GLP‑1 news from 2025
458 dated, sourced GLP-1 developments from 2025: approvals, trial results, prices, lawsuits, compounding and culture.
- Culture
Oprah Winfrey says she stopped GLP-1 drugs, regained about 20 pounds and restarted
Oprah Winfrey told People she stopped taking a GLP-1 medication about six months after starting it, regained roughly 20 pounds over the next 12 months, and then restarted treatment. She described the drugs as "going to be a lifetime thing". Fox News included her in a year-end roundup of celebrities who publicly discussed weight loss in 2025.
- Business
Novo Nordisk ends 2025 down nearly 49% and forecasts a sales decline for 2026
Novo Nordisk shares fell nearly 49% during 2025, the company's worst annual performance on record. The maker of Ozempic and Wegovy said 2026 sales and operating profit could fall 5% to 13% at constant exchange rates, far below the roughly 1.4% sales decline analysts expected. Full-year 2025 sales rose 6% to DKK 309.06 billion.
- Competition
Novo Nordisk and Eli Lilly cut Wegovy and Mounjaro prices in China
Novo Nordisk and Eli Lilly are lowering prices for their weight-loss drugs Wegovy and Mounjaro in China. Novo did not give details, but Chinese media reported the two highest Wegovy dosages were cut by 48%, to 987 yuan ($141) and 1,284 yuan per month in some provinces. Lilly's Mounjaro cut is set to start Jan. 1, with one listing showing a 10mg pen at about 445 yuan ($63), down from 2,180 yuan.
- Culture
Gold's Gym discounts GLP-1s for members as fitness chains add weight-loss programs
Gym chains are adding weight-loss training and, in some cases, discounts on GLP-1 drugs, Axios reported on Dec. 25, 2025. Equinox runs a program built for people losing weight, Life Time's Miora can include prescribing the medications, and Gold's Gym locations in the Washington, D.C. area give members price breaks on GLP-1s and some longevity drugs. About 1 in 8 U.S. adults have taken a GLP-1, per the KFF Health Tracking Poll from May 2024, and analysts say it is still unclear whether gyms will gain or lose from the trend.
- Business
CMS unveils BALANCE model to negotiate GLP-1 prices for Medicaid and Medicare
The Centers for Medicare & Medicaid Services announced BALANCE, a voluntary five-year model in which CMS negotiates GLP-1 prices and coverage terms with drugmakers on behalf of state Medicaid agencies and Medicare Part D plans. Medicaid coverage could begin as early as May 2026, and CMS says eligible Medicare beneficiaries would pay $50 a month for drugs such as Wegovy and Zepbound. A separate Medicare GLP-1 Bridge demonstration is set to run from July 1, 2026, through Dec. 31, 2027.
- Research and trials
FDA clears Wegovy pill, the first oral GLP-1 approved for weight loss
The FDA approved once-daily oral semaglutide 25 mg, sold as Wegovy, for chronic weight management and for reducing the risk of major cardiovascular events in adults with established heart disease who also have obesity or overweight. It is the first GLP-1 pill approved for weight loss. In the OASIS 4 trial, participants lost an average 13.6% of body weight over 64 weeks versus 2.2% with placebo.
- Research and trials
Tirzepatide linked to less CPAP use and lower mortality in sleep apnea study
A JAMA cohort study of 36,981 adults with type 2 diabetes, obesity and obstructive sleep apnea found that starting an incretin receptor agonist was associated with less CPAP use, lower all-cause mortality and fewer hospitalizations than starting an SGLT2 inhibitor. The mortality hazard ratio was 0.68, and the reductions were larger with tirzepatide than with GLP-1-only drugs.
- Regulation
FDA approves Mounjaro for children 10 and older with type 2 diabetes
The FDA approved Mounjaro (tirzepatide) on December 19, 2025 for children and adolescents 10 years and older with type 2 diabetes, expanding an indication that had covered only adults. The pediatric maximum dose on the label is 10 mg once weekly, compared with 15 mg for adults. The approval fulfilled a postmarketing requirement for a pediatric study that the agency had asked Eli Lilly to run.
- Competition
Altimmune says pemvidutide met 48-week liver markers in Phase 2b MASH trial
Altimmune reported on December 19, 2025, that pemvidutide met key 48-week measures in the Phase 2b IMPACT trial in people with MASH. The 1.8 mg dose lowered the Enhanced Liver Fibrosis score by 0.58 on average versus a 0.16 rise on placebo, and reduced liver stiffness measurement by 3.97 versus 0.03 on placebo, both statistically significant. Discontinuations for treatment-related adverse events were 0% at 1.2 mg and 1.2% at 1.8 mg, versus 3.5% on placebo, and the company intends to start a Phase 3 trial in 2026.
- Prices
White House launches TrumpRx.gov with lower prices listed for Ozempic, Wegovy and Zepbound
On February 5, 2026, the White House launched TrumpRx.gov, a site where patients with valid prescriptions can access discounted prices on 40 branded medicines. Ozempic and injectable Wegovy list at an average of $350 a month, as low as $199 depending on dose, down from $1,028 and $1,349; Zepbound averages $346, as low as $299, down from $1,088. The launch covers drugs from the first five manufacturers to sign most-favored-nation deals: AstraZeneca, Eli Lilly, EMD Serono, Novo Nordisk and Pfizer.
- Culture
Study links GLP-1 drugs to 5.3% drop in household grocery spending
A Cornell-led study published Dec. 18 in the Journal of Marketing Research found that US households cut grocery spending by an average of 5.3% within six months of starting a GLP-1 medication, and by more than 8% among higher-income households. Spending at fast-food chains, coffee shops and other limited-service restaurants fell about 8%, and savory snack spending fell about 10%. About one-third of users stopped during the study period, and their food spending returned to pre-adoption levels.
- Science
Novo Nordisk files for FDA approval of CagriSema for weight management
Novo Nordisk submitted a New Drug Application to the FDA on Dec. 18, 2025, for CagriSema, a once-weekly injection that combines cagrilintide 2.4 mg with semaglutide 2.4 mg for chronic weight management. In the 68-week REDEFINE 1 trial, participants taking CagriSema lost an average of 20.4% of body weight, counting everyone regardless of whether they stayed on treatment, compared with 3.0% for placebo. The drug is not approved, and Novo Nordisk says FDA review is expected in 2026.
- Competition
Lilly says orforglipron helped maintain weight loss after switching off Wegovy or Zepbound
Eli Lilly reported on December 18, 2025 that in the Phase 3 ATTAIN-MAINTAIN trial, people who had plateaued on the highest tolerated doses of Wegovy or Zepbound maintained most of their weight loss after switching to the experimental oral drug orforglipron for a year. Those who came from Wegovy kept all but 0.9 kg of their earlier loss on average, and those from Zepbound kept all but 5.0 kg. The trial met its primary endpoint and all key secondary endpoints against placebo, and Lilly said it has filed an obesity application with the FDA.
- Research and trials
Tirzepatide matches dulaglutide on heart risk in SURPASS-CVOT but shows no significant edge
In the SURPASS-CVOT trial, tirzepatide was noninferior to dulaglutide for a composite of cardiovascular death, heart attack or stroke in 13,299 adults with type 2 diabetes and atherosclerotic cardiovascular disease. The primary event occurred in 12.2% of the tirzepatide group and 13.1% of the dulaglutide group (hazard ratio 0.92; P=0.003 for noninferiority; P=0.09 for superiority). Tirzepatide did not show a statistically significant advantage over dulaglutide.
- Business
Novo Nordisk files for FDA approval of CagriSema, a combined GLP-1 and amylin obesity drug
Novo Nordisk submitted a New Drug Application to the U.S. Food and Drug Administration on Dec. 18, 2025 for CagriSema, a once-weekly injection combining cagrilintide 2.4 mg with semaglutide 2.4 mg for weight management. In the 68-week REDEFINE 1 trial, participants lost an average of 20.4% of body weight versus 3.0% on placebo, and 91.9% lost at least 5%. If approved, it would be the first FDA-cleared injectable combination of a GLP-1 receptor agonist and an amylin analog.
- Research and trials
Kailera begins Phase 3 testing of ribupatide, including a head-to-head with semaglutide
Kailera Therapeutics has opened its global KaiNETIC Phase 3 program for ribupatide, an experimental weight-loss drug also known as KAI-9531, and the first of three Phase 3 trials is now enrolling. One of the registered studies will test once-weekly ribupatide directly against semaglutide and placebo in adults with obesity who do not have diabetes. Ribupatide was licensed from China's Jiangsu Hengrui Pharmaceuticals, where it was called HRS9531.
- Science
Tirzepatide matches dulaglutide on heart events in four-year SURPASS-CVOT trial
The New England Journal of Medicine published the SURPASS-CVOT results on December 17, 2025. Among 13,165 analyzed patients with type 2 diabetes and atherosclerotic cardiovascular disease, cardiovascular death, heart attack or stroke occurred in 12.2% of those on tirzepatide and 13.1% of those on dulaglutide, meeting the bar for noninferiority (P=0.003) but not superiority (P=0.09). Gastrointestinal side effects were more common on tirzepatide (42.5% versus 35.9%), while weight loss and A1c reductions were larger.
- Prices
Lilly cuts Canadian list prices for Mounjaro and Zepbound by 20% or more
Eli Lilly is cutting the Canadian list prices of its tirzepatide drugs Mounjaro and Zepbound by 20% or more, according to a Globe and Mail report that Reuters cited on December 17. A four-week supply would cost 300 Canadian dollars for the 2.5 mg and 5 mg doses and 420 Canadian dollars for the 7.5 mg and 10 mg doses, with the new prices taking effect December 29. Lilly did not immediately respond to a request for comment, and Reuters said it could not immediately verify the report.
- Business
WeightWatchers rebuilds around GLP-1 users with prescribing arm and no-prescription track
WeightWatchers relaunched its platform for the GLP-1 era on December 16, 2025, adding prescribing through a clinical program called Med+ and a $20-a-month no-prescription track for people already taking a GLP-1 from another prescriber. The company reported an average 21% body-weight loss at 12 months among Med+ members on a GLP-1, company data from about 3,250 patients that has not been peer reviewed, and said more than 70% of surveyed members feel the program helps minimize side effects. Med+ membership was published at $25 a month for the first two months of a 12-month plan and $74 a month after that, with medication billed separately.
- Safety
GLP-1 vision loss lawsuits get their own federal court group
The U.S. Judicial Panel on Multidistrict Litigation created a separate federal consolidation for lawsuits claiming GLP-1 drugs cause non-arteritic anterior ischemic optic neuropathy (NAION), a form of sudden vision loss. MDL No. 3163 was created December 15, 2025, in the Eastern District of Pennsylvania before Judge Karen S. Marston, and held 216 pending cases as of September 1, 2026. It is separate from the older MDL covering gastrointestinal injuries, which had 4,022 pending cases.
- Safety
New federal MDL will handle Ozempic, Wegovy and Trulicity vision loss lawsuits
The U.S. Judicial Panel on Multidistrict Litigation created MDL No. 3163 on December 15, 2025 for lawsuits claiming GLP-1 drugs caused non-arteritic anterior ischemic optic neuropathy, or NAION. The order covered 21 actions and assigned them to Judge Karen S. Marston in Philadelphia, but refused Eli Lilly's request to fold the cases into the existing GLP-1 gastrointestinal MDL. The panel denied centralization for one case, leaving 20 to be transferred.
- Prices
North Carolina Medicaid restores GLP-1 obesity coverage after October cut
North Carolina Medicaid reinstated coverage of GLP-1 drugs for obesity on Dec. 12, 2025, about 10 weeks after dropping the benefit during a state budget fight. The reversal kept the national count of covering state Medicaid programs at 13 as of January 2026, according to KFF, after four other states ended their obesity coverage.
- Regulation
FDA leaders pushed to shorten review of Lilly's orforglipron weight-loss pill
FDA leaders pressed internal reviewers to speed up evaluation of Eli Lilly's experimental weight-loss pill orforglipron, at one point asking to cut the filing check from 60 days to one week and later suggesting two to three weeks, Reuters reported. Reviewers had set a May 20 target decision date; a shorter timeline could produce a verdict as early as March 28.
- Regulation
European committee backs Mounjaro for children 10 and older with type 2 diabetes
On Dec. 12, 2025, a European Medicines Agency committee recommended extending Eli Lilly's Mounjaro (tirzepatide) to children and adolescents aged 10 and older with type 2 diabetes. Until now, blood sugar treatment for children with the condition had been limited to metformin and insulin. In a late-stage trial, the drug helped patients aged 10 to 17 control blood sugar better and lose weight, though the size of those changes was not reported.
- Science
FDA approves Mounjaro for children 10 and older with type 2 diabetes
The FDA has approved Mounjaro (tirzepatide) for children 10 years of age and older with type 2 diabetes, based on a 30-week trial in 99 patients. The pediatric maximum dose is 10 mg once weekly, lower than the 15 mg adult maximum, and vomiting, abdominal pain, and low blood sugar appeared more common in children than in adults.
- Business
Lilly says retatrutide produced up to 71.2 pounds of weight loss in Phase 3 trial
Eli Lilly reported on Dec. 11, 2025 that retatrutide, an investigational triple hormone receptor agonist, helped adults with obesity and knee osteoarthritis lose an average of up to 28.7% of their body weight — 71.2 pounds — over 68 weeks in the Phase 3 TRIUMPH-4 trial. The 9 mg and 12 mg doses also cut knee pain scores on the WOMAC scale by about 74% to 76%, compared with 40% for placebo. The drug is not approved, and side effects and discontinuation rates were higher than with placebo.
- Competition
Lilly says retatrutide produced up to 28.7% weight loss and knee pain relief in Phase 3 trial
Eli Lilly reported on December 11, 2025 that its investigational triple-agonist drug retatrutide met all primary and key secondary goals in the Phase 3 TRIUMPH-4 trial of 445 adults with obesity and knee osteoarthritis. The 12 mg dose produced an average 28.7% (71.2 lbs) weight loss at 68 weeks, and the 9 mg dose cut WOMAC knee pain scores by an average of 4.5 points (75.8%), versus 2.1% weight loss and a 2.4-point pain drop on placebo. Retatrutide is not approved by the FDA.
- Research and trials
Tirzepatide matches dulaglutide on heart risk in SURPASS-CVOT, full results show
Full results from the SURPASS-CVOT trial, published in the New England Journal of Medicine, show that tirzepatide was noninferior to dulaglutide for a combined measure of cardiovascular death, heart attack and stroke in people with type 2 diabetes and existing heart disease. The event rate was 12.2% on tirzepatide versus 13.1% on dulaglutide, a difference that was not statistically significant for superiority. Gastrointestinal side effects were more common with tirzepatide.
- Culture
Destination XL and FullBeauty agree to merge into a $1.2 billion plus-size retailer
Destination XL Group and FullBeauty Brands have agreed to combine in an all-stock merger of equals, creating an inclusive-apparel company the two retailers value at roughly $1.2 billion. Destination XL sells big-and-tall men's clothing and FullBeauty sells plus-size women's clothing. The announcement, dated December 11, 2025, did not address GLP-1 medications or say whether weight-loss drug prescribing played a role in the decision.
- Research and trials
NEJM perspective calls generic liraglutide an overlooked lever on GLP-1 costs
Harvard drug-pricing researchers Suhas Gondi, Aaron Kesselheim and Benjamin Rome published a New England Journal of Medicine perspective arguing that generic liraglutide could reduce the fiscal burden of covering GLP-1 medicines, but only if patients, clinicians and insurers choose to use it. The piece appeared online on December 10, 2025, and in the journal's January 8, 2026 print issue, Volume 394, Number 2, pages 107-110. PubMed lists it as PMID 41370797 with no abstract.
- Culture
Lilly plans $6 billion Alabama plant to help make its oral GLP-1 pill
Eli Lilly said on Dec. 9, 2025 that it will invest more than $6 billion in a manufacturing plant in Huntsville, Alabama, that will produce active pharmaceutical ingredients, including for its experimental oral GLP-1 pill orforglipron. The company says the site will bring 450 permanent jobs and about 3,000 construction jobs, with construction set to begin in 2026 and completion expected in 2032. It is the third of four new U.S. sites Lilly plans to announce.
- Research and trials
First large trial of tirzepatide in PCOS begins enrolling in Germany
The University of Bonn and four German partner centers have started enrolling 198 premenopausal women in PERIODS, a randomized, double-blind, placebo-controlled phase 4 trial of tirzepatide in polycystic ovary syndrome. Treatment runs 72 weeks, and the main endpoint is menstrual bleeding during the final 52 weeks. Primary completion is listed as December 2028.
- Compounding
SAFE Drugs Act would tighten FDA oversight of compounded GLP-1 medicines
The SAFE Drugs Act of 2025, H.R. 6509, was introduced in the House on December 9, 2025. It would set a 20-unit monthly ceiling for 503A pharmacies compounding drugs deemed "essentially a copy" of an approved product, and require annual FDA reports when a pharmacy, facility, or physician ships more than 20 compounded prescriptions containing approved active ingredients to patients in other states. Senator Jim Banks introduced a Senate companion, announced in a February 6, 2026 press release.
- Policy
ADA guidance puts semaglutide and tirzepatide first for weight care in diabetes
The American Diabetes Association released Section 8 of its Standards of Care in Diabetes—2026 on December 8, 2025, covering obesity and weight management. Recommendation 8.18, graded A, says the preferred drug therapy for people with diabetes plus overweight or obesity should be a GLP-1 or dual GIP/GLP-1 receptor agonist with greater weight loss effect, and names semaglutide or tirzepatide. Related recommendations say treatment continues past weight goals and that the best dose may not be the highest approved one.
- Research and trials
Novo Nordisk's CagriSema reaches primary completion date in head-to-head trial against tirzepatide
REDEFINE 4, Novo Nordisk's phase 3 trial comparing CagriSema with tirzepatide in adults with obesity, reached its primary completion date on December 8, 2025, according to its registry listing. The trial enrolled 809 participants and ran for 84 weeks. No weight-loss results have been posted.
- Competition
Structure Therapeutics reports up to 15.3% weight loss with oral aleniglipron
Structure Therapeutics said on December 8, 2025 that its once-daily oral GLP-1 pill aleniglipron produced 11.3% placebo-adjusted weight loss at 36 weeks in the Phase 2b ACCESS study and up to 15.3% at the 240 mg dose in the exploratory ACCESS II study. Side-effect-related discontinuations averaged 10.4% across the active arms of the main study. The company said the data support starting a Phase 3 program in mid-2026.
- Policy
China adds Eli Lilly's Mounjaro to state insurance list for type 2 diabetes
China's National Healthcare Security Administration said Mounjaro, Eli Lilly's tirzepatide injection, will join the country's state-run health insurance scheme starting January 1 for type 2 diabetes. Reimbursement typically expands access in a country of 1.4 billion people while lowering the price per prescription, and analysts said the move could pressure rival GLP-1 makers. Lilly said the final reimbursement price will come in an official NHSA announcement.
- Business
Chemist Carolyn Bertozzi returns to Eli Lilly's board of directors
Carolyn R. Bertozzi, Ph.D., rejoined Eli Lilly's board of directors effective Dec. 8, 2025, taking a seat she held from 2017 to 2021. She will serve on the Science and Technology and Ethics and Compliance committees. Lilly calls her a Nobel Prize-winning chemist but does not say in the announcement which year the prize was awarded or what work it honored.
- Compounding
FDA seizes counterfeit Ozempic pens sold with a real lot number
The FDA said Dec. 5, 2025, that it seized dozens of units of counterfeit Ozempic (semaglutide) injection 1 mg that had been sold outside Novo Nordisk's authorized supply chain and reached the legitimate U.S. drug supply chain. The pens carry lot number PAR1229, which is also a genuine Ozempic lot number, and are identified by EXP/LOT text printed to the left of the expiration date and lot number. Six adverse events were reported for the lot, all involving authentic Ozempic, and testing of the seized product is not finished.
- Compounding
NextMed must pay $150,000 and halt deceptive GLP-1 ads under final FTC order
The Federal Trade Commission gave final approval on Dec. 3, 2025 to a consent order against telemedicine company NextMed and its principals, Robert Epstein and Frank Leonardo, over the marketing of prescription GLP-1 weight-loss programs. The order bars misleading cost claims, unsupported results claims, fake or manipulated reviews, and billing without informed consent, and requires a $150,000 payment the agency expects to use for consumer refunds.
- Science
Semaglutide shows no benefit in early Alzheimer's disease, full trial results confirm
Novo Nordisk presented detailed topline results from its two Phase 3 Alzheimer's trials on December 3, showing no difference between oral semaglutide and placebo on cognition or daily function. Seven fluid biomarkers moved by 10 percent or less, a change the Alzheimer's Drug Discovery Foundation called statistically significant but not clinically meaningful. The trials' planned one-year extension has been discontinued.
- Prices
ACA marketplace GLP-1 obesity coverage falls to 26 carriers for 2026
An analysis of the 300 carriers selling Affordable Care Act marketplace plans in 2026 found that 26 cover GLP-1 medications for treating obesity, in nine states. Enrollment in marketplace plans with that coverage fell from 3.6 million in 2024 to 2.8 million in 2026, and most carriers that do cover the drugs limit them to people with a body mass index of 40 or above.
- Compounding
Preprint counts 455 adverse event reports involving compounded tirzepatide
A preprint posted on medRxiv reports that FDA's adverse event database held at least 455 reports involving compounded tirzepatide as of December 2, 2025, including 339 serious events and 8 deaths. The same paper, whose authors work for Eli Lilly, describes a previously unidentified impurity in compounded tirzepatide products mixed with vitamin B12, present at up to 10 percent of total protein content. The paper has not been peer reviewed.
- Business
FDA approves Mounjaro and Zepbound KwikPen supplements after Lilly's December responses
Eli Lilly filed amendments on December 2, 2025 that FDA accepted as complete responses to its January 29, 2025 action letters on the Mounjaro and Zepbound KwikPen applications. FDA approved both supplements on January 20, 2026, adding six KwikPen presentations for each tirzepatide product, each holding four once-weekly doses.
- Prices
Lilly lowers Zepbound single-dose vial prices for cash-paying patients to $299 to $449 a month
Eli Lilly cut the self-pay price of Zepbound (tirzepatide) single-dose vials on December 1, 2025. The 2.5 mg starting dose fell to $299 a month from $349, the 5 mg vial dropped to $399 from $499, and the 7.5 mg through 15 mg vials are $449, down from $499, for patients who refill within 45 days. Prices outside the program run from $599 to $1,049 depending on dose.
- Culture
Review in Mayo Clinic Proceedings finds gut side effects in 40% to 70% of GLP-1 and GIP drug users
A clinical review published in Mayo Clinic Proceedings reports that 40% to 70% of patients taking GLP-1 and GIP receptor agonists experience gastrointestinal adverse effects. The review tells primary care physicians to start with dietary changes: smaller, more frequent meals, adequate hydration, and avoiding high-fat or high-sugar foods.
- Prices
US and UK agree to raise UK drug prices 25% in most-favored-nation push
The Office of the United States Trade Representative, the Department of Commerce and the Department of Health and Human Services announced on December 1, 2025 that the United Kingdom agreed to raise the net price of new prescription drugs there by 25%. The administration said the change would make the UK "pay their fair share for innovative medicines." The announcement did not name the drugs covered, a start date, or how the increase would be enforced.
- Safety
Mounjaro label adds use in children 10 and older and a severe gastrointestinal warning
In December 2025, the Mounjaro (tirzepatide) prescribing information changed in two ways: the type 2 diabetes indication was extended to children 10 years of age and older, with a maximum weekly dose of 10 mg instead of the adult 15 mg, and a new warning was added for severe gastrointestinal adverse reactions. The new warning states that Mounjaro is not recommended in patients with severe gastroparesis. Both changes are dated 12/2025 in the label.
- Culture
Cornell study links GLP-1 use to smaller grocery and fast-food bills
Research published Dec. 18 in the Journal of Marketing Research found that U.S. households cut grocery spending by 5.3% on average in the six months after someone in the home started a GLP-1 drug such as Ozempic or Wegovy, with drops above 8% among higher-income households. Limited-service restaurant spending fell about 8%. Roughly one-third of users stopped during the study period, and their spending returned to pre-adoption levels.
- Safety
Holding a GLP-1 dose before endoscopy cut retained stomach contents in Cleveland Clinic trial
In a 68-patient randomized trial, 25% of people who continued their GLP-1 medication before an upper endoscopy had clinically significant retained stomach contents after standard fasting, compared with 3.1% of those who skipped their last dose. Among patients who had only an upper endoscopy, 46.7% of continuers had significant residual volume versus 5% of those who held the drug. Every case meant the procedure could not be completed as planned, though there were no aspiration events or unplanned intubations.
- Culture
Bunnie XO says she had suicidal ideation while taking a GLP-1
Bunnie XO, the podcast host and wife of musician Jelly Roll, said she experienced "a bout of suicidal ideation" while taking a GLP-1 medication, according to an interview published in December 2025. She said both of her parents had diabetes and that her "insulin numbers are really crazy," and she described that period as a "rough month" while saying she is "good now."
- Compounding
Customs at Cincinnati intercepts about 5,000 GLP-1 peptide shipments from China
US Customs and Border Protection officers at the Port of Cincinnati identified more than 300 master carton smuggling attempts from China between December 2025 and March 25, 2026, concealing roughly 5,000 individual, pre-labeled peptide shipments, the agency said in a March 31, 2026 release. The goods included semaglutide, tirzepatide, retatrutide, cagrilintide and other peptides, and were mis-manifested to hide what was inside. The intercepts are the largest recent border action described in a published review of the gray-market peptide trade.
- Competition
Lilly's retatrutide shows 26.6% placebo-adjusted weight loss in knee osteoarthritis trial
Eli Lilly reported Phase 3 TRIUMPH-4 results in December showing retatrutide produced 26.6% placebo-adjusted weight loss at 68 weeks in people who have obesity or are overweight and also have knee osteoarthritis. Analysts at BMO Capital Markets said the result strengthened retatrutide's profile as a higher-efficacy next-generation option. Lilly also reported dysesthesia, a nerve-related side effect, in more than a fifth of patients on the 20-mg dose.
- Research and trials
Oprah Winfrey says she stopped a GLP-1 for 12 months, then restarted
Oprah Winfrey said she stopped taking a GLP-1 medication for about twelve months and then started again, describing what happened in between in an interview with People published in December 2025. The account is one person's experience rather than a clinical study, and it does not state which GLP-1 she took, what dose she was on, or how her weight changed during the pause.
- Competition
Novo Nordisk asks FDA to approve a higher dose of Wegovy, 7.2 mg
Novo Nordisk filed a supplemental New Drug Application with the FDA on Nov. 26, 2025, for a 7.2 mg dose of injectable semaglutide (Wegovy) for chronic weight management in adults with obesity. In the 72-week STEP UP trial, adults who stayed on 7.2 mg lost an average of 20.7% of body weight, compared with 17.5% on the currently marketed 2.4 mg dose and 2.4% on placebo. Review under an FDA expedited program is expected to take one to two months after the agency accepts the filing.
