GLP‑1 news from 2025
462 dated, sourced GLP-1 developments from 2025: approvals, trial results, prices, lawsuits, compounding and culture.
- Business
Novo Nordisk closes its worst year on record, down nearly 50%
Novo Nordisk shares fell nearly 49% during 2025 in Copenhagen trading, the company's worst annual performance. The slide reflected slowing US growth, compounded competition, the Alzheimer's failure and the loss of market share to Eli Lilly.
- Competition
Lilly and Novo Nordisk both cut weight-loss drug prices in China
Facing domestic rivals including mazdutide, the two companies lowered Chinese prices at the end of the year, the first significant discounting in that market.
- Culture
Axios reports the fitness industry pivoting around GLP-1 users
Gyms moved from fearing GLP-1s to courting users, with Equinox launching a weight-loss-specific training program and Gold's Gym offering members discounts on the drugs themselves.
- Business
CMS unveils the BALANCE model for GLP-1 coverage in Medicaid and Part D
A voluntary five-year CMS Innovation Center model offering negotiated GLP-1 prices with standardized coverage criteria, with Medicaid launch as early as May 2026 and Part D participation targeted for January 2027. A short-term Medicare Bridge demonstration was announced alongside it.
- Search trends
FDA approval of the Wegovy pill opens the highest-growth new query cluster on the topic
Approval of once-daily oral semaglutide 25 mg for weight management created demand for terms such as wegovy pill, glp-1 pill and weight loss pill, none of which had a settled consumer answer. It also began a four-way naming confusion with Rybelsus, Ozempic tablets and Foundayo.
- Research
FDA approves oral semaglutide 25 mg for weight management
The FDA approved once-daily oral semaglutide 25 mg under the Wegovy brand for chronic weight management and to reduce the risk of major adverse cardiovascular events in adults with obesity or overweight and established heart disease. It was the first GLP-1 pill cleared for weight loss anywhere in the world.
- Research
JAMA target trial emulation links incretin drugs to lower CPAP use and mortality
In 36,981 adults with type 2 diabetes, obesity and obstructive sleep apnea, starting an incretin drug rather than an SGLT2 inhibitor was associated with lower CPAP use (hazard ratio 0.92), lower all-cause mortality (0.68) and fewer hospitalizations (0.90), with larger reductions for tirzepatide than for GLP-1-only drugs.
- FDA & regulation
FDA approves Mounjaro for children and adolescents 10 and older with type 2 diabetes
NDA 215866 supplement S-039 expanded the indication and fulfilled postmarketing requirement PMR 4271-1. The pediatric maximum dosage on the label is 10 mg once weekly rather than the adult 15 mg. Some secondary coverage dated this approval to February 2026; the FDA approval letter is dated December 19, 2025.
- Competition
Altimmune's pemvidutide hits key 48-week endpoints in the Phase 2b IMPACT MASH trial
The balanced glucagon/GLP-1 dual agonist showed statistically significant improvements in non-invasive liver markers with about 1% of treated patients discontinuing for adverse events.
- Prices
White House announces its largest set of most-favored-nation pricing deals to date
A further fact sheet expanded the MFN program beyond the first five manufacturers ahead of the TrumpRx launch.
- Culture
Journal of Marketing Research publishes the definitive GLP-1 grocery study
The Cornell and Numerator analysis of tens of thousands of US households found grocery spending down an average of 5.3% within six months of starting a GLP-1, more than 8% for higher-income households, and limited-service restaurant spending down about 8%.
- Science
Novo Nordisk files CagriSema with FDA
Novo Nordisk submitted a New Drug Application for CagriSema, a once-weekly fixed-dose combination of the amylin analog cagrilintide with semaglutide, for chronic weight management. It remains the only genuinely new obesity drug under FDA review as of September 2026, with no published action date and no advisory committee announced.
- Competition
Orforglipron holds weight loss after patients switch off injections in ATTAIN-MAINTAIN
In the first trial of its kind, people who had plateaued on maximum-tolerated Wegovy or Zepbound and switched to orforglipron kept all but 0.9 kg and 5.0 kg of their prior weight loss over a year. Lilly confirmed it had filed the obesity NDA with the FDA under a Commissioner's National Priority Voucher.
- Research
SURPASS-CVOT published: tirzepatide non-inferior to dulaglutide
In 13,299 adults with type 2 diabetes and atherosclerotic disease, tirzepatide matched but did not beat dulaglutide on cardiovascular events (hazard ratio 0.92, p=0.09 for superiority).
- Business
CagriSema submitted to the FDA for weight management
Novo Nordisk submitted CagriSema, a once-weekly fixed-dose combination of cagrilintide and semaglutide, for US approval based on REDEFINE 1 and REDEFINE 2. If cleared it would be the first combination of a GLP-1 and an amylin analog approved for obesity.
- Research
Kailera opens the global KaiNETIC Phase 3 program for ribupatide
The first of three global Phase 3 trials of ribupatide (KAI-9531, licensed from Jiangsu Hengrui's HRS9531) began enrolling, including a head-to-head against semaglutide. It is the most advanced of the China-to-West obesity licensing deals.
- Science
SURPASS-CVOT published in the New England Journal of Medicine
The New England Journal of Medicine published the four-year trial in 13,165 analyzed patients. Gastrointestinal adverse events were more common on tirzepatide than dulaglutide (42.5% versus 35.9%), severe hypoglycemia was identical (0.7% each), adjudicated pancreatitis was identical (0.6% each), investigator-reported acute kidney injury was 3.4% versus 2.7%, and medullary thyroid cancer was reported in two tirzepatide patients, one of whose tumors carried a RET mutation. All-cause mortality was lower on tirzepatide in an exploratory analysis.
