses presented May 13, 2026 at the European Congress on Obesity. The 21.6% figure applies to a subgroup described as early responders, and Novo has not defined how early response was determined.
- Research and trials
Lower-dose Zepbound kept most of the weight loss in a Lancet maintenance trial
In the SURMOUNT-MAINTAIN trial, published May 12 in The Lancet, 378 adults with obesity who had already lost weight on tirzepatide were randomly assigned to keep taking their maximum tolerated dose, drop to 5 mg, or switch to placebo. After 52 more weeks, total weight change from baseline was −21.9% on the maintained dose, −16.6% on 5 mg, and −9.9% on placebo.
- Research and trials
Nature Medicine trial links pasteurized Akkermansia supplement to less weight regain after dieting
A randomized, double-blind trial published May 12 in Nature Medicine found that 90 adults with overweight or obesity who took daily pasteurized Akkermansia muciniphila MucT regained less weight over a 24-week maintenance phase than those on placebo, with better preserved insulin sensitivity. Danone Research described the benefit as about 3 kg, while independent expert José Pablo Miramontes González put the difference at about 2 kg. In a separate trial, Eli Lilly reported that people who switched from injectable Wegovy or Zepbound to oral Foundayo kept most of their earlier weight loss over a year.
- Business
Lilly marks 150 years as Indiana study puts its state economic impact at nearly $15.6 billion
Eli Lilly and Company celebrated its 150th anniversary in Indianapolis on Tuesday, the same week an Indiana University study reported that its direct operations contribute nearly $15.6 billion a year to Indiana's GDP, or 2.7% of the state's economic output. The study also estimated that every direct Lilly job supports 2.17 more in Indiana, and that the company's Indiana employment footprint will reach 52,400 jobs by 2030.
- Research and trials
Lilly says Foundayo and lower-dose Zepbound maintained weight loss in two trials
Eli Lilly reported on May 12, 2026 that two late-phase trials showed people largely maintained their weight loss after moving from higher doses of injectable incretin therapy to once-daily oral Foundayo (orforglipron) or to a lower 5 mg dose of Zepbound (tirzepatide). In ATTAIN-MAINTAIN, people who switched to Foundayo kept all but 0.9 kg of their prior weight loss on average after a year if they came from Wegovy, and all but 5.0 kg if they came from Zepbound. In SURMOUNT-MAINTAIN, staying on Zepbound at the maximum tolerated dose preserved all prior weight loss, while dropping to 5 mg held all but 5.6 kg on average.
- Research and trials
Novo Nordisk reports nearly 28% weight loss in early responders to higher-dose Wegovy
At the European Congress on Obesity on May 12, 2026, Novo Nordisk presented analyses showing that semaglutide 7.2 mg, sold as Wegovy HD, produced nearly 28% weight loss among participants who responded early in the STEP UP program. The figure describes a subgroup of early responders, not the average participant. An earlier analysis of higher-dose Wegovy reported average weight loss of about 21%.
- Compounding
Hims & Hers posts $92 million quarterly loss as it leaves compounded GLP-1s
Hims & Hers reported a $92 million loss for the first quarter of 2026, compared with a $49.5 million profit a year earlier, as it shifted its weight loss business from compounded semaglutide to branded GLP-1 drugs. Revenue rose 4% to $608 million but missed analyst expectations, and the stock fell about 15%. The company recorded $33 million in restructuring costs tied to its compounded GLP-1 supply chain.
- Science
Novo Nordisk presents Wegovy menopause data; Lilly follows with Foundayo analyses
Novo Nordisk presented analyses on May 12, 2026 at the European Congress on Obesity reporting substantial weight loss with Wegovy (semaglutide) in women at every stage of menopause, along with reported heart and migraine protection. Eli Lilly published comparable menopause analyses for Foundayo (orforglipron) about a month later, on June 7, 2026, reporting significant weight loss in women at every stage of menopause. The size of the weight loss, the number of women studied and the doses used in those analyses have not been reported.
- Competition
Viking reports 12.2% weight loss with oral VK2735 at 13 weeks
Viking Therapeutics presented additional Phase 2 data on May 12, 2026, showing its once-daily oral tablet VK2735 produced mean weight loss of up to 12.2% after 13 weeks at the highest dose, versus 1.3% for placebo. Weight loss rose with each dose level and had not plateaued by week 13. VK2735 is not approved, and Viking says it plans to begin Phase 3 trials of the oral form later this year.
- Regulation
FDA commissioner Marty Makary resigns and Kyle Diamantas becomes acting commissioner
Marty Makary resigned as FDA commissioner on May 12, 2026, and Kyle Diamantas, the agency's top food official, will step in as acting commissioner. President Donald Trump confirmed the resignation while taking questions from reporters ahead of a trip to China. The article does not say why Makary left or when a permanent commissioner will be named.
- Research and trials
Prespecified SURPASS-CVOT analysis finds 23% fewer major kidney events with tirzepatide than dulaglutide
In a prespecified exploratory analysis of the SURPASS-CVOT trial, the composite kidney outcome occurred in 6.0% of people taking tirzepatide versus 7.6% of those taking dulaglutide over a median follow-up of 4.0 years, a hazard ratio of 0.77 (95% CI 0.68 to 0.88). The lower rate was driven mainly by fewer new cases of persistent macroalbuminuria in people with low-to-moderate-risk chronic kidney disease and by a slower decline in kidney function in those with high-risk chronic kidney disease. The analysis was not the trial's primary endpoint.
- Policy
Lilly pauses India obesity awareness campaign after regulator warning
Eli Lilly halted its "We Know Now" obesity awareness campaign in India after the country's drug regulator said in a March advisory that campaigns creating brand recall or product visibility could violate rules against advertising prescription medicines. In a 16-page letter dated April 10, Lilly said it paused the campaign "out of an abundance of regulatory caution" and asked regulators for clearer rules. India's obesity market is projected to reach 80 billion rupees, or $839.37 million, a year by 2030, up from 17.34 billion rupees now.
- Competition
Foundayo prescriptions reach 7,335 in fourth week as Lilly's weight-loss pill trails oral Wegovy
Eli Lilly's weight-loss pill Foundayo was prescribed 7,335 times in the U.S. in its fourth week on the market, up from 5,612 in week three, analysts citing IQVIA data said. The numbers are modest next to Novo Nordisk's oral Wegovy pill, which was prescribed more than 134,000 times a week by its 16th week. Lilly says more than 20,000 patients have been treated with Foundayo so far.
- Prices
Omada Health joins Lilly Employer Connect to offer GLP-1 care through employers
Omada Health said on May 7, 2026 that it will serve as an independent program administrator in Eli Lilly's Employer Connect program, offering its GLP-1 Care Track — clinical evaluation, prescribing and medication management — to employers alongside its existing pharmacy benefit manager and cash-pay channels. The company also released results from a survey of more than 3,000 GLP-1 patients, finding that 18% had full insurance coverage for weight-loss GLP-1s and 44% paid more than $250 a month.
- Policy
CMS announces $50 monthly GLP-1 coverage for Medicare Part D beneficiaries
The Centers for Medicare & Medicaid Services said eligible Medicare Part D beneficiaries can get certain GLP-1 medicines for a $50 monthly copay from July 1, 2026, through December 31, 2027. The program, called the Medicare GLP-1 Bridge, covers weight-loss formulations of Wegovy, Zepbound and Foundayo. It is a shift for Medicare, which has long been barred from covering weight loss treatments.
- Culture
Lilly's Mounjaro overtakes Keytruda as the world's best-selling drug
Mounjaro brought in $8.7 billion in the first quarter of 2026, beating Merck's Keytruda at $7.9 billion and ending Keytruda's run as the world's top-selling medicine since early 2023. It is the first time a diabetes and weight-loss treatment has held the top spot. Counting Mounjaro and Zepbound together, Lilly's tirzepatide products sold $36.5 billion in 2025, against $31.6 billion for Keytruda.
- Prices
Business Group on Health survey finds 67% of large employers cover GLP-1s for weight management
A survey of 105 large employers released May 6, 2026 found that 67% currently cover GLP-1 medications for weight management, while nearly eight in 10 say the drugs are a major contributor to rising health care costs. Among employers that cover the drugs for weight management, 72% said they were likely to keep that coverage in 2027 and 10% said they likely would not. Separately, 87% expect oral GLP-1s to raise demand, and only 9% expect a price decrease.
- Prices
Lilly adds $4.5 billion to Indiana sites that will make tirzepatide
Eli Lilly said on May 6, 2026 that it will invest another $4.5 billion in two of the three manufacturing plants it is building in Lebanon, Indiana, raising its Indiana commitments since 2020 above $21 billion and its U.S. commitments above $50 billion. The Lebanon API plant, which will supply tirzepatide for Mounjaro and Zepbound, opens in 2027.
- Business
Novo Nordisk's Wegovy pill posts $355 million in first quarter as guidance rises
Novo Nordisk reported DKK 2.26 billion, about $355 million, in first-quarter sales for its oral Wegovy pill, its first full quarter on the U.S. market. The company logged about 1.3 million prescriptions in the quarter and more than 2 million since launch, which it called the strongest-ever GLP-1 volume launch in the U.S.. Novo raised its 2026 guidance to an adjusted sales and profit decline of 4% to 12%, from 5% to 13%.
- Business
Novo Nordisk CEO says drugmaker is seeking deals more than ever before
Novo Nordisk CEO Mike Doustdar told CNBC on May 6, 2026, that the company is looking for deals more than ever before and needs "not just the best, but the broadest pipeline in the world." He pointed to the GLP-1 and amylin candidate CagriSema, which Novo hopes will be approved at the end of this year, and said he disagrees with analysts who doubt the pipeline. The interview followed Novo's report that its Wegovy pill beat expectations in the first quarter and its decision to raise full-year profit guidance.
- Science
Lilly starts Phase 2 trial of brenipatide in diarrhea-predominant IBS
Eli Lilly has begun enrolling adults in a Phase 2 trial of brenipatide, also coded LY3537031, in irritable bowel syndrome with diarrhea. The study, registered as NCT07545759 and called RENEW-IBS-D, is planned for 531 participants. Lilly has not disclosed dosing, treatment length, the primary endpoint or whether the trial uses a placebo, and brenipatide is not approved for any use.
- Business
Ozempic tablets replace Rybelsus at US pharmacies
Ozempic (semaglutide) tablets in 1.5 mg, 4 mg and 9 mg strengths reached US pharmacies on May 4, 2026, and Novo Nordisk is retiring the Rybelsus brand in this country. The two products are not equivalent milligram for milligram, since Rybelsus 3 mg, 7 mg and 14 mg match Ozempic tablets 1.5 mg, 4 mg and 9 mg, so existing prescriptions have to be rewritten. Self-pay pricing runs from $149 to $299 a month, while Novo Nordisk says most insured patients with type 2 diabetes will pay as little as $25 for up to a three-month prescription.
- Business
Novo Nordisk launches Ozempic pill in US, retires Rybelsus brand
Novo Nordisk began selling reformulated oral semaglutide as the Ozempic pill in the United States on May 4, 2026, and retired the Rybelsus brand in the US market. The new tablet comes in 1.5 mg, 4 mg and 9 mg strengths and is sold through more than 70,000 pharmacies, with insured patients potentially paying $25 for up to a three-month supply and self-pay prices estimated at about $149 to $299 a month.
- Compounding
Novo Nordisk relaunches Rybelsus as the Ozempic pill in new strengths
Novo Nordisk's oral semaglutide for type 2 diabetes became available nationwide on May 4, 2026 under the Ozempic brand name, replacing Rybelsus with a smaller, more bioavailable tablet sold in 1.5 mg, 4 mg and 9 mg strengths. The new doses are bioequivalent to the old 3 mg, 7 mg and 14 mg tablets, so the number on a patient's label changes even though the medicine does not. Self-pay pricing runs from $149 to $299 a month, and Novo advertises copays as low as $25 a month for some insured patients.
- Regulation
France fines Novo Nordisk and Eli Lilly over obesity drug promotions
France's medicines regulator fined Novo Nordisk about $2 million and Eli Lilly about $127,000 over obesity drug advertising it said amounted to indirect promotion of prescription medicines. Novo's penalties covered Wegovy (€783,838.20) and Saxenda (€1 million), while Lilly's covered a Mounjaro campaign (€108,766). The regulator's decisions are dated April 29, 2026.
- Prices
Apotex wins Health Canada approval for generic semaglutide injection
Apotex announced on May 1, 2026 that Health Canada approved Apo-Semaglutide Injection, three days after Dr Reddy's became the first company to win Canadian approval for a generic semaglutide injection. Apotex's approval covers two prefilled pen formats, one delivering 0.25 mg or 0.5 mg doses and one delivering 1 mg doses. Neither company has announced a launch date, and Apotex holds only a tentative US approval that would let it launch after Novo Nordisk's exclusivity and patents expire.
- Prices
BALANCE GLP-1 model opens to state Medicaid programs, applications due July 31
State Medicaid agencies can begin joining the BALANCE model starting May 1, 2026, with participation rolling out through January 1, 2027. States must apply by July 31, 2026 and sign an agreement with CMS by January 1, 2027. BALANCE has been indefinitely delayed in Medicare Part D, where a separate short-term program, the Medicare GLP-1 Bridge, runs through December 31, 2027 at a $50 monthly copay.
- Prices
Colorado state employee plans cover GLP-1s for weight loss again starting May 1, 2026
Effective May 1, 2026, Colorado state employee health plans cover GLP-1 medications for weight loss, and the grandfathering rule that required existing users to fill a prescription at least once every 120 days ended the same day. Cigna members get Zepbound for weight loss unless a medical necessity requires another drug; Kaiser Permanente members go through that plan's pre-authorization process.
- Competition
Health Canada approves a second generic semaglutide injection, from Apotex
Health Canada authorized a generic semaglutide injection from the Canadian manufacturer Apotex on May 1, 2026, three days after clearing the country's first such product. Seven further applications for generic semaglutide are still being reviewed. The approvals, reported as the world's second for a generic form of Ozempic, followed Novo Nordisk's decision not to pay a C$250 annual fee.
- Business
Novo Nordisk says Ozempic pills reach US pharmacies May 4 at $149 to $299 a month
Novo Nordisk said Ozempic (semaglutide) tablets 1.5 mg, 4 mg and 9 mg will be available for adults with type 2 diabetes in the US starting Monday, May 4, 2026, at more than 70,000 pharmacies. Self-pay prices are $149 a month for the 1.5 mg starting dose, $199 for 4 mg and $299 for 9 mg, and the company said most insured patients with type 2 diabetes will pay as little as $25 for up to a three-month prescription.
- Compounding
FDA opens comment period on keeping semaglutide, tirzepatide and liraglutide off 503B list
The FDA published a notice on May 1, 2026 proposing not to include semaglutide, tirzepatide and liraglutide on the list of bulk drug substances that may be used under section 503B, opening a comment period that originally closed June 30, 2026. A separate notice published June 26, 2026 extended the comment period; the new deadline is not stated in the docket listing.
- Research and trials
Semaglutide misses smoking-resistance endpoint but cuts craving in small trial
An eight-week randomized trial published in JAMA Network Open found that once-weekly semaglutide did not significantly improve a laboratory measure of smoking resistance in adults who smoke daily. The same trial reported significant reductions in weekly cigarette craving, body weight and hemoglobin A1c. The laboratory analyses shown included 19 participants for the delay-time measure and 16 for the number of cigarettes smoked.
- Compounding
FDA proposes permanent 503B ban on compounded semaglutide and tirzepatide
In May 2026, the FDA proposed permanently excluding semaglutide, tirzepatide and liraglutide from the list of drugs that 503B outsourcing facilities may compound in bulk. The agency later extended the public comment deadline from June 30 to July 30, 2026, after industry groups asked for 60 more days and received 30. The proposal is not final, and no date for a final decision has been published.
- Culture
Study puts Lilly's Indiana impact at 47,520 jobs and 3.6% of state GDP
A May 2026 study from Indiana University's Indiana Business Research Center found that Eli Lilly and Company supports 47,520 jobs in Indiana and generates nearly $20.7 billion in economic activity, equal to 3.6% of the state's GDP. The research center counted 14,700 direct Lilly employees in Indiana and said jobs tied to the company pay an average of $142,130 a year. Lilly is investing $18 billion in a Boone County campus that the study projects will lift the company's total Indiana employment footprint to 52,400 jobs by 2030.
- Safety
Ozempic label revised again in May 2026 and still omits NAION warning
The Ozempic prescribing information carries a May 2026 revision date and lists ten Warnings and Precautions, but non-arteritic anterior ischemic optic neuropathy (NAION) is not among them. European regulators concluded in June 2025 that NAION is a very rare side effect of semaglutide, affecting up to 1 in 10,000 people, and recommended adding it to product information there.
- Competition
Amgen starts phase 3 study of switching from weekly GLP-1s to monthly MariTide
Amgen has launched a phase 3 trial testing whether patients now on weekly GLP-1 medicines can move to its once-monthly candidate MariTide. Monthly dosing is the main advantage Amgen claims over semaglutide and tirzepatide, which are given weekly. MariTide produced up to about 20% weight loss at 52 weeks in phase 2 and is not approved anywhere.
- Regulation
FDA approves instructions for use for single-dose Ozempic prefilled syringe
The FDA has approved an Instructions for Use for a single-dose Ozempic (semaglutide) prefilled syringe, and the drug's prescribing information, revised 05/2026, now lists that presentation in 0.25 mg, 0.5 mg and 1 mg strengths. It is the first Ozempic presentation that is not a dial pen, and it is used with a pinched skinfold and a 45-degree angle instead of a dose counter. Its in-use storage window is 28 days at 8 to 30 C, compared with 56 days for the pen.
- Regulation
Wegovy labeling adds single-dose syringes in five strengths
Wegovy's FDA-approved labeling now lists a single-dose syringe for the once-weekly semaglutide injection in 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg strengths. The drug had been supplied in single-dose pens, a higher-dose pen, and as a once-daily pill. When the syringes will reach pharmacies and what they will cost have not been reported.
- Science
Novo Nordisk starts Phase 3 AMAZE-12 trial of amycretin for weight maintenance
Novo Nordisk launched AMAZE-12, a Phase 3 trial of the investigational GLP-1/amylin drug amycretin, in May 2026. The study is aimed at maintaining weight lost through diet rather than producing initial weight loss. No efficacy results, trial size, duration or dosing details for the amycretin program have been reported.
- Compounding
FDA proposes excluding semaglutide, tirzepatide and liraglutide from the 503B compounding list
The FDA proposed on April 30, 2026 to keep semaglutide, tirzepatide and liraglutide off the 503B bulks list, saying large outsourcing facilities have no clinical need to compound them from bulk ingredients. The notice, docket FDA-2018-N-3240, ran 14 pages in the Federal Register on May 1, 2026. No final decision has been made.
- Research and trials
Semaglutide cut heavy drinking days in first randomized GLP-1 trial for alcohol use disorder, NIH says
Researchers randomly assigned 108 treatment-seeking adults with alcohol use disorder and obesity to weekly semaglutide or placebo alongside cognitive behavioral therapy for 26 weeks. Heavy drinking days fell 41.1% on semaglutide, 13.7 percentage points more than on placebo, with a number needed to treat of 4.3 versus 7 or higher for drugs already approved for alcohol use disorder, NIH said on April 30, 2026. The trial was published in The Lancet.
- Culture
Eating disorder clinicians say the GLP-1 boom is feeding a return to thin-ideal culture
Clinicians at eating disorder treatment programs say U.S. culture is turning back toward the thin ideal while GLP-1 medications spread, and that many people starting the drugs are not screened for eating disorders or monitored afterward. The National Eating Disorders Association puts lifetime eating disorder prevalence at 9 percent of Americans — nearly 31 million people — with one death every 52 minutes. Experts distinguish GLP-1s from 1990s diet pills such as fen-phen, which produced a $3.75 billion class-action settlement.