- Prices
Medicare sets $274 price for semaglutide starting in 2027
CMS announced a maximum fair price of $274 for a 30-day supply of semaglutide, sold as Ozempic, Rybelsus and Wegovy, beginning Jan. 1, 2027, which it says is 71% below the $959 list price recorded for 2024. The semaglutide group was Medicare Part D's largest by gross spending in 2024, at $15.2 billion, and about 2.28 million Part D enrollees used it that year. It is one of 15 drugs in the second round of Medicare price negotiations, which CMS said would have saved $12 billion in 2024.
- Culture
Circana forecasts GLP-1 households will account for over a third of US food and beverage sales by 2030
Market research firm Circana projects that US households with a GLP-1 user will represent more than 35% of food and beverage units sold by 2030, up from about 23% of households now. The report says people on drugs like Ozempic or Wegovy avoid high-carbohydrate and high-sugar items but still spend more than households without a user.
- Science
Novo Nordisk says amycretin improved blood sugar and weight in type 2 diabetes trial
In a phase 2 trial of 448 adults with type 2 diabetes, Novo Nordisk's investigational drug amycretin lowered HbA1c by up to 1.8 percentage points and produced weight loss of up to 14.5% with weekly injections over 36 weeks. Up to 89.1% of participants on the injected form reached an HbA1c below 7%. Amycretin is not approved, and the company plans a phase 3 program in type 2 diabetes in 2026.
- Competition
Novo Nordisk plans phase 3 trials of amycretin in type 2 diabetes for 2026
Novo Nordisk will start phase 3 testing of amycretin, an experimental drug that targets the GLP-1 and amylin receptors, in type 2 diabetes in 2026. In a 448-person phase 2 trial, weekly subcutaneous doses lowered HbA1c by up to 1.8 percentage points at 36 weeks and cut body weight by up to 14.5%, while once-daily oral doses lowered HbA1c by up to 1.5 points.
- Research and trials
Small open-label study reports 80 percent response to tirzepatide in hidradenitis suppurativa
In a 20-person, single-arm study, 16 adults with moderate-to-severe hidradenitis suppurativa (80 percent) met the standard response measure after 24 weeks of weekly tirzepatide, with some improvements still present after an 8-week washout. The study had no control group and no blinding, and the authors say larger randomized trials are needed to confirm the results.
- Research and trials
Novo Nordisk says oral semaglutide failed to slow Alzheimer's in two phase 3 trials
Novo Nordisk reported on Nov. 24, 2025 that the EVOKE and EVOKE+ phase 3 trials of once-daily oral semaglutide 14 mg did not beat placebo on the main measure of Alzheimer's disease progression in 3,808 adults aged 55 to 85 with early symptoms. Alzheimer's-related biomarkers improved, but the company said that did not translate into a delay in disease progression. The drug appeared safe and well tolerated, and the planned one-year extension was discontinued.
- Culture
Lizzo says the Ozempic boom is squeezing plus-size fashion and modeling work
Lizzo published an essay on Substack on Nov. 24 saying the popularity of weight-loss drugs has narrowed opportunities for people in larger bodies, pointing to shrinking extended-size clothing ranges and fewer plus-size modeling jobs. She wrote the piece in response to criticism of her own weight loss and said she still weighs more than 200 pounds.
- Business
Eli Lilly becomes first drugmaker to reach $1 trillion market value
Eli Lilly briefly hit $1 trillion in market value on Nov. 21, 2025, becoming the first drugmaker ever to reach that level. Combined sales of its tirzepatide medicines, Zepbound and Mounjaro, reached nearly $19 billion in the first nine months of 2025, passing Merck's Keytruda as the world's best-selling drug.
- Research and trials
ATTAIN-MAINTAIN completes, testing oral orforglipron after injected GLP-1 weight loss
The 376-participant ATTAIN-MAINTAIN trial has finished, testing once-daily oral orforglipron or placebo for 52 weeks in people who had plateaued on maximum tolerated tirzepatide or semaglutide. Participants were drawn from the SURMOUNT-5 study. No results have been posted to the trial record.
- Business
Lilly and Novo Nordisk back employer-direct programs for obesity drugs
Eli Lilly and Novo Nordisk are backing new programs that let employers buy obesity drugs directly through partner companies rather than traditional sales channels. Lilly's employer-focused model is set to launch in early 2026, and partner Waltz Health says its direct-to-employer access model will be available Jan. 1. Analysts estimate the obesity treatment market could be worth $150 billion a year by the early 2030s.
- Research and trials
Mazdutide 9 mg produces 18.55% mean weight loss at 60 weeks in Chinese Phase 3 trial
Innovent Biologics said its Phase 3 GLORY-2 trial of mazdutide 9 mg in Chinese adults with obesity met its primary and all key secondary endpoints, with mean weight loss of 18.55% at 60 weeks versus 3.02% on placebo. Among participants without type 2 diabetes, mean weight loss was 20.08%. The company plans to file for approval in China, and mazdutide is not approved in the United States.
- Prices
Novo Nordisk cuts self-pay price of Wegovy and Ozempic to $199 for first two months
Novo Nordisk began offering Wegovy and Ozempic to new self-paying patients at $199 a month for their first two months on Nov. 17, 2025, with $349 a month after that. The company also lowered its standard self-pay price for both drugs from $499 to $349 a month. The introductory rate applies to the two lowest doses and is scheduled to run through March 31, 2026, while the self-pay cost of Ozempic 2 mg stays at $499.
- Research and trials
Brain recordings suggest tirzepatide's effect on food noise may fade after about five months
Researchers recorded electrical activity directly inside the nucleus accumbens of a 60-year-old woman with obesity and loss-of-control eating while she took tirzepatide (Mounjaro, Zepbound). Her food preoccupation and the related brain signal went silent at her full dose, then returned about five months later, according to the case study published Nov. 17, 2025, in Nature Medicine. The authors describe a possible tolerance effect and say more research is needed; these drugs are not FDA-approved to treat food preoccupation.
- Prices
GoodRx launches $39 weight-loss telehealth plan and a $199 introductory Ozempic and Wegovy price
GoodRx said on Nov. 17, 2025 that it is launching a weight-loss telemedicine subscription at an introductory $39 a month and offering first-time users a $199 monthly cash price for Ozempic and Wegovy injection pens. The $199 price covers the first two fills of the two lowest doses through March 31, 2026, after which the standard price is $349 a month.
- Research and trials
Large cohort study finds no suicide safety signal for tirzepatide
In a propensity-matched study of 16,321 patient pairs, 17 people taking tirzepatide had a first recorded episode of suicidal ideation or a suicide attempt over a median of 365 days, compared with 33 people taking other anti-obesity medications, an adjusted hazard ratio of 0.52. The authors say the finding points to the absence of a safety signal for tirzepatide, not proof that the drug protects against suicide.
- Science
Small study links tirzepatide to a temporary quieting of binge-eating brain signals
Researchers who recorded electrical activity directly inside the brain of a woman with severe loss-of-control eating reported that tirzepatide appeared to quiet food-craving signals in the nucleus accumbens, then the effect faded about five months later. The Nature Medicine report covers four patients in a deep-brain stimulation trial; only one was taking tirzepatide, and the authors say the findings cannot be generalized.
- Culture
KFF poll finds 12% of US adults now take a GLP-1 drug as cost complaints persist
A KFF Health Tracking Poll published Nov. 14, 2025 found that 12% of US adults are currently taking a GLP-1 drug and 18% have ever taken one, up 6 percentage points from 18 months earlier. Among people who have taken the drugs, 56% said they were difficult to afford, and 27% of users with insurance paid the full cost themselves.
- Business
Novo Nordisk Foundation completes board overhaul, electing Sørensen as chair
At an extraordinary general meeting on Nov. 14, 2025, Novo Nordisk shareholders elected Lars Rebien Sørensen as chair, with Cees de Jong as vice chair and Britt Meelby Jensen and Stephan Engels as new board members. The Novo Nordisk Foundation, which holds 77% of voting rights while owning about 28% of the share capital, drove the change. The new board won more than 90% approval, but some minority investors protested or abstained over governance concerns.
- Business
Novo Nordisk shareholders elect new board at extraordinary general meeting
Novo Nordisk shareholders elected a new nine-member board of directors at an extraordinary general meeting on Nov. 14, 2025, with Lars Rebien Sørensen installed as chair. The vote gave the company's largest owner control of the board. The election was the only item on the agenda.
- Science
FDA approves Zepbound label update removing suicidal ideation warning and adding intestinal obstruction
The FDA approved supplement S-042 for Zepbound (tirzepatide), which Lilly submitted on November 14, 2025. The change adds intestinal obstruction and severe constipation including fecal impaction to the label's Postmarketing Experience section and removes the subsection on Suicidal Ideation and Behavior from Warnings and Precautions. The approval letter was signed February 25, 2026.
- Business
New Novo Nordisk chair signals interest in over-the-counter path for Wegovy
Novo Nordisk shareholders elected Lars Rebien Sorensen as board chair on Nov. 14, 2025, and he said he wants to add board members with recent pharmaceutical and over-the-counter experience, raising the possibility of a nonprescription path for obesity medicines. The revamped board won more than 90% approval, but some minority shareholders protested as the Novo Nordisk Foundation, which holds 77% of the company's voting rights, tightened its control. No over-the-counter application for Wegovy has been announced.
- Competition
Pfizer completes Metsera acquisition, adding experimental GLP-1 and amylin candidates
Pfizer closed its purchase of obesity drug developer Metsera on Nov. 13, 2025, paying $65.60 per share in cash, an enterprise value of about $7.0 billion, plus a contingent value right of up to $20.65 per share tied to three clinical and regulatory milestones. Fierce Biotech puts the total deal value at around $10 billion, up from the roughly $7.3 billion value of the September agreement, after a bidding fight with Novo Nordisk. The acquired pipeline includes MET-097i, a weekly and monthly injectable GLP-1 candidate about to start Phase 3, and MET-233i, a monthly amylin candidate in Phase 1.
- Business
Sandoz targets unbranded semaglutide in Canada by mid-2026
Sandoz chief executive Richard Saynor told Reuters that the company aims to launch unbranded semaglutide, the ingredient in Ozempic, in Canada by the end of June 2026, after Novo Nordisk's Canadian diabetes patent expires in January. He said he expects demand to outstrip supply and that Sandoz has given no sales forecast. Novo Nordisk's U.S. patents on Ozempic and Wegovy run to 2032.
- Competition
Lilly drops CVS as its employee pharmacy benefit manager after Zepbound formulary change
Eli Lilly is moving its employees' prescription drug coverage from CVS Health's Caremark to the pharmacy benefit manager Rightway, starting January 1, after Caremark dropped Lilly's Zepbound from its preferred list in favor of Novo Nordisk's Wegovy. Lilly did not directly say whether the two events are linked, and Reuters said it could not immediately verify the connection.
- Policy
Pharmacy group questions how the Lilly and Novo Nordisk GLP-1 pricing deal will work
Community pharmacy groups say important questions about the Trump administration's GLP-1 pricing agreements with Eli Lilly and Novo Nordisk remain unanswered, including whether the planned TrumpRx website will replace or sit alongside the manufacturers' direct-to-consumer programs. The agreements set a $245 monthly Medicare and Medicaid price for injectable Ozempic, Wegovy, Mounjaro and Zepbound, a $350 average monthly TrumpRx price for cash-paying vial buyers, and a $50 monthly Medicare copay.
- Culture
Lilly launches Zepbound clothing campaign with Tan France to address obesity stigma
Eli Lilly announced on Nov. 10, 2025 a Zepbound (tirzepatide) marketing campaign called the Changing the Thread Collection, built with stylist and Queer Eye star Tan France and centered on garments embroidered with stories from people living with obesity. An immersive display is scheduled for Nov. 14 and 15, 1 p.m. to 8 p.m., at 13 Crosby Street in New York City, with a companion website and a five-question quiz. France does not take Zepbound and was compensated for his time, the company says.
- Science
Wegovy liver benefits in MASH went beyond weight loss, Novo Nordisk analyses say
Novo Nordisk reported analyses dated Nov. 10, 2025 indicating that Wegovy (semaglutide 2.4 mg) was associated with liver health-related benefits in adults with MASH and liver scarring that were not solely based on weight loss. The findings follow the FDA's accelerated approval of Wegovy for MASH on Aug. 15, 2025, which covered adults with noncirrhotic MASH and moderate to advanced fibrosis, stages F2 to F3. The size of the liver benefit and the pathways involved have not been disclosed.
- Research and trials
Rhythm begins long-term study of oral bivamelagon for hypothalamic obesity
Rhythm Pharmaceuticals has started enrolling participants by invitation in a long-term phase 2 study of bivamelagon, an investigational oral MC4R agonist for hypothalamic obesity, listed on ClinicalTrials.gov as NCT07156578. The only approved medicine in this drug class is a daily injection, including for children as young as 4. The registry entry does not report a target enrollment number, study sites or an expected completion date.
- Research and trials
Study finds similar heart risk with tirzepatide and semaglutide in US insurance data
A real-world study of US insurance records found similar risk of heart attack, stroke or death among people who started tirzepatide versus semaglutide, with a hazard ratio of 1.06 (95% CI 0.95 to 1.18) across 297,842 people. In the same paper, semaglutide compared with sitagliptin had a hazard ratio of 0.82 (95% CI 0.74 to 0.91) for heart attack or stroke. The authors say the results support comparable cardiovascular benefit for the two drugs in clinical practice.
- Business
Pfizer wins Metsera with $10 billion offer as Novo Nordisk drops out
Pfizer agreed to buy obesity drug developer Metsera for up to $86.25 a share — $65.60 in cash plus contingent payments of up to $20.65 — valuing the biotech at more than $10 billion. Metsera's board accepted the offer on Nov. 7 after Novo Nordisk declined to raise its competing bid, which Metsera said carried "unacceptably high legal and regulatory risks." Shareholders vote Nov. 13.
- Prices
Reporters flag gaps in tirzepatide and semaglutide pricing agreement
Coverage of the Trump administration's pricing deal for weight loss drugs has identified several gaps. Several products in the agreement have not received FDA approval, including a multidose Zepbound pen and oral versions. The lowest advertised self-pay prices of $149 for pills and $350 for shots appear to apply mainly to starter doses, while higher doses of Zepbound could cost up to $449 a month.
- Culture
Lilly agrees to cut Zepbound prices and set a $50 Medicare copay
Eli Lilly said Nov. 6 it reached an agreement with the Trump administration to lower what patients pay for its obesity medicines. Medicare beneficiaries would pay no more than $50 a month for Zepbound and for orforglipron if approved, and self-pay patients would see Zepbound at $299 to $449 through LillyDirect. Lilly gets three years of tariff relief in return.
- Competition
Lilly and Novo Nordisk agree to $245 monthly GLP-1 prices for Medicare and Medicaid
The White House announced Nov. 6 that Eli Lilly and Novo Nordisk agreed to most-favored-nation pricing for their GLP-1 medicines, setting Medicare and Medicaid prices at $245 a month for Ozempic, Wegovy, Mounjaro and Zepbound and a $50 monthly copay for Medicare patients. Cash prices through a planned federal site called TrumpRx would start at $350 a month for Ozempic and Wegovy injections and about $150 for starting doses of oral versions. The agreements would let Medicare cover obesity drugs for the first time.
- Prices
Lilly and U.S. government agree to $50 Medicare copay for Zepbound and orforglipron
Eli Lilly and the U.S. government announced an agreement on Nov. 6, 2025 that caps Medicare copays at $50 a month for Zepbound (tirzepatide) and for orforglipron, Lilly's experimental obesity pill, starting as early as April 1, 2026, if regulators approve. Self-pay patients would pay $299 to $449 for the Zepbound multi-dose pen through LillyDirect, and Medicare and Medicaid would pay $245 for tirzepatide and semaglutide products.
- Culture
Trump announces GLP-1 discounts for some Medicare and Medicaid patients
President Trump said Eli Lilly and Novo Nordisk agreed to discount their GLP-1 medicines for certain Medicare and Medicaid enrollees and for buyers on a planned site called TrumpRx, with officials putting the typical monthly cost for eligible patients at $245 to $350. Trump repeatedly called the drugs "the fat drug" during the Oval Office event, which ended early after a company guest fainted.
- Business
White House deal sets $245 monthly Medicare price for Ozempic, Wegovy, Mounjaro and Zepbound
On Nov. 6, 2025, the White House announced agreements with Eli Lilly and Novo Nordisk setting a $245 monthly price for injectable Ozempic, Wegovy, Mounjaro and Zepbound in Medicare and Medicaid, with a $50 Medicare copay. The same drugs would sell for about $350 a month on a new government site, TrumpRx, and Medicare would cover Wegovy and Zepbound for obesity for the first time.
- Science
Lilly's eloralintide cut weight up to 20.1% in Phase 2 trial, company reports
Eli Lilly reported that eloralintide, an experimental once-weekly injection, produced average weight loss of 9.5% to 20.1% over 48 weeks in a Phase 2 trial of 263 U.S. adults with obesity or overweight, versus 0.4% with placebo. The data were presented at ObesityWeek 2025 and published in The Lancet. Lilly says Phase 3 enrollment will begin by the end of the year.
- Research and trials
Lilly's amylin drug eloralintide shows up to 20% weight loss in phase 2 trial
Eli Lilly's experimental once-weekly injection eloralintide helped adults with obesity or overweight lose between 9.5% and 20.1% of their body weight over 48 weeks in a phase 2 trial, compared with 0.4% on placebo. The drug is an amylin receptor agonist, a different mechanism from GLP-1 medicines like Ozempic, Wegovy and Zepbound. Lilly said it will begin enrolling phase 3 studies in obesity by the end of the year.
- Research and trials
Lilly's eloralintide shows up to 20.1% weight loss in Phase 2 trial
Eli Lilly reported Nov. 6, 2025 that its experimental once-weekly drug eloralintide produced average weight loss of 9.5% to 20.1% over 48 weeks in a Phase 2 trial of 263 adults with obesity or overweight, compared with 0.4% for placebo. The company described tolerability as favorable, with mostly mild to moderate gastrointestinal side effects. Lilly plans to begin Phase 3 enrollment for obesity by the end of 2025.
- Policy
Novo Nordisk and Eli Lilly win tariff relief and fast-track vouchers in GLP-1 pricing deal
The Trump administration announced a pricing agreement with Novo Nordisk and Eli Lilly on November 6, 2025 that lowers GLP-1 prices for Medicare, Medicaid and cash payers while giving the companies relief from pharmaceutical tariffs and fast-track regulatory vouchers. Injectable GLP-1s would cost $245 a month for Medicare and Medicaid patients, with Medicare co-pays capped at $50, and starter doses of the companies' experimental weight-loss pills would cost $149 a month if approved.
- Culture
Kennedy backs Trump deal with Lilly and Novo Nordisk to expand obesity drug access
On Nov. 6, 2025, Health Secretary Robert F. Kennedy Jr. endorsed the Trump administration's plan to expand access to obesity medications made by Eli Lilly and Novo Nordisk, including for Medicare and Medicaid patients, calling it "a momentous accomplishment." The reversal unsettled parts of his Make America Healthy Again movement, which has opposed Medicare coverage of GLP-1 weight-loss drugs, and some followers now question the movement's direction. Kennedy described the drugs as "a tool in the toolkit" and "not a silver bullet."
- Business
Lilly adds two executive committee members and widens roles for two top leaders
Eli Lilly said on Nov. 6, 2025, that Carole Ho will join as president of Lilly Neuroscience and Adrienne Brown was promoted to president of Lilly Immunology, with both taking seats on its Executive Committee. Daniel Skovronsky's title widened to chief scientific and product officer, and Jacob Van Naarden added corporate business development to his oncology role. The company said the changes are meant to speed its pipeline and strengthen patient access to its medicines.
- Regulation
Lilly expected FDA clearance for orforglipron by March 2026; the pill is now sold as Foundayo
Eli Lilly said on Nov. 6, 2025 that it expected the FDA to approve its experimental oral obesity drug orforglipron by March 2026, according to its chief executive. The drug is now sold in the United States under the brand name Foundayo, and Lilly said on Sept. 14, 2026 that it had captured more than 30% of new US patients starting oral weight-loss medicines. Pricing, trial results and insurance coverage details have not been reported.
- Policy
Lilly and Novo Nordisk agree to $245 Medicare prices for GLP-1 drugs
On Nov. 6, 2025, the Trump administration announced agreements with Eli Lilly and Novo Nordisk to sell semaglutide and tirzepatide at most-favored-nation prices: an average $350 a month for vials of the weight-management versions on TrumpRx, and $245 a month for injectable Ozempic, Mounjaro, Wegovy and Zepbound under Medicare and Medicaid, with a $50 Medicare copay. The deals also set Emgality at $299 per pen, Trulicity at $389 a month and Novo Nordisk insulins including NovoLog and Tresiba at $35 a month.
- Science
Review of tirzepatide mechanism cites GLP-1 receptor affinity figure that differs from discovery paper
A Lilly-authored narrative review published Nov. 6 in Diabetes Therapy describes how tirzepatide, sold as Mounjaro and Zepbound, activates the GIP and GLP-1 receptors. The review states tirzepatide's affinity for the GLP-1 receptor is roughly 18- to 20-fold weaker than native GLP-1, a wider gap than the roughly 5-fold figure reported in the drug's original discovery and receptor-occupancy papers. No new trial data are presented.
- Research and trials
Tirzepatide lowered uric acid in SURMOUNT-1 analysis, mostly through weight loss
A post hoc analysis of the SURMOUNT-1 trial found that tirzepatide reduced serum uric acid by 0.69 to 0.95 mg/dL depending on dose after 72 weeks, compared with 0.18 mg/dL on placebo, with 72.7 percent of the drop attributed to weight loss. Separate case reports describe short-term uric acid increases and gout attacks in the first months of treatment with tirzepatide and semaglutide.
- Business
Pfizer sues Novo Nordisk and Metsera as buyout bids climb past $10 billion
Pfizer and Novo Nordisk have each raised their offers for Metsera, a private obesity drug developer whose pipeline includes a once-monthly GLP-1 injection and an oral candidate. Metsera's board has called Novo's bid of up to $10 billion better than Pfizer's roughly $8.1 billion, and Pfizer has filed two lawsuits in Delaware.
- Research and trials
Novo Nordisk presents four analyses of oral semaglutide 25 mg at ObesityWeek 2025
On Nov. 5, 2025, Novo Nordisk presented four new analyses of oral semaglutide 25 mg at ObesityWeek 2025, covering cardiometabolic outcomes beyond weight loss. The analyses came from the 64-week OASIS 4 trial and reported that 71.1% of participants with prediabetes at baseline reached normal blood glucose, versus 33.3% on placebo. Novo said the data supported its then-pending US application for a weight-loss pill.
- Research and trials
Noom, Found and Hims & Hers sell compounded GLP-1 microdoses without evidence they work
On Nov. 4, 2025, STAT reported that Noom, Found and Hims & Hers had each launched programs prescribing compounded GLP-1 microdoses within about three months, following smaller telehealth companies, even though physicians and researchers say there is no robust clinical evidence that semaglutide or tirzepatide are effective at very small doses. A May 29, 2026 First Opinion piece in STAT by Harvard endocrinologist Jody Dushay said no legitimate long-term data support microdosing and that there is no agreed definition of a microdose.
- Competition
Hengrui and Kailera report 19.2% weight loss at 48 weeks for dual GLP-1/GIP drug HRS9531
Hengrui Pharma and Kailera Therapeutics reported that HRS9531, an investigational once-weekly dual GLP-1/GIP injection, produced a mean 19.2% weight loss at the 6 mg dose over 48 weeks in a Phase 3 trial in China, with no plateau. The trial enrolled 567 adults with obesity or overweight and no diabetes, while placebo produced 1.4% mean weight loss. Hengrui has filed for approval in China, and Kailera plans to begin global Phase 3 testing of 8 mg and 10 mg doses by the end of 2025.
- Safety
Study finds similar gastrointestinal safety for semaglutide, tirzepatide and dulaglutide
A new-user, active-comparator cohort study published in Annals of Internal Medicine compared dulaglutide, subcutaneous semaglutide and tirzepatide in adults with type 2 diabetes. The hazard ratio for a composite of five severe gastrointestinal events was 1.07 for tirzepatide versus semaglutide (95% CI, 0.90 to 1.26), 0.96 for tirzepatide versus dulaglutide (95% CI, 0.77 to 1.20) and 0.96 for semaglutide versus dulaglutide (95% CI, 0.87 to 1.06). The authors concluded the three drugs have similar gastrointestinal safety profiles.
- Business
Lilly plans $3 billion Dutch plant to make orforglipron and other oral medicines
Eli Lilly said on Nov. 3, 2025 that it plans to build a $3 billion manufacturing plant in Katwijk, the Netherlands, to expand production of oral medicines, including its experimental GLP-1 pill orforglipron. Lilly said the site would bring 500 manufacturing jobs and about 1,500 construction roles, with building expected to start in 2026 if permits are finalized. The company says it expects to submit orforglipron to regulators for obesity by the end of 2025.
- Compounding
Novo Nordisk pegs US compounded GLP-1 use at up to 1.5 million people
Novo Nordisk has estimated that as many as 1.5 million people in the United States are taking compounded versions of GLP-1 drugs, a cheaper option many turned to during the supply shortages. The company has paired that estimate with stepped-up enforcement and a cash-price push, including deeper discounts through its NovoCare platform. Novo also warned that its overall sales will decline this year as pricing pressure builds and Eli Lilly's Zepbound keeps gaining.
- Competition
Pfizer sues Novo Nordisk again over Metsera obesity drug bidding war
Pfizer filed a second lawsuit against Novo Nordisk on Nov. 3, accusing it of structuring a roughly $9 billion bid for Metsera to delay the biotech's obesity drugs rather than close a deal. Pfizer had agreed to pay up to $7.3 billion for Metsera in September, and a Delaware judge will hear the claims on Tuesday.
- Research and trials
Tirzepatide linked to lower albuminuria in post hoc analysis of SURMOUNT trials
A post hoc analysis of the SURMOUNT-1 and SURMOUNT-2 trials found that tirzepatide was associated with lower urine albumin-to-creatinine ratio than placebo at week 72, with an 8.4% difference in SURMOUNT-1 and 31.1% in SURMOUNT-2. Among participants who started with elevated albuminuria, reductions exceeded 40% in one trial and 55% in the other. Kidney filtration did not worsen.
- Competition
Zepbound passes Wegovy in US prescriptions as Lilly takes 58% of GLP-1 market
Eli Lilly's Zepbound has overtaken Novo Nordisk's Wegovy in U.S. prescription volume and in dollar sales, with Lilly now holding about 58% of U.S. GLP-1 prescriptions to Novo's 42%. Wegovy sales growth slowed to 18% year over year in the third quarter, down from 67% the quarter before. Novo has cut U.S. prices on Ozempic and Wegovy and says the pricing changes will have only a low single digit negative effect on 2026 sales growth.