- Prices
Lilly cuts Canadian prices for Mounjaro and Zepbound
The reductions followed the US pricing deal and the company's stated aim of narrowing the gap between what Americans and other rich-country patients pay.
- Business
WeightWatchers relaunches around GLP-1 users
WW International relaunched its platform for the GLP-1 era with prescribing through Med+, a no-prescription success track and new tools, under chief executive Tara Comonte. The rebuild capped a year in which the weight-loss industry restructured around the drugs.
- Safety
JPML creates a second GLP-1 MDL for vision loss claims
MDL 3163, In re: GLP-1 RAs Non-Arteritic Anterior Ischemic Optic Neuropathy Products Liability Litigation, was created in the Eastern District of Pennsylvania and assigned to Judge Marston, on the reasoning that NAION requires different experts and causation evidence than the gastrointestinal cases.
- Safety
JPML creates MDL 3163 on Eli Lilly's motion, declining to merge it with MDL 3094
The Panel centralized 21 NAION actions before Judge Marston but refused Lilly's alternative request to fold them into MDL 3094. Its reasoning was case management, not scientific difference: a separate MDL would let the judge set the level of coordination, make case tracking easier and facilitate orderly docketing, following In re Taxotere Eye Injury. Plaintiffs had unanimously asked for New Jersey instead. The order names Ozempic, Wegovy, Saxenda and Trulicity as the drugs at issue.
- Prices
North Carolina Medicaid reinstates GLP-1 coverage for obesity
After eliminating coverage in October 2025 during a legislative budget stalemate, North Carolina reinstated Medicaid coverage of GLP-1s for obesity treatment in December 2025, keeping the national count of covering state Medicaid programs at 13 as of January 2026.
- FDA & regulation
Reuters reports FDA leaders pushed staff to shorten the obesity pill review
The account described senior officials pressing reviewers to compress the orforglipron timeline under the new priority voucher program. The FDA later requested additional safety data after approval.
- FDA & regulation
Europe's regulator backs Mounjaro for children aged 10 and older
The EMA's committee recommended extending the type 2 diabetes indication to children, a week before the FDA did the same in the United States.
- Science
Mounjaro approved for children 10 and older with type 2 diabetes
The Mounjaro label's Recent Major Changes table dates the pediatric indication to 12/2025, supported by SURPASS-PEDS. The pediatric maximum is 10 mg weekly versus 15 mg in adults, and vomiting, abdominal pain and hypoglycemia were more common than in adults.
- Business
Retatrutide delivers up to 71.2 pounds of average weight loss in its first successful Phase 3 trial
The knee osteoarthritis trial also showed substantial pain relief, the first Phase 3 readout for the triple agonist that analysts expect to define Lilly's next decade.
- Competition
Retatrutide's first Phase 3 win: 28.7% weight loss plus knee pain relief in TRIUMPH-4
The first phase 3 trial of Lilly's triple agonist to report tested retatrutide in 445 adults with obesity and knee osteoarthritis. The 12 mg dose produced 28.7 percent weight loss at 68 weeks and WOMAC knee pain fell up to 4.5 points (75.8 percent), with 12 to 14 percent of treated participants completely free of knee pain versus 4.2 percent on placebo.
- Research
SURPASS-CVOT published in the New England Journal of Medicine
The full publication confirmed a primary endpoint event rate of 12.2% on tirzepatide versus 13.1% on dulaglutide (hazard ratio 0.92; 95.3% CI 0.83 to 1.01), meeting non-inferiority at p=0.003 but missing superiority at p=0.09. Gastrointestinal adverse events were more common with tirzepatide.
- Culture
Destination XL and FullBeauty agree to merge, consolidating plus-size retail
The big-and-tall specialist Destination XL and plus-size women's retailer FullBeauty Brands agreed to an all-stock merger of equals creating a roughly $1.2 billion inclusive-apparel business - two companies on the losing side of the GLP-1 size shift combining rather than competing.
- Research
NEJM perspective calls generic liraglutide an overlooked option
Harvard drug-pricing researchers Suhas Gondi, Aaron Kesselheim and Benjamin Rome published Generic Liraglutide - Overlooked but Not Forgotten, arguing that uptake of generic liraglutide could pull in more manufacturers, push prices lower and widen GLP-1 access at a fraction of brand cost. It appeared in print on 2026-01-08.
- Culture
Lilly announces a $6 billion plant in Huntsville, Alabama
The third of four new US sites will produce small molecule synthetic and peptide medicines including the oral GLP-1 orforglipron, with 450 permanent jobs and about 3,000 construction jobs. Alabama officials called it the largest capital investment for a project in state history.
- Research
PERIODS opens: the first properly powered trial of tirzepatide in PCOS
The University of Bonn, with four collaborating German centers, began enrolling in PERIODS, a randomized, double-blind, placebo-controlled phase 4 trial of tirzepatide in 198 premenopausal women aged 18 to 45 with a BMI of at least 27 and PCOS by Rotterdam criteria. Treatment runs 72 weeks — 20 weeks of escalation to the maximum tolerated dose, then 52 weeks of maintenance. The primary endpoint is the menstrual bleeding ratio across the final 52 weeks; the key secondary endpoint is the number of ovulations confirmed by weekly serum progesterone. Primary completion is December 2028.