- Safety
Semaglutide cut heavy drinking days in alcohol use disorder trial, Lancet study finds
A 26-week randomized, double-blind, placebo-controlled trial published April 30, 2026 in The Lancet found that once-weekly semaglutide lowered the share of heavy drinking days by 41.1 percentage points in 108 adults with alcohol use disorder and obesity, against 26.4 percentage points for placebo, with cognitive behavioral therapy given to both groups. Total alcohol intake, daily drinks and body weight also dropped more on the drug. Five participants stopped treatment because of side effects, mostly gastrointestinal.
- Business
Lilly posts $19.8 billion quarter as Mounjaro overseas sales pass US for the first time
Eli Lilly reported first-quarter 2026 revenue of $19.8 billion, up 56% from a year earlier, and raised its full-year revenue guidance to $82 billion to $85 billion. Mounjaro sales reached $8.66 billion and Zepbound sales were $4.16 billion, both driven by volume as prices fell.
- Safety
Semaglutide and tirzepatide injury lawsuits set September 2026 expert-evidence hearing
A case-management order entered April 30, 2026 set the expert-challenge and summary-judgment schedule in the federal GLP-1 gastrointestinal injury litigation, with a Rule 702 hearing reserved for September 2026. The order covers warning adequacy, federal preemption and general causation, and the rulings would apply to the semaglutide and tirzepatide claims alike.
- Safety
Novo Nordisk and Eli Lilly argue federal preemption in 4,000-case GLP-1 MDL
Manufacturers of Ozempic, Wegovy and Mounjaro filed summary judgment briefing on April 30, 2026 in the federal proceeding consolidating more than 4,000 GLP-1 injury claims, arguing in part that federal law preempts state failure-to-warn claims. Briefing continues through July 2026, with the first bellwether trials expected in mid-to-late 2026 and no settlements announced as of September 2026.
- Science
Tirzepatide shows larger drops in pill progestin levels than semaglutide, review finds
A PRISMA review in Obstetrics & Gynecology covering 10 studies and 305 participants found that combined oral contraceptive estrogen exposure was unchanged across GLP-1 and dual GLP-1/GIP drugs. Tirzepatide, lixisenatide and exenatide taken just before the pill lowered levonorgestrel peak levels by 45-66% and total exposure by 18-23%, while semaglutide and dulaglutide produced changes ranging from a decrease of 8% to an increase of 5%.
- Science
Study finds weekly GLP-1 added to therapy cut heavy drinking more than therapy alone
A study reported on April 30, 2026 found that adding a weekly GLP-1 medicine to cognitive behavioral therapy produced greater reductions in heavy drinking than cognitive behavioral therapy alone. No GLP-1 medicine is approved in the United States to treat alcohol use disorder, and the work is investigational. The drug tested, the number of participants and the size of the reduction have not been reported.
- Compounding
Judge dismisses part of Lilly lawsuit against compounder Empower Pharmacy
A federal judge on April 30, 2026 dismissed part of Eli Lilly's lawsuit against Empower Pharmacy, which accuses the compounder of misleading customers about compounded versions of the obesity drug tirzepatide. Other claims in the case can proceed, so the litigation continues on a smaller set of allegations. Which claims were dismissed, and the judge's reasoning, have not been reported.
- Compounding
Judge splits Lilly's compounded tirzepatide case against Empower, dismissing federal ad claim
A federal judge in Texas ruled on April 29, 2026, that Eli Lilly's federal false-advertising claim against compounding pharmacy Empower Clinic Services over compounded tirzepatide must be dismissed, while state consumer protection claims under eight states' laws can move forward. The court also threw out Lilly's Texas common law unfair competition claim. Lilly had accused Empower of selling unapproved versions of tirzepatide, the ingredient in Mounjaro and Zepbound, at a reported 70,000 doses a week.
- Research and trials
Zealand Pharma and Roche plan Phase 3 program for petrelintide in weight management
Zealand Pharma and Roche said on April 29, 2026 that petrelintide, an investigational once-weekly amylin analog, will move into Phase 3 trials for chronic weight management, with the program planned to start in the second half of 2026. In the Phase 2 ZUPREME-1 trial, participants lost up to 10.7% of their body weight at 42 weeks versus 1.7% on placebo, and the sponsors described the tolerability profile as close to placebo.
- Prices
Health Canada approves Dr. Reddy's generic semaglutide, a first for the G7
Health Canada cleared Dr. Reddy's generic semaglutide injection on April 28, 2026, the first generic semaglutide approved in a G7 nation, and Apotex received a second approval on May 1. The Canadian opening followed Novo Nordisk's failure to pay a CAD $250 patent maintenance fee. U.S. patents still run to 2032, according to Novo Nordisk's 2025 annual filing.
- Safety
Ozempic and Mounjaro stomach-injury lawsuits pass expert-challenge deadline
The deadline for Daubert motions, which ask a judge to keep expert testimony out of trial, passed on April 28, 2026 in MDL 3094, the federal case combining lawsuits alleging that Ozempic, Wegovy, Mounjaro and Zepbound caused stomach and intestinal injuries. Expert depositions had finished, and summary judgment briefing was set to continue through July 2026. About 4,022 cases were pending as of September 2026, and no settlements have been announced.
- Research and trials
Meta-analysis finds no clear birth defect signal for GLP-1 drugs taken around conception
A meta-analysis pooling 22 studies and 49,395 pregnancies found no statistically significant link between GLP-1 receptor agonist exposure around conception and major congenital malformations, cardiac malformations, preterm delivery, live birth, miscarriage, hypertensive disorders of pregnancy or cesarean delivery. A small association with kidney malformations, with an odds ratio of 1.23, was attributed largely to one imbalanced cohort. A separate tirzepatide pregnancy registry has not yet reported results.
- Research and trials
Boehringer reports up to 16.6% weight loss with survodutide in Phase 3 trial
Boehringer Ingelheim reported that survodutide, an experimental glucagon/GLP-1 dual agonist, produced up to 16.6% average weight loss at 76 weeks in the Phase 3 SYNCHRONIZE-1 trial, along with a 63% reduction in liver fat and 34% reduction in visceral fat in a small imaging substudy. Gastrointestinal side effects led about one in five participants at the higher dose to stop treatment in one account of the data, and the drug is not approved.
- Science
Survodutide posts 16.6% weight loss in first Phase 3 readout for a dual GLP-1/glucagon drug
Survodutide reported a mean 16.6% weight loss at 76 weeks in the Phase 3 SYNCHRONIZE-1 trial, with 3.2% for placebo, giving the dual GLP-1/glucagon class its first Phase 3 result. A 2026 obesity drug pipeline calendar describes that result as lower than the retatrutide and CagriSema benchmarks. Survodutide is not approved in the United States, and no filing or regulatory timeline has been reported.
- Compounding
Hims & Hers adds Zepbound, KwikPen and Foundayo prescriptions through LillyDirect
Hims & Hers said on April 23, 2026 that licensed providers on its platform can now send prescriptions for Zepbound vials, the Zepbound KwikPen and Foundayo to the LillyDirect pharmacy, where its customers can use Lilly's self-pay pricing. The announcement did not list specific prices, and both companies say the arrangement is not a partnership or affiliation. In April 2025, Hims & Hers listed branded tirzepatide at $1,899 a month while Lilly said Zepbound self-pay started at $349 a month on LillyDirect.
- Research and trials
Novo Nordisk reports oral semaglutide data in children and teens with type 2 diabetes
Novo Nordisk said data suggest oral semaglutide could become the first oral GLP-1 receptor agonist therapy for children and adolescents with type 2 diabetes, in an announcement dated April 23, 2026. Manufacturing details of the pediatric study, including its size, the doses tested and the results, have not been reported. Every semaglutide product currently approved in the United States is indicated for adults.
- Prices
White House announces most-favored-nation pricing deal with Regeneron
The White House announced a most-favored-nation drug pricing deal with Regeneron on April 23, 2026, adding the company to a program that ties U.S. prices to the lowest prices paid in other developed countries. The White House has not disclosed which Regeneron medicines are covered or what they will cost. The administration says 16 such deals have been announced since September 30, 2025, and that TrumpRx.gov, launched February 5, 2026, lists discounted prices on 40 branded medicines from five manufacturers.
- Prices
Analysis finds 12 million people lost coverage for Zepbound and 12 million for Wegovy
Research by the drug discount site GoodRx, using formulary data covering more than 190 million people, found that 12 million people lost commercial insurance coverage for Zepbound from 2025 to 2026 and 12 million lost coverage for Wegovy. Among people who kept coverage for a GLP-1 obesity drug, 88% face restrictions such as prior authorization or step therapy.
- Research and trials
First randomized trial of resistance training on semaglutide and tirzepatide publishes its protocol
BMJ Open published the protocol for LEAN-PREP, described as the first randomized trial of lifting weights in people taking semaglutide or tirzepatide. The six-month study plans to enroll 232 adults and assign them to a control group, resistance exercise, protein supplementation, or both, with quadriceps muscle cross-sectional area on MRI as the primary outcome. No results are available yet.
- Regulation
FDA approves 21 days of in-use storage with temperature cycling for Mounjaro and Zepbound
The FDA approved supplemental applications for Mounjaro and Zepbound on April 22, 2026, allowing single-dose tirzepatide vials and semi-finished syringes to be stored in and out of refrigeration for up to 21 days during patient use. The approval covers repeated cycling between 5 °C and 30 °C, based on a Lilly stability study that found no practical difference between cycled samples and controls.
- Regulation
Lilly revises Zepbound single-dose pen and vial instructions for use
Eli Lilly issued revised, FDA-approved Instructions for Use dated April 22, 2026, for the Zepbound single-dose pen and the Zepbound single-dose vial. The pen version includes a commonly asked questions section covering air bubbles, warming the pen and click sounds, while the vial version states that the needle and syringe are not included and gives a 1 mL syringe example.
- Prices
CMS shelves Medicare Part D launch of BALANCE for 2027 and extends GLP-1 Bridge
CMS announced on April 21, 2026 that the Medicare Part D portion of the BALANCE model will not start in 2027, one day after Part D plan sponsor applications were due. The agency extended the separate Medicare GLP-1 Bridge, a nationwide program with a $50 monthly copay, through December 31, 2027. The Medicaid side of BALANCE is unaffected and continues to roll out state by state.
- Compounding
Amazon One Medical starts nationwide GLP-1 program with cash prices from $149 a month
Amazon One Medical began offering GLP-1 treatment across the United States on April 21, 2026, pairing its primary care practice with Amazon Pharmacy for prescribing and delivery. Medication runs as low as $25 a month for patients whose insurance covers it, $149 a month for oral pills and $299 for injectables without insurance, with same-day delivery in nearly 3,000 cities.
- Competition
IQVIA puts 2025 obesity drug market at $66 billion and forecasts $92 billion for 2026
IQVIA's ForecastLink sizes global obesity medicine sales at $66 billion in list-price value for 2025, and the firm forecasts $92 billion in 2026, with a range of $105 billion to $200 billion for 2027 and beyond. IQVIA says oral therapies and off-patent semaglutide will shape pricing and access, and that the market is becoming more contested as new companies enter.
- Science
Paper tied to Eli Lilly describes impurity in compounded tirzepatide with B12
A paper in the peer-reviewed journal Expert Opinion on Drug Safety describes what its authors call a novel, widespread impurity in mass-compounded tirzepatide products that also contain vitamin B12. The article presents the analytical work behind a warning Eli Lilly issued in March, and its authors are affiliated with Lilly. The authors report that the impurity's clinical effects are unknown.
- Culture
Food brands treat GLP-1 packaging claims with caution as no label definition exists
FoodNavigator reported on April 21, 2026 that food and beverage companies are approaching GLP-1-related packaging claims carefully because no regulatory definition exists for terms like "GLP-1 friendly." The report says brands are signaling GLP-1 benefits indirectly with wording such as "high protein" and "supports muscle mass," and that consumer research shows a GLP-1 badge can have a polarizing effect on shoppers.
- Business
Lilly to buy Kelonia Therapeutics in deal worth up to $7 billion
Eli Lilly agreed on April 20, 2026, to acquire Kelonia Therapeutics, a clinical-stage Boston company developing CAR-T cancer therapies that are generated inside the patient's body. Lilly would pay $3.25 billion upfront and as much as $7.00 billion in total cash, with the remainder tied to clinical, regulatory and commercial milestones. Kelonia's lead program, KLN-1010, is a Phase 1 anti-BCMA CAR-T therapy for relapsed or refractory multiple myeloma.
- Safety
Judge lets Lilly's false-advertising claims against Mochi Health proceed
A federal judge in California largely denied Mochi Health's motion to dismiss Eli Lilly's lawsuit, allowing claims that the telehealth company misled consumers about compounded tirzepatide. The April 20, 2026 ruling lets Lilly pursue Lanham Act and California unfair-competition claims, while dismissing a civil conspiracy claim.
- Prices
GLP-1 BALANCE Model is delayed indefinitely in Medicare after Part D sign-up deadline passes
Medicare Part D sponsors had until April 20, 2026 to apply for the BALANCE Model, which was designed to expand Medicare coverage of GLP-1 obesity drugs beginning in 2027. One day later, on April 21, 2026, CMS announced an indefinite delay of the model in Part D and extended a separate short-term program, the Medicare GLP-1 Bridge, through the end of 2027.
- Safety
India seizes more than 260 suspected counterfeit Mounjaro pens, arrests two
Indian drug regulators in Haryana seized more than 260 suspected counterfeit pens of Eli Lilly's Mounjaro and arrested two people accused of making and selling them. Officials said the main accused ordered peptide raw materials from vendors on Alibaba and sold the pens on the online marketplace IndiaMART at a 27 percent discount. Samples have been sent to government laboratories, and the case has not been confirmed as counterfeit yet.
- Research and trials
Early insulin dose cuts with semaglutide in type 1 diabetes were mostly independent of weight loss
A post hoc analysis of the ADJUST-T1D trial found that semaglutide 1 mg weekly cut total daily insulin dose by 22.6% over 26 weeks in adults with type 1 diabetes and obesity. At week 4, 83% of that reduction was attributed to a direct drug effect rather than weight loss; by week 26 the split was roughly even, at 52% and 48%.
- Safety
India seizes more than 260 suspected counterfeit Mounjaro pens and arrests two people
Drug control officials in Haryana, India, seized more than 260 suspected counterfeit Mounjaro pens and arrested two people accused of making and selling them. The pens spanned strengths of 2.5 mg to 15 mg, were not stored at the required 2 to 8 degrees Celsius, and showed labeling differences from genuine product. Laboratory tests to confirm whether the pens are fake are still pending.
- Science
Preprint finds more lean mass lost with tirzepatide than semaglutide
An analysis of about 8,000 patients found that tirzepatide (Zepbound, Mounjaro) produced greater total weight loss than semaglutide (Wegovy, Ozempic) but also greater loss of lean body mass. Patients on tirzepatide lost an average of 1.1 percentage points more lean mass after three months and 2 points more after 12 months of continuous use. The study was posted online ahead of peer review, and both manufacturers disputed how to interpret the findings.
- Competition
Foundayo's first week brings 1,390 prescriptions as Lilly's oral obesity pill reaches market
Eli Lilly's oral obesity pill Foundayo (orforglipron) was prescribed 1,390 times in the U.S. in its first week, according to IQVIA data cited by analysts. Novo Nordisk's oral Wegovy (semaglutide), which launched about three months earlier, recorded 3,071 prescriptions in its first four days and 113,354 prescriptions in the same week Foundayo launched. Analysts say the earliest fair comparison will come at about eight to twelve weeks.
- Research and trials
Lilly's Foundayo meets heart safety goal in longest type 2 diabetes trial
Eli Lilly said April 16 that its oral GLP-1 pill Foundayo (orforglipron) met the main goal of the Phase 3 ACHIEVE-4 trial, showing no higher risk of major cardiovascular events than insulin glargine in 2,749 adults with type 2 diabetes at increased cardiovascular risk. The hazard ratio for the primary endpoint was 0.84, meeting the trial's preset non-inferiority bar. In a pre-planned analysis, all-cause death was 57% lower with Foundayo, a finding Lilly said was not controlled for multiple testing.
- Competition
Eli Lilly reports $19.8 billion in first-quarter revenue as Mounjaro and Zepbound drive growth
Eli Lilly posted first-quarter 2026 revenue of $19.8 billion, up 56% from a year earlier, with Mounjaro and Zepbound combining for $12.82 billion, about 65% of the total. Its new oral obesity drug, Foundayo, was approved April 1 and went on sale days before the quarter ended, so it contributed little to the quarter.
- Prices
Wegovy pill 4 mg cash price rises to $199 a month as introductory rate ends
The cash price of the 4 mg Wegovy pill rose from $149 to $199 a month on April 15, 2026, when Novo Nordisk's introductory price for that dose ended. The 1.5 mg starter dose stayed at $149 a month, and the 9 mg and 25 mg doses stayed at $299 a month.
- Prices
CMS proposes electronic prior authorization rules for drugs in Medicare, Medicaid and exchanges
CMS published a proposed rule on April 14, 2026 that would require Medicare Advantage, Medicaid, CHIP and exchange plan payers to offer electronic prior authorization for drugs, with a proposed compliance date of October 1, 2027. The rule would also set a 24-hour decision timeframe for drug prior authorizations in Medicaid and CHIP and adopt new federal data standards for prior authorization transactions. Comments closed June 15, 2026.
- Business
FDA requires additional safety trials for Lilly's Foundayo after approval
The FDA's April 1 approval letter for Foundayo, Eli Lilly's oral weight-loss drug, requires clinical trials on cardiovascular risk, drug-induced liver injury, retained stomach contents and breast-milk exposure, plus long-term pediatric, pregnancy and thyroid studies. The letter was posted on the agency's website April 14. Lilly says late-stage testing turned up no signs of liver damage.
- Regulation
FDA approval letter for Foundayo sets liver, heart and stomach safety studies
Documents posted by the FDA on April 14, 2026 show that the April 1 approval letter for Eli Lilly's obesity pill Foundayo obliges the company to study liver injury, cardiovascular events and delayed gastric emptying, and to measure drug levels in breast milk. Lilly called the requests standard for newly approved medicines and said no liver safety signals have appeared in its Phase 3 program to date. The requirements are not printed on the drug's label.
- Compounding
FDA warns New Life Pharma over unapproved semaglutide and tirzepatide vials
FDA issued a warning letter dated April 14, 2026, to New Life Pharma LLC saying its semaglutide and tirzepatide sterile multi-dose vials are unapproved new drugs. The letter cites sterility and quality-control failures found during a February 2026 inspection of the Northvale, New Jersey facility, and says the company refused investigators access to two areas. FDA said the sterility problems put patients at serious risk of infections.
- Research and trials
Review finds small studies link liraglutide and semaglutide to psoriasis improvement
A narrative review published April 27 in Frontiers in Immunology reports that small studies of GLP-1 receptor agonists, mainly liraglutide and semaglutide, found improvements in psoriasis severity that appeared to go beyond weight loss. The review cites a two-patient case series, a seven-patient cohort and one single case report, and says two open-label trials in psoriatic arthritis patients with obesity, NCT06588296 and NCT06864026, indicated improvements in disease activity alongside metabolic benefits. The authors say the joint evidence is limited by small samples and short follow-up, and that no study has yet tested these drugs in early psoriatic arthritis.
- Regulation
Apotex gets first FDA tentative approval for a generic Ozempic
Apotex announced on April 10, 2026 that the FDA granted the first tentative approval for a generic version of Ozempic (semaglutide injection), developed with India-based Orbicular Pharmaceutical Technologies. The status means the product satisfies FDA requirements but cannot be sold in the US until Novo Nordisk's patents and exclusivities end. A launch date and price have not been disclosed.
- Competition
Eli Lilly's India market share falls as generic semaglutide takes hold
Eli Lilly's share of India's GLP-1 weight-loss market dropped to 56% in March from 61% in February, while Novo Nordisk stayed at 25%, according to Pharmarack data. Thirteen Indian manufacturers have launched 26 semaglutide brands since the semaglutide patent expired, and prices have fallen sharply.