- Compounding
Lilly cuts self-pay Zepbound prices as federal TrumpRx site lists $299 starting tier
Eli Lilly lowered cash prices for its self-pay Zepbound tiers under a federal pricing agreement, and the federal TrumpRx.gov site now lists Zepbound starting at $299 a month. TrumpRx does not sell the drug; for Zepbound it directs buyers to LillyDirect, where prices run $299 for 2.5 mg, $399 for 5 mg and $449 for 7.5 mg to 15 mg when refills stay within 45 days.
- Business
Lilly and Novo Nordisk agree to $245 monthly price for GLP-1 injectables in Medicare and Medicaid
The Trump administration announced agreements with Eli Lilly and Novo Nordisk that set a $245 monthly price for injectable Ozempic, Mounjaro, Wegovy and Zepbound under Medicare, with the same price offered to state Medicaid programs. The companies also agreed to sell weight-management GLP-1 vials on the TrumpRx platform at an average $350 a month, about 30 percent below the $499 cash price they charge today.
- Research and trials
Waist size and blood pressure tracked weight regain after tirzepatide stopped, SURMOUNT-4 analysis finds
A post hoc analysis of the SURMOUNT-4 trial published in JAMA Internal Medicine sorted participants by how much weight they regained after stopping tirzepatide. Waist circumference grew by 0.8 cm in the group that regained the least and by 14.7 cm in the group that regained the most, while systolic blood pressure rose between 6.8 and 10.4 mm Hg across the same groups.
- Research and trials
AASLD guidance covers semaglutide for MASH with moderate-to-advanced fibrosis
The American Association for the Study of Liver Diseases issued a November 2025 update to its practice guidance on using semaglutide (Wegovy) to treat MASH with moderate-to-advanced fibrosis, after the FDA granted accelerated approval on August 15, 2025. The guidance says patients can be chosen with non-invasive tests rather than liver biopsy, and cites ESSENCE trial results in which 62.9% of semaglutide-treated patients had MASH resolve without worsening fibrosis versus 34.3% on placebo over 72 weeks.
- Culture
Book traces Ozempic's path from GLP-1 research to Novo Nordisk's rise
Aimee Donnellan's "Off the Scales: The Inside Story of Ozempic and the Race to Cure Obesity" went on sale Nov. 18, 2025, from St. Martin's Press. The 320-page, $30 book reconstructs the research behind semaglutide and the boardroom decisions that made Denmark's Novo Nordisk the most valuable company in Europe, according to the publisher. The Guardian's review says the book reports that trial participants lost up to 20 percent of their body weight.
- Business
Novo Nordisk says 9,000 job cuts are nearly complete
Novo Nordisk CEO Mike Doustdar said the company has notified employees affected by its 9,000-job restructuring in the vast majority of its locations, with the pace of the notices set by local laws. Doustdar announced the cuts in September as Novo faces heated competition in the U.S. market against rival Eli Lilly.
- Business
Tirzepatide passes Keytruda as world's best-selling medicine
Eli Lilly's tirzepatide, sold as Mounjaro for type 2 diabetes and Zepbound for obesity, recorded $10.1 billion in third-quarter sales, topping Merck's Keytruda at $8.1 billion. The combined brands also lead for the year to date, at $24.8 billion against $23.3 billion for Keytruda, according to Lilly's quarterly results released October 30, 2025.
- Business
Cochrane review finds liraglutide likely aids 5% weight loss, but other evidence is uncertain
A World Health Organization-funded Cochrane review of 24 randomized trials and 9,937 participants found liraglutide likely raises the share of adults with obesity who lose at least 5% of body weight, with a risk ratio of 2.10 versus placebo. The review rated evidence on percentage weight change, cardiovascular events, quality of life and mortality as limited or uncertain, and found low-certainty evidence of more adverse events and more withdrawals due to side effects. Twenty-two of the 24 trials were funded by the drug's manufacturer.
- Business
Novo Nordisk bids $9 billion for Metsera, triggering Pfizer lawsuits
Novo Nordisk launched an unsolicited bid of about $9 billion for the obesity biotech Metsera on October 30, 2025, challenging an acquisition Pfizer had already agreed to. Pfizer filed two lawsuits in Delaware, and Metsera said Novo's offer was superior while giving Pfizer until Tuesday to raise its bid.
- Business
Lilly revenue rises 54% on Mounjaro and Zepbound, and 2025 guidance goes up
Eli Lilly reported third-quarter 2025 revenue of $17.60 billion, up 54% from a year earlier, led by Mounjaro at $6.52 billion and Zepbound at $3.59 billion. The company raised its full-year 2025 revenue guidance to $63.0 billion to $63.5 billion and said it plans to submit its oral GLP-1 pill, orforglipron, to regulators by the end of the year for obesity.
- Research and trials
Protocol published for semaglutide trial in opioid use disorder
Researchers published the design of a phase II randomized, double-blind, placebo-controlled trial testing whether semaglutide helps outpatients with opioid use disorder stop using illicit and nonprescribed opioids. The trial is planned for 200 participants enrolled in an outpatient medications-for-opioid-use-disorder program, 100 on buprenorphine and 100 on methadone, with outcomes tracked over 19 weeks. No results are reported yet.
- Business
Zepbound vials will be available for pickup at Walmart pharmacies at LillyDirect self-pay prices
Eli Lilly and Walmart said Zepbound (tirzepatide) single-dose vials will be available for in-store pickup at nearly 4,600 Walmart pharmacies nationwide by mid-November 2025. The self-pay prices match LillyDirect home delivery: $349 a month for the 2.5 mg starting dose and $499 a month for higher doses. It is the first retail pickup option for LillyDirect, Lilly's direct-to-consumer platform.
- Culture
Lilly and Walmart launch retail pickup for Zepbound vials at self-pay prices
Eli Lilly and Walmart said Zepbound single-dose vials ordered through LillyDirect can be picked up at about 4,600 Walmart pharmacies nationwide by mid-November, the first retail pickup option for a manufacturer's direct-to-consumer price. Self-pay prices are $349 a month for the 2.5 mg starting dose and $499 a month for higher doses.
- Business
Lilly to invest $1.2 billion in Puerto Rico plant for oral GLP-1 pill orforglipron
Eli Lilly said on Oct. 29 it will spend more than $1.2 billion to expand and modernize its Lilly del Caribe site in Carolina, Puerto Rico, adding capacity for oral medicines including its experimental obesity pill orforglipron. The project is expected to create 100 permanent high-tech manufacturing jobs and up to 1,000 construction jobs, with construction starting in 2026 and production targeted for the end of 2028. Orforglipron is not yet approved; Lilly says it expects to submit it to regulators by the end of this year.
- Business
Lilly and NVIDIA build 1,000-GPU AI supercomputer for drug discovery
Eli Lilly announced on Oct. 28, 2025 that it is building a supercomputer with NVIDIA that it calls the most powerful owned and operated by a pharmaceutical company. The system uses more than 1,000 NVIDIA B300 GPUs and is the world's first NVIDIA DGX SuperPOD built with DGX B300 systems. CEO Dave Ricks later said it was built in Indianapolis and is already being used by scientists and in manufacturing.
- Compounding
FDA classifies Class II recall of ProRx compounded semaglutide injections
The FDA classified a ProRx LLC recall of compounded semaglutide injections as Class II on October 27, 2025, after the company pulled more than 36,000 multidose vials over a lack of sterility assurance. The voluntary recall began October 15, 2025, and the affected vials were distributed in Texas and Utah.
- Science
FDA approves Mounjaro heart-risk indication and tirzepatide label updates from SURPASS-CVOT
The FDA approved supplemental label changes for Eli Lilly's tirzepatide products, adding cardiovascular outcomes trial data to both Mounjaro and Zepbound and a new indication for Mounjaro to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high risk. The Mounjaro supplements were received October 27 and November 5, 2025, and signed August 27, 2026; the Zepbound supplement was dated October 24, 2025, and approved effective August 26, 2026.
- Compounding
Lilly sues two more Texas compounding pharmacies over tirzepatide replicas
Eli Lilly filed lawsuits on October 27, 2025 against two Texas compounding pharmacies, alleging they sold replicas of its tirzepatide medicines Mounjaro and Zepbound. The filings extend a campaign Lilly has brought in 34 states, while Novo Nordisk has filed similar suits in almost 40 states.
- Culture
Lilly partners with Shaquille O'Neal on sleep apnea awareness campaign
Eli Lilly and Company announced on Oct. 27, 2025 that it is partnering with Shaquille O'Neal on a campaign to raise awareness of moderate-to-severe obstructive sleep apnea, a condition the company says affects an estimated 24 million U.S. adults. The campaign, called "Don't Sleep on OSA," promotes symptom recognition and visits to a health care provider, and it does not name any Lilly medicine.
- Competition
Mazdutide beats semaglutide on blood sugar and weight in first head-to-head Phase 3
Innovent Biologics said its GLP-1/glucagon dual agonist mazdutide outperformed semaglutide on a combined blood sugar and weight-loss goal in a 349-patient Phase 3 trial in China, with 48% of mazdutide patients hitting the target versus 21% on semaglutide. Average HbA1c fell 2.03 percentage points with mazdutide and 1.84 with semaglutide, while average weight loss was 10.26% versus 6%. It is the first Phase 3 trial to compare a drug from the GLP-1/glucagon class directly with semaglutide.
- Business
Lilly completes acquisition of Adverum and its wet AMD gene therapy Ixo-vec
Eli Lilly agreed on Oct. 24, 2025 to acquire Adverum Biotechnologies for $3.56 a share in cash plus contingent value rights worth up to $8.91 more per share, and the tender offer expired on Dec. 8, 2025 with about 64% of shares tendered. The deal adds Ixo-vec, an experimental one-time gene therapy for wet age-related macular degeneration, to Lilly's pipeline. The total value of the acquisition was not disclosed.
- Regulation
EU regulator moves to add Mounjaro head-to-head semaglutide data to label
The European Medicines Agency's human medicines committee recommended on Oct. 23, 2025, that results from SURMOUNT-5, the trial that compared tirzepatide (Mounjaro) head-to-head with semaglutide, be added to section 5.1 of the EU summary of product characteristics for Mounjaro. Section 5.1 is where regulators describe clinical trial data; a European Commission decision on the label change is issued within two months for certain variation types or up to one year for others. The specific SURMOUNT-5 figures and the exact label wording have not been disclosed.
- Competition
Lilly licenses Cipla to sell tirzepatide in India under the brand Yurpeak
Eli Lilly signed an agreement allowing Cipla to sell Lilly's tirzepatide in India under a second brand name, Yurpeak, the companies said on Oct. 23. The product will be a once-weekly pre-filled injector pen in six dose strengths, priced the same as Lilly's Mounjaro. Financial terms were not disclosed.
- Science
Semaglutide heart benefit holds across all weight and waist groups in SELECT analysis
A prespecified analysis of the SELECT trial, published in The Lancet, found semaglutide reduced major adverse cardiovascular events consistently across all baseline weight and waist-circumference categories among 17,604 patients. Researchers estimated that 33% of the benefit was mediated through waist-circumference reduction, suggesting other mechanisms are also at work.
- Business
Novo Nordisk to replace chair and most of its board at Nov. 14 vote
Novo Nordisk will replace its board chair, vice chair and independent directors after the Novo Nordisk Foundation, which holds more than 70% of shareholder votes, pushed for a broader board overhaul than directors wanted. The Foundation has nominated Lars Rebien Sørensen, the company's chief executive from 2000 to 2016, as chair, with Cees de Jong as vice chair and three other members, for a vote on Nov. 14, 2025.
- Competition
Terns Pharmaceuticals halts oral GLP-1 drug TERN-601 after mixed Phase 2 results
Terns Pharmaceuticals said Oct. 21 it will stop developing TERN-601, an experimental once-daily oral GLP-1 pill for obesity, after 12-week Phase 2 data showed weight loss of up to 4.6% more than placebo. About 11.9% of the 134 participants stopped the drug because of side effects, and three patients had serious liver enzyme elevations after treatment ended. The company said it does not plan to invest further in metabolic disease.
- Research and trials
Novo Nordisk previews oral semaglutide 25 mg data ahead of ObesityWeek 2025
Novo Nordisk said on October 20, 2025 that it would present new data on oral semaglutide 25 mg and its obesity pipeline at ObesityWeek 2025. Four analyses of the 25 mg pill were presented at the meeting on November 5, 2025, and the FDA approved the pill for weight loss on December 22, 2025, based on a trial in which participants lost about 17% of body weight while on treatment.
- Regulation
FDA adds a cardiovascular indication to the oral GLP-1 Rybelsus
On October 17, 2025, the FDA cleared Rybelsus (semaglutide) to lower the risk of major adverse cardiovascular events in adults with type 2 diabetes at high risk, making it the first oral GLP-1 with that indication. In the SOUL trial, oral semaglutide 14 mg cut MACE risk by 14% relative to placebo over a mean follow-up of about four years, with a 2% absolute risk reduction at three years.
- Prices
Trump floats $150 monthly price for GLP-1 drugs, sending Lilly and Novo shares lower
President Donald Trump said he wants Americans to pay about $150 a month for brand-name GLP-1 weight-loss drugs, far below the roughly $1,000 list price of Ozempic. Shares of Eli Lilly, Novo Nordisk and Hims & Hers Health fell the next trading day. The Centers for Medicare and Medicaid Services said no GLP-1 prices have been negotiated yet.
- Business
Lilly's oral GLP-1 orforglipron tops two comparators in Phase 3 diabetes trials
Eli Lilly reported that its once-daily oral GLP-1 pill orforglipron met the main goal in two Phase 3 type 2 diabetes trials. In ACHIEVE-2, orforglipron lowered A1C by up to 1.7 percentage points versus 0.8 points for dapagliflozin, and in ACHIEVE-5 it lowered A1C by an additional 2.1 points when taken with insulin glargine.
- Research and trials
Lilly starts 4,500-person trial of tirzepatide and retatrutide in fatty liver disease without biopsy endpoint
Eli Lilly has begun SYNERGY-Outcomes, a 4,500-participant phase 3 master-protocol trial testing tirzepatide and retatrutide against placebo in adults with metabolic dysfunction-associated steatotic liver disease. The study does not use a liver-biopsy endpoint and instead measures hard liver outcomes over about 224 weeks, with primary completion estimated for 2030.
- Research and trials
Lilly's orforglipron pill beats dapagliflozin and adds to insulin in two Phase 3 diabetes trials
Eli Lilly reported on Oct. 15, 2025 that its experimental oral GLP-1 pill orforglipron lowered A1C by up to 1.7 percentage points versus 0.8 points for dapagliflozin in one Phase 3 trial in type 2 diabetes. In a second trial, orforglipron lowered A1C by up to 2.1 points from a baseline of 8.5% in people taking insulin glargine, compared with 0.8 points for placebo. Side effects were mostly gastrointestinal and generally mild to moderate, and the drug is not approved.
- Regulation
FDA adds intestinal obstruction and kidney injury to Ozempic label and updates Wegovy
The FDA approved revised prescribing information for the semaglutide injections Ozempic and Wegovy on October 14, 2025. Both labels now list intestinal obstruction and severe constipation including fecal impaction in their postmarketing experience sections, while Ozempic's label adds acute kidney injury and headache. The approval letters give no case counts or rates for these reports.
- Regulation
FDA asked Lilly to add intestinal obstruction to the Zepbound label
The FDA issued a supplement request letter to Eli Lilly on October 14, 2025, asking the company to update the Zepbound label based on its evaluation of a safety signal for intestinal obstruction and fecal impaction across the GLP-1 receptor agonist class. The signal was first flagged to Lilly in an April 28, 2025 notification, and the resulting supplement, submitted November 14, 2025, was approved. It adds intestinal obstruction and severe constipation including fecal impaction to the postmarketing experience section and removes suicidal ideation information from the label and Medication Guide.
- Competition
Kailera raises $600 million to move obesity drug KAI-9531 into global Phase 3
Kailera Therapeutics raised $600 million in a Series B round led by Bain Capital Private Equity to fund global Phase 3 trials of KAI-9531, an injectable obesity drug that acts on GLP-1 and GIP like Zepbound. A Phase 3 trial in China showed about 18% average weight loss over 48 weeks in 567 people. The FDA is likely to require a larger, longer, multi-country study before US clearance, and Kailera plans to start international Phase 3 testing by the end of 2026.
- Business
Novo Nordisk says notices nearly complete for 9,000 job cuts
Novo Nordisk has notified employees affected by its plan to cut about 9,000 jobs in the vast majority of the countries where it operates, CEO Mike Doustdar said in a LinkedIn post on Oct. 31, 2025. The company said the timing varied by country because of local labor laws. Layoff notices reportedly began going out on Oct. 14, 2025, across departments including medical and regulatory, clinical development, sales and finance.
- Competition
Novo Nordisk to buy Akero Therapeutics for up to $5.2 billion, adding MASH drug efruxifermin
Novo Nordisk agreed on October 9 to acquire Akero Therapeutics for $54 a share in cash, about $4.7 billion, plus a contingent value right of up to $6 a share that could raise the total to $5.2 billion. The deal adds efruxifermin, an FGF21 analog in phase 3 testing for MASH, to Novo's portfolio. Novo called it a potential first- and best-in-class treatment for mid- to late-stage liver disease.
- Compounding
Delaware judge dismisses Lilly's suit against Strive over compounded tirzepatide ads
A federal judge in Delaware dismissed Eli Lilly's false-advertising suit against Strive Pharmacy LLC on October 8, 2025, ruling the court lacks personal jurisdiction over the Arizona company. Lilly had challenged marketing of a compounded product combining tirzepatide with vitamin B12 and glycine. The court did not rule on whether the advertising was deceptive.
- Prices
North Carolina's state health plan gains right to negotiate GLP-1 prices directly
North Carolina's State Health Plan has reworked its contract with pharmacy benefit manager CVS Caremark so it can bargain directly with GLP-1 manufacturers and design a middle tier of coverage instead of an all-or-nothing benefit. The plan cut weight-loss coverage for the drugs in April 2024, when about 23,000 members were taking them at a cost of more than $800 a month each after rebates. Nothing has been restored yet, and officials say any deal is likely in 2026 or later.
- Competition
Novo Nordisk starts 9,000 job cuts, including production roles at North Carolina Wegovy plant
Novo Nordisk has begun global layoffs totaling about 9,000 jobs, including 5,000 in Denmark, out of a workforce of 78,400. Reuters reported the cuts reached the Clayton, North Carolina plant, which makes semaglutide for Wegovy and Ozempic, hitting roles from quality control to production line technicians. Novo expects the restructuring to save about $1.25 billion a year by 2026.
- Research and trials
Study links tirzepatide and semaglutide to fewer alcohol use disorder diagnoses
A target trial emulation using records from more than 120 million US patients found that adults with type 2 diabetes prescribed tirzepatide had a 53 percent lower rate of a first alcohol use disorder diagnosis than those prescribed DPP-4 inhibitors, with a hazard ratio of 0.47. Semaglutide was linked to a 32 percent lower rate, while liraglutide and dulaglutide showed no significant difference. The authors say randomized trials are needed, and alcohol use disorder is not an approved use of these drugs.
- Research and trials
Systematic review links GLP-1 drugs to better headache and vision outcomes in IIH
A systematic review published October 7, 2025 in The Journal of Headache and Pain found GLP-1 receptor agonist use was consistently associated with improved headache frequency, weight loss and less need for acetazolamide or surgery in people with idiopathic intracranial hypertension. The review covered nine clinical studies — one randomized controlled trial and eight observational studies — and its authors called for phase 3 randomized trials.
- Safety
Randomized trial of tirzepatide for alcohol use disorder begins enrolling
A phase 2 randomized trial of tirzepatide for alcohol use disorder has started recruiting adults, according to its ClinicalTrials.gov listing. The University of Southern California study plans to enroll 42 people and uses heavy drinking days as the primary outcome, with an estimated completion date of August 2026. Tirzepatide is not approved for alcohol use disorder.
- Science
2025 Nobel Prize in medicine goes to immune tolerance researchers, not GLP-1 drugs
The 2025 Nobel Prize in Physiology or Medicine was awarded on Oct. 6 to Mary E. Brunkow, Fred Ramsdell and Shimon Sakaguchi for discoveries about peripheral immune tolerance, the system that keeps the immune system from attacking the body's own tissue. The prize is 11 million Swedish kronor, shared equally among the three. The announcement recognized no GLP-1 researcher or drug.
- Business
Eli Lilly to invest more than $1 billion in India manufacturing partnerships
Eli Lilly said on October 6 that it will invest more than $1 billion in India over the coming years to expand manufacturing and supply through partnerships with local drugmakers. The company said the collaborations aim to increase availability of its key drugs, including obesity and diabetes treatments, but did not disclose which manufacturers or products are involved. Lilly launched its tirzepatide drug Mounjaro in India this year and does not operate its own manufacturing facility there.
- Research and trials
Review of 56 trials finds only semaglutide and tirzepatide top 10% weight loss
A systematic review and network meta-analysis of 56 randomized trials and 60,307 adults found that all six obesity medications studied beat placebo on weight loss, but only semaglutide and tirzepatide averaged more than 10% total body weight loss. Semaglutide was the only drug with proven reductions in major cardiovascular events and knee osteoarthritis pain, while tirzepatide was the only one with proven remission of obstructive sleep apnea and MASH.
- Research and trials
Cost and insurance, not side effects, lead patients to stop obesity drugs, Cleveland Clinic study finds
A Cleveland Clinic study of 288 adults who stopped injectable semaglutide or tirzepatide within a year found cost or insurance problems were the documented reason for 137 of them, or 47.6%. Side effects accounted for 14.6%, drug shortages 11.8%, switching to a compounded product 2.4%, and unsatisfactory weight loss 1.7%.
- Safety
European regulator opens review of possible tirzepatide-warfarin interaction
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee opened a new signal on tirzepatide interacting with warfarin and other coumarin derivatives and lowering INR, based on four cases raised by Spain at its 29 September to 2 October 2025 meeting. Drugmaker Eli Lilly was told to submit a cumulative review within 90 days and to discuss whether product information for tirzepatide medicines should change.
- Science
European obesity group names semaglutide and tirzepatide first-line obesity drugs
The European Association for the Study of Obesity published a guideline on Oct. 2, 2025 recommending semaglutide (Wegovy, Ozempic) and tirzepatide (Zepbound, Mounjaro) as the first-choice medicines for obesity and most related complications. The guideline splits recommendations by condition, favoring tirzepatide for obstructive sleep apnea and semaglutide for knee osteoarthritis and for people with established heart disease. It is not binding on individual countries.
- Research and trials
VA study finds liraglutide, semaglutide and dulaglutide similar on kidney and heart outcomes
A target-trial emulation of 21,790 veterans with type 2 diabetes found similar risks of kidney failure and major cardiovascular events whether they started liraglutide, semaglutide or dulaglutide. Death results were mixed: liraglutide's lower mortality compared with semaglutide held in one analysis but not another. The authors say randomized head-to-head trials are needed to confirm the findings.
- Culture
North Carolina Medicaid ends obesity coverage for Wegovy and Zepbound
North Carolina Medicaid stopped covering GLP-1 drugs for obesity on Oct. 1, 2025, citing shortfalls in state funding. Wegovy, Zepbound and Saxenda were removed from the preferred drug list, while coverage continues for diabetes, cardiovascular disease, MASH and sleep apnea. The change follows an earlier State Health Plan decision to cut weight-loss GLP-1 coverage for state employees.
- Safety
Semaglutide labels add a warning for severe gastrointestinal reactions
In October 2025, the US prescribing information for Ozempic and Wegovy injections, oral Wegovy tablets, and the oral semaglutide products Rybelsus and Ozempic tablets added a Severe Gastrointestinal Adverse Reactions section to Warnings and Precautions. The new sections state that gastrointestinal reactions are sometimes severe and that semaglutide is not recommended in people with severe gastroparesis. Wegovy labeling reports severe gastrointestinal reactions in 4.1% of treated adults compared with 0.9% on placebo.
- Research and trials
Tirzepatide cut HbA1c by 2.23 points in youth with type 2 diabetes, phase 3 trial finds
The Lancet published SURPASS-PEDS, a phase 3 trial of tirzepatide in 99 children and adolescents with type 2 diabetes across 39 sites in eight countries. At 30 weeks, pooled tirzepatide lowered HbA1c by a mean of 2.23 percentage points, while the placebo group rose 0.05 points, and BMI fell 7.4% on 5 mg and 11.2% on 10 mg. Gastrointestinal side effects were the most common and were mild to moderate in severity.
- Prices
Costco offers Wegovy and Ozempic at $499 a month for cash-paying members
Costco has begun selling Wegovy and Ozempic to cash-paying members for $499 a month, joining a wider retail push into discounted GLP-1 drugs. Walmart has rolled out a comparable arrangement with Eli Lilly for Zepbound. The Costco price sits above the $349 monthly cash price Novo Nordisk has announced for the lowest dose of the Wegovy injection, and Costco has not said which doses the $499 covers.
- Safety
UK regulator dismantles illegal tirzepatide factory, seizing 2,000 injection pens
Britain's Medicines and Healthcare products Regulatory Agency dismantled a factory in central England that it described as the world's largest seizure of unlicensed weight-loss medicines. The October operation took 2,000 injection pens labeled as containing tirzepatide, plus products labeled as containing retatrutide, tens of thousands of empty pens and raw chemicals. The MHRA said it was the first illicit weight-loss manufacturing facility found in Britain.
- Business
Victoza and Saxenda labels add warning on severe gastrointestinal reactions
In October 2025, Novo Nordisk's liraglutide labels for Victoza and Saxenda gained a new Warnings and Precautions subsection on severe gastrointestinal adverse reactions. Both now state that liraglutide is not recommended in patients with severe gastroparesis, language that previously did not appear in the labels' warnings sections.
- Culture
One in eight Americans has used a GLP-1 medicine like Ozempic, food-industry report says
About 12% of Americans — roughly 41 million people — have used a GLP-1 medicine, and about 20 million are taking one now, according to industry analysis cited in a food-industry report published Oct. 20, 2025. The same article cites a lower headline figure of 6% of Americans currently taking a GLP-1 and says that number could be wildly underestimated. Food companies are reformulating products around smaller portions as users report eating far less.
- Research and trials
Viking begins study of less frequent VK2735 dosing for weight-loss maintenance
Viking Therapeutics started a Phase 1 study in October 2025 to test whether its experimental obesity drug VK2735 can hold weight loss when given every other week or once a month instead of weekly. In a July 29, 2026 corporate update, the company said maintenance-dosing results are expected later in the third quarter of 2026. No results from that study have been reported yet.