- Compounding
SAFE Drugs Act of 2025 introduced in Congress
H.R. 6509 from Representatives Rudy Yakym and Andre Carson, with a Senate companion from Senator Jim Banks, would expand FDA oversight of compounders and require reporting by pharmacies shipping more than 20 out-of-state compounded GLP-1 prescriptions a month.
- Policy
ADA's 2026 Standards of Care name semaglutide and tirzepatide as preferred
The American Diabetes Association published Section 8 of its Standards of Care in Diabetes 2026, with recommendation 8.18 stating at evidence grade A that the preferred pharmacotherapy in people with diabetes and overweight or obesity should be a GLP-1 or dual GIP/GLP-1 receptor agonist with greater weight loss efficacy, naming semaglutide or tirzepatide. Recommendation 8.19 said treatment should continue beyond reaching weight goals, and 8.20 said the optimal dose may not be the maximum approved dose.
- Research
REDEFINE 4 completes: Novo Nordisk's CagriSema tested directly against tirzepatide
The 809-participant, 84-week open-label phase 3 trial reached its primary completion date. It was the first time a competitor ran a registration-grade head-to-head trial against tirzepatide in obesity.
- Competition
Structure Therapeutics reports up to 15.3% weight loss for oral aleniglipron
Phase 2b ACCESS data showed 11.3% mean weight loss and up to 15.3% at the 240 mg dose at 36 weeks, the strongest oral small-molecule data outside Lilly's program at the time.
- Policy
China adds Mounjaro to its state insurance list for diabetes
Inclusion in the national reimbursement drug list requires deep price cuts but unlocks volume, and it put tirzepatide within reach of far more Chinese patients.
- Business
Nobel laureate Carolyn Bertozzi returns to the Lilly board
The Stanford chemist who shared the 2022 Nobel Prize in Chemistry rejoined the board effective December 8, 2025, having served from 2017 to 2021, giving Lilly two Nobel laureates among its directors.
- Compounding
FDA seizes counterfeit Ozempic labeled with authentic lot number PAR1229
The FDA warned about counterfeit Ozempic in lot PAR1229, telling patients not to use pens where the EXP/LOT text appears to the left of the expiration date and lot number rather than above it. Six adverse events were reported, none appearing to be associated with the counterfeit product. FDA advised pharmacies to purchase only through authorized Novo Nordisk distributors.
- Compounding
FTC approves a final order against telehealth provider NextMed
The order carried a $150,000 judgment and barred misrepresenting costs, unsupported results claims, fake or undisclosed-connection reviews, and billing without informed consent, the first major FTC action against a GLP-1 telehealth marketer.
- Science
EVOKE topline data presented at the CTAD conference
Detailed topline results showed the semaglutide and placebo decline curves lying on top of each other on CDR-SB and every secondary measure. A CSF substudy found nominally significant reductions of 10 percent or less in seven biomarkers, while plasma GFAP rose about 4 percent and hs-CRP fell about 30 percent.
- Prices
Analysis shows ACA Marketplace GLP-1 coverage shrinking
Only 26 of 300 carriers offering 2026 Marketplace plans cover GLP-1s for obesity, across nine states, and enrollment with such coverage fell from 3.6 million in 2024 to 2.8 million in 2026.
- Compounding
FAERS analysis counts hundreds of compounded tirzepatide adverse events
A preprint analysis of FDA's adverse event database counts at least 455 reports involving compounded tirzepatide as of this date, including 339 serious events and 8 deaths. Preprint, not peer reviewed.
- Prices
Lilly cuts Zepbound self-pay vial prices to $299, $399 and $449
The 2.5 mg vial fell from $349 to $299, the 5 mg from $499 to $399, and 7.5 mg through 15 mg from $499 to $449 under the Self Pay Journey Program. Lilly's release listed out-of-program vial prices of $599, $699, $849 and $1,049. The cut moved Lilly's cheapest tier close to advertised compounded pricing.
- Culture
Mayo Clinic Proceedings puts GI side-effect rates at 40-70% and makes diet the first-line response
A clinical review for primary care physicians reported that 40% to 70% of patients on GLP-1 and GIP receptor agonists experience gastrointestinal adverse effects, and that management should begin with dietary modification: smaller, more frequent meals, adequate hydration, and avoiding high-fat or high-sugar foods.
- Prices
US and UK announce an agreement to raise UK drug prices by 25%
USTR, Commerce and HHS said the deal would increase the net price of new prescription drugs in the UK, part of the administration's argument that other wealthy countries underpay for innovation.
- Safety
Mounjaro adds a pediatric indication and a Severe Gastrointestinal Adverse Reactions warning
Two label changes landed in the same month. The indication was extended to children aged 10 and older with type 2 diabetes, with a maximum dose of 10 mg rather than the adult 15 mg. Separately, Warnings and Precautions 5.6 was added for severe gastrointestinal adverse reactions, stating that Mounjaro is not recommended in patients with severe gastroparesis.
- Culture
Cornell and Numerator quantify how GLP-1 use changes the grocery cart
An analysis of household grocery purchasing found measurable reductions in spending among households that began using GLP-1 drugs, concentrated in calorie-dense processed foods and snacks. It gave food manufacturers a data-backed reason to build GLP-1-oriented product lines.