- Business
Lilly's Foundayo pill reaches US pharmacies as early prescriptions trail oral Wegovy
Eli Lilly's Foundayo (orforglipron), a once-daily GLP-1 pill for weight loss, went on sale nationwide in the United States on April 9, 2026, after FDA approval on April 1. Self-pay pricing starts at $149 a month at the lowest dose, while eligible people with commercial coverage may pay as little as $25 a month. Early prescription data showed 1,390 fills in its first week, compared with more than 3,000 in the first few days of oral Wegovy's January launch.
- Business
Lilly's Foundayo oral GLP-1 pill reaches US pharmacies at $149 a month for self-pay
Eli Lilly's Foundayo (orforglipron) reached U.S. retail pharmacies and telehealth providers on April 9, 2026, about a week after FDA approval. Self-pay pricing starts at $149 a month at the lowest dose, and eligible commercially insured patients may pay as little as $25 with a savings card. The once-daily pill is the only GLP-1 for weight loss that can be taken without food or water restrictions, and in one trial the highest dose produced an average 12.4% weight loss.
- Culture
Georgetown-led study finds GLP-1 weight loss draws more stigma than diet and exercise
An experiment with 402 U.S. women found that a woman who lost 15% of her body weight with a GLP-1 medication was rated more harshly than one who lost the same amount through diet and exercise, largely because participants saw the drug as a "shortcut." Stigma was unexpectedly higher when the woman was portrayed as white rather than Black. The study was published April 9, 2026, in the American Psychological Association's journal Stigma & Health.
- Culture
Lilly launches oral GLP-1 Foundayo at $149 a month as early prescriptions trail Wegovy pill
Eli Lilly has started selling Foundayo (orforglipron), its once-daily oral GLP-1, to U.S. patients at a self-pay price of $149 a month. About 1,390 U.S. prescriptions were filled in the launch week, trailing Novo Nordisk's oral Wegovy pill, and one industry report described the early start as disappointing. Lilly's GLP-1 business continues to depend on its injectable tirzepatide products.
- Business
Amazon to stock Lilly's Foundayo weight-loss pill at kiosks with same-day delivery
On April 9, 2026, Amazon said its pharmacy unit will stock Eli Lilly's new weight-loss pill Foundayo at kiosks inside some of its primary care clinics and offer same-day delivery of the drug. About half of U.S. customers have access to same-day delivery, and all customers receive medications within four days. Lilly's self-pay price for the lowest monthly dose is $149.
- Compounding
FDA warns ProRx over sterility problems in compounded tirzepatide and semaglutide
The FDA issued a warning letter dated April 7, 2026, to ProRx LLC, a 503B outsourcing facility in Exton, Pennsylvania, after a September 2025 inspection found sterility and manufacturing failures. The company had already recalled one lot of compounded tirzepatide and various lots of compounded semaglutide in October 2025 over a lack of sterility assurance. The FDA said the facility's compounded tirzepatide did not qualify for the exemptions that 503B compounders rely on.
- Prices
Novo Nordisk starts selling Wegovy HD 7.2 mg nationwide at $399 a month self-pay
Novo Nordisk said on April 7, 2026 that Wegovy HD, its 7.2 mg semaglutide injection, is being sold across the United States. Adults paying cash can expect to pay $399 a month, $50 more than the standard Wegovy self-pay rate, while commercially insured patients may pay as little as $25 a month through a savings offer.
- Compounding
FDA warned three peptide sellers over tirzepatide and retatrutide products
The FDA sent warning letters dated March 31, 2026 to Lovega LLC (Pink Pony Peptides), Gram Peptides and Mile High Compounds LLC, saying the products they sell are unapproved new drugs. The nonprofit Partnership for Safe Medicines posted the letters in a compilation dated April 7, 2026, giving each firm 15 working days to respond.
- Business
Lilly begins shipping weight-loss pill Foundayo through LillyDirect
Eli Lilly started shipping Foundayo (orforglipron), its once-daily GLP-1 weight-loss pill, through LillyDirect on April 6, 2026, five days after FDA approval. Self-pay prices start at $149 a month for the lowest dose, and some commercially insured patients could pay as little as $25 a month. Analysts counted 1,390 U.S. prescriptions in the pill's first week, based on partial data.
- Prices
Foundayo joins Medicare GLP-1 Bridge as CMS limits Zepbound coverage to the KwikPen
CMS updated the Medicare GLP-1 Bridge's covered-drug list on April 6, 2026, adding all formulations of Foundayo (orforglipron) and stating that only the KwikPen version of Zepbound (tirzepatide) qualifies. The Zepbound single-dose pen and single-dose vials are excluded. The Bridge is set to run from July 1, 2026 through December 31, 2027, with a $50 copay for eligible Part D beneficiaries.
- Research and trials
Analysis estimates 28% lower heart risk for tirzepatide versus imputed placebo
An indirect analysis published in Diabetes Care estimated a hazard ratio of 0.72 for MACE-3 — a 28% lower relative risk — for tirzepatide compared with an imputed placebo, by chaining results from SURPASS-CVOT and REWIND. The same method produced hazard ratios of 0.70 for cardiovascular death or heart failure events and 0.61 for all-cause death. The comparison is a statistical construction, not a randomized trial of tirzepatide against placebo.
- Research and trials
Study of 1.8 million older adults compares safety of GLP-1 drugs and other diabetes medicines
A multinational study of 1,808,003 adults aged 65 and older with type 2 diabetes found that GLP-1 receptor agonists and SGLT2 inhibitors were linked to significantly lower risks of hypoglycemia and hyperkalemia than sulfonylureas. GLP-1 receptor agonists also showed lower peripheral edema risk than DPP-4 inhibitors, while SGLT2 inhibitors were linked to a higher risk of diabetic ketoacidosis than the other two classes.
- Business
Trump imposes 100% tariffs on patented drug imports, naming Novo Nordisk and Lilly in first wave
President Trump signed a proclamation on April 2, 2026 imposing a 100% tariff on imported patented pharmaceuticals, active ingredients and key starting materials. The rate starts July 31, 2026 for 17 named drugmakers and September 29, 2026 for other importers, with 20% or 0% rates for companies that agree to onshore production and most-favored-nation pricing terms.
- Compounding
New York Times profile of MEDVi came after FDA warning on compounded GLP-1 marketing
The New York Times profiled telehealth seller MEDVi on April 2, 2026, describing $401 million in 2025 revenue, 250,000 customers and a projection of $1.8 billion in 2026 sales, without mentioning an FDA warning letter issued six weeks earlier. The February 20 letter said the company misbranded the compounded semaglutide and tirzepatide it sells. Follow-up reporting found thousands of Meta ads running under apparently fabricated physician personas.
- Research and trials
Novo Nordisk analysis favors Wegovy pill over orforglipron on weight loss
Novo Nordisk released a company-sponsored analysis on April 2, 2026 reporting that oral semaglutide 25 mg, the Wegovy pill, produced greater average weight loss than orforglipron 36 mg, and that people taking orforglipron had roughly 14 times higher odds of stopping treatment because of gastrointestinal side effects. The result comes from a population-adjusted indirect comparison of the OASIS 4 and ATTAIN-1 trials, not a head-to-head study, and the full analysis has not been published.
- Prices
FDA approves Foundayo, a once-daily GLP-1 pill for obesity
The FDA approved Foundayo (orforglipron) on April 1, 2026, as the first once-daily GLP-1 pill for weight loss that can be taken without food or water restrictions. In the 72-week ATTAIN-1 trial, people on the highest dose who stayed on treatment lost an average of 27.3 pounds (12.4%), compared with 2.2 pounds (0.9%) on placebo. Lilly said the pill costs as little as $25 a month with commercial insurance and starts at $149 a month for self-pay.
- Prices
FDA restates compounding limits for semaglutide and tirzepatide copies
On April 1, 2026, the FDA restated that semaglutide and tirzepatide appear on neither its 503B bulks list nor its drug shortage list, and that it does not intend to act against a compounder that fills four or fewer essentially-a-copy prescriptions of a product in a calendar month. The agency also said adding vitamin B12 to a compounded GLP-1 does not by itself take the product outside the essentially-a-copy rule.
- Compounding
FDA sets four-prescription cutoff for compounded semaglutide and tirzepatide copies
In an April 1, 2026 update, the FDA said it does not currently intend to take action against a 503A compounder that fills four or fewer prescriptions per calendar month of a product that is "essentially a copy" of an approved drug. The notice walks through how the agency applies that test to a compounded product that combines semaglutide with vitamin B12. It also states that tirzepatide and semaglutide appear on neither the 503B bulks list nor the FDA drug shortage list.
- Regulation
FDA sets four-prescriptions-a-month threshold for compounded semaglutide and tirzepatide copies
The FDA said on April 1, 2026 that it does not intend to act against a compounder operating under section 503A that fills four or fewer prescriptions a month of a product that is essentially a copy of an approved drug. The agency also restated that neither tirzepatide nor semaglutide appears on its drug shortage list or on the 503B bulks list, and described when a compounded product counts as a copy, including a 10% strength test for semaglutide-plus-vitamin-B12 formulas.
- Compounding
FDA clarifies when compounded GLP-1 drugs count as copies of approved products
In an April 1, 2026 statement, the FDA said a compounded drug is "essentially a copy" of an approved product when it uses the same active ingredient at the same, similar or easily substitutable strength and the same route of administration. The agency gave a semaglutide-plus-vitamin-B12 example using a 10 percent strength test and said it does not intend to act against 503A compounders that fill four or fewer such prescriptions a month.
- Prices
FDA restates compounding rules, says tirzepatide and semaglutide stay off shortage and bulk lists
In an April 1, 2026 update, the FDA confirmed that tirzepatide and semaglutide appear on neither the drug shortage list nor the 503B bulks list, and repeated the conditions that 503A and 503B exemptions require. The agency also said it does not intend to act against a compounder filling four or fewer prescriptions a month of a product that is essentially a copy of a commercially available drug.
- Regulation
FDA clears Foundayo, the first oral GLP-1 for obesity, in fastest new drug approval since 2002
The FDA approved Foundayo (orforglipron) on April 1, 2026, for adults with obesity or with overweight plus at least one weight-related condition, making it the first oral GLP-1 pill cleared for weight loss in the US. The agency said the decision came 50 days after filing and 294 days before the application's January 20, 2027 PDUFA date, its fastest approval of a new molecular entity since 2002. Foundayo is the fifth approval and the first new molecular entity under the FDA's Commissioner's National Priority Voucher pilot.
- Business
NHS England moves tirzepatide prescribing into GP contract with £3,000 bonuses
From 1 April 2026, NHS England folded tirzepatide (Mounjaro) prescribing for obesity into the 2026/27 GP contract, paying practices up to £3,000 a year for managing eligible patients, with £25 million in ring-fenced funding. Participation by GP practices is optional, so access is expected to vary by area.
- Business
Novo Nordisk disputes claims that orforglipron outperforms the Wegovy pill
On April 1, 2026, Novo Nordisk's head of US operations, Jamey Millar, said reports claiming Foundayo (orforglipron) is more effective than the Wegovy pill for weight management are "inaccurate and misleading." He framed the two oral GLP-1 medicines as clinically distinct. No trial data, study names or weight-loss figures were included in the statement.
- Science
FDA sets stepped Foundayo dosing from 0.8 mg to 17.2 mg
The FDA approved Foundayo (orforglipron) on April 1, 2026, for adults with obesity or with overweight plus a weight-related condition, with a dosing schedule that starts at 0.8 mg once daily and can rise to a maximum of 17.2 mg. Patients spend at least 30 days at each step, so reaching higher doses takes months. The UK authorized the same tablet in August 2026.
- Research and trials
Obesity groups issue strong recommendation for semaglutide, tirzepatide and continuing medication in maintenance
The Obesity Society, the Obesity Medicine Association and the Obesity Action Coalition published a joint GRADE-based guidance statement on obesity medications in the journal Obesity on March 5, 2026. It gives strong recommendations for semaglutide and tirzepatide, both on moderate-certainty evidence, and a separate strong recommendation for continuing obesity medications during weight maintenance. The authors note obesity affects more than 40% of US adults.
- Competition
Semaglutide loses exclusivity in eight countries in first wave of 2026 patent expiries
Canada, Brazil, China, India, Mexico, Turkey, Saudi Arabia and South Africa are the first-wave markets losing patent and data protection for semaglutide in 2026, the active ingredient in Ozempic and Wegovy. IQVIA counts more than 70 companies seeking marketing authorization and another 70 able to manufacture the ingredient. In India, prices have already fallen by as much as 90 percent.
- Policy
Medicare Part D must cover one weight-management GLP-1 starting April 1, 2026
Under the Treat and Reduce Obesity Act signed in late 2025, Medicare Part D plans must cover at least one GLP-1 approved for chronic weight management as of April 1, 2026, with a $50 monthly copay cap and an exemption from the deductible. CMS separately announced the Medicare GLP-1 Bridge, a demonstration running July 1, 2026 through December 31, 2027 that offers eligible Part D enrollees certain GLP-1s for $50 a month. CMS estimated the new benefit would raise Part D premiums by $2 to $7 a month.
- Research and trials
Swedish cohort ties semaglutide to lower risk of worsening mental illness
A national cohort study published in The Lancet Psychiatry tracked 95,490 people in Sweden who had depression or anxiety and used antidiabetic medication between 2009 and 2022. Periods of semaglutide use were linked to a lower risk of the study's combined psychiatric outcome (adjusted hazard ratio 0.58), liraglutide to a smaller reduction (0.82), while exenatide and dulaglutide showed no association.
- Prices
Wegovy HD 7.2 mg reaches US pharmacies at $399 a month for self-pay patients
Novo Nordisk's Wegovy HD, a 7.2 mg semaglutide injection, is arriving in US pharmacies in April 2026 in a single-dose pen listed at $399 a month for patients who pay cash. The FDA approved the higher dose on March 19, 2026; in the 72-week STEP UP trial it produced average weight loss of about 19% versus about 4% for placebo. The label requires patients to have tolerated the 2.4 mg dose for at least four weeks before stepping up.
- Business
Novo Nordisk launches 7.2 mg Wegovy HD in the US with a $399 self-pay price
Novo Nordisk launched Wegovy HD, a 7.2 mg single-dose semaglutide pen, in the United States in April 2026, and NovoCare Pharmacy lists it at $399 a month for self-paying patients. Lower Wegovy injectable doses are listed at $349 a month after an introductory $199 offer that covers two monthly fills through December 31, 2026. The 7.2 mg pen also launched in the UK in June, with a European Union roll-out planned for the second half of 2026.
- Compounding
FDA warns Gram Peptides over tirzepatide and retatrutide sales
The FDA sent a warning letter dated March 31, 2026, to Gram Peptides of Rancho Santa Fe, California, saying the company sells tirzepatide, retatrutide and bacteriostatic water for injection as unapproved new drugs. The letter cites product descriptions about weight loss, blood sugar and appetite, and says selling bacteriostatic water alongside the peptides shows the products are meant for human injection.
- Compounding
FDA warns Gram Peptides and Prime Sciences over "research use only" peptide sales
The FDA sent warning letters dated March 31, 2026, to Gram Peptides and Prime Sciences, saying both firms sell unapproved new drugs for human use despite labeling them as research chemicals. The letters quote marketing text about weight loss, blood sugar and appetite to argue the products are intended as drugs, and say no approved applications are in effect for them. Both companies were given 15 working days to respond in writing.
- Business
Lilly closes $6.3 billion purchase of Centessa and its sleep-wake drug pipeline
Eli Lilly and Company completed its acquisition of Centessa Pharmaceuticals plc on June 24, 2026, wrapping up a deal first announced on March 31, 2026. Lilly paid $38.00 per share in cash, about $6.3 billion in upfront equity value, plus contingent value rights worth up to $9.00 per share — roughly $1.5 billion more — that pay only if the FDA approves an experimental orexin-2 receptor agonist for narcolepsy type 2, idiopathic hypersomnia or another indication.
- Prices
Novo Nordisk launches multi-month Wegovy subscriptions for cash-paying patients
Novo Nordisk launched three-, six- and 12-month Wegovy subscriptions on March 31, 2026, giving self-pay patients flat monthly prices of $329, $299 or $249 for the injection and $289, $269 or $249 for the 9 mg and 25 mg pill doses. The company says a 12-month plan saves up to $1,200 a year on the injection and $600 on the pill compared with paying month to month. The program runs through telehealth providers Ro, WeightWatchers and LifeMD first, with Hims & Hers and Sesame expected later.
- Prices
OPM keeps GLP-1 weight-loss coverage rule for federal plans and ties prior authorization to behavioral therapy
Carrier Letter 2026-07, dated March 31, 2026, keeps the requirement that FEHB and PSHB carriers cover at least one GLP-1 weight-loss drug and at least two other oral anti-obesity medications in plan year 2027. It adds that prior authorization for any anti-obesity medication must confirm the member is participating in intensive behavioral therapy before and during treatment. Carriers must file benefit and rate proposals by May 31, 2026, for coverage starting January 1, 2027.
- Business
Lilly is buying narcolepsy drug developer Centessa for up to $7.8 billion
Eli Lilly is acquiring Centessa Pharmaceuticals, a company working on treatments for narcolepsy and other sleep-wake disorders, for up to $7.8 billion. The deal, reported March 31, 2026, extends Lilly's push into sleep medicine, a field it entered commercially through Zepbound's sleep apnea approval. Centessa's lead candidate, cleminorexton, is in Phase 2 trials.
- Research and trials
Tirzepatide shows broader heart and kidney benefit than dulaglutide in post hoc SURPASS-CVOT analysis
A post hoc analysis of the SURPASS-CVOT trial found that a six-part composite of heart and kidney events occurred in 23.7 percent of people taking tirzepatide versus 27.4 percent of those taking dulaglutide, a number needed to treat of 27. The kidney composite alone had a hazard ratio of 0.79, and the researchers reported that all six components contributed to the overall difference.
- Safety
Study finds hair loss reporting gap between semaglutide and tirzepatide
A new analysis of FDA adverse event reports found semaglutide was linked to disproportionately more hair loss reports, with an adjusted reporting odds ratio of 1.23, while tirzepatide showed a negative association of 0.78. The study covered reports from the second quarter of 2022 through the second quarter of 2025 and also found a positive semaglutide signal for polycystic ovary syndrome. How the tirzepatide result compares with other published analyses has not been detailed.
- Competition
Viking completes enrollment in second Phase 3 trial of weight-loss drug VK2735
Viking Therapeutics said March 26, 2026 that it finished enrolling about 1,000 adults in VANQUISH-2, a 78-week Phase 3 trial of its once-weekly injectable VK2735 in people with type 2 diabetes who have obesity or are overweight. Participants were randomized to 7.5 mg, 12.5 mg, 17.5 mg or placebo, with the main goal being percent change in body weight at 78 weeks. It is the second of Viking's two Phase 3 studies of the drug.
- Culture
Destination XL blames GLP-1 drugs for size swings as quarterly sales fall 6%
Destination XL, a big-and-tall men's retailer, said fourth-quarter sales dropped 6% and reported a $29.6 million net loss, with its CEO attributing customer movement between sizes to GLP-1 use that he estimated covers about a quarter of its shoppers. A Circana report released the same day found 23% of U.S. households were using GLP-1 medications as of September, and that 55% of those households had already bought clothing or footwear mainly because their size changed.
- Culture
KFF poll finds 12% of US adults currently use GLP-1 drugs such as Ozempic
A KFF Health Tracking Poll conducted February 24 to March 2, 2026 found that 12% of U.S. adults say they currently use a GLP-1 medication, and 6% say they used one in the past but are not using one now. The poll's question lists brand names including Ozempic, Wegovy, Mounjaro and Zepbound but the published topline reports no use figures for individual brands. The full sample of 1,343 adults carries a margin of sampling error of plus or minus 3 percentage points.
- Competition
Novo Nordisk and United Biotechnology report UBT251 phase 2 diabetes results
In a 24-week phase 2 trial of 211 Chinese adults with type 2 diabetes, the experimental triple agonist UBT251 cut A1c by as much as 2.16% and body weight by as much as 9.8%, compared with 1.77% and 4.8% for semaglutide 1 mg. Novo Nordisk and United Laboratories announced the topline results on March 25, 2026, and say larger trials are planned.