- Policy
White House announces TrumpRx drug site and first Pfizer pricing deal
The White House unveiled TrumpRx on September 30, 2025, a federal website where people can buy prescription drugs at cash prices from manufacturers, along with its first most-favored-nation pricing agreement, with Pfizer. The site was not live at the time and was targeted for early 2026. Pfizer said many of its products would cost about 50% less on average there than buying without insurance, and it committed $70 billion to U.S. manufacturing and research in exchange for a three-year tariff exemption.
- Prices
First most-favored-nation drug pricing deal announced, opening run of 16 agreements
The first of the Trump administration's most-favored-nation drug pricing agreements with a manufacturer was announced on September 30, 2025. The White House said on February 5, 2026 that it had reached 16 such deals and launched TrumpRx.gov with reduced prices on 40 medicines, including Ozempic at an average of $350 a month and Zepbound at an average of $346 a month.
- Culture
STEP UP MRI substudy reports semaglutide 7.2 mg body composition at EASD 2025
An MRI-based substudy of the STEP UP trial, presented September 25, 2025 at the EASD 2025 meeting, reported how weight loss on semaglutide 7.2 mg and 2.4 mg splits between fat tissue and lean tissue. It found a lower lean-tissue proportion than DXA-based analyses have, which the posting says shows how much the measurement method shapes reported muscle-loss numbers. The specific percentages were not included in the posted presentation listing.
- Business
FDA approves Inluriyo, an oral pill for ESR1-mutated advanced breast cancer
The FDA on Sept. 25, 2025 cleared Inluriyo (imlunestrant) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that worsened after at least one endocrine therapy, Eli Lilly said. In the Phase 3 EMBER-3 trial, patients with the mutation went a median of 5.5 months before their cancer progressed on the drug, compared with 3.8 months on fulvestrant or exemestane, which Lilly described as a 38% lower risk of progression or death. The company said the medicine should reach U.S. pharmacies within weeks.
- Regulation
FDA updates Mounjaro and Zepbound breastfeeding labels after required milk study
On September 25, 2025, the FDA approved supplements for Mounjaro and Zepbound that revise the Lactation subsection of the prescribing information and the medication guides for both drugs. The changes are based on a required study of tirzepatide concentrations in breast milk, and the FDA said postmarketing requirement 4272-2 has been fulfilled.
- Competition
Lilly halts one bimagrumab trial in diabetes, citing strategic business reasons
Eli Lilly canceled a Phase 2 study of the experimental muscle-sparing drug bimagrumab that included people with type 2 diabetes, according to a federal database. The company cited "strategic business reasons," and a spokesperson said a separate bimagrumab study in people with obesity but not diabetes is still underway. A second trial is recruiting patients and lists initial results expected around April 2026.
- Business
Lilly says it plans to launch weight-loss pill orforglipron in India
Eli Lilly plans to launch its experimental obesity pill orforglipron in India, a senior executive said on September 25, 2025, though he gave no timeline. The drug has not been launched anywhere in the world, and Lilly plans to file for approval in the United States, Britain, the European Union, Japan and China. In the latest trial data, orforglipron lowered blood sugar and weight more than Novo Nordisk's older GLP-1 drug Rybelsus in adults with type 2 diabetes.
- Science
FDA label update for Zepbound adds kidney injury and pancreatitis details
The FDA approved a safety-related revision to Zepbound's label on Sept. 25, 2025, adding instructions to monitor kidney function in patients with fluid loss and publishing new pancreatitis figures. In two pooled weight-reduction trials, 0.2% of Zepbound-treated patients and 0.2% of placebo-treated patients had adjudication-confirmed acute pancreatitis; in obstructive sleep apnea trials the rate was 0.84 patients per 100 years of exposure versus 0 for placebo.
- Business
FDA updates Mounjaro and Zepbound labeling and Medication Guides
The FDA actioned labeling supplements for Mounjaro and Zepbound on Sept. 25, 2025, covering the package insert and Medication Guide for both tirzepatide brands. Supplement S-034 applies to Mounjaro under NDA 215866, and supplement S-031 applies to Zepbound under NDA 217806. The FDA database does not describe what wording changed.
- Compounding
Judge allows Lilly's 'personalized' ad claim against Henry Meds to continue
A federal judge on September 24, 2025, let Eli Lilly's claim that telehealth company Henry Meds falsely advertised compounded tirzepatide as "personalized" or "patient-specific" go forward, while dismissing for now Lilly's separate claim that the drugs were falsely marketed as "safe and effective." Lilly sued in April 2025, and the judge gave Lilly permission to refile the dismissed claim.
- Research and trials
BMJ Group retracts apple cider vinegar weight-loss trial and bars further citation
BMJ Group has retracted a March 2024 trial that reported roughly 9% body mass loss among 120 overweight or obese people in Lebanon who took daily apple cider vinegar for 12 weeks. Outside statisticians could not reproduce the results and found multiple analytical errors plus irregularities in the data. The authors called the errors honest mistakes and agreed to the retraction.
- Culture
Lilly to build $6.5 billion Houston plant for orforglipron and other pills
Eli Lilly said Sept. 23, 2025 that it plans to spend $6.5 billion on an active pharmaceutical ingredient plant at Generation Park in Houston, the second of four new U.S. sites it will announce this year. The facility is expected to employ 615 people permanently and generate about 4,000 construction jobs, and it will be among the sites making orforglipron, Lilly's experimental oral GLP-1 pill.
- Culture
IQVIA report finds tirzepatide launch drew four times as many prescribers as semaglutide
IQVIA published an analysis on September 23, 2025, saying the tirzepatide launch reached four times as many unique prescribers in its first 12 months as the earlier Ozempic and Wegovy launches. The report put GLP-1 use at 11 million unique US patients in the second quarter of 2025 and GLP-1 promotional spending above $7 billion by mid-2025.
- Competition
Pfizer to buy Metsera for $47.50 a share, with up to $22.50 more tied to milestones
Pfizer announced on September 22, 2025 that it will acquire Metsera, a clinical-stage obesity and cardiometabolic drug developer, for $47.50 per share in cash when the deal closes, an enterprise value of about $4.9 billion. Shareholders also get a contingent value right worth up to $22.50 per share, payable if three clinical and regulatory goals are met. The transaction is expected to close in the fourth quarter of 2025.
- Regulation
New FDA alert targets imported GLP-1 ingredients used in compounding
FDA issued Import Alert 66-80, which directs field divisions to detain shipments of GLP-1 bulk drug substances without physical examination unless the maker and drug are on the alert's Green List. The agency says it reviewed 48 GLP-1 active pharmaceutical ingredient sites and found 21% noncompliant under section 501 of the Food, Drug, and Cosmetic Act. The Green List covers manufacturers in Belgium, Canada and China making ingredients that include semaglutide, tirzepatide, liraglutide, exenatide and orforglipron.
- Research and trials
Tirzepatide cuts A1c by 2.28 points in first phase 3 trial in children and teens
In the first phase 3 trial of tirzepatide in young people, the drug lowered A1c by an average of 2.23 points over 30 weeks in 99 children and teens with youth-onset type 2 diabetes, while A1c rose 0.05 points on placebo — a treatment difference of -2.28 points. BMI fell 7.4% at the 5 mg dose and 11.2% at 10 mg, against 0.4% with placebo. The most common side effects were gastrointestinal and mild to moderate.
- Competition
China approves mazdutide for type 2 diabetes, a first for dual GCG/GLP-1 drugs
China's drug regulator approved mazdutide for blood sugar control in adults with type 2 diabetes, Innovent Biologics announced on Sept. 19, 2025. In a late-stage trial, the 6 mg dose lowered HbA1c by 2.15 percentage points at week 24 versus 0.14 for placebo, and cut body weight by 7.81% versus 1.26%. A second trial compared it with dulaglutide 1.5 mg and found larger weight loss, 9.24% versus 2.86% at week 28.
- Research and trials
Study finds racial gap in semaglutide prescribing among people with HIV
An analysis published September 19 in Diabetes Care found that among 11,617 people with HIV who met criteria for semaglutide, only 6.7 percent received the drug between 2019 and 2023. Eligible Black patients were 20 percent less likely to receive semaglutide than White patients, and the gap was wider among those with higher blood sugar levels.
- Research and trials
Oral semaglutide 25 mg produced 13.6% weight loss in adults without diabetes, trial reports
In the OASIS 4 trial, a once-daily 25 mg oral semaglutide tablet produced an estimated mean weight loss of 13.6% at week 64, compared with 2.2% for placebo, in 307 adults with overweight or obesity but without diabetes. Gastrointestinal side effects were reported by 74.0% of participants on the drug versus 42.2% on placebo. The results were published in the New England Journal of Medicine.
- Research and trials
Tirzepatide matches dulaglutide on heart outcomes but misses superiority in SURPASS-CVOT
In the SURPASS-CVOT trial, tirzepatide (Mounjaro) was noninferior to dulaglutide (Trulicity) for cardiovascular death, heart attack or stroke in 13,165 adults with type 2 diabetes and established cardiovascular disease (HR 0.92; 95.3% CI, 0.83-1.01), but it did not reach statistical superiority. All-cause death was less common with tirzepatide (HR 0.84; 95% CI, 0.75-0.94), a secondary finding that outside reviewers said should be interpreted cautiously.
- Research and trials
Annals editorial warns semaglutide and other GLP-1 drugs may add to muscle loss in older adults
An editorial in Annals of Internal Medicine warns that GLP-1 drugs such as semaglutide may worsen muscle loss in adults over 65, who already lose 12% to 16% of skeletal muscle mass to aging. A 2024 review cited in the editorial found that 15% to 60% of weight lost on these drugs may come from lean mass. The authors call for assessing muscle mass, physical function and nutrition in older patients before and during treatment.
- Research and trials
Orforglipron beats oral semaglutide on blood sugar and weight in first head-to-head trial
Eli Lilly reported that in the 52-week ACHIEVE-3 trial, its experimental oral GLP-1 pill orforglipron lowered A1C by 1.9 and 2.2 percentage points, compared with 1.1 and 1.4 points for oral semaglutide. Participants on the highest orforglipron dose lost an average of 19.7 pounds (9.2%) versus 11.0 pounds (5.3%) on the highest oral semaglutide dose. Orforglipron is not approved, and more participants stopped it because of side effects than stopped oral semaglutide.
- Science
Oral semaglutide 25 mg lowered weight 13.6% in OASIS 4 obesity trial
Results from the OASIS 4 trial, published September 17, 2025 in the New England Journal of Medicine, show once-daily oral semaglutide 25 mg produced a mean 13.6% weight loss at week 64 in adults with overweight or obesity, compared with 2.2% on placebo. Among participants who stayed on treatment, weight loss averaged 16.6% versus 2.7% with placebo. Gastrointestinal side effects were more common with the drug, and the trial tested the pill against placebo, not against injectable semaglutide.
- Competition
First head-to-head pill trial finds orforglipron beats oral semaglutide
Orforglipron, Eli Lilly's experimental diabetes pill, lowered A1c by 2.2 percentage points over 52 weeks, against 1.4 points for Novo Nordisk's oral semaglutide, in the Phase 3 ACHIEVE-3 study of about 1,700 adults with type 2 diabetes. The top orforglipron dose also produced 9.2% average weight loss, compared with 5.3%, and 9.7% of patients taking it stopped treatment because of side effects, versus 4.9% on the top oral semaglutide dose.
- Science
Lilly reports tirzepatide lowered A1C by 2.23 points in children and teens with type 2 diabetes
In SURPASS-PEDS, the first Phase 3 trial of tirzepatide in young people, 99 participants aged 10 to under 18 with type 2 diabetes were assigned to tirzepatide 5 mg, tirzepatide 10 mg or placebo for 30 weeks. Pooled tirzepatide lowered A1C by 2.23 percentage points versus a 0.05-point rise on placebo, an estimated treatment difference of -2.28% under the trial's efficacy estimand. Lilly said the drug met the primary and all key secondary endpoints, with the 10 mg dose cutting BMI by 11.2% compared with 0.4% on placebo.
- Research and trials
Johns Hopkins trial begins testing tirzepatide for binge eating disorder
A phase 2 trial run by Johns Hopkins with Eli Lilly has begun randomizing 105 adults with obesity and binge-eating disorder to tirzepatide, lisdexamfetamine dimesylate, or placebo, with guided self-help cognitive behavioral therapy for everyone in the study. The primary endpoint is the change in binge-eating episodes at 52 weeks, and completion is estimated for December 2027.
- Research and trials
Tirzepatide knee replacement trial keeps enrolling, with main results due in 2027
STOP KNEE-OA, a phase 4 trial sponsored by the University of Melbourne with Eli Lilly as a collaborator, is still enrolling 352 adults who have obesity and moderate-to-severe knee osteoarthritis and are already eligible for a knee replacement waiting list. Participants are randomized to 72 weeks of tirzepatide or placebo, and the main measure is how many people in each group go on to have the operation. Primary completion is estimated for May 2027.
- Research and trials
Lilly publishes full ATTAIN-1 results for its oral GLP-1 pill orforglipron
Eli Lilly published complete ATTAIN-1 results in The New England Journal of Medicine and presented them at the EASD annual meeting on Sept. 16, 2025, showing its investigational oral GLP-1 orforglipron helped adults with obesity lose weight over 72 weeks. At the highest 36 mg dose, average weight fell 11.2% to 12.4% depending on the analysis, versus about 1% to 2% on placebo, and 59.6% of that group lost at least 10% of their body weight under one analysis. The trial also reported reductions in waist circumference, systolic blood pressure, triglycerides and an inflammation marker.
- Compounding
FDA warns semaglutide and tirzepatide compounders and telehealth firms over marketing claims
The FDA, working with HHS, issued dozens of warning letters in September 2025 to compounding pharmacies, telehealth platforms and manufacturers marketing GLP-1 drugs. More than 50 of the letters went to companies compounding or making semaglutide and tirzepatide, with most dated September 9. Eli Lilly, Novo Nordisk and Hims & Hers also received letters about their marketing.
- Prices
Lilly to build $5 billion Virginia plant, first of four new U.S. sites
Eli Lilly said Sept. 16, 2025 that it will spend $5 billion on a manufacturing plant in Goochland County, Virginia, the first of four new U.S. sites it plans to announce this year. The facility is expected to create 2,450 jobs — more than 650 permanent manufacturing positions plus 1,800 construction jobs — and be completed within five years. It will make active ingredients and finished drug product for Lilly's bioconjugate and monoclonal antibody portfolio, including antibody-drug conjugates, not its GLP-1 medicines.
- Business
Lilly picks Virginia for first of four new US plants, a $5 billion site for cancer and biologic drugs
Eli Lilly said Sept. 16, 2025, that it will build a $5 billion manufacturing plant in Goochland County, Virginia, creating more than 650 permanent jobs and about 1,800 construction jobs. The site is the first of four new U.S. plants Lilly plans to announce this year, and it will make active ingredients and finished drug product for bioconjugates and monoclonal antibodies. The announcement did not name GLP-1 medicines among the products for the site.
- Research and trials
Survey links injectable semaglutide to a 46% drop in constant food thoughts
A survey of 550 US adults taking injectable semaglutide for weight management found that the share reporting constant thoughts about food throughout the day fell from 62% before treatment to 16% during treatment, a change reported as a 46% decline. Participants also reported improved mental health, and 83% said they were satisfied with treatment. The results were presented at the EASD 2025 meeting and later published in the journal Advances in Therapy.
- Research and trials
Semaglutide 7.2 mg beats 2.4 mg for weight loss in STEP UP trial
A phase 3b trial called STEP UP found that a once-weekly 7.2 mg dose of semaglutide produced 18.7% average weight loss in adults with obesity, compared with 15.6% for the 2.4 mg dose. Under a different counting method, the 7.2 mg dose reached 20.7%. The higher dose caused more nausea and more dysesthesia, and it is not approved for any use.
- Research and trials
Semaglutide 7.2 mg beat placebo on weight and blood sugar in obesity plus type 2 diabetes trial
In the phase 3b STEP UP T2D trial, 512 adults with obesity and type 2 diabetes took once-weekly semaglutide 7.2 mg, semaglutide 2.4 mg or placebo for 72 weeks. The 7.2 mg dose produced 13.2% average weight loss versus 3.9% with placebo, lowered HbA1c by an estimated 1.5 percentage points more than placebo, and reduced waist circumference by 6.5 cm more. The 7.2 mg dose is not an approved dose.
- Business
Novo Nordisk to cut 9,000 jobs, about 11.5% of its workforce
Novo Nordisk said on Sept. 10, 2025 that it will eliminate about 9,000 positions, roughly 11.5% of its 78,400-person global workforce, with about 5,000 cuts in Denmark. The maker of Ozempic and Wegovy expects the restructuring to save about 8 billion Danish kroner, or roughly $1.25 billion to $1.3 billion, a year by the end of 2026, and cut its 2025 operating profit growth forecast to 4% to 10%.
- Business
FDA sends Eli Lilly three warning letters over Zepbound and Mounjaro promotion
The FDA issued three warning letters to Eli Lilly dated September 9, 2025, including one about the 42-minute 2024 Oprah Winfrey special on weight-loss drugs, saying the presentation of Zepbound and Mounjaro left out or played down serious risks such as the boxed-warning contraindication for certain thyroid tumor histories. Novo Nordisk received a similar letter about the same broadcast covering Wegovy and Ozempic, and Hims & Hers was cited over claims about compounded semaglutide. The companies were given 15 working days to respond.
- Compounding
FDA cites Hims & Hers over claims about compounded semaglutide
The FDA sent a warning letter dated September 9, 2025, to Hims & Hers Health, Inc., which does business as Hers, over two claims on forhers.com about compounded semaglutide. The agency called "Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients" false or misleading, making the products misbranded. The company was given 15 working days to respond.
- Policy
FDA warning letters on drug ads name Lilly, Novo Nordisk and Hims & Hers
President Trump signed an executive order on September 9, 2025 covering disclosure in direct-to-consumer prescription drug advertising, and the FDA released dozens of letters that day, many aimed at companies selling weight-loss drugs. Warning letters named Eli Lilly, Novo Nordisk and telehealth firm Hims & Hers Health. FDA Commissioner Marty Makary said roughly 100 cease-and-desist notices and thousands of letters were planned.
- Safety
FDA says Eli Lilly videos for Zepbound and Mounjaro downplayed risks
FDA sent Eli Lilly warning letters dated Sept. 9, 2025 over promotional videos for Zepbound and Mounjaro, saying they omitted or played down serious risks, including the boxed warning and the MEN 2 contraindication. One letter covers the 42-minute Oprah Winfrey special that first aired March 18, 2024; a second covers an interview posted July 11, 2025 on a Fox25 website. FDA asked Lilly to respond within 15 working days and to submit a plan for corrective communications.
- Culture
FDA warns Novo Nordisk that Oprah Winfrey weight loss special misbranded Wegovy and Ozempic
The FDA issued Novo Nordisk a warning letter dated September 9, 2025, saying a promotional video tied to "An Oprah Special: Shame, Blame, and the Weight Loss Revolution" was false or misleading and misbranded Wegovy, Ozempic and Victoza. The special aired on ABC on March 18, 2024, and on Hulu the following day. FDA also said the material was not submitted to the agency when it was first published, as required.
- Competition
FDA warns GLP-1 Solution over compounded retatrutide and misleading claims
A warning letter dated September 9, 2025 says GLP-1 Solution's compounded retatrutide products are unapproved new drugs and misbranded drugs, citing four sections of the Food, Drug, and Cosmetic Act. FDA also said two claims on the company's website about compounded semaglutide and tirzepatide are false or misleading, citing two sections. FDA said it reviewed glp1solution.store in August 2025.
- Business
Lilly opens its AI drug discovery models to outside biotechs with TuneLab
Eli Lilly launched Lilly TuneLab on Sept. 9, 2025, a platform that lets biotechnology companies use AI and machine learning models trained on Lilly's research data, which Lilly says was obtained at a cost of more than $1 billion. Partners contribute their own training data in return, and the platform uses federated learning so neither side's proprietary data is directly exposed. Lilly says it plans to add in vivo small molecule predictive models later, with no date disclosed.
- Science
Lilly and Remedium Bio to develop gene therapies for obesity and type 2 diabetes
Eli Lilly and Boston-based Remedium Bio announced a multi-target research collaboration on September 8, 2025, to develop gene therapies for obesity and type 2 diabetes using Remedium's Prometheus platform. The companies say the goal is a single, dose-adjustable treatment aimed at multi-year effects rather than repeated injections, but no human testing has been reported and no dollar amounts were disclosed.
- Science
Trial design published for lowering tirzepatide dose to maintain weight loss
A new paper lays out the design of SURMOUNT-MAINTAIN, a randomized trial testing whether adults with obesity can hold onto their weight loss after stepping down to a 5 mg weekly dose of tirzepatide instead of continuing their maximum tolerated dose or switching to placebo. The Phase 3b trial enrolled 441 people, with the primary endpoint measured at Week 112, and is expected to finish around May 2026. No efficacy results have been reported yet.
- Compounding
FDA creates GLP-1 ingredient green list, making other imports subject to border detention
On September 5, 2025, the FDA announced a "green list" of GLP-1 active pharmaceutical ingredients from facilities it has inspected or evaluated and found to be in apparent compliance with its manufacturing standards. Ingredients from any other source are subject to detention without physical examination at the border. Import Alert 66-80, which puts the list into effect for FDA field staff, followed on September 19, 2025.
- Prices
North Carolina Medicaid ends obesity coverage for Wegovy and Zepbound over budget gap
NC Medicaid said on Sept. 5, 2025, that it would stop paying for GLP-1 medications used for weight management starting Oct. 1, 2025, citing shortfalls in state funding. Wegovy, Zepbound and Saxenda were pulled from the preferred drug list, while coverage stayed in place for diabetes and for a short list of other approved uses. Members already on Wegovy or Zepbound had to get new prior authorizations, because old approvals expired Sept. 30.
- Prices
Truveta links CVS formulary change to 9.6% Zepbound switching rate in July 2025
An analysis Truveta Research published September 5, 2025 found that 9.6% of patients on anti-obesity tirzepatide, sold as Zepbound, moved to a different GLP-1 drug in July 2025 — more than 16 times the average monthly rate earlier that year. Among those who switched, 82.8% went to anti-obesity semaglutide, sold as Wegovy, which CVS Caremark made its preferred obesity therapy starting July 1, 2025.
- Regulation
Novo Nordisk to stop selling Victoza in Europe by end of 2026
Novo Nordisk will stop marketing Victoza across the European Union and the European Economic Area by the end of 2026, the European Medicines Agency reports, citing commercial reasons. The medicine contains liraglutide and has held an EU-wide marketing authorisation since 30 June 2009 for type 2 diabetes in adults and children aged 10 and older. The EMA's conclusion that its benefits outweigh its risks is unchanged.
- Policy
Patients sue CVS Caremark over dropping Zepbound from its formularies
A class-action lawsuit filed in New York's Southern District Court alleges CVS Caremark broke federal benefits law by removing Zepbound from several formularies effective July 1, 2025 and giving preferred status to Wegovy instead. Caremark says the suit is without merit and that it has an exemption process in place.
- Culture
Truveta data shows CVS formulary change shifted July GLP-1 prescribing toward Wegovy
Truveta reported Sept. 5, 2025 that obesity-indication tirzepatide prescribing growth halved in July 2025, adding 0.03 percentage points after averaging 0.06 per month, while semaglutide rose 0.1 points, about five times its earlier monthly average. First-time tirzepatide prescriptions dipped slightly, their first drop in nearly a year, and first-time semaglutide prescriptions rose 4.9 percent. The shift coincided with CVS Caremark's July 1 change that made Wegovy the preferred obesity drug and dropped Zepbound.
- Business
FDA withdrawal of Byetta and Bydureon approvals takes effect
The FDA's withdrawal of 39 new drug applications, including the approvals for the exenatide products Byetta and Bydureon, took effect on September 3, 2025. The applicants told the agency the products were no longer marketed and asked for the approvals to be pulled, according to a Federal Register notice published August 4, 2025.
- Prices
Patients sue CVS Caremark over Zepbound formulary removal
Two patients filed a proposed ERISA class action against CVS Caremark on Sept. 3, 2025, alleging the pharmacy benefit manager dropped Zepbound coverage to carry out a rebate agreement with Novo Nordisk. CVS Caremark removed Zepbound from its standard control, advanced control and value formularies on July 1 and gave preferred status to Wegovy. CVS says the lawsuit is "without merit" and that it will defend itself.
- Research and trials
AASM tells sleep clinicians tirzepatide is a tool, not a cure, for sleep apnea
The American Academy of Sleep Medicine published guidance on September 3, 2025, telling sleep clinicians that tirzepatide (Zepbound) should be used alongside lifestyle change and continued sleep apnea therapy, and that CPAP should not be stopped without reassessment. Tirzepatide became the first FDA-approved sleep apnea medication in December 2023, based on the SURMOUNT-OSA trial in adults with moderate-to-severe OSA and obesity.
- Research and trials
Lilly ends two mid-stage trials of oral GLP-1 drug naperiglipron
Eli Lilly has stopped two of three Phase 2 trials of naperiglipron, an experimental once-daily oral GLP-1, citing "strategic business reasons." Each terminated study had enrolled a single patient; a third trial aiming for 275 people with overweight or obesity continues, with its results expected to guide the program.
- Prices
Lilly raises UK Mounjaro list prices by up to 170%, NHS reimbursement follows
Eli Lilly raised UK list prices for Mounjaro (tirzepatide) KwikPen pens effective September 1, 2025, with the 2.5 mg pen going from £92 to £133 and the 15 mg pen from £122 to £330. The Department of Health and Social Care redetermined NHS reimbursement prices to match, and Community Pharmacy England said the agreement was made so pharmacies would not dispense at a loss.
- Culture
Gallup finds U.S. obesity rate down to 37.0% as GLP-1 use for weight loss reaches 12.4%
Gallup reports that the U.S. adult obesity rate fell from a record 39.9% in 2022 to 37.0% in 2025, a statistically meaningful drop equal to about 7.6 million fewer adults with obesity. Over the same period, the share of adults who say they use a GLP-1 medicine specifically for weight loss rose to 12.4% from 5.8% in February 2024. Diabetes diagnoses reached an all-time high of 13.8%.
- Culture
Chrissy Teigen says she used Ozempic after her 2020 pregnancy loss
Chrissy Teigen said on her podcast Self-Conscious that she turned to Ozempic during the depression that followed her 2020 miscarriage, after losing a baby at 20 weeks and gaining about 40 pounds she was not comfortable with. She also said the loss of hunger cues was frustrating, because she knew she needed food for energy.
- Safety
Study links GLP-1 receptor agonists to higher risk of nonscarring hair loss
A study of electronic records from 67 US health care organizations found that adults prescribed GLP-1 receptor agonists had higher odds of nonscarring hair loss than matched controls, with adjusted odds ratios at 12 months of 1.76 for telogen effluvium, 1.64 for androgenetic alopecia and 1.40 for nonscarring hair loss overall. Alopecia areata was consistently more common in controls, suggesting no autoimmune effect. The work was presented at the 2025 European Academy of Dermatology and Venereology Congress and published in JAAD International.