- Safety
OCULUS trial randomizes patients to hold or continue their GLP-1 before endoscopy
In a Cleveland Clinic trial of 68 patients, 25% of those who continued their GLP-1 drug had clinically significant retained gastric volume after standard fasting, versus 3.1% of those who skipped the last dose. The investigators also questioned relying on symptoms to decide who needs a hold.
- Culture
Bunnie XO describes suicidal ideation on a GLP-1
The podcast host and wife of Jelly Roll told People she experienced "a bout of suicidal ideation" while taking a GLP-1, one of the highest-profile negative-experience disclosures of the era.
- Compounding
Customs reports intercepting thousands of GLP-1 peptide shipments from China
Customs and Border Protection at the Port of Cincinnati reports intercepting more than 300 master carton smuggling attempts holding roughly 5,000 individual GLP-1 peptide shipments, the supply line behind gray-market tirzepatide powder.
- Competition
Retatrutide posts strong results in knee osteoarthritis
Eli Lilly reported phase 3 TRIUMPH-4 data showing a 26.6% placebo-adjusted weight loss at 68 weeks in people with obesity or overweight and knee osteoarthritis. Analysts said the result strengthened retatrutide's profile as a higher-efficacy next-generation option.
- Research
Oprah Winfrey describes stopping a GLP-1 for twelve months and restarting
In a People interview, Oprah Winfrey said she had stopped using GLP-1 medication for about twelve months and described what followed before resuming. The account drew wide attention because it came from someone who had publicly credited the drugs, and because it illustrated the stop-restart cycling pattern that real-world data show is common. It is an anecdote, not evidence, but it shaped a great deal of consumer searching about stopping.
- Competition
Novo Nordisk files for FDA approval of Wegovy 7.2 mg
Novo Nordisk submitted a higher 7.2 mg dose of injectable semaglutide for US approval, with an EU decision expected in the first quarter of 2026.
- Prices
CMS announces a $274 Medicare negotiated price for semaglutide starting in 2027
The maximum fair price for the Ozempic, Rybelsus and Wegovy group was set at $274 for a 30-day supply, a 71% discount from the $959 list price CMS recorded for 2024. Semaglutide was the largest Part D drug by gross spending at $15.2 billion.
- Culture
Circana projects GLP-1 households will drive over a third of US food sales
A Circana report forecast that households with GLP-1 users would account for more than 35% of US food and beverage sales by 2030, reframing GLP-1 users from a niche segment into the industry's center of gravity.
- Science
Amycretin Phase 2 reports weight loss and HbA1c gains in type 2 diabetes
Novo Nordisk's dual GLP-1/amylin molecule improved weight and glucose control in its first diabetes population, with up to 89.1% of participants reaching HbA1c below 7%. Phase 3 in diabetes was planned for 2026.
- Competition
Novo Nordisk expands the amycretin program into type 2 diabetes
After positive Phase 2 diabetes data, Novo Nordisk committed to starting Phase 3 development of amycretin, now renamed zenagamtide, in type 2 diabetes during 2026.
- Research
Open-label study reports 80 percent response in hidradenitis suppurativa on tirzepatide
Twenty adults with moderate-to-severe hidradenitis suppurativa and a BMI of at least 27 received 24 weeks of tirzepatide. Sixteen (80 percent) achieved HiSCR, the standard response measure, with improvements in quality of life and pain, some persisting through an 8-week washout. The study had no control group and no blinding.
- Research
EVOKE and EVOKE+ fail: semaglutide does not slow Alzheimer's disease
Novo Nordisk announced that two phase 3 trials in 3,808 people with early symptomatic Alzheimer's disease did not show a statistically significant reduction in disease progression, despite movement in some biomarkers. The one-year extension was discontinued.
- Culture
Lizzo says the "Ozempic boom" is erasing plus-size people
In an essay responding to criticism of her own weight loss, Lizzo argued that extended clothing sizes are disappearing and plus-size models are no longer getting booked, writing that "we have a lot of work to do, to undo the effects of the ozempic boom."
- Business
Eli Lilly becomes the first drugmaker worth $1 trillion
Lilly briefly touched a $1 trillion market value, the first healthcare company ever to do so. Combined Zepbound and Mounjaro sales over the first nine months of 2025 came to nearly $19 billion, passing Keytruda as the best-selling medicine in the world.
- Research
ATTAIN-MAINTAIN completes, testing a switch from injections to an oral GLP-1
The 376-participant trial moved SURMOUNT-5 participants who had plateaued on maximum tolerated tirzepatide or semaglutide onto once-daily oral orforglipron, or placebo, for 52 weeks.
- Research
Mazdutide GLORY-2 reports up to 20.1% weight loss in Chinese adults with obesity
The 9 mg dose met the primary endpoint and all key secondary endpoints over 60 weeks. A separate Chinese Phase 3 comparing mazdutide against semaglutide reported better results on both glycemic and weight endpoints.
- Prices
Novo launches a $199 introductory self-pay offer for Wegovy and Ozempic
Novo Nordisk introduced a limited-time $199 per month price for the first fills of lower doses of Wegovy and Ozempic for self-paying patients, with $349 monthly after. The offer answered Eli Lilly's discounting and the coming TrumpRx prices.
- Research
Brain recordings suggest tirzepatide's effect on food noise may be temporary
In a first-in-human case published in Nature Medicine, researchers recorded electrical activity directly inside the nucleus accumbens of a woman on tirzepatide. Food preoccupation and its brain signature went quiet at full dose, then broke through again at months five to seven with seven severe episodes a month, pointing to a possible tolerance effect.