- Research and trials
Meta-analysis of semaglutide and tirzepatide trials finds lean mass is 25% to 39% of weight lost
A systematic review and meta-analysis of 20 randomized trials covering 15,782 participants found lean mass made up 25% to 39% of the weight lost with incretin drugs: semaglutide 35.2%, tirzepatide 25.4% and liraglutide 26.8%. Lifestyle intervention alone came in at 26.2%, while lifestyle plus resistance training showed the lowest share at 17.5%.
- Compounding
FTC launches healthcare task force with weight loss and telehealth marketing in its sights
FTC Chairman Andrew Ferguson issued a memorandum on March 20, 2026 directing the agency to create an internal Healthcare Task Force, listing misleading telehealth and weight loss programs among its consumer protection priorities. The memo cites healthcare at roughly 18% of U.S. GDP and calls for more coordination across FTC bureaus and with other federal agencies. The task force cannot write new statutes or regulations, but it formalizes a joint investigative and enforcement structure.
- Competition
Generic semaglutide goes on sale in India at up to 80% below Novo Nordisk prices
Novo Nordisk's semaglutide patent expired in India on March 20, and at least five Indian drugmakers began selling generic versions at up to 80% below the brand-name price. Sun Pharmaceutical priced a weekly injection from about 750 rupees ($8), and Dr. Reddy's launched a diabetes version at about 4,200 rupees a month, with plans to expand to Canada, Turkey and Brazil this year.
- Culture
NPR examines what 'GLP-1 Friendly' food labels mean for people on weight-loss drugs
Nutritionists told NPR that the term "GLP-1 Friendly" has no regulated definition, even as Conagra has added the label to 26 of its existing meals and Nestle's Vital Pursuit line markets smaller portions to GLP-1 users. A dietitian reviewing one labeled frozen dinner found 3 grams of fiber and shrimp listed below preservatives and stabilizers.
- Competition
Generic semaglutide launches in India after patent expiry, at prices far below Novo's brands
At least six Indian drugmakers launched generic semaglutide on March 21, 2026, the day after Novo Nordisk's core Indian patent expired, with prices from about 1,290 to 4,200 rupees a month against 8,800 to 10,850 rupees for Novo's starting doses. Some of the new products are approved for type 2 diabetes, others for weight management as well. Semaglutide remains patent-protected in the United States until 2032.
- Culture
Dinner traffic falls about 6% among regular GLP-1 users, restaurant strategist says
Dinner traffic at U.S. restaurants dropped about 6% among people who take GLP-1 drugs consistently, which works out to roughly a 0.4% decline in overall restaurant dinner sales, according to RRD's Dana Baggett. Breakfast pastries and sugary coffee drinks are also under pressure, while lunch has held up so far. Surveys cited in the report show about 60% of GLP-1 users dining out less often and about 70% who cut calories snacking less.
- Competition
Semaglutide patent lapses in China and India, opening a first wave of generic competition
Novo Nordisk's core semaglutide patent expired in China on March 20, 2026, and generic versions launched in India on March 21. The two countries are part of an eight-market first wave that also includes Canada, Brazil, Mexico, Turkey, Saudi Arabia and South Africa. The United States is not included, and no change to US supply, coverage or pricing has been reported.
- Competition
Semaglutide patent expires in India as generic versions launch at deep discounts
Semaglutide's main Indian patent expired on March 20, 2026, and within days more than five Indian manufacturers launched generic versions, several priced 70% to 90% below Novo Nordisk's product. By late April the number of brands had passed 40, with monthly costs ranging from about 1,250 to 4,200 rupees. Novo has responded with price cuts and co-marketing deals, while US patent protection on semaglutide runs into the early 2030s.
- Business
Lilly shareholders back $36.7 million 2025 pay package for CEO David Ricks
Eli Lilly shareholders approved a $36.7 million 2025 pay package for CEO David Ricks on an advisory vote at the company's May 4, 2026 annual meeting. The package was about 26% higher than his $29.2 million in 2024 and included $23.3 million in stock awards. Lilly's proxy statement tied the pay to company performance, noting that sales of Mounjaro and Zepbound, both tirzepatide, accounted for nearly all of its 2025 revenue increase.
- Regulation
FDA approves Wegovy HD, a 7.2 mg semaglutide injection for weight loss
The FDA approved Wegovy HD, a 7.2 mg weekly semaglutide injection, on March 19, 2026, for adults with obesity who have tolerated the 2.4 mg dose for at least four weeks. In the 72-week STEP UP trial, average weight loss was about 21% with 7.2 mg versus about 18% with 2.4 mg and about 2% with placebo. About one in three patients on the higher dose lost 25% or more of their body weight.
- Business
FDA approves Imcivree for acquired hypothalamic obesity
Rhythm Pharmaceuticals said the FDA expanded the approved use of IMCIVREE (setmelanotide) on March 19, 2026 to include acquired hypothalamic obesity in adults and children aged 4 and older, the first therapy cleared for that condition. In the phase 3 TRANSCEND trial of 142 patients, average BMI fell 15.8 percent at 52 weeks among those given the drug and rose 2.6 percent among those on placebo, an 18.4 percentage point difference. Rhythm estimates about 10,000 people in the US have the disorder.
- Research and trials
Oral semaglutide does not slow early Alzheimer's in two large trials, Lancet reports
The Lancet published full results of the evoke and evoke+ trials on March 19, 2026, showing that once-daily oral semaglutide up to 14 mg did not slow decline in 3,808 people with early Alzheimer's disease. The difference from placebo on the primary measure was -0.08 points in evoke (p=0.57) and 0.10 points in evoke+ (p=0.46). Both trials and their one-year extensions have been discontinued.
- Research and trials
Semaglutide linked to lower risk of psychiatric hospital care and sick leave in Swedish study
A Swedish national cohort study published March 19 in The Lancet Psychiatry found that periods of semaglutide use were linked to a 42 percent lower risk of psychiatric hospital care or sick leave in people with depression or anxiety. Reductions were 44 percent for depression, 38 percent for anxiety disorders and 47 percent for substance use. The study was observational, and the authors say controlled clinical trials are needed to confirm the results.
- Research and trials
Lilly's retatrutide lowered A1C and weight in first phase 3 diabetes trial
Eli Lilly said retatrutide, its investigational triple-hormone injection, met the main goal of a 40-week phase 3 trial in adults with type 2 diabetes. A1C fell by an average of 1.7% to 2.0% across doses versus 0.8% with placebo, and the highest dose produced 16.8% average weight loss versus 2.5% on placebo. Side effects were common, and discontinuation rates rose with dose.
- Regulation
FDA approves Wegovy HD, a 7.2 mg semaglutide shot, under priority voucher pilot
The FDA approved Wegovy HD, a 7.2 mg once-weekly semaglutide injection, on March 19, 2026, for long-term weight loss in adults with obesity or overweight with at least one weight-related condition. It is the fourth product cleared under the Commissioner's National Priority Voucher pilot and the first GLP-1 receptor agonist approved through it. In the STEP UP trial, the 7.2 mg dose produced 18.7% mean weight loss versus 3.9% with placebo at 72 weeks.
- Competition
FDA approves Imcivree for acquired hypothalamic obesity in adults and children
The FDA approved an expanded indication for Imcivree (setmelanotide) to treat acquired hypothalamic obesity in adults and children aged 4 and older, Rhythm Pharmaceuticals said on March 19, 2026. It is the first approved therapy for the rare condition, which the company estimates affects about 10,000 people in the United States. The approval is based on a Phase 3 trial in 142 patients that showed an 18.4% placebo-adjusted reduction in BMI at 52 weeks.
- Science
FDA approves higher-dose Wegovy injection at 7.2 mg for weight loss
On March 19, 2026, the FDA approved Wegovy HD, a once-weekly semaglutide injection of 7.2 mg for adults with obesity who have already tolerated the 2.4 mg dose for at least four weeks. In the 72-week STEP UP trial, average weight loss was about 19% to 21% at 7.2 mg, compared with about 16% to 18% at 2.4 mg and about 4% on placebo. Gastrointestinal side effects and altered skin sensation were more common at the higher dose.
- Business
HSBC downgrades Eli Lilly, questioning obesity-pill hype and Zepbound cash sales
HSBC cut its rating on Eli Lilly from "hold" to "reduce" on Tuesday, March 17, 2026, and lowered its price target to $850 from $1,070. Lilly shares fell 5.9% that day and are down more than 7% since the downgrade. The analyst cited pricing pressure, Novo Nordisk's price cuts and doubts that the coming obesity pill orforglipron will meet sales expectations.
- Science
Lilly begins early-stage study of brenipatide in people with overweight or obesity
Eli Lilly has started a Phase 1b study of brenipatide, also called LY3537031, listed on ClinicalTrials.gov as NCT07476118. The pharmacodynamics study has an estimated 150 participants and is described as enrolling healthy volunteers with overweight or obesity. Lilly has described the drug as aimed at indications beyond its core obesity and diabetes programs.
- Culture
Indiana commits $1 billion in tax credits to life sciences jobs in Eli Lilly's home region
Gov. Mike Braun announced a plan to direct $1 billion in Indiana tax credits over 10 years toward agriculture and life sciences employers, with a goal of 100,000 high-wage jobs in a decade. The Central Indiana region, where Eli Lilly, Elanco Animal Health and Corteva Agriscience operate, is the first to lead the effort. The announcement names no medicine or product.
- Prices
Lilly expands Zepbound KwikPen self-pay pricing to pharmacies nationwide
Eli Lilly said on March 16, 2026 that Zepbound (tirzepatide) KwikPen self-pay pricing is now available at major pharmacies nationwide as well as through LillyDirect, starting at $299 a month for the 2.5 mg dose. A new KwikPen Self-Pay Savings Card is open to all patients, including the uninsured, with prices of $399 for the 5 mg dose and $449 for 7.5 mg through 15 mg under a refill program. The card covers only the KwikPen, not Zepbound single-dose vials or the single-dose pen, and expires December 31, 2026.
- Safety
Trial on holding GLP-1 or GIP drugs before endoscopy stops early over stomach contents
The OCULUS randomized trial stopped at an interim analysis of 60 patients after clinically significant residual gastric volume occurred in 25.0% of those who continued their GLP-1 or GIP agonist before upper endoscopy, compared with 3.1% of those who held one dose. No aspiration or intubation occurred in either group. Among 25 patients who followed a clear-liquid diet the day before, none had clinically significant residual volume whether or not the drug was held.
- Research and trials
Roche opens two Phase 3 trials of enicepatide, a dual GLP-1 and GIP drug
Roche has begun Phase 3 testing of enicepatide, an experimental dual GLP-1 and GIP agonist, with two studies registered in March 2026. The first, NCT07351045, is designed for about 2,000 participants and started enrolling around March 16. A second study, NCT07351058, opened about a week later and is listed for people with obesity or overweight and type 2 diabetes.
- Competition
Structure Therapeutics reports 16.3% weight loss with oral aleniglipron at 44 weeks
Structure Therapeutics reported March 16, 2026, that its once-daily oral aleniglipron produced placebo-adjusted weight loss of 16.3% (39 lbs) at 180 mg and 16.0% (37 lbs) at 240 mg at 44 weeks in the Phase 2 ACCESS II study. In an ongoing extension study, a 120 mg dose produced 16.2% (40.5 lbs) weight loss at 56 weeks, with no sign of a plateau. The company plans to start Phase 3 testing in the third quarter of 2026 using a 2.5 mg starting dose.
- Culture
Oscars 2026 red carpet reignites debate over GLP-1 weight-loss drugs in Hollywood
Coverage of the March 15, 2026 Academy Awards turned into an argument about GLP-1 weight-loss drugs after a red carpet that outlets described as unusually thin. India Today and Times Now named Demi Moore, Emma Stone, Nicole Kidman, Barbie Ferreira, Kathy Bates and Melissa McCarthy, none of whom has publicly said whether they use the medications. Doctors quoted in the coverage warned about off-label side effects including muscle loss, and about supply pressure on patients with diabetes.
- Business
All 15 drugmakers selected for Medicare's third price talks agree to participate
The Centers for Medicare & Medicaid Services said on March 13, 2026 that all 15 manufacturers whose drugs were selected for the third cycle of Medicare drug price negotiation have chosen to participate. The maker of the one drug selected for renegotiation in the same cycle is also staying in the program. Negotiations take place in 2026, and any negotiated prices take effect beginning in 2028.
- Prices
All 15 drugmakers agree to join third Medicare drug price negotiation cycle
The companies that make all 15 drugs selected for the third round of Medicare drug price negotiations have agreed to participate, CMS said on March 13, 2026. Negotiations take place in 2026, and any negotiated prices become effective beginning in 2028. Separately, negotiated prices from the second cycle — which includes Ozempic, Rybelsus and Wegovy (semaglutide) — begin January 1, 2027.
- Business
Kroger pharmacies add Zepbound KwikPen with Lilly self-pay savings card
Kroger said on March 13, 2026 that the Zepbound KwikPen, a multi-dose version of Eli Lilly's weight-management medication, is now available at participating Kroger Family of Pharmacies. The company said its pharmacies will honor manufacturer-sponsored programs including Lilly's KwikPen Self-Pay Savings Card for Zepbound, subject to each program's eligibility rules. Kroger described it as the first time self-pay patients may be eligible for Lilly's savings program for this product at a retail pharmacy location.
- Research and trials
Most who stop semaglutide or tirzepatide restart or switch, study finds
A study of 7,938 adults who stopped injectable semaglutide or tirzepatide found that 19.6% restarted the same drug within a year and 35.2% received another obesity treatment. Average weight change in the year after stopping was +0.5% for patients treated for obesity and -1.3% for those treated for type 2 diabetes, though individual results varied widely.
- Culture
Lilly calls for recall after finding impurity in compounded tirzepatide with vitamin B12
Eli Lilly said on March 12, 2026, that its testing found a previously unidentified impurity in compounded tirzepatide products that also contain vitamin B12, and that the impurity turned up in all 10 samples it tested. The company notified the FDA and asked for a nationwide recall. A compounding industry group said Lilly has not released enough detail to judge the health risk.
- Business
Novo Holdings assets fall 34% in 2025 as Novo Nordisk's market value drops
Novo Holdings reported on March 12, 2026 that its total assets under management fell 34% in 2025, from €142 billion to €93 billion, almost entirely because of the drop in Novo Nordisk's market value. Its own investment portfolio returned 9.2% in constant exchange rates, but a weaker dollar and Novo Nordisk's suspended share buyback dragged on results. Novo Nordisk has forecast a 5% sales decline in 2026, mainly due to lower US drug prices.
- Safety
FDA retires FAERS and launches AEMS, a single look-up tool for adverse event reports
On March 11, 2026, the FDA replaced FAERS, VAERS and AERS with the Adverse Event Monitoring System, one public dashboard for reports of side effects. The agency said the old patchwork of seven databases handled about 6 million reports a year and cost about $37 million annually, and it expects AEMS to save roughly $120 million over five years. Reports now post in real time instead of quarterly.
- Regulation
FDA approves Biocon's generic Victoza, a fifth liraglutide copy
The FDA approved Biocon Pharma's abbreviated new drug application ANDA215245 for liraglutide, a generic version of Victoza, on March 11, 2026, under standard review. The product is a 6 mg/mL subcutaneous solution rated AP1 for therapeutic equivalence, with a listed first marketing date of April 25, 2026. It is the fifth abbreviated application referencing Victoza to be approved, alongside Teva's authorized generic.
- Business
Lilly to invest $3 billion in China as it seeks approval for orforglipron
Eli Lilly said on March 11, 2026 that it plans to invest $3 billion in China over the next decade to build capacity for its experimental obesity and type 2 diabetes pill orforglipron. Lilly filed for approval of the pill with China's drug regulator at the end of 2025. The investment includes a $200 million deal with contract manufacturer Pharmaron.
- Safety
Preprint reports unknown impurity in compounded tirzepatide with vitamin B12
A preprint posted March 9, 2026 reports that researchers found a previously uncharacterized impurity in ten compounded tirzepatide samples that also contained vitamin B12, at levels up to 10% of total protein content. The impurity formed through a chemical interaction between tirzepatide and vitamin B12, according to the paper. No data on the impurity's effect on safety or effectiveness were reported, and the paper has not been peer reviewed.
- Compounding
Novo Nordisk drops patent suit against Hims & Hers as telehealth company shifts to branded Wegovy and Ozempic
Novo Nordisk dropped its patent infringement lawsuit against Hims & Hers on March 9, 2026, after the telehealth company agreed to stop advertising compounded GLP-1 drugs and sell branded Ozempic and Wegovy instead. Hims will offer injectable and oral semaglutide at the same price as other telehealth platforms, while keeping the option to supply compounded product when a provider decides it is clinically necessary. Hims shares rose more than 40% in morning trading.
- Prices
Lilly sets $50 Medicare cap for Zepbound and Mounjaro as CMS details BALANCE
Federal officials released new implementation details for the BALANCE model on March 9, 2026, while Eli Lilly said Zepbound, Mounjaro and orforglipron would reach participating Medicare Part D plans on January 1, 2027. Lilly put most beneficiaries' monthly costs at no more than $50 after the deductible, with up to $245 a month plus a dispensing fee before it. State Medicaid agencies can apply to join from May 1, 2026.
- Competition
AbbVie's amylin drug ABBV-295 shows up to 9.8% weight loss in Phase 1 trial
AbbVie reported on March 9, 2026 that ABBV-295, an amylin analog it is developing for obesity, produced average weight loss of 7.75% to 9.79% at week 12 in weekly-dosing groups and 7.86% to 9.73% at week 13 in less frequent dosing groups in a 76-person Phase 1 study. Placebo groups lost about 0.25%. AbbVie said no serious adverse events were reported, and a Phase 2 trial is listed to begin in the third quarter of 2026.
- Prices
Amazon Pharmacy lists Zepbound KwikPen at $299 a month for cash-paying customers
Amazon Pharmacy said on March 9, 2026 that it now carries Eli Lilly's Zepbound KwikPen, a multi-dose tirzepatide injector, and lists the 2.5 mg starter dose at $299 a month for customers paying cash. The company said manufacturer coupons are applied automatically at checkout and that customers have saved more than $200 million through that program, with GLP-1 drugs the largest savings category. Same-day delivery reaches nearly 3,000 cities and towns, a network Amazon plans to grow to nearly 4,500 by the end of 2026.
- Compounding
Hims & Hers to stop advertising compounded GLP-1s and sell branded Ozempic and Wegovy
Novo Nordisk and Hims & Hers announced on March 9, 2026 that they settled their dispute over compounded semaglutide. Hims & Hers will offer FDA-approved Ozempic and Wegovy at Novo Nordisk's self-pay prices and stop advertising compounded GLP-1 drugs, and Novo Nordisk dismissed its patent infringement lawsuit while reserving the right to refile it.
- Policy
Lilly says some basic Medicare drug plans may charge more than $50 for its GLP-1 medicines
Eli Lilly said on March 9, 2026 that most Medicare Part D plan options will hold out-of-pocket costs for its GLP-1 medicines to $50 a month, but that a small number of basic plans may charge more. Under the CMMI BALANCE Model, Zepbound, Mounjaro and orforglipron, if approved, will be available through participating Part D plans starting January 1, 2027, with most beneficiaries capped at $50 after the deductible is met and limited to $245 a month before that. CMS said it has completed negotiations with Lilly and Novo Nordisk for the model, and state Medicaid agencies and Part D plan sponsors can now apply to take part.
- Culture
Axios-Ipsos poll finds cost ranks low among reasons Americans skip weight-loss drugs
An Axios-Ipsos poll conducted March 6–9, 2026 found that 18% of U.S. adults say they or someone in their immediate circle has taken a prescription weight-loss drug in the last three months. Only 16% of people who said they were not interested cited cost, while 51% said they preferred to manage their weight through diet and exercise. Familiarity with the new Wegovy pill stood at 39%.
- Competition
China approves Sciwind's ecnoglutide for chronic weight management
Sciwind Biosciences said China's National Medical Products Administration approved its ecnoglutide injection on March 6, 2026 for chronic weight management in adults with overweight or obesity, a second Chinese indication for the drug. In the Phase 3 SLIMMER trial, the 2.4 mg dose produced a mean 15.4% weight reduction at 48 weeks and 92.8% of participants lost at least 5% of their body weight. Ecnoglutide is not approved in the United States.