- Research and trials
Analysis ranks tirzepatide doses above semaglutide for average weight loss
A network meta-analysis of eight randomized trials covering 7,179 non-diabetic adults with obesity found that tirzepatide at its maximum tolerated dose produced a mean difference of −20.90% in body weight versus placebo, compared with −14.40% for semaglutide at its maximum tolerated dose. Tirzepatide 15 mg came in at −18.08% and semaglutide 2.4 mg at −11.78%. The highest odds of discontinuing treatment because of adverse events were seen with semaglutide and tirzepatide at their maximum tolerated doses.
- Prices
TRICARE ends weight-loss drug coverage for TRICARE For Life and other groups
The Defense Health Agency ended TRICARE coverage of weight-loss medications, including Zepbound and Wegovy, for TRICARE For Life, direct-care-only, TRICARE Plus, foreign force and NATO beneficiaries on Aug. 31, 2025. Prior authorizations for obesity drugs that had already been approved became invalid for those groups that day. Coverage of GLP-1 drugs for type 2 diabetes, including Mounjaro and Ozempic, continues for all plans when prior authorization criteria are met.
- Science
Novo Nordisk reports Wegovy linked to 57% lower heart risk than tirzepatide in real-world analysis
Novo Nordisk released a real-world analysis on August 31, 2025, reporting that Wegovy (semaglutide) was associated with a 57% lower risk of heart attack, stroke or death than tirzepatide in people with obesity and cardiovascular disease. The analysis followed patients in routine care rather than assigning them by chance to one medicine or the other, so it can show a link but cannot prove cause and effect. The announcement did not include the number of patients studied, follow-up time or publication status.
- Safety
Gym users are buying unapproved retatrutide online before Lilly's launch
Business Insider reported on Aug. 30, 2025, that bodybuilders and other gym users are buying and injecting retatrutide, an experimental Eli Lilly weight-loss drug that is not FDA-approved, from online research labs. One 24-year-old said he injected 0.5 milligrams a week for about a month after seeing it promoted on TikTok. Eli Lilly said anyone selling retatrutide for human use is breaking the law.
- Business
Denmark cuts 2025 growth forecast, blaming Novo Nordisk slowdown
Denmark's economy ministry lowered its 2025 GDP growth forecast to 1.4% from 3%, pointing to weaker expectations for Novo Nordisk, higher U.S. tariffs and revised figures for earlier years. Pharmaceuticals are now expected to add 1.3 percentage points to Danish goods export growth this year, down from 8.1 points in 2024. The ministry raised its 2026 forecast to 2.1% from 1.4%.
- Safety
Judge sides with Lilly on injury claim in compounded tirzepatide case against Mochi Health
The U.S. District Court for the Northern District of California disagreed with Mochi Health's argument that Eli Lilly had failed to show an economic or reputational injury from compounded tirzepatide sales. Lilly's lawsuit accuses Mochi Health, two Mochi Medical entities and Aequita Pharmacy of misleading consumers into buying compounded versions of Mounjaro and Zepbound. How the court resolved the rest of the motion to dismiss has not been reported.
- Business
Lilly partners with JD Health to sell Mounjaro and Zepbound directly in China
Eli Lilly announced on August 29, 2025 that it will sell its obesity, Type 2 diabetes and alopecia areata medicines directly to consumers in China through a digital platform run with JD Health. The companies describe the platform as a "one-stop" shop for chronic disease management with consultations, prescriptions, shipping, follow-up care and disease education. Lilly cited roughly 148 million adults in China with diabetes and more than 500 million who are overweight or obese as the market behind the move.
- Business
Teva launches generic Saxenda, the first generic GLP-1 approved for weight loss
Teva Pharmaceuticals said the FDA approved its generic version of Saxenda (liraglutide injection) and that it launched in the U.S. on Aug. 28, 2025, making liraglutide the first generic GLP-1 approved for weight management. Teva cited Saxenda annual sales of $165 million as of June 2025. A generic liraglutide for type 2 diabetes was approved and launched by Meitheal Pharmaceuticals in April 2025.
- Research and trials
Review sets nutrition targets for patients on GLP-1 obesity drugs
A narrative review published in Obesity Pillars, the journal of the Obesity Medicine Association, sets out daily nutrition targets for people taking GLP-1 medications: protein at 1 to 1.5 grams per kilogram of body weight, fluids above 2 to 3 liters, and fiber at 21 to 25 grams for women and 30 to 38 grams for men. The review also says many patients on GLP-1 therapy receive no nutrition advice and struggle to maintain their weight reduction.
- Prices
Lilly halts UK Mounjaro orders ahead of September price rise
Eli Lilly stopped taking and shipping new Mounjaro orders in the United Kingdom on Aug. 27, 2025, days before a price increase of up to 170% was due to take effect there. The monthly list price for the highest dose was set to rise from 122 pounds to 330 pounds, or about $164.81 to $445.80. Lilly said it acted to head off stockpiling and planned to reopen ordering on Sept. 1.
- Business
Lilly says oral orforglipron met its goal in a third phase 3 obesity trial
Eli Lilly reported Aug. 26, 2025 that orforglipron, its investigational once-daily oral GLP-1 pill, met the main goal of the Phase 3 ATTAIN-2 trial. Adults with obesity or overweight and type 2 diabetes lost an average of 10.5% of body weight (22.9 pounds) at 72 weeks on the highest dose, with A1C falling 1.3% to 1.8% across doses. Lilly says it now has the full clinical data package needed to begin global regulatory submissions for obesity.
- Culture
Serena Williams says she used a GLP-1 through Ro and joins the company as a paid ambassador
Serena Williams said on Aug. 21, 2025 that she used a GLP-1 medication through the telehealth company Ro to lose weight after her second child, and that she is joining Ro as a paid celebrity patient ambassador in a multi-year campaign to normalize the drugs for weight loss. Ro did not name the specific medication in its announcement, and Williams has not disclosed how much weight she lost. The company said her husband is an investor in Ro and sits on its board, but did not disclose what Williams is paid.
- Safety
Lilly asks federal panel to consolidate 21 GLP-1 vision-loss lawsuits
Eli Lilly asked the Judicial Panel on Multidistrict Litigation on Aug. 19, 2025 to centralize 21 federal lawsuits claiming GLP-1 medicines cause the eye condition NAION, which can lead to permanent blindness. Lilly wants the cases sent to Judge Karen S. Marston in the Eastern District of Pennsylvania, where the GLP-1 gastrointestinal-injury MDL 3094 is pending, or alternatively added to that MDL.
- Prices
Novo Nordisk cuts Ozempic cash price to $499 a month for self-paying patients
Novo Nordisk lowered the cash price of Ozempic (semaglutide) to $499 a month for patients who pay without insurance, in an announcement dated August 18, 2025. Ozempic is approved for type 2 diabetes, cardiovascular risk reduction and slowing kidney disease in certain patients. The announcement does not say which dose strengths or other semaglutide products the price covers.
- Research and trials
FDA grants accelerated approval to Wegovy for liver disease MASH
The FDA granted accelerated approval on Aug. 15, 2025, to Wegovy (semaglutide) injection 2.4 mg for adults with MASH and moderate to advanced liver scarring, but not cirrhosis. In the phase 3 ESSENCE trial at 72 weeks, 63% of people taking semaglutide had MASH resolve with no worsening of fibrosis versus 34% on placebo, and 37% had less scarring with no worsening of MASH versus 22% on placebo. The approval is based on liver biopsy findings, and a longer trial testing whether the drug prevents liver-related events runs to 2029.
- Safety
Judge rules gastroparesis claims in GLP-1 litigation need objective stomach-emptying testing
Judge Karen S. Marston ruled on August 15, 2025 that anyone alleging gastroparesis in the federal GLP-1 stomach-injury litigation must support the diagnosis with a properly performed gastric emptying study, and she excluded two of the plaintiffs' diagnostic experts. The order, docketed as Doc. 468, applies to cases against both Novo Nordisk and Eli Lilly. Gastroparesis is the largest injury category in the docket, at roughly three-quarters of complaints.
- Prices
Lilly raises Mounjaro's UK list price by up to 170%, sparing NHS patients
Eli Lilly said on Aug. 14, 2025 that it will raise the UK list price of its tirzepatide drug Mounjaro by as much as 170%, effective in September. A month's supply at the highest dose goes from £122 to £330, and lower doses rise less. Private buyers absorb the change; patients covered by the National Health Service do not, because the NHS has its own discounted deal.
- Business
Lilly signs deal worth up to $1.3 billion with Superluminal for AI-discovered obesity drugs
Eli Lilly signed a collaboration with Superluminal Medicines worth up to $1.3 billion to use artificial intelligence to discover small-molecule drugs aimed at GPCR targets for obesity and cardiometabolic diseases. Lilly gets exclusive rights to develop and commercialize compounds from the collaboration once Superluminal delivers candidates meeting pre-set criteria, and Superluminal is eligible for upfront and near-term payments, an equity investment, milestones and tiered royalties. No target or compound has been disclosed, and Superluminal's own obesity candidate — which is not part of the deal — is expected to enter human trials in 2026.
- Compounding
Novo Nordisk files 14 more lawsuits over compounded semaglutide
Novo Nordisk announced 14 new lawsuits against sellers of compounded drugs labeled "semaglutide," targeting pharmacies and telehealth companies. The company says its campaign now totals 132 complaints filed in federal courts across 40 states, with 44 permanent injunctions already issued. An FDA alert dated July 29 warns of overdoses from compounded GLP-1 products.
- Business
Lilly CEO David Ricks buys $1 million of stock after shares fall
Eli Lilly CEO David Ricks bought just over $1 million of Lilly shares in the open market on Tuesday, Aug. 12, 2025, according to a Barron's report. The purchase followed a sharp drop in the stock after the company's earnings report, a decline the report's headline links to obesity drug data. Other Lilly executives also bought stock that day, the report said.
- Safety
Texas sues Eli Lilly, alleging kickbacks led prescribers to Mounjaro and Zepbound
Texas Attorney General Ken Paxton and the group Health Choice Alliance sued Eli Lilly on Aug. 12, 2025, alleging the company gave medical providers illegal incentives to prescribe its drugs, including Mounjaro and Zepbound. The plaintiffs say the alleged arrangements tainted millions of dollars in Texas Medicaid claims. Lilly said it will defend itself and noted that judges and the federal government have rejected earlier claims from the same group.
- Safety
Study links semaglutide and tirzepatide to higher rate of rare optic nerve diagnoses
A target-trial emulation of 159,398 propensity-matched adults with type 2 diabetes found higher two-year rates of NAION (0.04% vs 0.02%; hazard ratio 1.76) and other optic nerve disorders (0.12% vs 0.07%; hazard ratio 1.65) among patients prescribed semaglutide or tirzepatide than among those taking other diabetes drugs. The overall risk was low, and the study combined the two drugs into one exposure group, so it cannot attribute the finding to either drug on its own.
- Safety
Texas sues Eli Lilly over alleged kickbacks tied to Mounjaro and Zepbound
Texas Attorney General Ken Paxton and co-plaintiff Health Choice Alliance sued Eli Lilly on Aug. 12, 2025, alleging the company used a "Free Nurse Program" and a "Support Services Program" to illegally induce providers to prescribe its drugs, including Mounjaro and Zepbound. Lilly denies the claims and says it will vigorously defend. Health Choice Alliance brought similar claims against Lilly in 2017; a federal judge dismissed them in 2018 and the Fifth Circuit upheld that ruling in 2021.
- Research and trials
Orforglipron produced 12.4% average weight loss in first ATTAIN obesity trial, Lilly says
Eli Lilly reported on Aug. 7, 2025 that adults with obesity or overweight who stayed on the highest dose of orforglipron lost an average of 27.3 pounds, or 12.4% of body weight, over 72 weeks in the ATTAIN-1 trial, compared with 2.2 pounds (0.9%) on placebo. Counting every participant whether or not they finished the trial, the averages were 25 pounds (11.1%) and 5.3 pounds (2.1%). The oral GLP-1 pill later received FDA approval on April 1, 2026, under the brand name Foundayo.
- Business
Novo Nordisk names Mike Doustdar CEO weeks before 9,000-job restructuring
Maziar Mike Doustdar became president and chief executive officer of Novo Nordisk on 7 August 2025, taking over the maker of Ozempic and Wegovy from Lars Fruergaard Jørgensen. About a month later, the company said it would eliminate roughly 9,000 positions, close to 11.5% of its workforce, and trimmed its full-year operating profit growth outlook to 4% to 10%.
- Business
Lilly raises 2025 outlook as Mounjaro and Zepbound sales jump, but orforglipron data misses expectations
Eli Lilly reported second-quarter revenue of $15.56 billion, up 38% from a year earlier, and raised its full-year 2025 revenue guidance to $60 billion to $62 billion. Mounjaro revenue rose 68% to $5.20 billion and Zepbound rose 172% to $3.38 billion, both above analyst estimates. The same morning, the first Phase 3 obesity result for Lilly's experimental pill orforglipron showed more than 12% weight loss at the highest dose, below what Wall Street had expected, and the shares fell as much as 12% in premarket trading.
- Competition
Eli Lilly's orforglipron pill produced 12.4% weight loss in phase 3 trial
Eli Lilly reported full phase 3 ATTAIN-1 results showing its once-daily pill orforglipron led to an average 12.4% weight loss at 72 weeks at the highest dose, compared with 0.9% for placebo, in adults with obesity or overweight and no diabetes. The drug, which needs no food or water timing restrictions, was later approved by the FDA on April 1, 2026, under the brand name Foundayo.
- Business
Lilly's oral GLP-1 orforglipron yields 27.3 pounds average weight loss in phase 3 trial
Eli Lilly reported Aug. 7, 2025 that its investigational once-daily pill orforglipron helped adults with obesity lose an average of 27.3 pounds (12.4%) over 72 weeks at the highest dose tested, compared with 2.2 pounds (0.9%) for placebo. All three doses met the trial's primary and key secondary goals. The company says it plans to submit the drug to regulators by year-end 2025.
- Culture
Eli Lilly casts comedian Kym Whitley in a Zepbound campaign built on her weight story
Comedian and actress Kym Whitley is working with Eli Lilly on a Zepbound campaign that tells her own story of losing and regaining weight, told with humor rather than before-and-after photos. Lilly says the story has drawn more than 140 million impressions. Influencer Nita Danielle also appears in the campaign, which Lilly describes as a paid, earned, shared and owned media push.
- Business
Novo Nordisk trims 2025 profit outlook again and cuts about 9,000 jobs
Novo Nordisk now expects full-year operating profit growth of 4% to 10% at constant currencies, down from 10% to 16% and from a 16% to 24% target set in May. The company is also removing about 9,000 positions worldwide, roughly 11% of its workforce, a step it says should save about $1.25 billion a year by 2026.
- Research and trials
Tirzepatide improved sleep and quality-of-life scores in SURMOUNT-OSA, analysis finds
In the two phase 3 SURMOUNT-OSA trials, people with moderate-to-severe obstructive sleep apnea and obesity who took tirzepatide 10 mg or 15 mg reported significantly better sleep-related impairment, sleep disturbance, functioning and quality-of-life scores than those on placebo at 52 weeks. The gains included PROMIS sleep measures, EQ-5D-5L and most SF-36 v2 domains, plus Epworth Sleepiness Scale changes among participants not using positive airway pressure.
- Business
FDA withdraws approval of Byetta and Bydureon at applicants' request
The FDA is withdrawing approval of 39 new drug applications, including Byetta, Bydureon, Bydureon Pen and Bydureon BCise, after the applicants told the agency the products are no longer marketed and asked for the approvals to be pulled. The withdrawal takes effect September 3, 2025, and product already in inventory may be dispensed until it is depleted or expires.
- Safety
Novo Nordisk sues 12 compounding defendants over compounded semaglutide
Novo Nordisk filed lawsuits against 12 compounding defendants on August 4, 2025, expanding its civil campaign against compounded semaglutide. By mid-2025 the company had filed more than 130 lawsuits across 40 states against telehealth companies, compounding pharmacies and medical spas. The filings follow FDA's February 2025 decision to remove semaglutide from the drug shortage list, which tightened federal limits on compounding copies.
- Safety
Judge rules on gastroparesis evidence in GLP-1 lawsuits against Novo Nordisk and Eli Lilly
In August 2025, Judge Karen S. Marston issued a 78-page ruling on the medical documentation required to support gastroparesis allegations in the federal GLP-1 litigation, MDL 3094. The court requires objective diagnostic testing for gastroparesis claims, and a gastric emptying study is described as the strongest support for a claim. Questions about general causation and federal preemption remain unresolved, with bellwether trials expected no earlier than mid-2026.
- Safety
Wegovy label adds acute kidney injury warning tied to fluid loss
The Wegovy prescribing information added a Warnings and Precautions section on acute kidney injury due to volume depletion in August 2025, according to the label's list of recent major changes. That section tells prescribers to monitor kidney function in patients who report reactions that could lead to volume loss. A separate entry, dated October 2025, covers severe gastrointestinal adverse reactions.
- Policy
Wegovy label drops BMI numbers from its weight-loss indications
The current Wegovy prescribing information describes who qualifies for weight management as adults with obesity, or adults with overweight plus at least one weight-related comorbid condition, and names no BMI cutoffs. Its change log lists Indications and Usage revisions in 08/2025 and 12/2025, and the labeling record reviewed is dated June 18, 2026.
- Culture
CDC: 26.5% of US adults with diabetes used GLP-1 injectables in 2024
New federal data show 26.5% of U.S. adults with diagnosed diabetes used a GLP-1 injectable in 2024, equal to about 6.9 million people. Use peaked at 33.3% among adults ages 50 to 64 and rose with body mass index, from 16.7% among those at a healthy weight to 32.4% among those with obesity.
- Regulation
FDA approves 7.2 mg Wegovy HD under accelerated voucher program
The FDA approved semaglutide 7.2 mg injection, sold as Wegovy HD, on March 19, 2026, for long-term weight reduction in adults with obesity or overweight with at least one weight-related condition. It is the first GLP-1 receptor agonist cleared under the Commissioner's National Priority Voucher pilot program. In the STEP UP trial, the higher dose produced 18.7% mean weight loss versus 3.9% for placebo at 72 weeks, with a higher rate of dysesthesia than the 2.4 mg dose.
- Research and trials
Lilly says Mounjaro matched Trulicity on heart events and cut all-cause deaths in large trial
Eli Lilly reported July 31 that Mounjaro (tirzepatide) met the main goal of the SURPASS-CVOT trial by matching Trulicity (dulaglutide) at preventing cardiovascular death, heart attack or stroke in adults with type 2 diabetes and established heart disease, with an 8% lower rate of those events. The trial also found a 16% lower rate of death from any cause with Mounjaro, an endpoint Lilly says was not controlled for multiple comparisons.
- Business
Mounjaro matches Trulicity on heart risk in first head-to-head trial
Eli Lilly reported on July 31, 2025 that Mounjaro (tirzepatide) was non-inferior to Trulicity (dulaglutide) for cardiovascular death, heart attack or stroke in 13,299 adults with type 2 diabetes and established heart disease. The MACE-3 rate was 8% lower with Mounjaro (hazard ratio 0.92; 95.3% CI 0.83 to 1.01), meeting the prespecified non-inferiority goal but not establishing superiority. All-cause death was 16% lower with Mounjaro, a secondary result that was not adjusted for multiple comparisons.
- Business
Trump administration sent drugmakers most-favored-nation pricing letters on July 31, 2025
On July 31, 2025, President Trump sent letters to leading pharmaceutical manufacturers outlining steps to bring U.S. drug prices in line with the lowest prices paid in other developed nations, following a May 12, 2025 executive order on most-favored-nation pricing. The letters set off company-by-company negotiations that produced a Pfizer agreement on September 30, 2025, and Eli Lilly and Novo Nordisk agreements on November 6, 2025, with announced TrumpRx prices of $350 a month for Ozempic and Wegovy and $245 Medicare prices for Ozempic, Wegovy, Mounjaro and Zepbound.
- Business
FDA approves multiple-dose tirzepatide vials for Mounjaro and Zepbound
Eli Lilly received FDA approval for two supplements adding a multiple-dose single-patient-use vial to the labeling for Mounjaro (NDA 215866/S-041) and Zepbound (NDA 217806/S-037). Both supplements were dated and received July 31, 2025, and the approval letters were signed January 7, 2026. The letters do not disclose the vial's concentration, price or launch date.
- Culture
'Ozempic face' is driving cosmetic surgery demand, surgeons say
A CNN report published July 30 says facial hollowing and sagging after rapid weight loss on GLP-1 drugs, nicknamed "Ozempic face," is helping fuel demand for fillers, fat grafting and facelifts. The American Society of Plastic Surgeons found 2 in 5 of its members' GLP-1 patients were considering cosmetic surgery and 1 in 5 already had it. One New Jersey patient who lost 45 pounds on Wegovy estimates she will have spent about $80,000 on cosmetic procedures.
- Business
Novo Nordisk cuts 2025 outlook and picks insider Maziar Mike Doustdar as CEO
On July 29, Novo Nordisk lowered its 2025 sales growth forecast to 8% to 14% from 13% to 21% and named company veteran Maziar Mike Doustdar as chief executive, effective Aug. 7. Reuters put the market value lost at about $70 billion and said shares fell as much as 29.8% before recovering part of the decline. The maker of Wegovy and Ozempic blamed continued use of compounded GLP-1s, slower market expansion and competition.
- Competition
Dr. Reddy's plans generic semaglutide launches in 87 countries in 2026
Dr. Reddy's Laboratories said it plans to launch a generic version of semaglutide, the drug in Wegovy and Ozempic, in 87 countries during 2026, starting with Canada, India, Brazil and Turkey as patents expire. Chief executive Erez Israeli said Western markets would open between 2029 and 2033 and that he expects the product to generate "hundreds of millions of dollars" in sales. Semaglutide patents expire in several countries starting in 2026, including India, Canada, China, Brazil and Turkey.
- Regulation
FDA approves Lupin's generic liraglutide injection, database record shows
The FDA approved Lupin Pharmaceuticals' application ANDA215421 for a generic liraglutide injection on July 22, 2025, according to the agency's drug approval database. The product is listed as a 6 mg/mL subcutaneous solution in two package configurations. Pricing, launch timing and availability have not been disclosed.
- Culture
Lilly signs 'Happy Gilmore 2' actress Kym Whitley as Zepbound patient spokesperson
Eli Lilly said on July 21, 2025, that actress Kym Whitley, who appears in the summer sequel "Happy Gilmore 2," is a patient spokesperson for Zepbound, the company's tirzepatide obesity drug. Whitley tells her story in a Q&A on Lilly's Zepbound website and discussed the drug during the film's press tour. The report describes her as Lilly's first official celebrity spokesperson for the weight-loss medication, which Lilly sells in single-dose vials at $499 a month for its highest dose strengths through LillyDirect.
- Regulation
Ohio pharmacy board bars compounded semaglutide and tirzepatide copies
Ohio's board of pharmacy issued guidance in July 2025 that treats compounded semaglutide and tirzepatide as copies of approved drugs that can no longer be made, expressly prohibits the investigational peptides retatrutide and cagrilintide, and requires active ingredients to be purchased from an Ohio-licensed distributor. The board also reports summarily suspending more than thirty clinics and medical spas since the beginning of 2025.
- Policy
Senators fault Lilly and Pfizer telehealth platforms over prescribing patterns
Four senators released findings on July 17, 2025 from a nine-month investigation into the direct-to-consumer telehealth platforms run by Eli Lilly and Pfizer. The report says patients who reached a provider through the platforms received a prescription 85% of the time through PfizerForAll and 74% through LillyDirect, and that some prescribers wrote overwhelmingly for the sponsoring company's drugs. Both companies say their platforms do not incentivize doctors to prescribe their own medications.
- Research and trials
Analysis: slow starters on tirzepatide often still reach 5% weight loss by week 72
A post hoc analysis of the SURMOUNT-1 trial found that 18% of adherent participants taking tirzepatide lost less than 5% of their body weight in the first 12 weeks. Of those late responders, 70% reached 5% weight loss by week 24 and 90% did by week 72, with an average total loss of 11.0% compared with 22.5% for early responders.
- Culture
Kinsey Institute survey links GLP-1 drugs to changes in dating and sex for most users
A survey of 2,000 single U.S. adults found that 59% of GLP-1 users said the drug changed their dating life and 52% said it changed their sex life, in both positive and negative ways. Men reported bigger shifts than women in both directions, including more dating-app matches and more fear of being judged for taking the medication.
- Science
Tirzepatide tops semaglutide for weight loss in 72-week head-to-head trial
In the SURMOUNT-5 trial, adults with obesity but without type 2 diabetes lost an average of 20.2% of their body weight on tirzepatide and 13.7% on semaglutide after 72 weeks. Waist circumference fell 18.4 cm with tirzepatide and 13.0 cm with semaglutide, and 19.7% of the tirzepatide group lost at least 30% of body weight versus 6.9% of the semaglutide group. Eli Lilly, which makes tirzepatide, funded the study.
- Regulation
Zepbound KwikPen is authorized and available in Canada, Eli Lilly says
Health Canada authorized Zepbound KwikPen, a tirzepatide injection, on May 13, 2025, and Eli Lilly Canada announced the product is now available there. It is the first Health Canada-approved obesity treatment that activates both the GIP and GLP-1 hormone receptors. In the SURMOUNT-1 trial, adults lost an average of 21.8 kg (48 lbs) at the highest 15 mg dose over 72 weeks, compared with 3.2 kg (7 lbs) on placebo.
- Regulation
Zepbound KwikPen approved and launched in Canada for chronic weight management
Eli Lilly Canada said July 9, 2025 that Zepbound KwikPen (tirzepatide injection) is now available in Canada for chronic weight management in adults. Health Canada authorized the once-weekly pen on May 13, 2025. In the SURMOUNT-1 trial cited by the company, adults on the highest 15 mg dose lost an average of 21.8 kg (48 lbs) over 72 weeks, compared with 3.2 kg (7 lbs) on placebo.
- Safety
Review finds no consistent aspiration risk signal for GLP-1 drugs before procedures
A review in the Journal of the Endocrine Society combined results from seven retrospective cohort studies and found no consistent increase in aspiration or pneumonia risk for GLP-1 users around elective surgery or upper endoscopy. The three elective surgery studies had a combined risk ratio of 1.00 (95% CI 0.76-1.30) and the four endoscopy studies had a combined risk ratio of 1.10 (95% CI 0.95-1.27). A parallel analysis of opioids in one included study found a risk ratio of 2.68, suggesting the method could detect a signal from a drug that slows gut motility.