- Prices
GoodRx launches a $39 weight-loss telehealth subscription and lists the $199 GLP-1 cash price
GoodRx began carrying Novo Nordisk's self-pay prices across more than 70,000 pharmacies and added its own low-cost telemedicine option for people who need a prescription.
- Research
Tirzepatide-specific suicidality analysis finds no safety signal
A propensity-matched cohort of 16,321 pairs found suicidal ideation or attempts in 17 tirzepatide patients versus 33 on other anti-obesity medications over a median year, an adjusted hazard ratio of 0.52 with an absolute difference of about one case per 1,000. The authors said the key message is the absence of a signal, not proof of protection.
- Business
Novo Nordisk Foundation completes its board takeover
At an extraordinary general meeting, shareholders elected Lars Rebien Sorensen as chair of Novo Nordisk along with Cees de Jong as vice chair and new members Britt Meelby Jensen and Stephan Engels. The Foundation holds 77% of voting rights while owning about 28% of share capital, and some minority investors objected.
- Science
Lilly files the supplement that would remove Zepbound's suicidal ideation warning
FDA receives supplement S-042, which responds to an October 14, 2025 request to add intestinal obstruction and severe constipation to Postmarketing Experience and, following a January 13, 2026 request letter, removes the Suicidal Ideation and Behavior subsection.
- Business
New Novo chair floats an over-the-counter future for Wegovy
Speaking after his election, Lars Rebien Sorensen said he wanted to strengthen the board's pharmaceutical and over-the-counter expertise, raising the prospect of a consumer-health path for obesity medicines. No regulator has approved a GLP-1 for over-the-counter sale.
- Business
Sandoz signals unbranded semaglutide for Canada by mid-2026
Sandoz's chief executive told Reuters the company expected to be among the first to sell generic semaglutide in Canada after Novo Nordisk's Canadian patent lapse, a market the US patent estate does not permit until the 2030s.
- Competition
Lilly drops CVS as its own employee pharmacy benefit manager
After CVS Caremark made Wegovy its preferred obesity drug, Lilly moved its own workers' drug benefit elsewhere, a pointed gesture in a dispute about how formularies are built.
- Policy
Pharmacists question how the GLP-1 pricing deal will actually work
Community pharmacy groups flagged unresolved questions about whether TrumpRx would replace manufacturer direct-to-consumer programs or sit alongside them, and pointed to a likely May 2026 start for Medicaid and January 2027 for Medicare pricing. The rollout ultimately differed from those early expectations.
- Science
Wegovy shows liver benefits in MASH beyond weight loss alone
Novo Nordisk reported analyses indicating that semaglutide 2.4 mg improved liver health measures in adults with MASH and liver scarring through pathways not explained solely by weight reduction. The data supported the accelerated approval granted in August 2025.
- Research
Rhythm begins long-term phase 2 enrollment for an oral MC4R agonist
A long-term phase 2 study of bivamelagon, Rhythm Pharmaceuticals' investigational oral MC4R agonist for hypothalamic obesity, began enrolling by invitation. If it succeeds it would replace the daily injection that is currently the only option in this class, including for children as young as four.
- Research
Real-world study finds semaglutide and tirzepatide equally protective for the heart
Propensity-matched US insurance data showed a head-to-head hazard ratio of 1.06 (95% CI 0.95-1.18) for heart attack, stroke or death, despite tirzepatide's larger weight loss.
- Business
Pfizer wins the $10 billion fight for Metsera
Metsera accepted a sweetened Pfizer offer of up to $86.25 per share, valuing the biotech near $10 billion, and Novo Nordisk withdrew the next day citing its own pipeline. Metsera cited US antitrust risk in Novo's structure as a deciding factor.
- Prices
Reporters flag the gaps in the tirzepatide pricing deal
Coverage noted that several products in the agreement were not yet FDA-approved, including the Zepbound multi-dose pen, that the lowest advertised self-pay prices applied mainly to starter doses, and that the deal did not extend Medicare coverage to weight loss alone.
- Competition
Lilly and Novo Nordisk agree to most-favored-nation pricing on GLP-1 drugs
The White House announced most-favored-nation agreements setting Medicare and Medicaid prices for Ozempic, Wegovy, Mounjaro and Zepbound at $245 a month with a $50 patient copay, and cash prices starting near $350 on TrumpRx. Oral GLP-1 starting doses were set around $149 to $150 a month, and Medicare agreed to cover obesity treatment for the first time.
- Prices
Lilly and the US government agree on tirzepatide pricing, including a $50 Medicare copay
Lilly announced that Medicare beneficiaries would pay no more than $50 a month for the Zepbound multi-dose pen from as early as April 1, 2026, that self-pay prices for that pen would run $299 to $449, that Mounjaro would be added to LillyDirect at 50% to 60% off list, and that Medicare and Medicaid would pay $245. The deal excludes the commercial channel and gives Lilly three years of tariff relief.
- Culture
Trump announces GLP-1 price deals and calls them "the fat drug"
At an Oval Office event with Eli Lilly and Novo Nordisk, President Trump announced discounted GLP-1 pricing for eligible Medicare and Medicaid patients and for TrumpRx buyers, repeatedly calling the medicines "the fat drug."