- Policy
WHO Foundation and Lilly launch $1.68 million obesity care collaboration through 2029
The WHO Foundation announced on March 6, 2026 that it is collaborating with Eli Lilly and Company, which is committing $1.68 million through 2029 to strengthen health systems for obesity prevention and care, mainly in resource-limited countries. The announcement cites World Health Organization figures showing 1 in 8 people worldwide were living with obesity in 2022, and it names no specific obesity medicines, prices or supply commitments.
- Prices
Eli Lilly opens Employer Connect, pricing Zepbound at $449 a month for employers
Eli Lilly launched Employer Connect on March 5, 2026, a program that sells the single-patient-use Zepbound KwikPen to employers through network pharmacies at a flat $449 a month across all doses, with no rebates. Employers design coverage with more than 15 independent program administrators, and employees pay whatever their employer does not subsidize.
- Regulation
FDA warns Novo Nordisk over unreported deaths in semaglutide patients
The FDA sent Novo Nordisk Inc. a warning letter dated March 5, 2026, describing serious violations of postmarketing adverse drug experience rules found during a 2025 inspection of the company's New Jersey headquarters. The letter cites three deaths among patients taking semaglutide, one by suicide, that were not submitted to the agency within the required 15 calendar days. The FDA did not conclude that the drug caused those deaths.
- Business
Lilly launches Employer Connect platform with Zepbound KwikPen priced at $449
Eli Lilly launched Employer Connect on March 5, 2026, a platform that pairs employers with more than fifteen independent program administrators to design obesity coverage for workers. Through the program, Lilly sells the Zepbound (tirzepatide) KwikPen to network pharmacies at a discounted price of $449 for all doses, with what employees pay depending on the cost-share model their employer picks.
- Research and trials
Weight regain after stopping GLP-1 drugs follows a predictable curve, analysis finds
A systematic review and meta-regression published in eClinicalMedicine estimates that people who stop GLP-1 receptor agonists regain about 60% of the weight they lost within one year. The regain curve was fitted from six randomized trials with 3,236 participants and has a half-life of about 23 weeks, with the model projecting a plateau at 75.3% of the weight lost.
- Research and trials
Large VA study links GLP-1 drugs to lower risk of substance use disorders
A BMJ cohort study published March 4, 2026 found that US veterans with type 2 diabetes who started GLP-1 receptor agonists were less likely to be diagnosed with alcohol, cannabis, cocaine, nicotine and opioid use disorders than those who started SGLT-2 inhibitors. Among veterans who already had a substance use disorder, GLP-1 initiators had lower rates of substance-related emergency visits, hospital admissions and deaths. The authors say the observational findings warrant further evaluation.
- Research and trials
VA study links GLP-1 drugs to fewer overdoses and addiction deaths
A study of more than 600,000 veterans with type 2 diabetes found that those who started GLP-1 drugs had 50% fewer substance-related deaths and 39% fewer overdoses than those who did not. Among veterans already living with addiction, the drugs were also tied to 25% fewer suicide attempts. The drugs were linked to lower rates of new alcohol, opioid, cocaine and nicotine use disorders.
- Compounding
FDA sends 30 warning letters to telehealth firms over compounded GLP-1 marketing
The FDA said on March 3, 2026 that it issued 30 warning letters to telehealth companies and online wellness clinics over false or misleading claims about compounded GLP-1 medicines. Regulators objected most to statements implying compounded products match FDA-approved drugs, and to branding that hid who actually made the drug. Recipients were given 15 working days to respond.
- Prices
Medicare GLP-1 Bridge guidance sets $50 copay and prior authorization rules for Wegovy and Zepbound
The agency that runs Medicare has published answers to common questions about its temporary GLP-1 obesity coverage program, fixing a flat $50 monthly copay and spelling out the prior authorization and clinical criteria ahead of the July 1 start. The guidance confirms the $50 will not count toward the Part D out-of-pocket cap. Covered products are all formulations of Wegovy and Foundayo and the KwikPen version of Zepbound.
- Safety
Judge names plaintiff leadership team in federal GLP-1 vision loss litigation over Ozempic
Judge Karen S. Marston has appointed the plaintiffs' leadership team for MDL 3163, the federal consolidation of claims that GLP-1 drugs caused the vision condition NAION, with Parvin Aminolroaya of Seeger Weiss among the co-lead counsel. The MDL had 216 pending cases as of September 2026, up from 86 in May, and a Science Day hearing on the science is set for June 2, 2026.
- Business
Novo Nordisk shares hit two-year low as analysts cut GLP-1 outlooks
Novo Nordisk's US-listed shares touched $35.91 on March 3, 2026, a two-year low, after the company guided 2026 sales to fall 5% to 13% and several brokerages downgraded the stock. By March 25 the shares traded near $36.66, down about 30% year to date and roughly 50% from a year earlier.
- Research and trials
Semaglutide and other GLP-1 use tied to better joint surgery outcomes and higher bone risk
Two analyses presented March 2 at the American Academy of Orthopaedic Surgeons 2026 Annual Meeting found that GLP-1 use was associated with fewer postoperative emergency department visits and lower surgical site infection rates after knee and hip replacement. A separate study of 73,483 matched patients found GLP-1 users had higher five-year rates of osteoporosis (4.1% vs 3.2%), gout (7.4% vs 6.6%) and osteomalacia (2% vs 0.1%). Both studies are observational and have not been reported as published in a peer-reviewed journal.
- Regulation
FDA approves Eli Lilly's oral GLP-1 Foundayo for weight loss
On March 1, 2026, the FDA approved Foundayo (orforglipron), Eli Lilly's once-daily oral GLP-1 pill, for weight loss. The approval gives Lilly an oral entry alongside its injectable obesity products and puts it in direct competition with Novo Nordisk's oral Wegovy. Orforglipron is a non-peptide GLP-1, distinguishing it from semaglutide-based pills.
- Compounding
Thirty FDA warning letters and a Hims & Hers deal shift the compounded semaglutide market
The FDA made public thirty warning letters on March 3, 2026, telling telehealth companies and online wellness clinics to fix allegedly misleading claims about compounded GLP-1 drugs. Six days later, Novo Nordisk and Hims & Hers settled their patent fight, with Hims & Hers agreeing to sell branded Ozempic and Wegovy and to stop marketing compounded versions except where medically necessary. A separate account describes a March wave of more than fifty letters that also reached compounding pharmacies, a larger count the two accounts have not reconciled.
- Safety
US Ozempic label still lacks NAION warning as other regulators act
As of the May 2026 revision of Ozempic's US prescribing information, the label still carries no warning about non-arteritic anterior ischemic optic neuropathy (NAION), an eye condition that can cause vision loss. European regulators concluded in June 2025 that NAION is a very rare side effect of semaglutide, affecting up to 1 in 10,000 people, and Australia's TGA said on July 23, 2026 that it will add warnings there. The gap in the US label is central to vision-loss lawsuits filed against Novo Nordisk.
- Research and trials
Tirzepatide one-year persistence holds near 65% while semaglutide rate climbs
A Prime Therapeutics claims analysis found that 64.8% of commercially insured adults without diabetes who started tirzepatide (Zepbound) in the first half of 2024 stayed on it for a year, compared with 58.6% for semaglutide (Wegovy). Overall one-year persistence across the products studied rose from 33.2% in 2021 to 60.9% in the first half of 2024.
- Research and trials
Claims analyses disagree on semaglutide versus tirzepatide heart risk
Two separate analyses of US insurance claims reached opposite results on cardiovascular risk with semaglutide versus tirzepatide. In people with obesity and cardiovascular disease but no diabetes, semaglutide was linked to a 29% lower rate of heart attack, stroke or death; in older adults with obesity and type 2 diabetes, tirzepatide was linked to lower rates of MACE and death. Neither study was randomized.
- Research and trials
Pooled analysis supports adding tirzepatide to basal insulin in type 2 diabetes
An analysis pooling data from two phase 3 trials found that adding tirzepatide to titrated basal insulin lowered A1c, fasting blood sugar and insulin dose in all 1,072 participants studied, across four subgroups, with no significant differences between them (P < 0.001 for the reductions; all interaction P values above 0.1). Clinically significant low blood sugar was uncommon overall and rates were highest among younger participants who started with an A1c above 8.5% and had type 2 diabetes for 10 years or more.
- Compounding
HHS Secretary says 14 of 19 FDA-restricted peptides will return to compounding
On February 27, 2026, Health and Human Services Secretary Robert F. Kennedy Jr. said roughly 14 of the 19 peptides on the FDA's Category 2 restricted compounding list would move back to Category 1. Reports indicate the substances would come off the restricted list on April 23, 2026, with the FDA's Pharmacy Compounding Advisory Committee scheduled to review them July 23 and 24, 2026. FDA scientists have since said there is not enough evidence to support changing the designation for any of the seven peptides under review.
- Research and trials
Small Italian study links tirzepatide plus CPAP to better apnea control but lower CPAP use
In a 20-patient study from Rome, adding tirzepatide to CPAP produced far greater weight loss and better sleep apnea control than CPAP alone. CPAP adherence at six months was 60 percent in the combination group versus 90 percent on CPAP alone, a gap that did not reach statistical significance in such a small sample. The research letter was published February 27, 2026.
- Research and trials
Orforglipron tops oral semaglutide on A1C and weight, with more side effects, in ACHIEVE-3
Full results of the 52-week ACHIEVE-3 trial, published Feb. 26, 2026 in The Lancet, show orforglipron 36 mg cut A1C by 2.2 percentage points versus 1.4 for oral semaglutide 14 mg, and produced 19.7 pounds (9.2%) of average weight loss versus 11.0 pounds (5.3%). More people on orforglipron stopped treatment because of side effects: 9.7% at 36 mg versus 4.9% at 14 mg oral semaglutide.
- Prices
Massachusetts insurance commission ends GLP-1 coverage for weight management alone
The Massachusetts Group Insurance Commission voted 10-7 in February 2026 to stop covering GLP-1 medications when they are prescribed solely for weight management, after Governor Maura Healey asked the commission to cut more than $100 million from the health plans used by state and many municipal employees. The commission dropped proposed deductible and copay increases following union opposition, but kept the GLP-1 coverage change. Unions, including the Massachusetts Teachers Association, are organizing to restore coverage.
- Business
Walgreens adds weight management visits to its virtual care service
Walgreens Virtual Healthcare began offering weight management services on Feb. 26, 2026, adding on-demand follow-up visits by chat or video for medication adjustments and side effect management. The company did not disclose pricing, insurance acceptance, availability by state, or whether its virtual clinicians can write prescriptions.
- Culture
General Mills CEO tells analysts anti-obesity drugs will have a lasting effect on food
General Mills CEO Jeff Harmening told the Consumer Analyst Group of New York conference that anti-obesity drugs will have a "lasting influence" on the food market, pointing to smaller portions and protein- and fiber-focused products. About one in eight U.S. adults say they take a GLP-1 drug, and a Cornell study cited in the report found grocery spending falls 6% in households with a user. Morningstar's Erin Lash said most food companies "don't seem overly concerned to this point".
- Regulation
FDA approves Zepbound label change dropping suicidality warning, adding intestinal obstruction
On February 25, 2026, the FDA approved a labeling supplement for Zepbound (tirzepatide) that removes the suicidal ideation and behavior warning and the matching Medication Guide text. The same approval adds intestinal obstruction and severe constipation including fecal impaction to the postmarketing adverse reactions list, and adds a note that severe gastrointestinal reactions have been reported after market with GLP-1 receptor agonists.
- Business
Novo Nordisk and Vivtex sign deal worth up to $2.1 billion for oral obesity drugs
Novo Nordisk will partner with Boston startup Vivtex in a deal worth up to $2.1 billion to develop oral versions of biologic drugs for obesity, diabetes and other metabolic diseases. Vivtex licenses its oral delivery technology, while Novo handles global development and commercialization and pays an undisclosed upfront sum plus milestones and royalties.
- Safety
UK raids net almost 2,000 doses labeled as tirzepatide and retatrutide
The UK Medicines and Healthcare products Regulatory Agency announced on Feb. 25 that raids at two sites in Lincolnshire and Nottinghamshire seized nearly 2,000 doses of illegal weight-loss drugs, along with manufacturing equipment, packaging materials and commercial vehicles. The products were labeled as containing tirzepatide, sold in the US as Mounjaro and Zepbound, and retatrutide, an experimental drug still in trials. It is the agency's second major operation against illicit weight-loss manufacturing in four months.
- Compounding
Novo Nordisk to cut US list prices for Wegovy, Ozempic and Rybelsus to $675 a month in 2027
Novo Nordisk said on February 24, 2026 that it will lower the US list price of its semaglutide medicines Wegovy, Ozempic and Rybelsus to $675 a month, effective January 1, 2027. The cut is about 50% for Wegovy and about 35% for Ozempic. Direct-to-patient self-pay prices, which are already far lower than list price, are not changing.
- Safety
UK regulators find falsified Mounjaro KwikPen 15 mg pens at one online pharmacy
The UK Medicines and Healthcare products Regulatory Agency said five falsified Mounjaro (tirzepatide) KwikPen 15 mg pre-filled pens were supplied through one online pharmacy in Birmingham, England, and that all 15 mg pens labeled with batch number D873576 are fake. Testing confirmed the pens contained tirzepatide, but regulators said sterility cannot be assured. No patient harm requiring treatment has been reported.
- Regulation
FDA approves two more generic liraglutide injections from Biocon and Orbicular
The FDA approved Biocon Pharma's ANDA217063 and Orbicular's ANDA217234 on Feb. 24, 2026, both standard-review abbreviated applications for liraglutide injection at 18 mg/3 mL (6 mg/mL). The products are listed as prescription subcutaneous solutions, and Cipla USA appears as a manufacturer on the Orbicular application. Launch dates, pricing and insurance coverage have not been disclosed.
- Business
FDA approves Mounjaro for children 10 and older with type 2 diabetes
The FDA has approved Mounjaro (tirzepatide) for children and adolescents aged 10 years and older with type 2 diabetes, based on the SURPASS-PEDS trial of 99 patients. In that 30-week trial, A1c fell by a mean of 2% across the two Mounjaro doses and by 1.8 percentage points more than placebo, and the maximum pediatric dose is 10 mg weekly.
- Competition
Novo Nordisk partner reports up to 19.7% weight loss with UBT251 in China trial
Novo Nordisk and The United Laboratories reported that UBT251, an experimental once-weekly triple agonist injection, produced mean weight loss of up to 19.7% after 24 weeks in a phase 2 trial of 205 Chinese adults with overweight or obesity. Placebo patients lost 2.0%. The drug acts on the GLP-1, GIP and glucagon receptors and has not been approved anywhere.
- Research and trials
Case series finds less frequent semaglutide and tirzepatide dosing held weight loss
Obesity published a retrospective case series of 30 adults who reached a weight plateau on weekly semaglutide or tirzepatide and then switched to reduced-frequency dosing, usually every other week, at their existing dose. Over a mean 36.3 weeks, average weight went from 74.1 kg at the plateau to 72.4 kg on the reduced schedule, and body composition and metabolic syndrome measures were maintained. The study was not a randomized trial.
- Prices
Novo Nordisk to cut Wegovy, Ozempic and Rybelsus list price to $675 a month in 2027
Novo Nordisk said it will lower the list price of its semaglutide medicines — Wegovy, Ozempic and Rybelsus — to $675 per month starting January 1, 2027. That is a reduction of about 50% for Wegovy and about 35% for Ozempic from current list prices, and it applies to all doses. The company said the change does not affect direct-to-patient self-pay prices.
- Policy
England to pay GPs up to £3,000 a year for prescribing Mounjaro
Under England's 2026/27 GP contract, family doctors can earn up to £3,000 a year for prescribing Eli Lilly's Mounjaro (tirzepatide) and another £1,000 for referring patients to weight-loss programs, backed by £25 million in guaranteed funding. The incentive is meant to speed an NHS rollout that has been slow, with some eligible patients not being offered the drug.
- Business
Zepbound KwikPen listed as newest presentation in updated FDA approval history
Drugs.com updated its Zepbound approval history on Feb 24, 2026 to list the multi-dose KwikPen as the brand's newest presentation, alongside the single-dose pen, single-dose vial and multi-dose vial. All six strengths, from 2.5 mg to 15 mg, appear in each format. The page lists an availability entry for the KwikPen dated Feb 23, 2026.
- Research and trials
CagriSema misses non-inferiority goal against tirzepatide in 84-week head-to-head trial
Novo Nordisk said CagriSema, its experimental cagrilintide-and-semaglutide combination, produced 23.0% weight loss over 84 weeks but did not meet the trial's primary goal of proving it was at least as effective as tirzepatide 15 mg, which produced 25.5%. Under a second analysis that counted treatment effect regardless of adherence, the figures were 20.2% for CagriSema and 23.6% for tirzepatide. Novo's Copenhagen shares closed down 16.5%, and CagriSema remains unapproved in the US.
- Prices
Lilly sells Zepbound KwikPen at same self-pay price as vials, starting at $299 a month
Eli Lilly began selling the four-dose Zepbound KwikPen on February 23, 2026, after the FDA approved a label expansion for a device that delivers a month of tirzepatide in one pen. Self-pay pricing through LillyDirect starts at $299 a month and matches the prices of Zepbound single-dose vials at every dose, with 7.5 mg and higher at $449 when refills are made within 45 days. The same $449 purchase offer now applies to both the vials and the KwikPen.
- Regulation
FDA approves Zepbound KwikPen, one device holding four weekly doses
Eli Lilly said on Feb. 23, 2026 that the FDA approved a label expansion for Zepbound (tirzepatide) to include a four-dose, single-patient-use KwikPen, which puts a month of weekly injections into one device instead of four single-dose pens. Self-pay patients can get all doses in either the KwikPen or a single-dose vial at the same price through LillyDirect, starting at $299 a month for the 2.5 mg dose. Pen needles are not included and the device must be primed before each injection.
- Culture
Lilly says Zepbound led 2025 weight management prescriptions as four-dose KwikPen is cleared
Eli Lilly said Feb. 23, 2026, that the FDA approved a label expansion for Zepbound (tirzepatide) adding a four-dose KwikPen that holds a month of treatment in one device. Lilly also said no weight management medicine was prescribed more often in 2025, and that a third of patients new to branded weight management drugs received Zepbound self-pay vials.
- Business
Lilly launches four-dose Zepbound KwikPen at same self-pay prices as vials
Eli Lilly said Feb. 23, 2026 that the FDA approved a label expansion for Zepbound (tirzepatide) covering a four-dose, single-patient-use KwikPen that holds a month of weekly injections in one device. The pen is available in all six strengths through LillyDirect, with self-pay prices matching Lilly's single-dose vials and starting at $299 a month for the 2.5 mg dose.
- Business
Eli Lilly signs tariff agreement tied to onshoring and most-favored-nation drug pricing
Eli Lilly signed a company-specific Section 232 tariff agreement with the Secretary of Commerce dated February 23, 2026, listed in Annex II of a pharmaceutical tariff proclamation scheduled for Federal Register publication on April 9, 2026. The proclamation sets a 100 percent baseline duty on patented pharmaceuticals and ingredients, 20 percent for companies with approved onshoring plans, and zero until January 20, 2029 for companies with both approved onshoring plans and most-favored-nation pricing agreements.
- Research and trials
Novo Nordisk plans higher-dose CagriSema trials after REDEFINE 4 miss
CagriSema 2.4 mg/2.4 mg produced 23.0% weight loss over 84 weeks in the open-label REDEFINE 4 trial, compared with 25.5% for tirzepatide 15 mg, and the trial did not meet its primary endpoint of non-inferiority. Novo Nordisk says REDEFINE 11, testing the drug's full weight-loss potential, will report in the first half of 2027, and a higher-dose phase 3 trial will begin in the second half of 2026. An FDA decision on CagriSema for weight management is expected by late 2026.