- Prices
Lilly opens all six Zepbound vial doses to cash-paying patients at $349 to $499 a month
On July 7, 2025, Eli Lilly made every approved strength of Zepbound (tirzepatide) single-dose vials available through LillyDirect's self-pay program, with the 2.5 mg starting dose at $349 a month and the other five doses at $499. The $499 tier for doses above 5 mg requires refills purchased within 45 days of the previous delivery; without that, Lilly listed monthly prices from $599 to $1,049.
- Research and trials
Pilot study finds tirzepatide raised testosterone and improved erectile function in men with obesity
A two-month pilot study of 83 men with obesity and low testosterone found that those given tirzepatide lost more weight and had higher levels of luteinizing hormone, follicle-stimulating hormone, sex hormone-binding globulin and testosterone than men treated with lifestyle changes alone or with transdermal testosterone. Erectile function scores improved more with tirzepatide than with lifestyle change alone and by about the same amount as with testosterone. Patients were not randomly assigned to their treatment groups, and the study did not measure sperm parameters or long-term outcomes.
- Research and trials
CVS Caremark drops Zepbound coverage and makes Wegovy the preferred GLP-1
CVS Caremark stopped covering Zepbound on its most common commercial formulary on July 1, 2025, making Wegovy the preferred GLP-1 for weight management. The template covers between 25 million and 30 million people. Members with active Zepbound prior authorizations were moved to Wegovy without repeating that process, and a formulary exception exists for people who already tried Wegovy without success or with severe side effects.
- Prices
CVS Caremark drops Zepbound coverage for weight loss, with Wegovy as the preferred option
CVS Caremark stopped covering Zepbound (tirzepatide) for weight management on July 1, 2025, making Wegovy (semaglutide) the preferred GLP-1 on its largest commercial formulary template, which covers 25 million to 30 million people. Members with existing Zepbound approvals, including some approved for sleep apnea, were told to move to Wegovy or pay full price. Early prescribing data show semaglutide use rose and tirzepatide growth slowed the following month.
- Competition
FTC finalizes order against telehealth seller NextMed over GLP-1 weight-loss ads
The Federal Trade Commission gave final approval on December 3, 2025 to an order against telemedicine company NextMed and its two principals, who were accused of using deceptive cost and weight-loss claims, fake reviews and fake testimonials to sell GLP-1 weight-loss programs. The order requires a $150,000 payment, which the agency expects to use for consumer refunds.
- Compounding
WeightWatchers exits bankruptcy in 42 days, cutting about $1.15 billion in debt
WeightWatchers emerged from Chapter 11 bankruptcy in July 2025 after a 42-day case that removed roughly $1.15 billion of debt and left its clinical business in place. Reporting after the case put revenue growth at WW Clinic, the company's clinical arm, at 57 percent year over year, with about 135,000 clinical members by early 2026.
- Safety
FDA flags intestinal obstruction and fecal impaction as possible risk for GLP-1 drugs including Mounjaro and Zepbound
The FDA's adverse-event monitoring report for April through June 2025 lists intestinal obstruction and fecal impaction as a potential signal of serious risk for the whole GLP-1 receptor agonist class, a group of 14 product listings that includes Mounjaro, Zepbound, Ozempic, Wegovy and Rybelsus. The agency's status note for that entry, dated March 13, 2026, says it is still evaluating whether regulatory action is needed. No label change for the class is shown in the listing.
- Safety
WHO issues global alert linking semaglutide to rare NAION eye risk
The World Health Organization published a medical product alert on June 27, 2025 about non-arteritic anterior ischemic optic neuropathy (NAION) in users of semaglutide, sold as Ozempic, Rybelsus and Wegovy. WHO cited a European Medicines Agency finding that NAION is a very rare side effect, occurring in up to 1 in 10,000 users, and said patients with sudden vision changes should get medical care without delay.
- Research and trials
Lilly starts two phase 3b trials pairing tirzepatide with mirikizumab in IBD
Eli Lilly has begun two phase 3b trials that add tirzepatide, sold as Mounjaro and Zepbound, to the biologic mirikizumab in adults with inflammatory bowel disease plus obesity or overweight. The ulcerative colitis trial plans to enroll 350 adults with a week-52 endpoint combining clinical remission and at least 10 percent weight reduction, while the Crohn's disease trial plans 290 adults and adds endoscopic remission. Estimated primary completion is April and May 2028.
- Safety
UK regulators begin genetic study of GLP-1 pancreatitis cases
The UK's Medicines and Healthcare products Regulatory Agency and Genomics England began on June 26, 2025 asking patients hospitalised with acute pancreatitis linked to a GLP-1 medicine such as Ozempic, Mounjaro or Wegovy to join the Yellow Card Biobank and provide a saliva sample. The study will look for genetic traits that might make some people more susceptible to the condition. The MHRA says evidence shows almost a third of medicine side effects could be prevented with genetic testing, and that adverse drug reactions cost the NHS more than £2.2 billion a year in hospital stays alone.
- Science
Most patients starting Wegovy or Zepbound now stay on them for a year, claims analysis finds
An analysis of U.S. pharmacy claims by Prime Therapeutics found that 63% of patients who started Wegovy or Zepbound in early 2024 were still taking one of the drugs a year later, up from 40% among Wegovy patients who started in 2023. A separate longer-term look found only 14% of Wegovy patients were still on the drug after three years, down from 24% at the two-year mark.
- Business
WeightWatchers exits bankruptcy as a private company after cutting $1.15 billion in debt
WW International, the parent of WeightWatchers, emerged from Chapter 11 on June 24, 2025, as a private company after a reorganization plan confirmed the previous week eliminated about $1.15 billion in debt. The company filed for bankruptcy in May 2025 and said then that it hoped to finish the process in about 45 days. Member subscriptions and its clinical program, which can prescribe brand GLP-1 medications, continued without interruption.
- Compounding
Novo Nordisk ends Hims & Hers partnership over compounded Wegovy copies
Novo Nordisk said on June 23, 2025 that it is terminating its collaboration with Hims & Hers Health, cutting the telehealth company off from branded Wegovy through NovoCare Pharmacy roughly two months after the deal was announced. Novo accused Hims & Hers of illegal mass compounding under the "false guise" of personalization and of deceptive marketing. Hims & Hers shares closed more than 34% lower, while Novo shares fell more than 5%.
- Research and trials
Weekly semaglutide helped adults with type 1 diabetes and obesity reach blood sugar and weight goals in first randomized trial
In a 26-week trial called ADJUST-T1D, 36 percent of adults with type 1 diabetes and obesity who took once-weekly semaglutide alongside an automated insulin delivery system met a combined goal for blood sugar time in range, low rates of low blood sugar and at least 5 percent weight loss, compared with none of those on placebo. Average weight loss was about 18.5 pounds. Semaglutide is not approved for type 1 diabetes.
- Research and trials
Amgen's MariTide produced up to about 20% weight loss at 52 weeks in Phase 2
In a Phase 2 trial, Amgen's experimental obesity drug MariTide produced average weight loss of up to about 20% at 52 weeks in people without diabetes and up to about 17% in those who had it, with no sign that the losses had plateaued. MariTide is designed for injections once a month or less often, and it is now being tested in Phase 3.
- Prices
More than 60 insurers sign pledge to simplify prior authorization by 2027
On June 23, 2025, HHS and CMS announced a voluntary pledge, signed by more than 60 health insurers, to simplify prior authorization. Insurers committed to reduce the list of services requiring pre-approval and to honor existing approvals for 90 days when a patient changes plans, both effective January 1, 2026, and to standardize electronic requests through FHIR-based APIs by January 1, 2027, with at least 80 percent of electronic approvals answered in real time in 2027.
- Research and trials
Bimagrumab plus semaglutide produced 22.1% weight loss with less lean mass loss in BELIEVE trial
In the phase 2b BELIEVE trial, adults with overweight or obesity who took bimagrumab plus semaglutide 2.4 mg lost 22.1% of their body weight over 72 weeks, with 92.8% of that loss coming from fat and lean mass down 2.9%. Semaglutide alone produced 15.7% weight loss and a 7.4% drop in lean mass, while bimagrumab alone produced 10.8% weight loss and a 2.5% gain in lean mass. Results were presented June 23, 2025 at the American Diabetes Association Scientific Sessions in Chicago.
- Culture
NHS England lets family doctors prescribe Mounjaro to about 220,000 patients
Starting Monday, June 23, 2025, GPs in England can prescribe Mounjaro (tirzepatide) for weight loss for the first time, part of an NHS rollout expected to reach about 220,000 patients over three years. In the first year, patients must have a BMI above 40 plus at least four other obesity-related health conditions. GP and pharmacy groups raised concerns about workload and supply.
- Research and trials
EU panel backs Ozempic label update for peripheral artery disease
The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on June 23, 2025, to add peripheral artery disease data from the STRIDE trial to the Ozempic label. In STRIDE, once-weekly semaglutide 1.0 mg improved maximum walking distance by 13%, a mean treatment difference of 39.9 meters versus placebo at week 52, in 792 people with type 2 diabetes and symptomatic PAD. The European Commission is expected to act on the recommendation within about two months.
- Prices
England starts funding tirzepatide in primary care under phased obesity plan
On 23 June 2025, England's Integrated Care Boards became required to fund tirzepatide (Mounjaro) in primary care for prioritized groups of patients, 180 days after NICE published final guidance. NHS England's interim guidance targets about 220,000 patients across the first three years, out of an eligible population NICE estimated at 3.4 million, with full access spread across as long as 12 years.
- Research and trials
CagriSema trials show 20.4% and 13.7% average weight loss in two phase 3 studies
Two phase 3 trials of CagriSema, which combines cagrilintide with semaglutide, reported average weight loss of 20.4% in adults with overweight or obesity and no diabetes, and 13.7% in adults with type 2 diabetes, both over 68 weeks. Placebo groups lost 3.0% and 3.4% respectively. Gastrointestinal side effects were reported by roughly 7 to 8 in 10 participants on the combination.
- Research and trials
Design paper describes SURMOUNT-MMO, a 15,374-person tirzepatide outcomes trial
The design of SURMOUNT-MMO has been published in the journal Obesity, describing a 15,374-participant, event-driven trial of tirzepatide at 664 sites in 27 countries. Participants are adults with obesity who do not have diabetes, and the primary endpoint has five components, including all-cause death. The authors describe it as the first incretin outcome trial to enroll people who have not yet developed cardiovascular disease.
- Research and trials
Lilly's oral GLP-1 orforglipron cut A1C up to 1.6 points in Phase 3 diabetes trial
Full results from the 40-week ACHIEVE-1 trial show Eli Lilly's experimental once-daily pill orforglipron lowered A1C by 1.3% to 1.6% across three doses in adults with type 2 diabetes, versus 0.1% with placebo. The highest 36 mg dose produced average weight loss of 16.0 pounds (7.9%). The results were published in The New England Journal of Medicine and presented at the American Diabetes Association meeting.
- Research and trials
Novo Nordisk reports about 21% weight loss with semaglutide 7.2 mg in STEP UP trial
Novo Nordisk reported that once-weekly semaglutide 7.2 mg produced average weight loss of about 21% in adults with obesity in the STEP UP trial, with about a third of participants losing 25% or more. Published trial results reported a mean weight loss of 18.7% versus 3.9% for placebo, while the company's announcement described 20.7% for the same trial. The FDA later approved the 7.2 mg dose as Wegovy HD on March 19, 2026, and a US launch in a single-dose pen was expected in April 2026.
- Culture
Lizzo says she tried Ozempic and other GLP-1 drugs before choosing diet changes
Lizzo, 37, said on the June 19 episode of the Just Trish podcast that she tried Ozempic and other GLP-1 medications and stopped them early in her weight loss effort. She credited a switch away from veganism and toward whole foods, including beef, chicken and fish, for the results she wanted. She also said taking the drugs is not cheating.
- Business
FDA approves Mounjaro for type 2 diabetes in children 10 and older
The FDA approved a supplement from Eli Lilly that expands Mounjaro (tirzepatide) to patients aged 10 and older with type 2 diabetes. The agency said the filing fulfills a postmarketing requirement from Mounjaro's May 13, 2022, approval, which called for a 30-week pediatric study followed by a 22-week open-label extension. The approval letter does not include the trial's enrollment or results.
- Science
Scholar Rock says apitegromab cut lean mass loss during Zepbound treatment in phase 2 trial
Scholar Rock reported June 18, 2025, that adding its experimental drug apitegromab to tirzepatide (Zepbound) cut the share of weight lost as lean mass from 30.2% to 14.6% over 24 weeks in a phase 2 trial. Total weight loss was slightly lower with the combination, 12.3% versus 13.4%. Apitegromab is not approved for weight loss; the FDA is reviewing it for spinal muscular atrophy, with a decision expected by September.
- Research and trials
Bariatric surgery outperformed injectable GLP-1s in real-world weight loss study
In a study of 51,085 patients, those who had sleeve gastrectomy or gastric bypass lost 24% of their body weight after two years, compared with 4.7% for patients prescribed injectable semaglutide or tirzepatide for at least six months and 7% for those on continuous therapy for a full year. The results were presented June 17, 2025 at the ASMBS annual meeting, and no journal publication has been disclosed.
- Business
Lilly completes purchase of Verve Therapeutics and its gene editing heart treatments
Eli Lilly completed its acquisition of Verve Therapeutics on July 25, 2025, about five weeks after the deal was announced, in a transaction valued at up to roughly $1.3 billion. Lilly paid $10.50 per share in cash, or about $1.0 billion, plus a contingent value right worth up to $3.00 more per share if Verve's lead gene editing treatment, VERVE-102, reaches a U.S. Phase 3 trial in atherosclerotic cardiovascular disease within ten years.
- Business
Lilly adds 12.5 mg and 15 mg Zepbound vials, making all six doses available self-pay for $499 or less
Eli Lilly said on June 16, 2025 that the 12.5 mg and 15 mg doses of Zepbound (tirzepatide) will be sold as single-dose vials through LillyDirect's self-pay pharmacy, at $499 a month. With those two strengths added, every approved dose of the drug is available in vial form for $499 a month or less, regardless of insurance status. Providers could start prescribing the two highest doses on July 7, 2025, with patient shipments beginning in early August.
- Science
Diabetes journal weighs blocking or activating the GIP receptor that tirzepatide targets
The journal Diabetes published a point-counterpoint pair on June 16, 2025: one article argues for activating the GIP receptor, the other for blocking it, and both describe weight loss as the outcome. The case for blocking cites three GIP receptor gene variants linked to lower BMI, while the case for activating rests on tirzepatide, which acts on both the GIP and GLP-1 receptors. A companion commentary by Campbell and Drucker says the leading explanations for the paradox remain unproven.
- Safety
Europe's drug safety committee lists NAION as very rare semaglutide side effect
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee concluded that NAION, an eye condition that can cause permanent vision loss, is a very rare side effect of the semaglutide medicines Ozempic, Rybelsus and Wegovy, possibly affecting up to 1 in 10,000 users. Observational studies in adults with type 2 diabetes point to about twice the risk of NAION, or roughly one extra case per 10,000 person-years of treatment. The World Health Organization followed with a medical product alert dated 27 June 2025.
- Compounding
Fifth Circuit upholds FDA decisions ending semaglutide and tirzepatide shortages
A federal appeals court has upheld the FDA's decisions to remove semaglutide and tirzepatide from the national drug shortage list. The August 27 ruling from the US Court of Appeals for the Fifth Circuit rejected a challenge from the Outsourcing Facilities Association, a trade group for compounding pharmacies. Compounded versions made up an estimated 30% of the GLP-1 weight-loss market in 2024.
- Safety
Kidney analysis of two tirzepatide trials finds no adverse filtration signal
A post hoc analysis of the SURMOUNT-1 and SURMOUNT-2 trials reported that tirzepatide lowered urine albumin and did not produce unfavorable changes in estimated glomerular filtration rate. At week 72, the placebo-corrected reduction in urine albumin-to-creatinine ratio was 8.4% in SURMOUNT-1 and 31.1% in SURMOUNT-2. Acute kidney injury was reported in 0.3% to 0.6% of tirzepatide groups versus 0.2% on placebo in SURMOUNT-1, and in 1% on the 10 mg dose versus 0.3% on placebo in SURMOUNT-2.
- Research and trials
Lilly's amylin drug eloralintide shows about 11% weight loss in early trial
Eli Lilly's experimental amylin analog eloralintide produced about 11% weight loss over 12 weeks in a phase 1 trial of 100 patients, according to data released ahead of the American Diabetes Association conference. Weight loss reached 11.3% in the best-performing dose group and fell as low as 2.6% in another. Analysts called the results strong, and Lilly is testing the drug both alone and with tirzepatide.
- Business
Novo Nordisk passes SAP to again become Europe's most valuable company
Novo Nordisk returned to the top of the European market on June 13, 2025, rising above German software firm SAP, according to Reuters. The Danish drugmaker reached $367.91 billion in market value including its unlisted shares, based on LSEG data, with chipmaker ASML in third place. The report gave no market values for SAP or ASML and did not say what moved the shares.
- Science
Novo Nordisk to move experimental obesity drug amycretin into Phase 3 trials
Novo Nordisk announced on June 12, 2025 that it will advance amycretin, an experimental drug that targets both the GLP-1 and amylin receptors, straight into Phase 3 testing in weekly injectable and daily oral forms. In a Phase 1b/2a trial of 125 adults with overweight or obesity, the highest injectable dose produced an estimated mean weight loss of 24.3% over 36 weeks versus 1.1% with placebo. A separate Phase 1 oral trial showed 13.1% mean weight loss at 100 mg daily after 12 weeks versus 1.2% with placebo.
- Research and trials
Tirzepatide heart trial SURPASS-CVOT completes more than four years of follow-up
SURPASS-CVOT, the largest and longest trial of tirzepatide, has reached its completion date after more than four years of follow-up. The study randomized 13,299 participants at 640 sites in 30 countries and compared tirzepatide with dulaglutide 1.5 mg instead of a placebo. Results have not been reported.
- Research and trials
Tirzepatide users regained weight after stopping, SURMOUNT-CN follow-up finds
A real-world follow-up of phase 3 SURMOUNT-CN participants found that 26 weeks after stopping tirzepatide, body weight rose 9.1% in the 10 mg group and 12.3% in the 15 mg group. Measured from the trial's start, however, net weight was still down 8.7% and 10.6%, with waist circumference about 10.5 cm below baseline.
- Business
Eli Lilly signs Juvena deal worth more than $650 million for muscle drugs
Eli Lilly will partner with Juvena Therapeutics to search for drug candidates that improve muscle health and body composition. The deal includes an upfront payment that was not disclosed and more than $650 million in potential milestone payments. Juvena will use its AI-enabled screening platform, and Lilly holds an exclusive license to lead candidates against multiple targets.
- Research and trials
Study ties lower real-world weight loss to stopping semaglutide or tirzepatide early
A Cleveland Clinic study of 7,881 adults found average one-year weight loss of 8.7% after starting injectable semaglutide or tirzepatide, compared with 11.9% among those who stayed on treatment and 3.6% among those who stopped within three months. Most patients, 80.8%, were on low maintenance doses. The authors say higher discontinuation rates and lower doses likely explain why results were smaller than in phase 3 trials.
- Regulation
Europe adds vision-loss risk to Ozempic, Wegovy and Rybelsus labels
The European Medicines Agency's safety committee concluded that NAION, a rare eye condition that can cause vision loss, is a very rare side effect of semaglutide, affecting up to 1 in 10,000 people. The committee recommended updating the European product information for Ozempic, Rybelsus and Wegovy and said treatment should be stopped if NAION is confirmed.
- Safety
European regulator labels NAION a very rare side effect of semaglutide
The European Medicines Agency's safety committee concluded on 6 June 2025 that NAION, an eye condition that can cause sudden vision loss, is a very rare side effect of semaglutide, the drug in Ozempic, Rybelsus and Wegovy, affecting up to 1 in 10,000 people who take it. Large studies in adults with type 2 diabetes suggest about a two-fold relative increase in risk, or roughly one additional case per 10,000 person-years of treatment. The UK's Medicines and Healthcare products Regulatory Agency repeated the finding in a safety update published on 5 February 2026.
- Safety
UK regulator warns Mounjaro and other GLP-1 drugs may weaken oral contraceptives
The UK's Medicines and Healthcare products Regulatory Agency issued its first public alert on contraception and weight-loss medicines on June 5, 2025, after receiving 40 reports of pregnancies in people using GLP-1 drugs. The agency said Mounjaro may reduce the effectiveness of oral contraceptives in people who are overweight. It counted 26 pregnancy-related reports for Mounjaro, eight for semaglutide and nine for liraglutide.
- Business
Lilly pays up to $870 million for Camurus long-acting incretin technology
Eli Lilly agreed on June 3, 2025, to pay Camurus up to $870 million for rights to use its FluidCrystal delivery technology with up to four Lilly incretin compounds. The deal includes up to $290 million in upfront, development and regulatory milestones plus $580 million tied to sales milestones and tiered mid-single-digit royalties. Lilly's once-weekly Mounjaro and Zepbound are in the drug classes covered, and rivals are developing monthly options.
- Competition
China approves mazdutide for weight management as first GLP-1/glucagon dual agonist
China's drug regulator approved mazdutide, a dual GLP-1/glucagon receptor agonist, for chronic weight management, the first drug of its kind cleared in China. Innovent Biologics also announced approval for blood sugar control in adults with type 2 diabetes. In Phase 3 trials in Chinese adults with type 2 diabetes, mazdutide lowered HbA1c by about 1.6 to 2.2 percentage points and body weight by 5.6% to 9.2%, beating placebo and dulaglutide 1.5 mg. No US approval has been reported.
- Competition
Regeneron licenses late-stage GLP-1/GIP obesity drug from Hansoh Pharma
Regeneron is paying $80 million upfront and up to about $1.93 billion in milestones for rights to a GLP-1/GIP dual agonist from Hansoh Pharma, outside mainland China, Hong Kong and Macau. The compound is described as Phase 3-ready. The deal adds an incretin drug to a 2025 obesity licensing wave that includes Roche, Novo Nordisk, Eli Lilly and AbbVie.
- Science
Review proposes unified theory for opposing GIP receptor drug strategies
A review published May 29, 2025, in the Journal of Clinical Medicine argues that one biological framework can explain why drug developers have pursued both GIP receptor agonists and GIP receptor antagonists for metabolic disease. The article, by three scientists at the Indiana Biosciences Research Institute, proposes that agonism acts on GABAergic neurons while antagonism releases a brake on GLP-1 action in glutamatergic ones. It is a review of previously published evidence and reports no new trial results.
- Regulation
FDA adds hair loss to Mounjaro label and removes two limitations of use
The FDA approved a labeling supplement for Mounjaro (tirzepatide) on May 28, 2025, adding alopecia to the Postmarketing Experience section and removing two Limitations of Use: that the drug is not indicated for type 1 diabetes and that it has not been studied in patients with a history of pancreatitis. Eli Lilly and Company submitted the supplement on February 28, 2025, after the FDA requested the alopecia addition in a February 3, 2025, letter. The agency said the revisions align Mounjaro's labeling with recently approved changes to other products in the GLP-1 receptor agonist class.
- Business
FDA record shows revised Mounjaro package insert dated May 28, 2025
The FDA lists a revised package insert for Mounjaro (tirzepatide), the Eli Lilly injection, with an action date of May 28, 2025, filed as supplement S-031 to application NDA 215866. The supplement is classified as "Labeling-Package Insert." The record does not describe what text in the insert changed.
- Business
Lilly agrees to acquire SiteOne Therapeutics for up to $1 billion
Eli Lilly and Company announced on May 27, 2025 that it will acquire SiteOne Therapeutics, a private biotechnology company developing non-opioid pain medicines, for up to $1.0 billion in cash. The deal includes STC-004, a Nav1.8 inhibitor described as ready for Phase 2 testing in pain. The companies did not disclose how much of the $1.0 billion is an upfront payment versus later milestone payments, or when the transaction will close.
- Compounding
Deadline passes for large-scale compounding of semaglutide copies
The FDA's 90-day enforcement discretion period for 503B outsourcing facilities to compound copies of semaglutide ended on May 22, 2025, after the 503A window for state-licensed pharmacies and physicians closed on April 22. FDA had declared the semaglutide injection shortage resolved on February 21, 2025, and Novo Nordisk announced new programs to support access to Wegovy the same day the 503B deadline passed.
- Culture
FDA compounding allowance for semaglutide expires as copycats persist
The FDA's temporary authorization letting pharmacies compound copies of semaglutide expired on May 22, 2025. Novo Nordisk says copycat sales have continued "under the false guise of 'personalisation'," and on September 10 the company announced 9,000 job cuts and lowered its earnings forecast for the third time this year.
- Compounding
Connecticut attorney general warns clinics over compounded tirzepatide and semaglutide
Connecticut Attorney General William Tong sent a May 21, 2025 letter telling weight loss clinics, med spas and medical practices that advertising or prescribing compounded GLP-1 weight loss medications could violate the Connecticut Unfair Trade Practices Act. The letter cites FDA safety concerns including dosing errors, the use of salt forms of semaglutide and tirzepatide from overseas manufacturers, and adverse event reports, some of which required medical intervention.
- Prices
Cigna's Evernorth caps monthly out-of-pocket cost for Wegovy and Zepbound at $200
Cigna's pharmacy benefits unit, Evernorth, announced on May 21, 2025 that employers can add a program capping members' monthly out-of-pocket cost at $200 for Wegovy (semaglutide) and Zepbound (tirzepatide). About half of Cigna's clients currently cover the drugs, and the cap is less than half what patients pay in cash through the manufacturers' direct-to-consumer sites.
- Competition
Eli Lilly letter criticizes insurers over dropped obesity drug coverage
Eli Lilly published an open letter on May 21, 2025 criticizing recent insurance coverage changes for obesity medicines, saying they force patients to stop treatment or pay out of pocket. The letter names no insurers, pharmacy benefit managers or specific drugs, and says Medicare covers no obesity management medications while only a handful of states cover them for Medicaid patients. Lilly lists four positions, including covering obesity medicines the same way treatments for other chronic diseases are covered.
- Business
Novo Nordisk CEO Lars Fruergaard Jørgensen to step down after eight years
Novo Nordisk announced on May 16, 2025 that CEO Lars Fruergaard Jørgensen will step down after eight years, saying the change reflects market challenges and the company's share price decline. The shares have fallen 59% from a June 2024 peak and Novo's market value has halved to about $310 billion as Eli Lilly's Zepbound passed Wegovy in US prescriptions. Jørgensen will stay on until a successor is found.
- Science
Analysis finds Wegovy heart benefit appeared before major weight loss
A new analysis of the SELECT trial found that the reduction in cardiovascular events with Wegovy (semaglutide) appeared early, before clinically meaningful changes in body weight, Novo Nordisk said on May 13, 2025. The overall SELECT trial previously showed semaglutide 2.4 mg cut the risk of major adverse cardiovascular events by 20 percent in adults with overweight or obesity. The company has not disclosed how early the benefit appeared or how it defined clinically meaningful weight change.