- Business
White House deal sets $245 Medicare price and TrumpRx pricing for GLP-1s
Eli Lilly and Novo Nordisk agreed to most-favored-nation pricing: $245 per month for injectable Ozempic, Wegovy, Mounjaro and Zepbound in Medicare and Medicaid, a $50 Medicare copay, and roughly $350 per month on the TrumpRx platform. Medicare would cover Wegovy and Zepbound for obesity for the first time.
- Science
Eloralintide Phase 2 results published, moving Lilly beyond incretins
Lilly reports 48-week Phase 2 results for its selective amylin receptor agonist in The Lancet and at ObesityWeek: weight reductions of 9.5% to 20.1% versus 0.4% with placebo in 263 US adults, with nausea and fatigue the main adverse events. Phase 3 enrollment was planned to start by year-end.
- Research
Eloralintide posts up to 20% weight loss in phase 2 and heads to phase 3
Lilly's amylin analog matched injectable GLP-1 territory on its own, and the company said phase 3 would start within weeks. The result landed the same day as the White House pricing deal and was partly lost in the noise.
- Research
Lilly's amylin drug eloralintide reports about 20.1% weight loss in Phase 2
Eli Lilly reported up to about 20.1% average weight loss at 48 weeks for eloralintide, a selective amylin receptor agonist, with tolerability the company described as favorable. It is unusually high for an amylin drug used on its own and triggered a five-trial Phase 3 program.
- Policy
Pricing deal brings tariff relief and priority review vouchers
Administration officials said Novo Nordisk and Eli Lilly would receive relief from pharmaceutical tariffs as part of the pricing agreement, with Lilly exempted for three years. Both companies were also promised fast-track regulatory vouchers for future medicines.
- Culture
RFK Jr. reverses course and backs expanded GLP-1 access
STAT reported that the health secretary, who had opposed public coverage of obesity drugs, now framed expanded availability as a tool against chronic disease, unsettling parts of the Make America Healthy Again movement.
- Business
Lilly adds Carole Ho and Adrienne Brown to its executive committee
Ho arrived from Denali Therapeutics to run neuroscience; Brown, who led the US Mounjaro launch, took immunology. Skovronsky's title widened to chief scientific and product officer and Van Naarden took on corporate business development.
- FDA & regulation
Lilly says it expects FDA approval of its obesity pill in March 2026
Executives told investors the orforglipron decision would come under the FDA's national priority voucher program. The approval arrived on April 1, 2026.
- Policy
Novo and Lilly also cut prices on insulin, Trulicity and Emgality
Beyond the GLP-1 headline, the most-favored-nation agreements set Trulicity at $389 a month, Emgality at $299 per pen and Novo Nordisk insulins including NovoLog and Tresiba at $35 a month. The companies also guaranteed MFN prices on all new medicines they bring to market.
- Science
Lilly-authored review restates tirzepatide's mechanism, with a discrepancy
Galindo, Coskun and colleagues publish 'Insights into the Mechanism of Action of Tirzepatide' in Diabetes Therapy. The review cites GLP-1 receptor affinity as roughly 18- to 20-fold weaker than native GLP-1, a larger gap than the roughly 5-fold figure in the original discovery and occupancy papers.
- Research
Tirzepatide lowers uric acid in a SURMOUNT-1 post hoc analysis
Serum uric acid fell 0.69 to 0.95 mg/dL by dose at 72 weeks on tirzepatide versus 0.18 mg/dL on placebo, regardless of starting uric acid or BMI. Mediation analysis attributed 72.7 percent of the drop to weight loss. Separate case reports describe transient uric acid rises and gout flares in the first months of treatment.
- Business
Pfizer and Novo escalate a bidding war for obesity biotech Metsera
Pfizer and Novo Nordisk traded raised offers for Metsera, an obesity biotech developing a once-monthly injectable GLP-1 and an oral candidate. Pfizer sued Novo and Metsera in Delaware, alleging breach of contract and anticompetitive conduct, and the FTC raised concerns.
- Research
STAT News reports telehealth companies launching compounded microdose programs
STAT News reported that Noom, Found and Hims & Hers had each launched compounded GLP-1 microdose programs within about three months, despite no clinical evidence that deliberately sub-therapeutic dosing works. The reporting marked the point at which microdosing moved from a social media term to a commercial product category, and STAT returned to the subject in May 2026 to confirm the evidence base had not changed.
- Competition
Hengrui and Kailera report 19.2% weight loss from Chinese Phase 3 of HRS9531
The GLP-1/GIP dual agonist now called ribupatide produced 19.2% mean weight loss at the 6 mg dose over 48 weeks with no plateau, and a new drug application was submitted in China.
- Safety
Annals of Internal Medicine study finds tirzepatide and semaglutide have similar gastrointestinal safety
A new-user active-comparator cohort study in adults with type 2 diabetes compared dulaglutide, subcutaneous semaglutide and tirzepatide head to head. In 46,620 matched pairs, the hazard ratio for a composite of acute pancreatitis, biliary disease, bowel obstruction, gastroparesis and severe constipation was 1.07 for tirzepatide versus semaglutide. The authors concluded the three drugs have similar gastrointestinal safety profiles.
- Compounding
Novo warns that 1.5 million US patients still use compounded GLP-1s
Novo Nordisk estimated that as many as 1.5 million Americans were taking lower-cost compounded versions of GLP-1 treatments, a habit formed during the shortage years. The figure framed the company's aggressive enforcement and cash-price strategy.
- Competition
Pfizer sues Novo Nordisk over the Metsera bidding war
Pfizer filed a second lawsuit accusing Novo Nordisk of an anticompetitive plot to stall its Metsera acquisition. Pfizer had received early termination of antitrust review on October 31.