- Science
Zepbound KwikPen launches through LillyDirect at $299 a month
Eli Lilly said the FDA approved a label expansion for Zepbound (tirzepatide) to include a four-dose KwikPen that holds a full month of treatment, available now by prescription through LillyDirect for self-pay patients. All six doses are offered in either the multi-dose pen or single-dose vials at the same self-pay price, starting at $299 a month for the 2.5 mg dose.
- Compounding
FDA warns 30 telehealth companies over compounded GLP-1 marketing claims
The FDA announced on March 3, 2026 that it issued 30 warning letters to telehealth companies over false or misleading claims about compounded GLP-1 products, including compounded semaglutide and tirzepatide. The agency said some ads implied the compounded drugs were the same as FDA-approved medicines or hid who made them. Each company has 15 working days to respond in writing with a plan to correct the violations.
- Compounding
FDA warned MEDVi over compounded semaglutide and tirzepatide claims before New York Times profile
The FDA sent MEDVi a warning letter dated Feb. 20, 2026, saying its website misbranded compounded semaglutide and tirzepatide by implying MEDVi was the compounder and by claiming the products had the same active ingredient as Wegovy, Ozempic, Mounjaro and Zepbound. Six weeks later, on April 2, The New York Times profiled MEDVi, reporting a projected $1.8 billion in 2026 sales with two full-time employees.
- Prices
First Circuit upholds Cigna plan's exclusion of weight-loss drugs
The First Circuit on Feb. 19, 2026 affirmed the dismissal of a lawsuit claiming a Cigna-administered health plan's weight-loss drug exclusion was disability discrimination. The court did not decide whether obesity can be a disability, finding instead that the complaint did not plausibly allege the plaintiff's obesity substantially limits a major life activity. A parallel case against Elevance Health remains on appeal.
- Compounding
Hims & Hers agrees to acquire Eucalyptus for up to $1.15 billion
Hims & Hers said on Feb. 19, 2026 that it signed an agreement to acquire the international digital health company Eucalyptus for up to $1.15 billion, about $240 million of it in cash at closing. The deal adds Australia and Japan to Hims & Hers' markets and expands its presence in Germany, Canada and the United Kingdom. It is expected to close in mid-2026, pending regulatory approvals.
- Culture
Cedar Gate analysis finds bariatric surgery down 13% as GLP-1 use climbs 67%
An analysis from Cedar Gate Technologies, an IQVIA business, found bariatric surgery volume fell 13% over the past year while the number of members taking GLP-1 medications rose 67% over two years. The same analysis put the average bariatric surgery at $24,215 in 2024 and the average annual GLP-1 prescription cost at about $5,200 per patient.
- Research and trials
Two 2026 studies differ on whether tirzepatide reduces asthma flare-ups
A research letter published Feb. 18, 2026 found asthma exacerbations in 3.0 percent of tirzepatide users versus 3.8 percent of matched non-users among adults with obesity, with fewer events per affected patient. A separate head-to-head study published Sept. 7, 2026 reported no difference in exacerbation risk between tirzepatide and semaglutide among patients with asthma and type 2 diabetes (11.0 percent vs 11.1 percent).
- Regulation
European Commission approves 7.2 mg Wegovy dose for adults with obesity
The European Commission approved a 7.2 mg once-weekly maintenance dose of Wegovy (semaglutide) for adults with obesity on February 17, 2026, clearing it in all 27 EU countries after a CHMP positive opinion on December 12, 2025. In the STEP UP trial of 1,407 adults, those taking the higher dose lost about 21% of body weight on average when they took the medicine as planned, compared with about 2% on placebo, and about one in three lost 25% or more. The dose is already approved and available in the UK, and applications are pending with the FDA and several other countries.
- Business
Lilly stockpiles $1.5 billion of orforglipron ahead of FDA decision
Eli Lilly reported about $1.5 billion in pre-launch inventory of orforglipron, its experimental oral weight-loss pill, as of Dec. 31, up from nearly $550 million a year earlier. The FDA's target decision date on the pill is April 10. Novo Nordisk's Wegovy pill, already on the market, topped 26,000 prescriptions in its second full week.
- Safety
VA study finds doubled risk of rare optic nerve stroke with semaglutide
A target trial emulation of 102,361 U.S. veterans with type 2 diabetes found 173 NAION events and a weighted cumulative risk of 0.29% with semaglutide versus 0.13% with SGLT2 inhibitors over a median 2.1 years. The authors said counseling about the risk may be warranted even though absolute incidence is low.
- Business
Novo Nordisk says it is exploring a Wegovy vial as Lilly's Zepbound vials expand
Novo Nordisk said in a February 11, 2026 Reuters report that it is exploring vials among other device presentations for its weight-loss drug Wegovy, with some presentations launching this year and others later. Rival Eli Lilly began selling single-dose Zepbound (tirzepatide) vials in 2.5 mg and 5 mg strengths in 2024 and added 7.5 mg and 10 mg vials in 2025. Novo Nordisk has not disclosed doses, pricing or a launch date for a Wegovy vial.
- Competition
AstraZeneca moves oral GLP-1 elecoglipron to phase 3 without releasing weight loss results
AstraZeneca said on February 10 that elecoglipron, its experimental oral GLP-1 pill, met the primary endpoints in two phase 2 trials and will advance to phase 3 development this year. The company did not release the weight loss figures from the 310-patient VISTA obesity study or the diabetes results from the 406-participant SOLSTICE study, saying the data will come at the American Diabetes Association conference in June.
- Research and trials
Lilly begins phase 3 trial of eloralintide as an add-on to weekly incretin drugs
Eli Lilly has started enrolling about 900 adults with persistent obesity or overweight who already take a weekly incretin medicine into a phase 3 trial. Participants will be randomly assigned to eloralintide, an experimental amylin drug, or placebo for roughly 80 weeks while staying on their existing incretin. Lilly's pipeline also lists a separate eloralintide "incretin add-on" program in phase 3 for obesity.
- Competition
Oral ribupatide from Hengrui and Kailera shows 12.1% weight loss at 26 weeks in Phase 2 trial
Hengrui Pharma and Kailera Therapeutics reported that once-daily oral ribupatide produced mean weight loss of up to 12.1% at 26 weeks in a 166-person Phase 2 trial in China, with no plateau observed. Vomiting was reported in 11.4% of participants at the 25 mg dose and 7.5% at 50 mg, and no permanent discontinuations for nausea, vomiting, diarrhea or constipation were reported. Hengrui plans to move the tablet into a Phase 3 trial in China, while Kailera plans a global Phase 2 trial in 2026.
- Compounding
Novo Nordisk sues Hims & Hers over compounded semaglutide patent
Novo Nordisk filed a patent infringement lawsuit against Hims & Hers on Feb. 9, 2026, saying its compounded semaglutide products infringe U.S. Patent 8,129,343, and asked a court to permanently block those sales and award damages. Novo said its testing found impurities as high as 86% in compounded injectable semaglutide and up to 75% in compounded oral versions. The suit followed Hims & Hers' launch, and two-day withdrawal, of a $49 compounded semaglutide pill.
- Business
Hims & Hers shares fall 29% after Novo Nordisk semaglutide suit and DOJ referral
Hims & Hers Health shares fell about 29% as investors weighed a Novo Nordisk patent lawsuit over compounded semaglutide and a referral to the Justice Department. The decline followed the company's February 5 launch of a low-cost compounded semaglutide pill, which it halted days later under FDA pressure. Novo Nordisk argues compounded versions are not justified because semaglutide is no longer in shortage.
- Business
Lilly to acquire Orna Therapeutics for up to $2.4 billion
Eli Lilly agreed on Feb. 9, 2026, to acquire Orna Therapeutics, a Watertown, Massachusetts biotech working on cell therapies made inside the body, for up to $2.4 billion in cash, including milestone payments. Orna's lead program, ORN-252, is a CD19-targeting in vivo CAR-T therapy described as clinical trial-ready for B cell-driven autoimmune diseases. The deal is separate from Lilly's GLP-1 and incretin business.
- Safety
Study links GLP-1 drugs such as semaglutide and tirzepatide to higher hair loss odds
A retrospective cohort study of 547,993 matched adults found that GLP-1 receptor agonist users had higher odds of telogen effluvium (adjusted odds ratio 1.76), androgenetic alopecia (1.64) and non-scarring hair loss overall (1.40) at 12 months than controls. Alopecia areata was consistently more common in the control group, which the authors read as evidence the drugs do not significantly affect autoimmune hair loss.
- Culture
Super Bowl LX draws four weight-loss drug advertisers as 30-second spots top $10 million
Novo Nordisk, Eli Lilly, Ro and Hims & Hers all advertised weight-loss drugs during Super Bowl LX on Feb. 8, with 30-second spots costing as much as $10 million and surpassing that level for the first time. Novo used a 90-second in-game spot to introduce its new Wegovy pill, Ro debuted with Serena Williams, and Hims & Hers returned with a commercial narrated by Common. Lilly advertised Zepbound around the game.
- Culture
Lady Gaga Super Bowl cameo sparks "Ozempic face" speculation with no evidence
Lady Gaga appeared as a surprise guest during Bad Bunny's Super Bowl LX halftime show at Levi's Stadium on Feb. 8, 2026, and online posts quickly began speculating about her appearance using the phrase "Ozempic face." Gaga has not confirmed using Ozempic, and there is no evidence to support the claims. It was her first halftime appearance since she headlined the show in 2017.
- Compounding
FDA plans to restrict GLP-1 ingredients for compounders as Hims & Hers drops semaglutide pill
The FDA said on February 6, 2026 that it intends to limit the active ingredients used in compounded GLP-1 drugs, and the Department of Health and Human Services said it would send Hims & Hers to the Justice Department. Hims & Hers began selling a compounded semaglutide pill for $49 a month on February 5 and said on February 7 that it would stop. Novo Nordisk sued the company for patent infringement on February 9.
- Regulation
FDA moves to restrict compounded GLP-1 ingredients and names Hims & Hers
The FDA said on February 6, 2026 that it intends to restrict GLP-1 active ingredients used in compounded drugs that are mass-marketed as alternatives to approved products, naming Hims & Hers and other compounding pharmacies. The agency also said it is acting on misleading direct-to-consumer marketing after warning letters sent in the fall of 2025, and warned that violations could lead to seizure and injunction.
- Policy
White House launches TrumpRx.gov with discounted Ozempic, Wegovy and Zepbound prices
The White House launched TrumpRx.gov on the night of Feb. 5, 2026, a referral site that links patients to drugmakers' discount programs instead of selling medicine itself. Listed monthly cash prices for Ozempic and injectable Wegovy fall from $1,028 and $1,349 to an average of $350 and as low as $199 depending on dose, while the Wegovy pill is listed as low as $149 and Zepbound as low as $299. Insurance is not accepted on the site, and experts say some patients could pay more than they would through coverage.
- Research and trials
Study finds faster hip bone loss on semaglutide and tirzepatide in people without diabetes
A single-center retrospective study matched 255 people taking semaglutide or tirzepatide with 255 non-users and found greater annualized total hip bone loss in users without diabetes (-1 percent versus -0.6 percent), but no difference between groups among people with diabetes. A separate study of matched older adults with type 2 diabetes found lower one-year rates of femoral fracture and falls with semaglutide and tirzepatide than with DPP-4 inhibitors.
- Compounding
Hims & Hers drops $49 compounded semaglutide pill after FDA threat and Novo Nordisk lawsuit
Hims & Hers launched a compounded semaglutide pill at $49 a month on February 5, 2026, undercutting the new Wegovy pill at $149. Federal regulators said they would restrict compounded GLP-1 ingredients and referred the product to the Justice Department, and Hims & Hers said two days later it would stop offering the pill. Novo Nordisk sued the company for patent infringement on February 9.
- Prices
TrumpRx.gov launches with coupons for Ozempic, Wegovy and Zepbound
The federal drug price website TrumpRx.gov went live on February 5, 2026, listing coupons for 40 branded medicines from five manufacturers. Ozempic and injectable Wegovy are listed as low as $199 a month, the Wegovy pill as low as $149 and Zepbound as low as $299, against list prices above $1,000 a month.
- Competition
Eli Lilly posts 43% revenue growth as Zepbound and Mounjaro sales pull ahead of Novo Nordisk
Eli Lilly reported fourth-quarter 2025 revenue of $19.3 billion, up 43%, with Mounjaro at $7.4 billion and Zepbound at $4.3 billion. The company guided to $80 billion to $83 billion in 2026 revenue, while Novo Nordisk expects its 2026 sales to fall 5% to 13%.
- Culture
FDA calls Novo Nordisk's Wegovy pill TV ad false or misleading
The FDA's Office of Prescription Drug Promotion sent Novo Nordisk a letter dated Feb. 5, 2026 saying a TV commercial for the oral Wegovy pill is false or misleading and misbrands the drug. The agency said taglines including "live lighter" and "a way forward" imply better results than other GLP-1 weight-loss drugs, and benefits beyond weight loss, that have not been demonstrated. Novo Nordisk said it is responding to the FDA, which gave the company 15 working days to reply in writing.
- Safety
UK regulator links semaglutide to rare vision-loss condition NAION
Britain's Medicines and Healthcare products Regulatory Agency said on Feb. 5, 2026 that semaglutide products Ozempic, Wegovy and Rybelsus may very rarely be linked to non-arteritic anterior ischemic optic neuropathy, or NAION, a condition that causes sudden vision loss. The MHRA said the risk may affect up to 1 in 10,000 people taking the drug and that product information will be updated in the coming months. UK regulators have received three reports of suspected NAION since 2018, against roughly 10.2 million packs dispensed in the past five years.
- Prices
TrumpRx launches with Zepbound listed at $299 and Mounjaro at $499
TrumpRx.gov, the federal most-favored-nation drug price site, went live on February 5, 2026, listing the tirzepatide brands Zepbound and Mounjaro and routing buyers to Eli Lilly's LillyDirect. The Zepbound vial page shows an original price of $1,087.00, savings of $788.00 and a final price of $299.00, while the Mounjaro page shows $1,112.16, $613.16 in savings and a final price of $499.00.
- Business
Novo Nordisk warns of 2026 sales and profit decline as two top executives leave
Novo Nordisk said it expects 2026 sales and operating profit to fall by 5% to 13%, after posting 10% sales growth and 6% operating profit growth in 2025. The company also said its U.S. operations head and its product and portfolio strategy head are leaving. Shares fell more than 15% after the disclosures.
- Culture
Lilly reports Mounjaro and Zepbound brought in $36.5 billion in 2025
Eli Lilly reported 2025 revenue of $65.2 billion, up 45% from 2024, on Feb. 4, 2026. Its two tirzepatide brands, Mounjaro and Zepbound, produced $36.5 billion combined. Lilly guided 2026 revenue to a range of $80 billion to $83 billion.
- Business
Lilly reports $65.2 billion in 2025 revenue as Mounjaro and Zepbound drive 45% growth
Eli Lilly reported 2025 revenue of $65.2 billion, up 45% from 2024, and guided to $80 billion to $83 billion for 2026. Mounjaro brought in $23.0 billion for the year and Zepbound $13.5 billion, together about 56% of company revenue. Lilly also said it has filed its oral GLP-1 pill orforglipron for obesity in the U.S. and Japan and for obesity and type 2 diabetes in the European Union.
- Business
FDA approves Ozempic brand name for Novo's oral semaglutide diabetes pill
The FDA approved Ozempic tablets in 1.5 mg, 4 mg and 9 mg doses for adults with type 2 diabetes, replacing the oral semaglutide sold in the U.S. as Rybelsus in 3 mg, 7 mg and 14 mg strengths. Novo Nordisk announced the change on Feb. 4, 2026, and the reformulated pill began reaching U.S. pharmacies on May 4. The Rybelsus brand is being retired in the U.S. but stays in use elsewhere.
- Competition
Lilly forecasts 25% growth in 2026 while Novo Nordisk expects sales to fall
Eli Lilly said it expects 2026 revenue of $80 billion to $83 billion, above the $77.62 billion analysts had forecast, with the midpoint implying 25% growth. Novo Nordisk, reporting a day earlier, said its sales and profit could decline by 5% to 13% this year as U.S. prices fall and patents expire in China, Brazil and Canada.
- Business
Lilly says Mounjaro and Zepbound sales more than doubled to $11.7 billion in a quarter
Eli Lilly reported on Feb. 4, 2026 that Mounjaro and Zepbound, its two tirzepatide brands, brought in $11.7 billion in combined quarterly sales, more than double a year earlier. The company guided for 2026 above rival Novo Nordisk and said it does not expect its coming oral GLP-1 pill to cut into injectable sales. How the total splits between the two brands was not disclosed.
- Business
Novo Nordisk drops the Rybelsus name in the US and sells oral semaglutide as Ozempic tablets
Novo Nordisk said on February 4, 2026 that its oral semaglutide tablet for type 2 diabetes will be marketed in the United States as Ozempic tablets, retiring the Rybelsus brand here, in 1.5 mg, 4 mg and 9 mg strengths. The company said the pills would reach US pharmacies in the second quarter of 2026 and they began rolling out nationwide on May 4, 2026. The new strengths do not match the old Rybelsus 3 mg, 7 mg and 14 mg tablets dose for dose.
- Business
Novo Nordisk starts DKK 15 billion share buyback as it warns of pricing pressure
Novo Nordisk said on February 4, 2026, that it will repurchase up to DKK 15 billion (about $2.4 billion) of its shares, alongside a smaller DKK 3.8 billion buyback running through May 4, 2026. The announcement followed 2025 sales of DKK 309.06 billion and guidance that adjusted sales and adjusted operating profit will both fall 5% to 13% at constant exchange rates in 2026.
- Research and trials
GLP-1 receptor agonists linked to blunted thirst signal in small analysis
A secondary analysis of 54 participants with normal fluid levels found that a GLP-1 receptor agonist inhibited the vasopressin system, with copeptin falling by a median of 12% versus placebo. The paper cites earlier work showing reduced fluid intake and reduced urine output on long-term treatment. It describes the finding as a mechanism behind the clinical advice to drink on a schedule rather than on thirst.
- Business
Lilly drops three clinical programs, including a gene therapy from Prevail
Eli Lilly disclosed on Feb. 4, 2026, that it has discontinued three clinical-stage programs: a gene therapy for FTD-GRN frontotemporal dementia from its $1 billion-plus Prevail Therapeutics acquisition, an anti-CD19 antibody studied in multiple sclerosis and rheumatoid arthritis, and a radioligand therapy for prostate cancer. The company said none of the decisions were driven by safety concerns. Lilly's research and development spending rose 26% to $3.8 billion in the most recent quarter.
- Business
Novo Nordisk reports 10% 2025 sales growth and guides to a 2026 sales decline
Novo Nordisk reported 2025 net sales of DKK 309.1 billion, up 6% in Danish kroner and 10% at constant exchange rates, with operating profit of DKK 127.7 billion, down 1% in kroner after about DKK 8 billion in restructuring costs. The company guided to its first full-year sales decline of the GLP-1 era, expecting adjusted sales and adjusted operating profit to each fall 5% to 13% at constant exchange rates in 2026, citing lower realized prices, competition and a semaglutide patent expiry in some international markets.
- Business
Novo Nordisk expects 2026 sales to fall as much as 13% on US pricing pressure
Novo Nordisk guided to a 5% to 13% decline in 2026 sales and operating profit at constant exchange rates, far below the roughly 2% sales drop analysts expected. The maker of Ozempic and Wegovy cited lower US prices, patent expirations outside the US, and rising competition, and its shares fell sharply.
- Compounding
Judge dismisses Lilly's tirzepatide false-advertising suit against Willow Health
A federal judge in the Central District of California dismissed Eli Lilly's false-advertising lawsuit against Willow Health Services with prejudice on Feb. 3, 2026, ending the case at the pleading stage. The court granted Willow's motion to dismiss Lilly's Lanham Act claims and denied leave to amend, finding Lilly had not plausibly alleged that Willow's marketing directly caused lost sales.
- Competition
Pfizer's monthly GLP-1 injection PF'3944 shows up to 12.3% placebo-adjusted weight loss in Phase 2b
Pfizer said its experimental monthly GLP-1 injection PF'3944 met the primary endpoint of the Phase 2b VESPER-3 trial, with 10% and 12.3% placebo-adjusted weight loss at 28 weeks on the two monthly regimens planned for Phase 3. Weight loss had not leveled off at 28 weeks, and the study continues to week 64. The drug is investigational and no approval timeline has been disclosed.