- Policy
Trump's May 2025 most-favored-nation order set framework for GLP-1 price cuts
President Trump signed an executive order on May 12, 2025, directing his administration to bring US prescription drug prices in line with prices paid in other developed countries, with a promised reduction of up to 59%. The order led to letters to manufacturers in July 2025, a first pricing deal with Pfizer on September 30, 2025, and agreements with Eli Lilly and Novo Nordisk in November 2025 that cut the cash price of Ozempic and Wegovy to $350 a month and set Medicare prices for four GLP-1 drugs at $245.
- Research and trials
Tirzepatide trial in type 1 diabetes adds 20-month arm and 465 adults
A second trial of tirzepatide in type 1 diabetes has begun, randomizing 465 adults with type 1 diabetes and overweight or obesity to the drug or a placebo for about 20 months. The study, SURPASS-T1D-2, uses the same week-40 HbA1c primary endpoint as its companion trial, and together the two studies plan to enroll 1,370 people. The registry lists a primary completion date of November 2026.
- Research and trials
Tirzepatide beats semaglutide for weight loss in first randomized head-to-head obesity trial
In SURMOUNT-5, the first randomized head-to-head trial of tirzepatide and semaglutide in adults with obesity, tirzepatide produced an average 20.2% weight loss at 72 weeks versus 13.7% for semaglutide. Waist circumference fell 18.4 cm versus 13.0 cm, and side-effect rates were similar between the two groups. The results were published May 11, 2025, in The New England Journal of Medicine and funded by Eli Lilly.
- Culture
Wellness companies rebuild around weight-loss drugs after WeightWatchers bankruptcy
Health and wellness companies are rebuilding their businesses around GLP-1 weight-loss drugs after WeightWatchers filed for bankruptcy on Tuesday, citing the popularity of the medicines. Telehealth firms such as Noom and Hims & Hers have leaned on cheaper compounded versions, but the FDA is now blocking those sales because Wegovy, Zepbound, Ozempic and Mounjaro are no longer in shortage.
- Business
Lilly shifts three executives as it refocuses on U.S. and global launches
Eli Lilly announced on May 8, 2025 that it is moving three executives into new roles, including a new president for its cardiometabolic health business. Ilya Yuffa will run Lilly USA, Patrik Jonsson will lead markets outside the U.S., and Kenneth Custer, who helped lead early development of tirzepatide, takes over cardiometabolic health. The changes follow a quarter in which Lilly's revenue rose 45%, driven by Mounjaro and Zepbound.
- Regulation
Judge upholds FDA removal of Mounjaro and Zepbound from shortage list
On May 7, 2025, a federal judge in Texas upheld the FDA's decision to remove tirzepatide injection products — Mounjaro and Zepbound — from the agency's drug shortage list, rejecting arguments from compounding groups that the FDA needed notice-and-comment rulemaking and acted arbitrarily. The Fifth Circuit later affirmed, pointing to Lilly supply data that showed an 11.6 million-dose surplus by November 2024 after about $23 billion in manufacturing investment.
- Regulation
Federal court upholds FDA removal of tirzepatide from shortage list
A federal court in the Northern District of Texas ruled on May 7, 2025 that the FDA acted within its authority when it removed two tirzepatide injection products from the drug shortage list. The FDA has treated the tirzepatide shortage as resolved since October 2024, and its discretionary enforcement periods for 503A pharmacies and 503B outsourcing facilities ended on February 18 and March 19, 2025. The ruling limits compounding of essentially copies of tirzepatide injections.
- Competition
Generic Qsymia reaches pharmacies from two makers, with discount prices near $60 a month
Teva Pharmaceuticals began selling generic Qsymia (phentermine and topiramate extended-release) in all four strengths on May 7, 2025, and Dr. Reddy's Laboratories started marketing its own versions of the same strengths on June 12, 2025. Discount-card prices for the generic run about $59 to $63 for 30 capsules, compared with average cash prices of roughly $249 to $276 for the brand.
- Culture
WeightWatchers files for Chapter 11, cutting $1.15 billion in debt as GLP-1 drugs reshape dieting
WW International, the parent of WeightWatchers, filed for Chapter 11 bankruptcy protection on May 6, 2025, in a prepackaged deal with lenders to eliminate about $1.15 billion of its roughly $1.6 billion in debt. The company reported a $345.7 million net loss for 2024 and a 5.6% decline in subscription revenue as GLP-1 weight-loss drugs pulled members away from diet programs. It exited the court-supervised reorganization on June 24, 2025, after the bankruptcy court approved the plan.
- Compounding
Novo Nordisk wins two Texas rulings against compounded semaglutide sellers
A Texas federal court denied a compounding trade group's request to freeze the FDA's decision that the semaglutide shortage is over, leaving in place the agency's finding that Wegovy and Ozempic are fully available. A separate ruling permanently bars MediOak Pharmacy LLC from marketing or selling compounded "semaglutide," and Novo Nordisk says the grace period for 503B outsourcing facilities ends May 22, 2025.
- Research and trials
Lilly pulls US heart failure application for tirzepatide after FDA seeks another trial
Eli Lilly withdrew its US application to add a heart failure with preserved ejection fraction (HFpEF) indication to tirzepatide after the FDA told the company a second confirmatory trial would be required, chief scientific officer Dan Skovronsky said during a May 1, 2025 investor briefing. Lilly had based the filing on its phase 3 SUMMIT trial. On January 30, 2026, EU regulators declined to back the drug, sold as Mounjaro in Europe, for a type of heart failure.
- Prices
CVS Caremark drops Zepbound from standard formularies, making Wegovy preferred for weight loss
CVS Caremark removed tirzepatide (Zepbound) from its standard formularies for obesity treatment effective July 1, 2025, and made semaglutide (Wegovy) the preferred GLP-1 for the plans it manages. CVS told clients the change would save employer clients 10% to 15% year over year. People already taking Zepbound could seek a formulary exception, switch to Wegovy, or pay the full cost.
- Prices
CVS Caremark picks Wegovy over Zepbound for its biggest commercial drug lists
Novo Nordisk said Wegovy will hold the preferred GLP-1 position for obesity on CVS Caremark's largest commercial template formularies starting July 1, 2025, with Eli Lilly's Zepbound excluded. CVS Health said the formulary reaches "tens of millions of lives," and the arrangement lets CVS sell Wegovy to cash payers for $499 at more than 9,000 stores.
- Business
Lilly first-quarter revenue rises 45% as CVS picks Wegovy over Zepbound
Eli Lilly reported $12.73 billion in first-quarter 2025 revenue on May 1, up 45% from a year earlier, on strong sales of Mounjaro and Zepbound. The company also lowered its full-year adjusted earnings guidance because of a $1.57 billion deal charge. The same day, CVS Health said its pharmacy benefit manager would make Novo Nordisk's Wegovy the preferred weight-loss drug on its main formularies instead of Zepbound, and Lilly shares closed down more than 11%.
- Business
Victoza and Saxenda labels remove pregnancy contraindication
The FDA-approved prescribing information for Novo Nordisk's liraglutide products records a May 2025 revision that removed pregnancy from the contraindications section and moved the topic to Use in Specific Populations. Saxenda's label now says to discontinue the drug when pregnancy is recognized, while Victoza's says to use it during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Research and trials
Meta-analysis of GLP-1 receptor agonist trials finds thyroid and colorectal cancer signals
A meta-analysis of 50 randomized controlled trials found no overall increase in cancer risk among people taking GLP-1 receptor agonists, but reported higher odds of thyroid cancer (1.55) and colorectal cancer (1.27). The authors say the thyroid signal needs more study and suggest the colorectal finding may reflect more diagnostic procedures rather than a true increase.
- Research and trials
Semaglutide cleared liver inflammation and improved scarring in phase 3 MASH trial
A phase 3 trial of once-weekly semaglutide 2.4 mg injections found that steatohepatitis resolved without fibrosis worsening in 62.9% of participants with MASH, compared with 34.3% of those on placebo. Liver scarring improved without steatohepatitis worsening in 36.8% versus 22.4%. The findings come from a planned week-72 interim analysis of the first 800 of 1,197 patients in the ongoing ESSENCE trial, which is funded by Novo Nordisk.
- Safety
FDA logged 520 adverse event reports tied to compounded semaglutide by April 2025
By April 30, 2025, the FDA had received 520 adverse event reports connected to compounded semaglutide. The agency cited that count as justification for enforcement deadlines that required compounding pharmacies to stop making products that were essentially copies of the brand-name drug, with a cutoff of April 22, 2025 for state-licensed 503A pharmacies and May 22, 2025 for 503B outsourcing facilities.
- Compounding
Novo Nordisk enlists Hims & Hers, LifeMD and Ro to sell Wegovy through NovoCare Pharmacy
Novo Nordisk said on April 29, 2025 that Hims & Hers, LifeMD and Ro would offer every dose of Wegovy through its NovoCare Pharmacy direct-to-patient program. LifeMD and Ro list a $499 monthly cash price, while Hims & Hers sells a bundle starting at $599. Novo ended the Hims & Hers partnership about eight weeks later.
- Culture
Charles Barkley becomes a GLP-1 ambassador for telehealth company Ro
Ro announced on April 29, 2025 that NBA Hall of Famer Charles Barkley is joining the company as a GLP-1 celebrity ambassador. According to the announcement, Barkley shed close to 50 pounds on a GLP-1 medication, stopped because of supply and access problems, regained much of the weight, and is now restarting treatment through Ro.
- Science
Mouse study finds blocking GIP receptors depends on GLP-1 signaling, unlike tirzepatide's GIP activation
A study in male mice published in Nature Metabolism found that the weight and food intake effects of blocking the GIP receptor disappeared in mice lacking either the GIP receptor or the GLP-1 receptor, but survived when the GIP receptor was removed only from certain neurons. That is the opposite of the pattern seen with GIP receptor activation, and gene-activity sequencing showed that blockade, not activation, closely resembled GLP-1 receptor signaling in the brainstem.
- Research and trials
Lilly starts 905-person phase 3 trial of tirzepatide in type 1 diabetes
Eli Lilly has begun SURPASS-T1D-1, a phase 3 study that plans to randomly assign 905 adults with type 1 diabetes and overweight or obesity to weekly tirzepatide or placebo. The primary endpoint is change in HbA1c at week 40, and primary completion is listed for November 2026.
- Compounding
Eli Lilly sues four companies over compounded tirzepatide
Eli Lilly and Co. sued Willow Health Services and three other companies in federal courts in New Jersey and California, accusing them of selling compounded tirzepatide products for weight loss without FDA approval or proper testing. The filings, reported April 25, 2025 by the legal trade publication Texas Lawyer, are described as a "slew of lawsuits" involving Lilly's Mounjaro and Zepbound. The other three defendants, the total number of complaints and any damages sought have not been reported.
- Prices
Judge denies injunction on compounded semaglutide, letting FDA deadlines stand
A federal district court in Texas denied a preliminary injunction motion from compounding facilities over compounded semaglutide on April 24, 2025. State-licensed pharmacies and physicians must stop compounding copies of the drug now, while larger outsourcing facilities have until May 22, 2025. The FDA declared the semaglutide injection shortage resolved on February 21, 2025.
- Safety
Texas court refuses to freeze FDA finding that ended semaglutide shortage
A federal judge in Texas on April 24 denied a compounding trade group's request to pause the FDA's determination that injectable semaglutide is no longer in short supply, keeping in force the finding that all doses of Ozempic and Wegovy are fully available nationwide. Novo Nordisk says that leaves most compounded copies of the drug unlawful, with FDA enforcement possible against 503A pharmacies immediately and against 503B outsourcing facilities after May 22, 2025. A separate ruling permanently bars MediOak Pharmacy LLC from selling compounded "semaglutide".
- Compounding
FDA warns Houston compounder Empower Pharma over sterility and labeling problems
The FDA sent a warning letter to Empower Pharma, a Houston-based 503B outsourcing facility that Eli Lilly has sued over compounded tirzepatide, citing missing label information, unsanitary conditions for drugs that should be sterile and deficient corrective actions. The letter followed an August inspection of the Houston site and was posted to the FDA's website on April 22. Compounded tirzepatide was not among the Empower products listed in the letter.
- Safety
Eli Lilly sues four telehealth sellers over compounded tirzepatide
Eli Lilly filed lawsuits on April 23, 2025 against Mochi Health, Fella Health and Delilah, Willow Health Services and Henry Meds over compounded tirzepatide. The complaints center on products Lilly says were never clinically tested, including an oral version and injections blended with additives such as glycine and l-arginine. Lilly is asking courts to stop the companies from marketing or selling tirzepatide.
- Compounding
Eli Lilly sues four telehealth companies over compounded tirzepatide
Eli Lilly filed lawsuits on April 23, 2025 against Mochi Health, Willow Health, Fella Health and Delilah, and Henry Meds, alleging they sell illegal compounded copies of tirzepatide, the active ingredient in Zepbound and Mounjaro. The suits follow earlier April complaints against two compounding pharmacies. Compounded tirzepatide has sold for as little as $99 a month, against a Zepbound list price of more than $1,086.37 a month.
- Business
Novo Nordisk widens CenterWell deal to fill and deliver Wegovy
Novo Nordisk expanded its partnership with Humana's CenterWell Pharmacy in late April so the pharmacy handles prescription fulfillment and home delivery of Wegovy for patients who buy the drug directly from Novo. The arrangement extends NovoCare, the direct-to-patient pharmacy Novo launched in March, where self-paying patients pay $499 a month. The move came as CVS Caremark named Wegovy its preferred GLP-1 on its largest commercial template formularies starting July 1.
- Compounding
FDA deadline passes for 503A pharmacies to stop compounding semaglutide copies
The FDA's 60-day enforcement grace period for state-licensed 503A compounding pharmacies to stop making compounded semaglutide injections that are essentially copies of Ozempic and Wegovy ended on April 22, 2025. Outsourcing facilities under section 503B have until May 22, 2025. Compounding semaglutide products that are not essentially a copy, for an individual patient's documented need, remains permitted.
- Culture
Zepbound leads Wegovy with nearly 339,000 weekly US prescriptions
IQVIA data show Zepbound (tirzepatide) filled close to 339,000 US prescriptions in the week ending April 18, 2025, roughly 127,000 more than Wegovy (semaglutide). The same period brought news that CVS Health would stop covering Zepbound for obesity while keeping Wegovy, and Eli Lilly shares closed almost 12% lower.
- Research and trials
Lilly says oral GLP-1 pill orforglipron succeeded in first Phase 3 diabetes trial
Eli Lilly reported on April 17, 2025 that its once-daily pill orforglipron lowered A1C by 1.3% to 1.6% from a baseline of 8.0% in 559 adults with type 2 diabetes over 40 weeks, with 16.0 pounds of average weight loss at the highest dose. It is the first oral small-molecule GLP-1 drug to complete a Phase 3 trial. Orforglipron is not approved, and Lilly says it plans to seek regulatory clearance starting with weight management by the end of 2025.
- Competition
Lemme GLP-1 Daily fraud class action dismissed without prejudice in New York
A federal fraud class action against supplement maker Lemme Inc. over its Lemme GLP-1 Daily product was voluntarily dismissed without prejudice on April 16, 2025, in the Southern District of New York. The case was filed March 9, 2025, and Lemme moved to dismiss on April 8, 2025. No court ruled on the merits, so the allegations were never tested.
- Safety
Review finds GLP-1 drugs linked to retained stomach contents but not aspiration during anesthesia
A systematic review and meta-analysis published April 15, 2025 in the journal Anaesthesia pooled 28 observational studies and found no association between GLP-1 receptor agonist use and pulmonary aspiration during procedures needing anesthesia or sedation (odds ratio 1.04, 95% CI 0.87–1.25). The same review found GLP-1 users had clearly higher odds of residual gastric contents despite fasting (odds ratio 5.96, 95% CI 3.96–8.98). Certainty of evidence was rated low.
- Business
FDA seizes counterfeit Ozempic 1 mg pens after Novo Nordisk warning
The FDA seized counterfeit Ozempic (semaglutide) injection 1 mg after Novo Nordisk notified the agency on April 3, 2025 that several hundred counterfeit units were in the U.S. drug supply chain. The pens carry lot number PAR0362 and serial numbers beginning with the digits 51746517. The FDA says it is aware of six adverse event reports tied to the lot, none of which appear to be linked to the counterfeit product.
- Competition
Pfizer ends oral GLP-1 danuglipron after one liver injury case
Pfizer said on April 14, 2025 that it is discontinuing danuglipron, an experimental once-daily oral GLP-1 receptor agonist for chronic weight management, after one symptom-free trial participant showed possible drug-induced liver injury that cleared when the drug was stopped. Pfizer said liver enzyme elevations across the drug's safety database of more than 1,400 participants were in line with approved medicines in the same class, but it ended the program after reviewing all danuglipron data and recent regulator feedback.
- Compounding
Trade commission bars imports of tirzepatide products that infringe Lilly's trademark
The U.S. International Trade Commission issued a general exclusion order on April 9, 2025, barring imports of products containing or purporting to contain tirzepatide that infringe Eli Lilly's trademark or carry a false designation of origin. Because it is a general order, it binds any importer, not only the companies named in the case. Cease and desist orders were also issued against Arctic Peptides, Triggered Brand and Strate Labs, and the notice was published in the Federal Register on April 15, 2025.
- Safety
Counterfeit Ozempic 1 mg pens seized from US supply chain, FDA says
The FDA seized several hundred counterfeit Ozempic (semaglutide) 1 mg injection pens on April 9, 2025, after Novo Nordisk told the agency on April 3 that the units had reached the U.S. supply chain. The fakes carry lot number PAR0362 and serial numbers starting with 51746517. Testing continues, and the FDA says it does not yet know what the pens contain or whether they are safe.
- Research and trials
Switching to tirzepatide beats raising the dulaglutide dose in type 2 diabetes trial
In the 40-week SURPASS-SWITCH trial, 282 adults with type 2 diabetes who were not at their A1c goal on dulaglutide 0.75 mg or 1.5 mg were assigned either to switch to tirzepatide or to raise their dulaglutide dose to 4.5 mg. HbA1c fell 0.77 percentage points more and weight fell 6.9 kg more with the switch. Rates of serious adverse events were similar in the two groups.
- Research and trials
Weight regain after stopping GLP-1 drugs averaged 9.69 kg for semaglutide and tirzepatide, review finds
A systematic review and meta-analysis of eight randomized trials covering 2,372 participants found that people regained weight after stopping GLP-1 medications. Pooled average regain was 9.69 kg for semaglutide or tirzepatide and 2.20 kg for liraglutide. The amount regained was proportional to the weight people had originally lost.
- Policy
Trump administration drops plan to extend Medicare coverage to Wegovy and Zepbound
On April 4, the Trump administration declined to finalize a Biden-era rule that would have let Medicare and Medicaid pay for obesity drugs including Wegovy and Zepbound. CMS said the move was "not appropriate at this time," with projected costs of $25 billion for Medicare and $15 billion for Medicaid over 10 years. CMS had estimated more than 7 million people would have gained coverage.
- Business
Novo Nordisk reshuffles executive team after Camilla Sylvest departs
Novo Nordisk announced changes to its executive leadership team effective April 3, 2025, after Camilla Sylvest, executive vice president of Commercial Strategy & Corporate Affairs, left the company following a 28-year career there. Ludovic Helfgott, previously head of Rare Disease, added Product & Portfolio Strategy to his remit, covering commercial strategy, medical affairs and business development across all therapy areas. Thilde Hummel Bøgebjerg, an 18-year company veteran, was promoted to lead Quality, IT & Environmental Affairs, and Tania Sabroe took on Global Communication in addition to her existing role.
- Compounding
FDA warns Empower Pharmacy over sterile production conditions at two Houston sites
The FDA issued two warning letters dated April 2, 2025 to Empower Clinic Services, LLC, which does business as Empower Pharmacy and Empower Pharma, citing insanitary conditions in sterile drug production at its 503A pharmacy and its 503B outsourcing facility in Houston. Inspections in August and in September–October 2024 found gaps in environmental monitoring, sterilization and airflow testing, and the agency said one batch was released after microbial growth was detected inside a critical production area. The company recalled one lot of pyridoxine HCl injection in September 2024 for lack of sterility assurance.
- Business
Meitheal launches generic liraglutide injection as Victoza shortage continues
Meitheal Pharmaceuticals has launched a generic liraglutide injection, 18 mg/3 mL, after FDA approval under ANDA218115; the company says it is Meitheal's first injector-pen product. FDA's National Drug Code directory lists two Meitheal carton sizes with a marketing start date of April 2, 2025. Meitheal noted that brand-name Victoza was in active shortage on both the FDA and ASHP shortage lists as of March 24, 2025.
- Business
Knownwell to offer weight-management care through LillyDirect
Knownwell, a primary care practice, said on April 2, 2025 that it will provide health and weight-management services on LillyDirect, Eli Lilly's direct-to-consumer online health platform. People using LillyDirect will be able to see knownwell physicians for personalized care. The practice offers in-person and virtual primary care, nutrition counseling and behavioral health services that it says are covered through patients' insurance.
- Business
Drug import probe opened in April 2025 led to 100% tariffs and a Lilly pricing deal
The Commerce Department opened a Section 232 national security investigation into pharmaceutical imports on April 1, 2025. The probe found that about 53% of patented drugs distributed in the U.S. are produced abroad and produced an April 2, 2026 proclamation setting a 100% tariff on patented pharmaceuticals, with lower rates for companies that onshore production or sign most-favored-nation pricing agreements. Eli Lilly later agreed to MFN pricing and U.S. manufacturing investments in exchange for tariff relief.
- Compounding
Lilly sues two pharmacies and four telehealth firms over compounded tirzepatide
Eli Lilly sued compounding pharmacies Strive and Empower on April 1, 2025, accusing them of skirting the FDA's ban on making compounded tirzepatide. Later in April, Lilly filed four more lawsuits in California against telehealth companies Fella Health, Willow Health, Henry Meds and Mochi Health. Compounding of tirzepatide was supposed to stop by March 19 after the FDA said the drug was no longer in shortage.
- Business
Hims & Hers adds Zepbound as Lilly says it has no affiliation with the company
Hims & Hers said on April 1, 2025 that it would sell Eli Lilly's Zepbound (tirzepatide) on its platform, and its shares rose. The same day, Lilly issued a statement saying it has no affiliation with Hims & Hers, noting that Zepbound can be prescribed by any licensed healthcare professional and that self-pay patients can get it starting at $349 a month through LillyDirect, with some commercially insured patients eligible to pay as low as $25.
- Research and trials
Semaglutide resolved liver inflammation in most MASH patients in phase 3 trial
The New England Journal of Medicine published part 1 of the ESSENCE trial, which found that once-weekly semaglutide 2.4 mg resolved steatohepatitis without worsening fibrosis in 62.9% of patients with MASH and stage 2 or 3 fibrosis, compared with 34.3% on placebo. Fibrosis improved without worsening steatohepatitis in 36.8% versus 22.4%. The trial is ongoing and longer-term outcomes are not yet available.
- Science
GLP-1 pioneers share $3 million Breakthrough Prize for work behind semaglutide
The 2025 Breakthrough Prize in Life Sciences went to five scientists for discovering and characterizing the gut hormone GLP-1 and developing it into drugs for diabetes and obesity. Daniel Drucker, Joel Habener, Jens Juul Holst, Lotte Bjerre Knudsen and Svetlana Mojsov share the $3 million award, announced April 5 in Los Angeles.
- Policy
OMA and ACOFP issue joint primary care roadmap for obesity treatment
The Obesity Medicine Association and the American College of Osteopathic Family Physicians published a joint clinical perspective in Obesity Pillars on March 17, 2025, outlining how family physicians should diagnose and treat obesity. The document names four pillars of care and lists seven barriers that keep primary care practices from starting anti-obesity medications, including insufficient visit time, weak reimbursement and weight bias.
- Culture
WeightWatchers launches a GLP-1 Companion Program inside its app
WeightWatchers has introduced a GLP-1 Companion Program, a medication-tailored plan that lives inside the company's app and is described as behavioral support alongside GLP-1 drugs rather than a replacement for them. The April 2025 announcement appears as a blog post that is restricted to paying members. Pricing, eligibility and clinical details of the program have not been disclosed on the public page.
- Science
Oral semaglutide cut major cardiovascular events by 14% in SOUL trial
Full SOUL results, presented March 29, 2025 at ACC.25 and published in the New England Journal of Medicine, show that 12.0% of adults with type 2 diabetes and heart or kidney disease taking oral semaglutide had a major cardiovascular event versus 13.8% on placebo over roughly four years. Confirmatory kidney and limb outcomes did not differ significantly, and 20% to 30% of participants discontinued, largely because of gastrointestinal side effects.
- Research and trials
Novo Nordisk's semaglutide improved walking distance in peripheral artery disease trial
In the phase 3b STRIDE trial, once-weekly semaglutide 1 mg improved maximum walking distance by 13% versus placebo over 52 weeks in adults with type 2 diabetes and symptomatic peripheral artery disease. The results were presented March 29, 2025, at the American College of Cardiology meeting and published the same day in The Lancet. Novo Nordisk has asked the FDA to add the walking benefit to the Ozempic label.
- Research and trials
SUMMIT analysis finds tirzepatide benefit holds in kidney disease and flags eGFR test mismatch
An analysis of the SUMMIT trial found that chronic kidney disease did not reduce the relative benefit of tirzepatide on major heart failure events in patients with obesity-related heart failure with preserved ejection fraction. The same analysis reported that cystatin C-based eGFR ran about 9 mL/min/1.73 m2 lower than creatinine-based eGFR at baseline, with the two formulas often disagreeing for individual patients.
- Prices
England starts funding tirzepatide in specialist weight management services
As of March 24, 2025, England's integrated care boards are required to fund tirzepatide (Mounjaro) for obesity in NHS specialist weight management services for adults who meet NICE's criteria. NHS England estimated 3.4 million people would qualify and negotiated a funding variation that phases full access over up to 12 years, starting with about 220,000 patients in the first three years.
- Competition
Eli Lilly launches Mounjaro in India at about $50 a vial, beating Novo Nordisk
Lilly began selling Mounjaro (tirzepatide) in India on March 20, 2025, pricing a 5 mg vial at 4,375 rupees, or about $50.67, and a 2.5 mg vial at 3,500 rupees, about $40.54. Novo Nordisk's Wegovy had already been approved in India but had no confirmed launch date at the time; Novo launched it there on June 24, 2025, and India's regulator approved a Mounjaro pen on June 26, 2025.
- Regulation
Tirzepatide compounding wind-down ends for 503B facilities as FDA deadline passes
The FDA's 90-day enforcement wind-down for 503B outsourcing facilities compounding copies of tirzepatide closed on March 19, 2025, after a similar period for 503A pharmacies and physicians ended February 18, 2025. Both tiers are now outside the shortage-based exemptions for tirzepatide, while the equivalent semaglutide deadlines fall on April 22 and May 22, 2025.