- Research
Post hoc analysis reports lower albuminuria on tirzepatide in the SURMOUNT obesity trials
Across SURMOUNT-1 and SURMOUNT-2, urine albumin-to-creatinine ratio fell 8.4% and 31.1% versus placebo at week 72, with reductions above 40% in participants who started with elevated albuminuria. Kidney filtration did not worsen.
- Competition
Zepbound overtakes Wegovy in US prescriptions
Eli Lilly's Zepbound passed Wegovy in US prescription volume and in dollar sales, with Lilly holding about 58% of total US 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.
- Compounding
Federal pricing agreement cuts Lilly's direct-to-consumer Zepbound prices
Under the November 2025 agreement with the administration, Lilly agrees to lower its self-pay Zepbound tiers, and the TrumpRx channel begins listing Zepbound cash prices.
- Business
Federal pricing agreement sets Mounjaro at $245 a month for Medicare and Medicaid
Under the most-favored-nation arrangement announced by the administration, injectable Mounjaro is priced at $245 a month for Medicare and state Medicaid programs, and a Medicare GLP-1 Bridge would follow in July 2026.
- Research
SURMOUNT-4 post hoc grades cardiometabolic reversal by how much weight came back
JAMA Internal Medicine published a post hoc analysis of SURMOUNT-4 sorting participants by degree of regain after tirzepatide stopped. Waist circumference grew 0.8 cm in those who regained least and 14.7 cm in those who regained most, with systolic blood pressure rising 6.8 to 10.4 mm Hg across the same groups. It supplied the clearest evidence that health benefits track the weight rather than the history of having taken the drug, and that partial regain preserves partial benefit.
- Research
AASLD updates its MASH practice guidance for semaglutide
The American Association for the Study of Liver Diseases issued a guidance update covering semaglutide for MASH with moderate-to-advanced fibrosis following the August 2025 accelerated approval.
- Business
Novo CEO says the 9,000 job cuts are nearly complete
Mike Doustdar told Reuters that employees affected by the restructuring had been notified in the vast majority of Novo Nordisk locations. The company had booked about 8 billion Danish kroner in one-off costs in the third quarter.
- Business
Tirzepatide passes Keytruda to become the world's best-selling medicine
Third-quarter results put tirzepatide, counting Mounjaro and Zepbound together, at $10.1 billion for the quarter against $8.1 billion for Merck's Keytruda, taking the year-to-date lead as well. The milestone belongs to the molecule across both brands, not to Zepbound on its own.
- Business
Cochrane review delivers a cautious verdict on liraglutide for obesity
A WHO-funded Cochrane review of 24 randomized trials and 9,937 participants concludes liraglutide likely increases the proportion of people achieving at least 5% weight loss, while rating evidence on percentage weight change, cardiovascular events, quality of life and mortality as limited or uncertain. It flags increased adverse events and notes 22 of 24 trials were manufacturer-funded.
- Business
Lilly reports Q3 2025 revenue of $17.6 billion, up 54%, and raises guidance
Mounjaro reached $6.52 billion and Zepbound $3.59 billion. Full-year revenue guidance rose to $63.0 to $63.5 billion.
- Research
Protocol published for a randomized semaglutide trial in opioid use disorder
Researchers published the design of a randomized, double-blind, placebo-controlled trial testing whether semaglutide helps outpatients with opioid use disorder achieve abstinence from illicit and non-prescribed opioids.
- Business
LillyDirect and Walmart launch the first retail pickup at direct-to-consumer prices
Zepbound vials became collectable at nearly 4,600 Walmart pharmacies by mid-November at the same price as home delivery: $349 for 2.5 mg and $499 for other doses. Lilly disclosed that about 35% of new Zepbound prescriptions in the second quarter of 2025 were filled through LillyDirect.
- Culture
Zepbound vials go on sale for pickup at Walmart pharmacies
LillyDirect cash prices became available for in-store pickup at about 4,600 Walmart pharmacies, the first retail pickup option for a manufacturer's direct-to-consumer price. The Reddit thread announcing it drew hundreds of comments in a day.
- Business
Lilly puts $1.2 billion into Puerto Rico for oral drug capacity
Part of Lilly's broader $50 billion US manufacturing plan, adding about 100 permanent skilled jobs and up to 1,000 construction jobs at a site operating for 60 years, with oral drug production targeted by the end of 2028.
- Compounding
FDA classifies a Class II recall of ProRx compounded semaglutide injections
The recall was issued for lack of sterility assurance, one of several 2025 and 2026 compounded GLP-1 recalls tied to sterility and particulate problems.
- Science
Lilly files cardiovascular outcomes supplements for both tirzepatide brands
FDA receives prior approval supplements dated 2025-10-24 for Zepbound (S-041) and 2025-10-27 and 2025-11-05 for Mounjaro (S-044 and S-045), adding SURPASS-CVOT data to both labels and seeking a cardiovascular indication for Mounjaro.
- Compounding
Lilly sues two more Texas companies over tirzepatide replicas
The campaign widens again to additional sellers of products Lilly says are replicas of Mounjaro and Zepbound.
- Culture
Lilly signs Shaquille O'Neal for a sleep apnea awareness campaign
The campaign promoted screening for obstructive sleep apnea rather than the drug directly, using the only approved drug indication for the condition as the hook.