- Business
Novo Nordisk posts 6% sales growth for 2025 and forecasts a decline in 2026
Novo Nordisk reported full-year 2025 sales of 309.06 billion Danish kroner, up 6% in kroner and 10% at constant exchange rates, with operating profit up 6% at constant rates. The company also said it expects 2026 sales and operating profit to fall 5% to 13% at constant exchange rates, a steeper drop than analysts expected, and its U.S. shares fell as much as 14%.
- Culture
Analysts cut obesity drug market forecasts by about 30%, citing falling US prices for Wegovy and Zepbound
Wall Street analysts have lowered their 2030 forecasts for the global obesity drug market by roughly 30%, to about $100 billion, and some have pushed the $150 billion milestone out to 2035, Reuters reported Feb. 2. Goldman Sachs now estimates $105 billion in global obesity drug sales by 2030, down from $130 billion, as US prices for GLP-1 drugs fell from about $1,000 a month to starting prices of $149 to $299 on company websites.
- Research and trials
Novo Nordisk says CagriSema beat semaglutide on blood sugar and weight in diabetes trial
In the 68-week phase 3 REIMAGINE 2 trial, CagriSema lowered average HbA1c by 1.91 percentage points and body weight by 14.2% in adults with type 2 diabetes, compared with 1.76 points and 10.2% for semaglutide 2.4 mg. Novo Nordisk said superiority held across all tested doses and that it will discuss a diabetes regulatory pathway with authorities.
- Research and trials
Claims analysis links tirzepatide for sleep apnea to fewer CPAP starts
A Komodo Health claims analysis found that new tirzepatide starts among people with obstructive sleep apnea rose 16 percent in the six months after the FDA approved the drug for that condition in December 2024. Only 4 percent of patients with no prior CPAP use who started tirzepatide began CPAP within six months, compared with 22 percent of those who did not receive a GLP-1 drug. Primary care and generalist settings wrote about 84 percent of the prescriptions, while sleep medicine wrote 0.2 percent.
- Research and trials
REST trial opens to test tapering semaglutide versus stopping abruptly
A team at Mount Sinai Hospital in Toronto began recruiting in February 2026 for REST, a randomized trial comparing a 16-week gradual semaglutide dose reduction with abrupt discontinuation in adults with obesity who have lost at least 10% of body weight and plateaued. The primary outcome is percentage change in body weight, with 24-hour ambulatory blood pressure and fasting ghrelin as secondary outcomes. Completion is listed for May 2029.
- Safety
Zepbound label drops suicidal ideation warning and updates gastrointestinal section
The Zepbound prescribing information lists "Suicidal Behavior and Ideation (Removed)" with a date of 02/2026, and records an update to its Severe Gastrointestinal Adverse Reactions warning (5.2) the same month. The label's most recent revision is dated August 2026. The labeling documents do not explain why the warning was removed.
- Business
Two more generic liraglutide 3 mg products enter US market, FDA listings show
Cipla USA and Orbicular each began marketing a generic liraglutide 3 mg product in late February 2026, according to FDA drug listing data, ending Teva's six-month run as the only generic supplier of the weight-management version. Biocon Pharma's version is listed with a March 27, 2026 first marketing date. The listings include no prices, insurance information or pharmacy stock data.
- Regulation
Saxenda label drops suicidal behavior and ideation warning
The February 2026 revision of the Saxenda prescribing information removed subsection 5.9, Suicidal Behavior and Ideation, and generic liraglutide injection labels were updated the same month. A 2026 pharmacovigilance analysis of 42,941 European reports counted 37 suicide- or self-injury-related cases for liraglutide, 141 for semaglutide and 47 for tirzepatide. The study authors say the findings do not establish a causal link.
- Research and trials
Truveta records show greater six-month weight loss with tirzepatide than semaglutide
In a retrospective study of 2,396 US adults without diabetes who stayed on treatment for six months, tirzepatide produced an average 11.15% weight loss versus 8.83% for semaglutide, an adjusted difference of 2.32 percentage points. The gap appeared even though a larger share of semaglutide patients were on higher doses. The study was funded by Eli Lilly, which sells tirzepatide.
- Safety
Court dismisses Lilly lawsuit against compounded tirzepatide seller Willow Health
A federal judge in the Central District of California granted Willow Health Services' motion to dismiss Eli Lilly's first amended complaint over Willow's marketing of compounded tirzepatide, in an order filed February 3, 2026. The same order records that Lilly holds regulatory exclusivity for tirzepatide until at least May 2027 and that Mounjaro and Zepbound are the only FDA-approved tirzepatide medicines, both given by injection.
- Compounding
FDA proposes rule to block liposomal compounded semaglutide copies
The FDA issued a proposed rule that would prohibit compounding with liposomal delivery, the approach behind the Hims & Hers oral semaglutide pill. The proposal, which would put semaglutide on a list of drugs that are demonstrably difficult to compound, has not been finalized and drew numerous comments questioning its language and the agency's statutory authority. It comes as Novo Nordisk sued Hims & Hers on February 9, 2026, over compounded semaglutide in pill form, and as the FDA referred the company to the Justice Department.
- Culture
Eli Lilly runs "Never Over" brand film during the Milan Cortina Winter Olympics
Eli Lilly is airing a minute-long brand film called "Never Over" during the 2026 Winter Olympics in Milan Cortina, made with agency Wieden + Kennedy Portland. The spot compares the scientific method to athletic training and closes with the line "Health is never over." Lilly also ran a spot in the Super Bowl LX pregame program and a Kisunla commercial featuring sponsored Team USA athletes.
- Research and trials
Switching from dulaglutide to tirzepatide helped in every patient group tested, analysis finds
A subgroup analysis of the phase IV SURPASS-SWITCH trial found that adults with type 2 diabetes who switched from weekly dulaglutide to weekly tirzepatide had significantly greater reductions in A1c and body weight at week 40 than those who continued dulaglutide. The advantage appeared in every prespecified patient group, including by age, diabetes duration, baseline dulaglutide dose, BMI, ethnicity and sex. A1c improvements were larger in people who started with higher A1c and lower BMI.
- Business
US semaglutide market estimated at $24.1 billion in 2026 as generic rivals stay abroad
Market researchers estimate the U.S. semaglutide market at $24.10 billion in 2026, about 61.2% of global revenue for the drug. The global market is projected at $39.37 billion this year and $86.05 billion by 2034, while semaglutide's U.S. exclusivity runs to 2032 and generic versions launch in India at up to 80% below Novo Nordisk's prices.
- Competition
AstraZeneca pays $1.2 billion upfront for CSPC weight-loss drug portfolio
AstraZeneca agreed on January 30, 2026 to pay CSPC Pharmaceuticals $1.2 billion upfront for rights outside China to eight obesity and type 2 diabetes programs, including the once-monthly injectable candidate SYH2082. Reuters reported the deal could be worth up to $18.5 billion if all milestone payments are made, with CSPC eligible for up to $3.5 billion in research and development milestones and up to $13.8 billion in sales-related milestones.
- Research and trials
EU regulators decline separate heart failure use for Mounjaro but add SUMMIT data to label
The European Medicines Agency decided on January 30, 2026 against a stand-alone heart failure indication for tirzepatide (Mounjaro), while agreeing to place the SUMMIT trial results in the medicine's product information. In SUMMIT, 731 adults with obesity and heart failure with preserved ejection fraction were studied; the combined rate of cardiovascular death or a worsening heart failure event was 9.9% on tirzepatide and 15.3% on placebo, a hazard ratio of 0.62. EMA said the drug did not lower cardiovascular deaths and that a benefit separate from weight loss remains unproven.
- Regulation
FDA approves renaming Rybelsus tablets to Ozempic tablets
The FDA approved a January 30, 2026 labeling change that renames the reformulated oral semaglutide tablet Rybelsus as Ozempic tablets, in 1.5 mg, 4 mg and 9 mg strengths. The renamed product keeps the same type 2 diabetes uses, including cardiovascular risk reduction in high-risk patients. The two oral formulations are not interchangeable milligram for milligram.
- Prices
Lilly picks Pennsylvania for $3.5 billion plant making injectable obesity drugs including retatrutide
Eli Lilly announced Jan. 30, 2026, that it will invest more than $3.5 billion in a new factory in Pennsylvania's Lehigh Valley to make injectable weight-loss medicines, including the experimental drug retatrutide. Pennsylvania is putting $100 million toward the project, which Lilly says will bring 850 company jobs and about 2,000 construction jobs. Construction is set to begin in 2026, but the site is not expected to be operational until 2031.
- Policy
Lilly CEO calls Medicare obesity coverage a 'game changer' for orforglipron launch
Eli Lilly CEO Dave Ricks said on Jan. 30, 2026, that coming Medicare coverage of obesity drugs could be a major catalyst for the company's experimental obesity pill, orforglipron. Lilly is preparing a full launch in the second quarter and expects Medicare coverage for the treatment to follow immediately, Ricks said. Under November 2025 pricing deals, certain Medicare patients will pay a $50 monthly copay for approved injectable and oral GLP-1 drugs.
- Safety
UK regulator adds severe pancreatitis warnings to semaglutide and tirzepatide labels
The UK's Medicines and Healthcare products Regulatory Agency updated the product information for every GLP-1 and dual GLP-1/GIP receptor agonist on 29 January 2026, adding language about rare necrotising and fatal acute pancreatitis. The agency counted 1,296 Yellow Card pancreatitis reports across the class from 2007 through October 2025, including 19 deaths and 24 necrotising cases, against an estimated 25.4 million packs dispensed in the past five years.
- Regulation
EU regulators decline heart failure indication for Mounjaro but add trial data to label
European regulators declined to add a separate heart failure indication to Mounjaro, the tirzepatide medicine, for adults with obesity and chronic heart failure with preserved ejection fraction. The European Medicines Agency instead agreed to include results from the 731-patient trial submitted with the application in the product information, after concluding the drug did not reduce cardiovascular deaths but did significantly cut heart failure hospitalizations and improve quality of life.
- Business
Trump says Eli Lilly plans six new US manufacturing plants
President Donald Trump said on January 29, 2026 that Eli Lilly plans to build six new manufacturing plants in the United States. Lilly had already announced it would invest at least $27 billion to expand U.S. production, with four plants planned and three confirmed in Alabama, Virginia, and Texas. The locations, costs, and construction timing for the six plants have not been disclosed.
- Prices
Medicare Advantage insurers denied 4.1 million prior authorization requests in 2024, analysis finds
A KFF analysis of federal data found Medicare Advantage insurers made nearly 53 million prior authorization determinations in 2024 and denied 4.1 million of them, or 7.7 percent. Only 11.5 percent of those denials were appealed, and 80.7 percent of appeals overturned the denial. The data are aggregated and do not show denial rates for specific drugs or services.
- Culture
Novo Nordisk outspent Eli Lilly on US GLP-1 ads while losing prescription share
Novo Nordisk spent close to $500 million advertising Wegovy and Ozempic in the United States in the first nine months of 2025, more than double the roughly $214 million Eli Lilly spent on Zepbound and Mounjaro, according to advertising tracking data from MediaRadar seen by Reuters. The spending rose as supplies recovered from 2024 shortages, but Lilly's Zepbound still overtook Wegovy in US prescriptions and took about 60% of the obesity drug market for 2025.
- Business
Novo Nordisk spent nearly $500 million on US ads for Wegovy and Ozempic in nine months
Novo Nordisk spent an estimated $487 million advertising Wegovy and Ozempic in the US in the first nine months of 2025, more than double Eli Lilly's $214 million for Zepbound and Mounjaro, according to MediaRadar data reported by Reuters. Wegovy accounted for $316 million and Ozempic $169 million of Novo's total, up 54% and 44% from the same period in 2024. Both companies declined to comment on their advertising budgets.
- Policy
Medicare selects 15 more drugs, including Trulicity, for its next round of price talks
CMS on January 27, 2026 named 15 more drugs for Medicare price negotiation, the third cycle of the program and the first to include physician-administered Part B drugs. Negotiations run during 2026, with negotiated prices taking effect January 1, 2028. The 15 drugs had about 1.8 million Medicare users and $27 billion in total Part B and Part D spending from November 2024 through October 2025.
- Competition
Roche's CT-388 shows 22.5% weight loss, company plans phase 3 obesity trials
Roche said Jan. 27, 2026 that its dual GLP-1/GIP drug CT-388 produced 22.5% placebo-adjusted weight loss at 48 weeks in a phase 2 trial of 469 people, with no sign of a plateau. The highest 24-mg dose led to more than 5% weight loss in 95.7% of patients and more than 30% in 26.1%. Roche plans two phase 3 obesity trials this quarter.
- Competition
Sun Pharma wins Indian approval for generic semaglutide injection
Sun Pharmaceutical Industries said on January 23, 2026 that India's drug regulator approved its generic semaglutide injection for chronic weight management, to be sold as Noveltreat after the Indian patent expires. Sun and other Indian manufacturers then launched generic versions in March 2026, undercutting Novo Nordisk's original India price by up to 80%, according to CNBC.
- Culture
Eli Lilly's new short film 'My Focus' frames obesity around health rather than appearance
Eli Lilly released a one-minute short film, "My Focus," earlier in January 2026, its third unbranded short about weight stigma. The film holds a single tight close-up on one man's face for its entire run and ends with text saying it takes strength to focus on health. The campaign runs on digital, social and print channels through the first quarter of 2026.
- Regulation
EU adds pediatric type 2 diabetes use to Mounjaro label and updates breastfeeding guidance
A European Commission decision dated 22 January 2026 extended Mounjaro's EU indication to adolescents and children aged 10 years and older whose type 2 diabetes is not adequately controlled with metformin, or basal insulin, or both, based on the SURPASS-PEDS study. The same decision date covers an update to the prescribing information's breastfeeding section, which now states that tirzepatide "could be considered for use during breast-feeding" after a single 5 mg dose produced breast milk concentrations that were undetectable to very low compared with plasma.
- Regulation
Lilly issues Zepbound KwikPen instructions ahead of US launch
Eli Lilly has issued the FDA-approved Instructions for Use for the Zepbound KwikPen ahead of the device's US launch. The document, dated January 21, 2026, requires priming before every weekly injection, a dose-window icon that must be visible before the needle is withdrawn, and tells patients not to count clicks when dialing a dose. Pen needles are not included with the device.
- Regulation
FDA clears four-dose KwikPen versions of Mounjaro and Zepbound
The FDA approved KwikPen versions of Mounjaro and Zepbound, both tirzepatide, on Jan. 20, 2026, in six strengths each. Each pen delivers four once-weekly doses and is labeled for one patient only. The labels add a warning against sharing a pen even if the needle is changed.
- Research and trials
Tirzepatide maintenance trial tests a lower dose instead of stopping
SURMOUNT-MAINTAIN, a 112-week phase 3b trial of tirzepatide, has completed at 20 US sites. It randomized 378 of 441 enrolled participants at week 60 to keep their maximum tolerated dose, step down to 5 mg, or switch to placebo. It is described as the first randomized test of dose reduction rather than discontinuation, and results have not been reported.
- Compounding
FDA warns GenoGenix over sterility and labeling failures at Boca Raton compounding site
The FDA issued a warning letter dated Jan. 20, 2026, to GenoGenix LLC, a Boca Raton, Florida, facility registered as a 503B outsourcing compounder, citing sterility failures, labeling omissions and the use of two bulk ingredients that are not eligible for compounding. The firm told the FDA it has stopped drug production and distribution and recalled sterile products within expiry on July 30, 2025.
- Prices
Thirteen state Medicaid programs cover GLP-1s for obesity as of January, KFF finds
KFF reported on Jan. 16, 2026 that 13 state Medicaid programs covered GLP-1 drugs for obesity treatment under fee-for-service as of January 2026, down from 16 in October 2025 after California, New Hampshire, Pennsylvania and South Carolina ended coverage and North Carolina restored it. Medicaid prescriptions for the drugs rose from about 1 million in 2019 to more than 8 million in 2024, and gross spending rose from roughly $1 billion to nearly $9 billion.
- Safety
FDA warning letter to Boothwyn Pharmacy cites insanitary conditions in compounded GLP-1s
The FDA issued a warning letter to Boothwyn Pharmacy, LLC, dated January 16, 2026 and published February 10, 2026, citing insanitary conditions and compounded products that did not meet their stated strength, quality or purity, including GLP-1 products. The agency can follow up with recalls, seizure, injunctions or criminal action if the violations are not addressed, and the letter is part of a broader enforcement push against compounded GLP-1s.
- Culture
Jefferies estimates weight-loss drugs could save four US airlines $580 million in fuel
A Jefferies analysis estimates that growing use of GLP-1 weight-loss drugs could save American, Delta, Southwest and United as much as $580 million in jet fuel this year, because lighter passengers make planes lighter. The model assumes a 10% slimmer society, which would cut total passenger weight by about 2% and fuel use by about 1.5%.
- Regulation
FDA pushes orforglipron decision date to April 10 as priority voucher reviews slip
The FDA has extended its target decision date for Eli Lilly's oral obesity drug orforglipron to April 10, 2026, later than the March 28 date agency leaders had pushed for, according to internal regulatory documents reported Jan. 15. Reviews for three other drugs awarded the agency's new priority vouchers have also been pushed back. Lilly CEO David Ricks told investors on Jan. 14 that the company still expects a second-quarter decision.
- Research and trials
Pooled SURMOUNT analysis finds no rise in depression risk with tirzepatide
A post hoc analysis pooling SURMOUNT-1, SURMOUNT-2 and SURMOUNT-3 found PHQ-9 depression scores fell slightly more on tirzepatide than placebo by week 72, an estimated treatment difference of −0.6 (p < 0.001), and 18.2% versus 24.3% of participants moved into a more severe symptom category. Suicidal ideation was reported by 0.6% of each group, and nonfatal suicidal behavior by two tirzepatide-treated participants and none on placebo. The analysis excluded people with known major psychiatric illness.
- Research and trials
Analysis finds sleep apnea improvements, not only weight loss, explain some tirzepatide benefits
A secondary analysis of the SURMOUNT-OSA trials reports that tirzepatide improved heart and metabolic risk markers in people with obstructive sleep apnea and obesity. Improvements in inflammation, insulin resistance and triglycerides were partly explained by changes in sleep apnea measures independent of weight loss, while systolic blood pressure change tracked weight loss. Diastolic blood pressure showed no significant mediation by either weight or sleep apnea changes.
- Compounding
Compounding pharmacy Strive sues Lilly and Novo Nordisk over GLP-1 competition
Strive Compounding Pharmacy sued Eli Lilly and Novo Nordisk on Jan. 14, 2026, alleging the drugmakers used exclusive telehealth contracts, pressure on payment processors and negative messaging to push compounded GLP-1 medicines out of the market. The case, filed in federal court in the Western District of Texas, asks the court to stop the alleged conduct and "restore competitive conditions". Both companies deny the claims.
- Regulation
FDA approves generic liraglutide injection from Orbicular and Cipla
The FDA approved ANDA217590, a generic liraglutide injection, on January 14, 2026, according to the agency's drug approval database. The product is listed as a 6 mg/mL subcutaneous solution under the Orbicular label (NDC 81607-018) and the Cipla USA label (NDC 69097-920). No price, launch date or insurance coverage information appears in the approval record.
- Research and trials
Study links tirzepatide to lower dementia risk than semaglutide in type 2 diabetes
A retrospective analysis of electronic health records found tirzepatide (Mounjaro, Zepbound) was associated with a lower two-year dementia risk than semaglutide (Ozempic, Wegovy, Rybelsus) and than SGLT2 inhibitors in adults with type 2 diabetes. The hazard ratio was 0.69 versus semaglutide and 0.66 versus SGLT2 inhibitors. The authors called the findings hypothesis-generating and said randomized trials are needed.