- Regulation
Washington commission issues stop service order against a GLP-1 compounder
Washington's Pharmacy Quality Assurance Commission imposed a stop service order on a GLP-1 sterile compounder over sterile compounding and licensure failures. The pharmacy was not named, and the order's date and duration have not been reported. The action came as federal rules on compounded copies of semaglutide and tirzepatide have tightened and states have split on how aggressively to enforce them.
- Business
Lilly CEO Dave Ricks's 2024 pay reported at $114 million as Mounjaro and Zepbound sales climb
Eli Lilly CEO Dave Ricks was paid about $114 million in 2024, according to a company proxy statement to investors, in a year when combined sales of the tirzepatide drugs Mounjaro and Zepbound reached $16.4 billion. A separate report on the same filing put his compensation package at $29.2 million, up 10% from $26.6 million in 2023.
- Regulation
FDA sets March 19 end date for compounded tirzepatide from outsourcing facilities
The FDA confirmed that its enforcement discretion period for compounded tirzepatide injections has ended for state-licensed pharmacies and physicians, and that outsourcing facilities have until March 19, 2025. The March 10 update followed a March 5 court ruling that denied a request to block the agency's timeline. Semaglutide compounding deadlines are set at April 22 and May 22, 2025, unless a pending court decision moves them later.
- Competition
Class action says Lemme GLP-1 Daily capsules lack evidence for weight loss claims
A proposed class action filed March 10, 2025 in New York federal court claims Lemme GLP-1 Daily capsules cannot reduce hunger or promote weight loss by raising the body's own GLP-1, and a second case is pending in California state court. The complaints point to research on the ingredient Eriomin showing an average GLP-1 increase of about 17.5% but no reductions in body weight, BMI, waist-to-hip ratio or calorie intake.
- Research and trials
Novo Nordisk says CagriSema produced nearly 16% weight loss in type 2 diabetes trial
Novo Nordisk reported on March 10, 2025 that CagriSema produced nearly 16% weight loss at 68 weeks in adults with obesity or overweight and type 2 diabetes, compared with about 3% for placebo, in the phase 3 REDEFINE 2 trial. The company said it plans to file for regulatory approval in the first quarter of 2026.
- Safety
Preprint links semaglutide to higher hair loss rate in women
A preprint posted March 6, 2025 reports that women taking semaglutide for weight loss were diagnosed with hair loss about twice as often as women taking bupropion-naltrexone, with an adjusted hazard ratio of 2.08. The overall adjusted hazard ratio was 1.52, with a confidence interval that included 1.0, and the paper has not been peer reviewed.
- Research and trials
Tirzepatide trial in polycystic kidney disease begins enrolling 126 adults
A phase 2 trial has begun randomizing 126 adults with autosomal dominant polycystic kidney disease to tirzepatide titrated to 5 mg weekly or placebo for 12 months. The main measure is change in height-adjusted total kidney volume on MRI, and the listed primary completion date is June 2029. People with diabetes and people taking tolvaptan are excluded.
- Compounding
Teladoc and LifeMD to offer branded Zepbound vials through LillyDirect's pharmacy partner
Teladoc Health and LifeMD said on March 6, 2025 that they each signed agreements with Gifthealth, the pharmacy partner behind Eli Lilly's LillyDirect, to offer branded Zepbound (tirzepatide) vials to patients paying cash instead of using insurance. Teladoc said it does not offer compounded versions of the drugs, while LifeMD has offered compounded versions and said it is prepared to respond to changes. The deals come as the FDA and a federal court move to curtail compounded copies of branded GLP-1 drugs.
- Business
Teladoc and LifeMD to offer branded Zepbound vials as compounded copies face limits
Teladoc Health and LifeMD said on March 6 they signed agreements with Gifthealth, the pharmacy partner behind Eli Lilly's LillyDirect site, to offer branded Zepbound vials to patients who pay cash. Prices listed at the time were $349 a month for the 2.5 mg vial and $499 for the 5 mg vial, with higher doses promoted at $499. The deals came one day after a federal judge denied an injunction that would have let compounding pharmacies keep making copies of Zepbound in the U.S..
- Regulation
Judge denies compounding groups' request to pause FDA tirzepatide shortage ruling
On March 5, 2025, a federal district court in Texas denied a preliminary injunction sought by compounding groups in Outsourcing Facilities Association v. FDA, keeping tirzepatide injection products off the FDA's shortage list. The ruling left in place a March 19, 2025 deadline after which the FDA can act against outsourcing facilities that compound copies of Mounjaro and Zepbound. Eli Lilly's supply data showed an 11.6 million-dose surplus by November 2024 after about $23 billion in manufacturing investment.
- Prices
Novo Nordisk opens NovoCare Pharmacy, selling Wegovy at $499 a month
Novo Nordisk launched NovoCare Pharmacy on March 5, 2025, a direct-to-patient service that ships all doses of Wegovy (semaglutide) to patients' homes for $499 a month for people paying cash. The 28-day list price for the drug is $1,349, and the company says 90% of Wegovy patients who have coverage pay $0 to $25 a month. The program is limited to uninsured patients or those whose commercial insurance does not cover obesity medicines; Medicare and Medicaid enrollees are not eligible.
- Regulation
Judge denies request to block FDA's tirzepatide compounding deadlines
A federal district court in Texas denied a preliminary injunction on March 5, 2025 in Outsourcing Facilities Association v. FDA, letting the FDA's tirzepatide compounding deadlines take effect. Enforcement discretion for state-licensed pharmacies and physicians compounding tirzepatide under section 503A has ended, and for 503B outsourcing facilities it runs until March 19, 2025.
- Research and trials
Tirzepatide produced large weight loss in Japanese adults with obesity in a phase 3 trial
In the SURMOUNT-J trial, Japanese adults with obesity disease who took once-weekly tirzepatide lost substantially more weight than those on placebo over 72 weeks. The placebo-adjusted difference in body weight change was -16.1% at the 10 mg dose and -21.1% at the 15 mg dose. About 94% and 96% of participants on those doses lost at least 5% of body weight, compared with 20% on placebo.
- Compounding
Lilly launches ad campaign warning patients about compounded weight-loss drugs
Eli Lilly began running an advertising campaign on Feb. 28, 2025, urging patients to "be a healthy skeptic" about unapproved weight-loss drugs sold outside the approved supply chain. The campaign followed a Super Bowl commercial from telehealth company Hims & Hers selling a compounded weight-loss drug, and it comes as Lilly's Zepbound and Novo Nordisk's Wegovy have been removed from the FDA's shortage list, leaving compounding pharmacies that sell hundreds of thousands of doses running out of time to produce them.
- Culture
Scott Disick says on 'The Kardashians' that he used Mounjaro
Scott Disick confirmed on the Thursday, February 27, 2025 episode of "The Kardashians" that he used Mounjaro, nearly a year after viewers said they spotted the drug in his refrigerator. The 41-year-old told Khloé Kardashian, 40, that he was not embarrassed, after she called to tell him the older clip had gone viral.
- Prices
Lilly pledges $27 billion for four new US plants, three making drug ingredients
Eli Lilly said on Feb. 26, 2025 that it will build four new US manufacturing sites, a move CNBC and CNN reported at $27 billion and one that lifts Lilly's total US capital commitments since 2020 above $50 billion. Three of the plants will make active pharmaceutical ingredients, including tirzepatide, the molecule in Zepbound and Mounjaro, according to CNBC. Lilly has not chosen locations and says the plants will not make medicines for about five years.
- Prices
Lilly cuts Zepbound vial prices and adds 7.5 mg and 10 mg doses
On Feb. 25, 2025, Eli Lilly cut the cash price of its 2.5 mg Zepbound vial to $349 a month and its 5 mg vial to $499, about $50 less per dose than before. It also began selling 7.5 mg and 10 mg single-dose vials, listed at $599 and $699 but priced at $499 for a first fill or a refill within 45 days of the previous delivery.
- Research and trials
SURMOUNT-1 scan substudy finds tirzepatide weight loss is about 75% fat and 25% lean mass
In a SURMOUNT-1 substudy, 160 adults with obesity or overweight had body scans at baseline and week 72. Those taking tirzepatide lost 21.3% of body weight, 33.9% of fat mass and 10.9% of lean mass, compared with 5.3%, 8.2% and 2.6% for placebo. About 75% of the weight lost was fat and 25% was lean tissue in both groups, a ratio the authors say held across sex, age and weight-loss subgroups.
- Compounding
Compounding trade group sues FDA over semaglutide shortage list removal
The Outsourcing Facilities Association and a Texas compounding pharmacy sued the FDA on February 24, 2025, arguing the agency acted "recklessly and arbitrarily" when it removed semaglutide injection products from the national drug shortage list on February 21. The delisting starts a countdown for compounded semaglutide: 503A pharmacies may keep compounding until April 22, 2025, and 503B outsourcing facilities until May 22, 2025.
- Compounding
FDA ends semaglutide shortage listing and sets spring deadlines for compounders
On Feb. 21, 2025, the FDA declared the shortage of injectable semaglutide, sold as Ozempic and Wegovy, resolved. State-licensed pharmacies and physicians have 60 days, until April 22, 2025, to stop compounding copies, while outsourcing facilities have 90 days, until May 22, 2025. A compounding trade group said "hundreds of thousands" of patients may need to switch to an FDA-approved product.
- Compounding
FDA ends semaglutide shortage listing and sets compounding deadlines
The FDA removed semaglutide from its 506e drug shortage list on February 21, 2025, ending a listing that began in 2022. Compounding pharmacies have 60 days (until April 22, 2025) and outsourcing facilities have 90 days (until May 22, 2025) to stop making, shipping and dispensing products that are "essentially a copy" of Novo Nordisk's approved semaglutide. The agency said it weighed Novo Nordisk's data against information from telehealth companies, compounders, trade groups and individuals.
- Business
Lilly stockpiles about $550 million of experimental weight-loss pill orforglipron
Eli Lilly recorded nearly $550 million in pre-launch inventory for orforglipron, its experimental oral weight-loss drug, in a February 2025 filing — more than a year before the drug is expected to launch. A separate report put the figure at $548 million and said the stockpile consists mainly of orforglipron. An analyst said the build is larger and earlier than is typical for a drug still in late-stage testing.
- Compounding
Enforcement shield ends for pharmacies compounding tirzepatide copies
The 60-day wind-down period that protected state-licensed 503A pharmacies from FDA enforcement for compounding copies of tirzepatide, the drug in Mounjaro and Zepbound, expired on February 18, 2025. The FDA had determined on December 19, 2024 that the tirzepatide shortage was resolved, and confirmed on February 11, 2025 that its deadlines were unchanged. Outsourcing facilities under section 503B have until March 19, 2025.
- Regulation
FDA ends enforcement discretion for state-licensed pharmacies compounding tirzepatide
The 60-day window of FDA enforcement discretion for state-licensed pharmacies and physicians compounding tirzepatide injections ended February 18, 2025, under a December 19, 2024 order declaring the tirzepatide shortage resolved. FDA later said the March 5, 2025 denial of a preliminary injunction in Outsourcing Facilities Association v. FDA means that discretion period has ended, while outsourcing facilities under section 503B have until March 19, 2025.
- Business
Novo Nordisk alleges fraud over ocedurenone deal, seeks up to $830 million from KBP Biosciences
Novo Nordisk is seeking up to $830 million from Singapore-based KBP Biosciences, saying it was misled when it bought the hypertension drug ocedurenone in a 2023 deal worth up to $1.3 billion. A Singapore court froze the worldwide assets of KBP and its founder, Huang Zhenhua, and said Novo Nordisk will begin arbitration in New York. Novo Nordisk recorded a loss of about 5.7 billion Danish crowns, roughly $800 million, on the drug in June 2024 after adverse trial results.
- Regulation
European Commission adds sleep apnea use to Mounjaro's EU label
The European Commission adopted a labeling change for Mounjaro on February 14, 2025 that adds obstructive sleep apnea as an approved use in the European Union, following a December 12, 2024 opinion from the European Medicines Agency. The variation, numbered II/0027, updates the product's prescribing information and package leaflet based on two placebo-controlled trials in adults with moderate-to-severe sleep apnea and obesity.
- Research and trials
Tirzepatide linked to lower risk of papilledema and vision loss in intracranial hypertension study
A propensity-matched study of 193 patients with idiopathic intracranial hypertension treated with tirzepatide and 193 similar patients given standard care found a 68 percent lower risk of papilledema and a 73.9 percent lower risk of visual disturbance or blindness over 24 months. The findings are observational, drawn from electronic health records in the TriNetX network through November 2024, and rest on recorded diagnoses rather than standardized eye examinations.
- Research and trials
Low-dose semaglutide cut lab alcohol use and craving in 48-person randomized trial
A nine-week phase 2 randomized trial found that weekly low-dose semaglutide reduced grams of alcohol consumed and peak breath alcohol concentration during a laboratory drinking task, and lowered weekly alcohol craving, compared with placebo in 48 adults with alcohol use disorder who were not seeking treatment. Average drinks per calendar day and number of drinking days did not change.
- Safety
Small trial finds low-dose semaglutide cut lab alcohol intake in adults with alcohol use disorder
A phase 2 randomized trial found that nine weeks of low-dose semaglutide reduced the alcohol consumed during a post-treatment laboratory drinking task in 48 adults with alcohol use disorder, with medium to large effect sizes for grams of alcohol consumed and peak breath alcohol concentration. Semaglutide also reduced drinks per drinking day and weekly alcohol craving, but did not change average drinks per calendar day or the number of drinking days. The authors say the findings justify larger clinical trials.
- Regulation
FDA clarifies tirzepatide compounding deadlines pending court ruling
The FDA said on February 11, 2025 that it has not changed its enforcement plans for compounded tirzepatide. State-licensed pharmacies and physicians have until February 18, 2025, and outsourcing facilities until March 19, 2025 — or the date a federal court rules on a pending injunction motion, whichever is longer.
- Compounding
FDA holds off on enforcing compounded tirzepatide limits until court rules
On February 11, 2025, the FDA said it would not enforce its restrictions on compounded copies of tirzepatide until a federal district court rules on a preliminary injunction motion in Outsourcing Facilities Association v. FDA. The agency had previously set deadlines of February 18, 2025 for 503A compounding pharmacies and March 19, 2025 for 503B outsourcing facilities. The FDA declared the semaglutide shortage resolved on February 21, 2025, with enforcement discretion running until April 22 and May 22, 2025.
- Business
Lilly signs liver disease and cancer deals with OliX and AdvanCell
Eli Lilly signed two collaborations on Monday: one with South Korea's OliX Pharmaceuticals covering an experimental gene silencer, OLX75016, for MASH and other cardiometabolic conditions, and one with Australia's AdvanCell for radiopharmaceutical cancer therapies. Financial terms for both deals were not disclosed. Lilly is separately positioning Zepbound (tirzepatide) for a MASH expansion, where a Phase 2 trial showed nearly 75% of patients on 15 mg reached MASH resolution without worsening of fibrosis.
- Culture
Hims & Hers Super Bowl ad for compounded GLP-1s draws a 650% traffic spike and pushback
Hims & Hers ran a Super Bowl ad on Feb. 9 promoting compounded GLP-1 weight-loss medications, and the company says site traffic rose more than 650% in the hours afterward while the Hers app climbed to No. 2 in Apple's Health & Wellness category. Novo Nordisk answered with print ads warning about compounded semaglutide, and two senators and a pharmaceutical trade group asked the FDA to act.
- Culture
Two senators ask FDA to act on Hims & Hers Super Bowl ad for compounded semaglutide
Sens. Dick Durbin and Roger Marshall sent the FDA a letter on Feb. 7, 2025, arguing that a Hims & Hers commercial airing during the Super Bowl omits side effect and safety information and shows a "not FDA-approved" notice for only three seconds of its 60-second run. The company says it follows existing law, while a compounding trade group says the ad never names a specific drug and so needs no risk disclosure.
- Regulation
FDA approves four-pack carton for Zepbound single-dose vials
The FDA approved supplement S-020 for Zepbound (tirzepatide) on February 7, 2025, allowing the drug's labeling to include single-dose vials in a four-pack carton. Eli Lilly submitted the supplement on October 15, 2024. The letter does not address pricing, the dose strengths in the four-pack, or when the new packaging will reach pharmacies.
- Business
FDA record shows February 2025 labeling update for Zepbound
The FDA's approval record for Zepbound (tirzepatide) lists a labeling supplement with an action date of Feb. 7, 2025, covering the package insert and container and carton labels. The supplement is SUPPL-20 to New Drug Application 217806, held by Eli Lilly and Co. The record does not describe what text in the labeling changed.
- Business
Lilly reports 2024 revenue up 32%, driven by Mounjaro and Zepbound
Eli Lilly reported 2024 revenue of $45.0 billion, up 32% from 2023, with Mounjaro bringing in $11.54 billion and Zepbound $4.93 billion in its first full year on the market. Fourth-quarter revenue rose 45% to $13.53 billion, and the company guided 2025 revenue to $58.0 billion to $61.0 billion.
- Research and trials
Liraglutide lowered BMI in children ages 6 to 11 in SCALE Kids trial
In the SCALE Kids trial, 82 children aged 6 to under 12 with obesity were assigned in a 2:1 ratio to once-daily liraglutide or placebo plus lifestyle interventions for 56 weeks. Mean BMI fell 5.8% with liraglutide and rose 1.6% with placebo, a difference of 7.4 percentage points. No medication is approved to treat nonmonogenic, nonsyndromic obesity in children younger than 12.
- Business
Lilly says weight-loss drug demand is strong as Mounjaro and Zepbound miss sales estimates
Eli Lilly reported fourth-quarter 2024 revenue of $13.53 billion, up 45%, driven by volume growth from Mounjaro and Zepbound, though both drugs again fell short of analyst sales estimates. The company guided 2025 revenue to $58.0 billion to $61.0 billion and said demand remained strong, sending shares up nearly 5%.
- Business
Novo Nordisk reports DKK 290.4 billion in 2024 sales and guides to slower 2025 growth
Novo Nordisk said Feb. 5, 2025 that full-year 2024 sales reached DKK 290.4 billion, up 25% in Danish kroner and 26% at constant exchange rates, with operating profit of DKK 128.3 billion. Ozempic sales were DKK 120.3 billion and Wegovy sales were DKK 58.2 billion. The company guided to 2025 sales growth of 16% to 24% at constant exchange rates, slower than 2024.
- Research and trials
Weekly exenatide fails to slow Parkinson's in phase 3 trial; Lancet later flags paper
In a phase 3 trial at six UK hospitals, once-weekly extended-release exenatide did not slow Parkinson's disease over 96 weeks: motor scores measured off medication worsened by a mean of 5.7 points with exenatide and 4.5 points with placebo among 194 participants (p=0.47). The Lancet published the results on Feb. 4, 2025, and on June 22, 2026 issued an Expression of Concern about the paper without stating a reason in the notice.
- Business
FDA approves Mounjaro and Zepbound KwikPens a year after action letters
The FDA approved KwikPen versions of Mounjaro and Zepbound, both tirzepatide, on January 20, 2026, roughly a year after sending action letters on the same two applications. Each approval adds six presentations of a pen holding 4 once-weekly doses. The letters do not disclose the dose strengths, pricing, or launch timing.
- Research and trials
FDA approves Ozempic to lower kidney and cardiovascular death risk in type 2 diabetes with CKD
The FDA has approved Ozempic (semaglutide) to reduce the risk of kidney disease worsening, kidney failure and death from cardiovascular disease in adults with type 2 diabetes and chronic kidney disease, Novo Nordisk announced on Jan. 28, 2025. The approval is based on the FLOW trial, which found a 24% relative risk reduction and a 4.9% absolute risk reduction at three years compared with placebo, on top of standard of care. The company says Ozempic is the only GLP-1 receptor agonist approved for these kidney outcomes.
- Regulation
FDA approves Ozempic to lower kidney and cardiovascular risk in type 2 diabetes and CKD
The FDA approved Ozempic (semaglutide) injection to reduce the risk of worsening kidney disease, kidney failure and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. The Jan. 28, 2025 decision was based on the FLOW trial, which showed a 24% relative risk reduction for the combined kidney and cardiovascular endpoint, reported as a 4.9% absolute risk reduction at three years. Novo Nordisk said Ozempic is the only GLP-1 receptor agonist with a kidney indication.
- Prices
Colorado to limit Wegovy and Zepbound coverage for state employees, saving $17 million
Colorado will cover GLP-1 medications for its roughly 40,000 state employees only for type 2 diabetes, cardiovascular disease and obstructive sleep apnea starting July 1, 2025. The state projects the change will save nearly $17 million a year, after plan spending on the drugs rose from $1.5 million in the last half of 2023 to $7 million in the last half of 2024. Employees who take the drugs for obesity would pay more than $1,000 a month out of pocket.
- Policy
Semaglutide selected for second round of Medicare drug price talks
The Biden administration on Jan. 17 named semaglutide, the active ingredient in Ozempic, Wegovy and Rybelsus, among 15 drugs selected for the second round of Medicare price negotiations. Negotiations run through 2025 and any agreed prices would take effect Jan. 1, 2027. The 15 drugs accounted for about $41 billion, or 14%, of Medicare Part D gross prescription drug costs from November 2023 through October 2024.
- Competition
High-dose Wegovy produces 18.7% weight loss but trails Zepbound's 20.9%
Novo Nordisk said a 7.2-milligram dose of Wegovy led people with obesity to lose an average of 18.7% of their body weight over 72 weeks, compared with 15.6% for the currently approved 2.4-milligram dose and 3.9% for placebo. Zepbound, whose active drug is tirzepatide, produced 20.9% weight loss over 72 weeks in its own pivotal trial.
- Research and trials
Lancet commission proposes diagnosing clinical obesity by organ dysfunction, not BMI alone
A 58-member Lancet Diabetes & Endocrinology Commission published a new framework on Jan. 14, 2025 that separates clinical obesity — a chronic systemic illness with documented organ dysfunction — from preclinical obesity, in which excess body fat is present but organ function is preserved. The report, endorsed by 76 organizations, says BMI should be used as a population-level screen rather than an individual measure of health, and argues clinical obesity should not require a second disease to justify treatment or coverage.
- Business
Lilly warns on fourth-quarter revenue as Mounjaro and Zepbound sales miss forecasts
Eli Lilly said on Jan. 14 that fourth-quarter 2024 revenue will be about $13.5 billion, roughly $400 million below the low end of its own guidance, including about $3.5 billion from Mounjaro and about $1.9 billion from Zepbound. The company's shares fell 8%, their worst day since 2021. Lilly guided 2025 revenue to $58 billion to $61 billion.
- Business
Lilly agrees to buy Scorpion Therapeutics' PI3K-alpha cancer drug program for up to $2.5 billion
Eli Lilly and Company announced a definitive agreement on Jan. 13, 2025, to acquire Scorpion Therapeutics' PI3K-alpha inhibitor program, whose lead drug STX-478 is in a Phase 1/2 trial for breast cancer and other advanced solid tumors. Scorpion shareholders could receive up to $2.5 billion in cash, including an upfront payment and later payments tied to regulatory and sales milestones. Scorpion will spin out a separate company to hold its employees and its non-PI3K-alpha pipeline.
- Compounding
Lilly sues two med spas over products marketed as tirzepatide
Eli Lilly said on Jan. 13 that it sued two medical spas, Thrive Health and Wellness LLC and Valhalla Vitality LLC, accusing them of selling unapproved products that they claim contain tirzepatide, the active ingredient in Zepbound and Mounjaro. The company has already sued more than two dozen medical spas, wellness centers and compounding pharmacies over similar products.
- Research and trials
Three years of tirzepatide cut type 2 diabetes risk in people with obesity and prediabetes
In a three-year follow-up of the SURMOUNT-1 trial, 1.3% of adults with obesity and prediabetes who took tirzepatide were diagnosed with type 2 diabetes, compared with 13.3% of those on placebo, for a hazard ratio of 0.07. Average weight loss at 176 weeks ranged from 12.3% to 19.7% depending on dose, versus 1.3% on placebo. The results are the longest randomized follow-up of tirzepatide published.
- Research and trials
Tirzepatide weight loss plateaus within about six to nine months, analysis of two trials finds
A post hoc analysis of the SURMOUNT-1 and SURMOUNT-4 trials found that median time to a weight plateau on tirzepatide ranged from 24.3 weeks in participants who started with overweight to 36.1 weeks in those with class II or class III obesity. By week 72, 87.6% to 90.2% of participants had reached a plateau. Higher doses, younger age and female sex were linked to a later plateau.
- Policy
CMS says Medicare drug plans can now cover Zepbound for sleep apnea
The Centers for Medicare & Medicaid Services confirmed on Jan. 8 that Medicare Part D plans may cover Eli Lilly's Zepbound for obstructive sleep apnea after the FDA cleared the drug for that use on Dec. 20. Part D still bars coverage of obesity drugs prescribed for weight loss alone, but allows it for a separate FDA-approved purpose. Plans may require prior authorization, and insurers can still decline.
- Culture
Cornell and Numerator study finds GLP-1 users cut grocery spending about 6%
A study from Cornell University's S.C. Johnson College of Business and the consumer data firm Numerator found that households with at least one GLP-1 user cut grocery spending by about 6% in the six months after starting the medication, a reduction of roughly $416 a year. Higher-income households cut back more, and spending on chips, sweet bakery items, side dishes and cookies fell the most.
- Compounding
Lilly moves to join lawsuit over compounded copies of Zepbound and Mounjaro
Eli Lilly asked a federal court in Fort Worth, Texas, to let it join a compounding industry lawsuit over the FDA's finding that tirzepatide is no longer in short supply. The FDA affirmed that finding on Dec. 19 and said it would not take enforcement action for at least 60 days, while the compounding group seeks a court order reversing it.
- Compounding
Eli Lilly joins FDA's side in tirzepatide compounding lawsuit
Eli Lilly joined Outsourcing Facilities Association v. FDA in January 2025 as an intervenor, backing the FDA's decision that the tirzepatide shortage was over. The FDA first declared the shortage resolved on Oct. 2, 2024, reversed three weeks later, and reaffirmed the delisting in December 2024. The 5th U.S. Circuit Court of Appeals later affirmed the FDA, citing an 11.6 million-dose supply surplus by November 2024 and about $23 billion in manufacturing investment.
- Safety
Ozempic label adds severe gastroparesis caution but does not say the drug causes it
Ozempic's prescribing information was updated in January 2025 to state the drug is "not recommended in patients with severe gastroparesis." The label does not say the medication causes the condition, a distinction at the center of the federal litigation over GLP-1 drugs. Lawsuits involving Ozempic and other GLP-1 medicines have been grouped into two multidistrict litigations, with 4,022 cases counted as of September 2026 and no global settlement announced.