- Research and trials
FDA wants suicide warning removed from Saxenda, Wegovy and Zepbound labels
Federal regulators have asked the makers of Saxenda, Wegovy and Zepbound to take the suicidal thoughts and behavior warning off those labels. The request, dated Jan. 13, 2026, followed FDA reviews of 91 placebo-controlled trials covering 107,910 patients and of claims data on 2,243,138 people, neither of which showed an increased risk.
- Research and trials
ADA's Obesity Association publishes 2026 standards for obesity medications
The Obesity Association, a division of the American Diabetes Association, published "Pharmacologic Treatment of Obesity in Adults" on January 13, 2026. The guideline calls for offering obesity medications as part of an initial treatment plan for adults with obesity and related conditions, and sets weight-loss goals of at least 5%, 10% or 15% depending on which complications are present. It pairs specific drugs, including semaglutide and tirzepatide, with conditions such as type 2 diabetes, sleep apnea and MASH.
- Business
Novo Nordisk CEO sets 2026 priorities and calls obesity a consumer business
New Novo Nordisk CEO Maziar Mike Doustdar told the J.P. Morgan Healthcare Conference on Jan. 13 that the company will focus 2026 on commercial execution, direct-to-patient expansion and pipeline progress. He said obesity "acts a lot more as a consumer business than a traditional medication," after a year in which Novo ceded the U.S. weight-loss lead to Eli Lilly. Novo said 7% of the more than 550 million people with diabetes worldwide get a GLP-1, and about 2% of the more than 900 million with obesity.
- Compounding
Alabama settles with Cullman clinic over unapproved semaglutide and tirzepatide
Alabama Attorney General Steve Marshall announced a January 12, 2026, settlement that permanently closes Aurora IV and Wellness, a Cullman infusion clinic, and bars its owners, Amanda and Chris Medders, from patient care. The Medderses will pay $17,267.50 to consumers who complained plus $7,000 in penalties and fees, and Amanda Medders has given up her nursing license.
- Business
Lilly and Nvidia open joint AI lab for drug discovery with up to $1 billion
Eli Lilly and Nvidia announced on January 12, 2026 that they will open a joint artificial intelligence lab based in the San Francisco Bay Area, with the two companies investing up to $1 billion in talent, infrastructure and computing over five years. The lab will pair Lilly scientists with Nvidia AI engineers to build models for biology and chemistry, and will also explore AI use in clinical development and manufacturing. Lilly says the effort expands on its existing AI supercomputer, which it calls the most powerful in the pharmaceutical industry.
- Culture
FDA tells Novo Nordisk its Wegovy pill launch ad is false or misleading
Novo Nordisk's first direct-to-consumer TV ad for the oral Wegovy pill aired during the Golden Globes on 11 January 2026, starting the company's "Live lighter" campaign for the first oral GLP-1 weight-loss drug sold in the US. In an Untitled Letter dated 5 February 2026, the FDA called the ad "false or misleading," saying it suggests the pill delivers weight loss and other benefits beyond what other approved GLP-1 treatments have been shown to provide.
- Business
Wegovy pill now selling as Eli Lilly's oral GLP-1 nears a U.S. decision
The first GLP-1 pill for obesity, Novo Nordisk's Wegovy, is now available in the U.S. at cash prices of $149 to $299 per month, and Eli Lilly's orforglipron is expected to get a U.S. approval decision within months. Analysts forecast that oral GLP-1s could capture about 24%, or roughly $22 billion, of the global weight-loss drug market by 2030, while doctors expect pills to attract patients seeking modest weight loss rather than replace injections.
- Research and trials
Lilly says Zepbound plus Taltz beats Taltz alone in psoriatic arthritis
Eli Lilly said Jan. 8, 2026 that adding Zepbound (tirzepatide) on top of its immunology drug Taltz helped adults with psoriatic arthritis and obesity more than Taltz did alone. The company did not disclose response rates, patient numbers, doses or statistical details. It is not yet clear whether the result will change prescribing, because demand for Zepbound is already high for weight loss.
- Research and trials
Review of obesity drugs including semaglutide finds regain of about 0.4 kg a month after stopping
A systematic review and meta-analysis published by BMJ pooled 37 studies and 9,341 participants and found that weight returns at about 0.4 kg per month after a weight-management medication is stopped. In randomized controlled trials the rate compared with control was 0.3 kg per month, and regain was faster after a drug than after a behavioral weight-loss program. The authors project that improvements in cardiometabolic markers fade within about 1.4 years and say the findings suggest caution about short-term use.
- Regulation
FDA approves multi-dose tirzepatide vials for Mounjaro and Zepbound
The FDA approved a multiple-dose, single-patient-use vial for both Mounjaro and Zepbound (tirzepatide) on January 7, 2026, adding a vial-and-syringe option to the single-dose pens and single-dose vials already sold. Zepbound's labeling lists the vial in six strengths, each holding 2.4 mL, or four 0.6 mL doses. The approval letters do not disclose pricing, a launch date or whether Mounjaro's vial uses the same fill volume.
- Business
Lilly to buy Ventyx Biosciences for $1.2 billion in push beyond weight-loss drugs
Eli Lilly agreed on January 7, 2026, to acquire Ventyx Biosciences, a San Diego developer of oral immune drugs, for $1.2 billion in cash, or $14.00 per share. The deal adds a class of experimental anti-inflammatory medicines called NLRP3 inhibitors to Lilly's pipeline, which is best known for the GLP-1 drugs Mounjaro and Zepbound. It is expected to close in the first half of 2026.
- Regulation
Lilly issues Instructions for Use for Zepbound multi-dose vial with 30-day discard rule
Eli Lilly issued FDA-approved Instructions for Use for the Zepbound multi-dose vial on Jan. 7, 2026, under the identifier ZEP-0001-MDV-IFU-20260107. The document sets a 0.6 mL injection volume, which differs from the 0.5 mL single-dose vial and pen, and says a vial must be discarded after 30 days at room temperature, 30 days after first use, or four weekly doses, whichever comes first, even if medicine remains.
- Science
Arrowhead says RNA drug doubled tirzepatide's weight loss in small early trial
Arrowhead Pharmaceuticals reported that its experimental RNA drug ARO-INHBE, given with tirzepatide, produced 9.4% weight loss at 16 weeks in four patients with type 2 diabetes, roughly double the 4.8% seen in five patients who took tirzepatide alone. The company also said the combination tripled reductions in visceral, total and liver fat, based on three patients. The results come from small Phase I/IIa trials, and the drug is not approved.
- Business
Lilly pays Nimbus up to $1.3 billion for another oral obesity drug
Eli Lilly signed a multi-year research and licensing deal with Nimbus Therapeutics on January 6, 2026, to develop an AI-discovered oral medicine for obesity and other metabolic diseases. Lilly will pay $55 million in upfront and near-term milestone payments, with up to $1.3 billion more in development, commercial and sales milestones, plus royalties if a drug is approved. It is Lilly's second metabolic agreement with the Boston biotech.
- Compounding
Novo Nordisk launches Wegovy pill in the U.S. at $149 a month for cash payers
Novo Nordisk launched the Wegovy pill in the U.S. on Jan. 5, 2026, the first oral GLP-1 medicine approved for weight loss. The 1.5 mg starter dose costs $149 a month for cash payers, and the 4 mg dose stays at $149 through April 15 before rising to $199. Commercially insured patients could pay as little as $25 a month using a savings offer.
- Business
Novo Nordisk's oral Wegovy pill launched in the US in January 2026
Novo Nordisk's Wegovy pill, an oral form of semaglutide, launched in the US in January 2026 as the first oral GLP-1 approved for obesity. Within eight weeks it captured about one-third of new-to-brand prescriptions, most of them cash-pay, and roughly two-thirds of users were new to GLP-1 therapy. By the week ending 17 July, weekly Wegovy pill prescriptions topped 265,000, with more than 5 million filled since launch.
- Safety
Analysis of FDA reports finds a probable signal linking tirzepatide to a rare optic nerve condition
An analysis of the FDA Adverse Event Reporting System covering January 2022 to June 2025 identified 28 cases of ischemic optic neuropathy with tirzepatide as the primary suspect drug, with a reporting odds ratio of 2.599. The authors say the result meets Evans criteria for a probable drug-event association. They note that this kind of report data cannot prove the drug caused the condition.
- Competition
FDA grants breakthrough therapy designation to pemvidutide for MASH
The FDA granted Breakthrough Therapy Designation to Altimmune's investigational pemvidutide for MASH on January 5, 2026. The agency based the decision on 24-week Phase 2b data showing statistically significant MASH resolution without worsening of fibrosis, along with 48-week data reported in December 2025 showing improvements in non-invasive liver tests. A Phase 3 trial is planned, but no start date has been disclosed.
- Prices
GoodRx lists Wegovy pill at $149 a month for two lowest doses
GoodRx said on January 5, 2026, that the newly approved Wegovy pill (oral semaglutide) is available at a cash price of $149 a month for the two lowest doses at more than 70,000 pharmacies through its platform. The $149 price covers the 1.5 mg and 4 mg doses through April 15, 2026, after which the 4 mg dose will cost $199 a month; the 9 mg and 25 mg doses are priced at $299 a month. GoodRx also said users will soon be able to connect with licensed prescribers through GoodRx for Weight Loss.
- Science
Novo Nordisk's Canadian semaglutide data protection expires, opening door to generics
Novo Nordisk's Canadian data exclusivity for semaglutide expired on January 4, 2026, after the core Canadian compound patent had already lapsed over an unpaid maintenance fee. Health Canada has since approved two generic semaglutide injections — Dr. Reddy's on April 28, 2026, and Apotex on May 1, 2026 — and is reviewing seven more submissions. US compound patent protection for Ozempic, Wegovy and Rybelsus runs to 2032.
- Competition
Semaglutide patent protection ends in Canada, the first G7 country
Core semaglutide patent protection lapsed in Canada on January 4, 2026, making it the first G7 country where patents covering the molecule itself have expired. Sandoz, Apotex, Teva and Aspen filed generic applications quickly, but no Canadian generic approval has been announced. In the US, semaglutide remains protected until at least December 2031, with follow-on patents running to 2042.
- Prices
Four state Medicaid programs end GLP-1 obesity coverage
California, New Hampshire, Pennsylvania and South Carolina ended Medicaid coverage of GLP-1 drugs for obesity treatment effective January 1, 2026, citing budget pressure. KFF counted 16 covering states in October 2025; after the four cuts and North Carolina's December reinstatement, the count stood at 13 in January 2026. Medicaid coverage of the same drugs for diabetes, cardiovascular risk and sleep apnea remains required.
- Business
Semaglutide exclusivity starts to end outside the US as generic makers prepare
Canada's data protection for semaglutide ended in January 2026, and semaglutide patents expire in March 2026 in India, China and Brazil. Generic drugmakers have been preparing launches, with Indian and Canadian firms expected to move first, while US patents on the drug run to 2032.
- Prices
Harvard Pilgrim and Blue Cross Blue Shield of Massachusetts drop GLP-1 weight-loss coverage
Harvard Pilgrim Health Care removed coverage of all weight-loss drugs, including GLP-1s, on January 1, 2026, and Blue Cross Blue Shield of Massachusetts stopped covering GLP-1s for weight loss as employer plans renew. Both insurers still pay for the drugs when prescribed for type 2 diabetes, and Blue Cross Blue Shield of Michigan also ended weight-loss GLP-1 coverage.
- Business
Lilly posts January 1 list prices for Mounjaro, Zepbound and Trulicity
Eli Lilly's pricing pages, citing wholesale price data accessed January 1, 2026, list Mounjaro (tirzepatide) at $1,112.16 per monthly fill of four pens, Zepbound (tirzepatide) at $499 to $1,086.37 per fill, and Trulicity (dulaglutide) at $1,006.93 a month. All three figures are list prices set for wholesalers, not patient bills, and no earlier numbers appear on the pages for comparison.
- Business
Mounjaro's China insurance listing cut Lilly's international prices 36% while volume rose 113%
Mounjaro (tirzepatide) entered China's National Reimbursement Drug List on January 1, 2026. In the second quarter, Eli Lilly's revenue outside the US rose 80% as volume climbed 113%, partly offset by a 36% drop in prices collected, which the company tied largely to that listing. China revenue grew 93% at constant currency.
- Prices
North Dakota starts requiring ACA marketplace and small-group plans to cover GLP-1 drugs
North Dakota now requires individual ACA marketplace policies and small-group employer plans sold in the state to cover GLP-1 and GIP medications, and state officials say it is the first state to do so. The coverage applies to qualifying plans that began Jan. 1, 2025, under an essential health benefit package CMS approved in 2023. Large-group and grandfathered plans are excluded.
- Prices
New federal prior authorization deadlines start, but pharmacy benefit drugs like GLP-1s are excluded
A federal rule's new prior authorization deadlines took effect January 1, requiring Medicare Advantage, Medicaid, CHIP and Marketplace plans to decide standard medical requests within 7 calendar days and expedited requests within 72 hours. Medicaid managed care plans previously had 14 days for standard requests, and state fee-for-service programs had no specific federal deadline. The rule excludes drugs covered under the pharmacy benefit.
- Prices
Express Scripts and Optum Rx set 2026 tirzepatide coverage, leaving Zepbound vials off their lists
Two large pharmacy benefit managers have set their 2026 formulary positions for tirzepatide. Express Scripts covers the Zepbound pen and excludes the Zepbound vial, while Optum Rx places the Zepbound auto-injector at Tier 2 with prior authorization and marks the Zepbound solution, the vial, as excluded. Both cover Mounjaro with prior authorization.
- Prices
Kansas state employee health plan raises GLP-1 BMI cutoff to 35 for weight management
The Kansas State Employee Health Plan will cover GLP-1 medications for weight management only for members with a BMI of 35 or higher, applying to prescriptions issued or renewed after January 1, 2026. Wegovy is the plan's preferred GLP-1, while Zepbound is non-preferred unless a member has tried and failed a preferred product or cannot use one for medical reasons.
- Prices
Massachusetts GIC to require Vida Health prescriptions for weight-loss GLP-1 coverage
Starting Jan. 1, 2026, Massachusetts Group Insurance Commission members on active-employee or non-Medicare plans must have weight-loss medication prescribed by a Vida Health provider for it to be covered under their CVS pharmacy benefits. The requirement runs through June 30, 2026, and members already taking the drugs get a 90-day grace period through the end of March 2026 to enroll with Vida and provide medical information. Members who are diabetic and retirees on a Medicare plan are not subject to the requirement.
- Prices
Medicare Part D out-of-pocket cap rises to $2,100 for 2026
The Medicare Part D out-of-pocket cap on covered prescription drugs moved to $2,100 for 2026, up from $2,000 in 2025 and $8,000 in 2024. After an enrollee spends that amount, the plan pays 100% of covered drug costs for the rest of the year. The limit applies to stand-alone Part D plans and to Medicare Advantage plans that include drug coverage.
- Policy
Medicare negotiated prices take effect for 10 drugs, with semaglutide set for 2027
Negotiated prices for the first 10 Medicare Part D drugs took effect January 1, 2026 under the Inflation Reduction Act, the first time the program has applied government-set prices. CMS estimated Medicare would have saved $6 billion had the prices been in effect in 2023, a 22% net reduction, and that beneficiaries will save $1.5 billion in 2026. Semaglutide's negotiated price does not start until January 1, 2027.
- Prices
Novo Nordisk narrows Ozempic patient assistance program for 2026
Novo Nordisk's Patient Assistance Program will no longer provide Ozempic to Medicare beneficiaries who have Part D coverage, starting with the 2026 program year. Uninsured applicants for Ozempic must now have household income at or below 200% of the federal poverty level, while other covered Novo Nordisk medicines keep a 400% limit. Rybelsus and unbranded biologic insulins are also being removed from the program.
- Regulation
FDA asks makers of Saxenda, Wegovy and Zepbound to drop suicide warning
On January 13, 2026, the FDA said a review of 91 placebo-controlled trials covering 107,910 patients found no increased risk of suicidal ideation or behavior with GLP-1 receptor agonists, and asked the sponsors of Saxenda, Wegovy and Zepbound to remove that warning from their labels. Wegovy's prescribing information now lists the warning as removed in 01/2026, and Zepbound's lists it as removed in 02/2026.
- Prices
CVS Caremark holds GLP-1 formulary steady for 2026, keeping Wegovy preferred
CVS Caremark has confirmed no new GLP-1 formulary changes for January 2026, leaving Wegovy (semaglutide) preferred and Zepbound (tirzepatide) excluded on its Standard Control, Advanced Control and Value formularies. The Zepbound exclusion took effect July 1, 2025 and was estimated to affect about 200,000 patients. Some self-funded employers have opted out of the exclusion, so coverage still varies by plan.
- Research and trials
Viking's VK2735 Phase 2 results published, showing up to 14.7% weight loss at 13 weeks
Final results from the Phase 2 VENTURE trial of Viking Therapeutics' experimental obesity drug VK2735 were published in January 2026 in Obesity, the journal of The Obesity Society. Participants lost an average of up to 14.7% of their body weight after 13 weekly injections, with no sign of a plateau, and the drug was reported safe and well tolerated over that period. Viking's larger Phase 3 VANQUISH trials, testing 78 weeks of treatment, are fully enrolled.
- Prices
New Jersey becomes 26th state to require copay assistance count toward patient cost limits
New Jersey has become the 26th state to enact a law requiring that copay assistance count toward a patient's cost-sharing limits, according to an analysis published by Drug Channels. Those 26 states cover an estimated 17 percent of the US commercial insurance market, or more than 34 million people, for 2025. The laws do not apply to self-funded employer plans.
- Business
Novo Nordisk renames reformulated Rybelsus as Ozempic tablets
The reformulated oral semaglutide Novo Nordisk launched in December 2024 as Rybelsus (R2 formulation) was renamed Ozempic tablets as of January 30, 2026, according to the drug's FDA approval history. The 1.5 mg, 4 mg and 9 mg tablets keep their type 2 diabetes indications, while Wegovy remains the brand for weight reduction. Patients needed a new prescription to move to the renamed product.
- Research and trials
First randomized tirzepatide trial in type 1 diabetes reports weight loss and lower insulin use
The first randomized trial of tirzepatide in adults with type 1 diabetes found that 12 weeks of low-dose treatment reduced body weight by 10.3 kg, compared with 0.7 kg on placebo, and lowered total daily insulin dose by 35% relative to placebo. The HbA1c difference between groups was 0.4 percentage points. A 2026 systematic review of eight studies rated the overall certainty of the evidence in this area as low to very low.
- Competition
China approves Sciwind's ecnoglutide for weight management after diabetes clearance
China's drug regulator approved Sciwind Biosciences' ecnoglutide injection for chronic weight management on March 6, 2026, about five weeks after clearing it for type 2 diabetes. In the Phase 3 SLIMMER trial in Chinese adults, the 2.4 mg dose produced a placebo-adjusted average weight loss of 15.1% at 48 weeks, and 92.8% of participants lost at least 5% of body weight. Pfizer's China division holds exclusive mainland China commercialization rights under a February 2026 deal worth up to $495 million in upfront and milestone payments.
- Regulation
Health Canada clears Rybelsus for cardiovascular risk reduction
Health Canada has approved Rybelsus (semaglutide) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or are at high risk for those events. The clearance, issued in January 2026, follows the US approval of the same indication in October 2025. Rybelsus is an oral tablet taken once daily in the morning on an empty stomach.
- Culture
Vanessa Williams says she took Mounjaro while managing menopause
Vanessa Williams told Hello! Magazine that she began taking Mounjaro when she entered menopause, calling the drug "a game-changer" and describing how her body changed suddenly at 51. She is part of a run of celebrity disclosures that frame GLP-1 use around midlife, pregnancy or a diagnosed condition rather than appearance alone.
- Business
Higher-dose Wegovy 7.2 mg approved in the UK and EU, and now in the US
Wegovy HD, a once-weekly semaglutide injection at 7.2 mg, is approved for adults with obesity in the United Kingdom and the European Union, and it won US Food and Drug Administration approval on March 19, 2026. In the 72-week STEP UP trial, the 7.2 mg dose produced 20.7% mean weight loss, and 31.2% of participants lost at least 25% of their body weight. Novo Nordisk expects to launch the drug in the US in April 2026 in a single-dose pen.