- Competition
Mazdutide beats semaglutide in the first head-to-head Phase 3 of a GLP-1/glucagon agonist
Innovent reported that mazdutide outperformed semaglutide on both blood sugar and weight endpoints in a Chinese Phase 3 trial, the first direct comparison of the two classes.
- FDA & regulation
CHMP recommends adding SURMOUNT-5 to the EU Mounjaro label
The head-to-head result against semaglutide entered section 5.1 of the EU summary of product characteristics.
- Competition
Lilly licenses Cipla to sell tirzepatide under a separate Indian brand
The arrangement gave Lilly a second brand and a local partner in India, where a wave of generic semaglutide was about to arrive on patent expiry.
- Science
Lancet analysis of SELECT finds cardiovascular benefit across adiposity levels
A prespecified analysis reported semaglutide's cardiovascular benefit was not confined to those with the highest BMI or waist circumference, feeding the debate about weight-independent mechanisms.
- Business
Novo Nordisk board resigns; Foundation proposes a new slate
Chair Helge Lund and several independent directors resigned citing disagreements with the Novo Nordisk Foundation over governance. The Foundation proposed former chief executive Lars Rebien Sorensen as chair along with four other candidates, to be voted on at an extraordinary general meeting.
- Competition
Terns Pharmaceuticals abandons its oral GLP-1 after weak Phase 2 data and liver signals
TERN-601 produced a maximum placebo-adjusted weight loss of 4.6% over 12 weeks, an 11.9% adverse-event discontinuation rate, and three cases of grade 3 liver enzyme elevations. Terns exited metabolic disease.
- FDA & regulation
FDA approves a cardiovascular indication for oral semaglutide
The FDA cleared oral semaglutide (Rybelsus) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high risk. It was the first oral GLP-1 to carry a cardiovascular indication.
- Business
ACHIEVE-2 and ACHIEVE-5 succeed
Lilly reported superior glycemic control in two more Phase 3 diabetes trials: orforglipron beat dapagliflozin in ACHIEVE-2 and beat placebo added to insulin glargine in ACHIEVE-5, reconfirming its potential as a foundational type 2 diabetes treatment.
- Research
SYNERGY-OUTCOMES begins: a MASH phase 3 that skips the liver biopsy
Lilly started a 4,500-participant master-protocol trial testing tirzepatide and retatrutide against placebo in high-risk fatty liver disease. Unlike every other late-stage MASH program, it has no histologic endpoint for accelerated approval and goes straight for hard liver outcomes over about 224 weeks, with primary completion estimated for 2030.
- FDA & regulation
FDA approves October 2025 gastrointestinal labeling changes for semaglutide
Ozempic and Wegovy labels added a postmarketing statement about severe gastrointestinal reactions and listed intestinal obstruction, severe constipation including fecal impaction, acute kidney injury and headache.
- FDA & regulation
FDA asks Lilly to update the Zepbound label over intestinal obstruction reports
A supplement request letter followed an April 28, 2025 notification that FDA was evaluating a newly identified safety signal for intestinal obstruction and fecal impaction across the GLP-1 class.
- Competition
Kailera Therapeutics raises $600 million to push ribupatide into global Phase 3
The biotech holding rights outside Greater China to Hengrui's obesity portfolio raised a large Series B on the back of Chinese Phase 3 data showing about 18% mean weight loss over 48 weeks.
- Business
Novo Nordisk layoffs begin across departments
Reported layoff notices began going out on October 14, 2025, affecting human resources, clinical development, rare disease, medical and regulatory, legal, marketing, sales, finance and public affairs. The company said local labor laws meant the pace varied by country.
- Compounding
Delaware court issues its opinion in Lilly v. Strive Pharmacy
The District of Delaware rules on the pleadings in Lilly's suit against Strive over compounded tirzepatide, shaping which trademark and false-advertising theories survive.
- Prices
North Carolina renegotiates with CVS Caremark for the right to bargain directly on GLP-1s
The State Health Plan announced an agreement giving it the ability to negotiate directly with GLP-1 manufacturers and to offer an intermediate level of coverage rather than all-or-nothing, a contractual limitation the treasurer said had forced the 2024 exclusion.
- Competition
Novo Nordisk begins cutting 9,000 jobs worldwide
Under new CEO Mike Doustdar, Novo Nordisk started a restructuring targeting about 11% of its workforce and roughly DKK 8 billion ($1.25 billion) in annual savings by the end of 2026, redirecting spending toward diabetes and obesity.
- Research
Target trial emulation finds the largest alcohol use disorder reduction with tirzepatide
Using records from more than 120 million US patients, researchers emulated four trials in adults with type 2 diabetes. Tirzepatide was associated with a 53 percent lower rate of a first alcohol use disorder diagnosis versus DPP-4 inhibitors, the largest reduction among the four incretin drugs tested. No randomized trial of tirzepatide in alcohol use disorder exists.
- Research
Systematic review finds GLP-1 drugs improve idiopathic intracranial hypertension outcomes
A review in the Journal of Headache and Pain concluded GLP-1 drugs may improve headache, visual function and weight in IIH with reduced reliance on acetazolamide and surgery, and flagged two prospective semaglutide trials including IIH:DUAL.
- Safety
First randomized trial of tirzepatide for alcohol use disorder begins enrolling
A phase 2 trial at the University of Southern California with NIAAA funding began recruiting 42 adults with alcohol use disorder and overweight or obesity, with heavy drinking days as the primary outcome. Estimated completion is August 2026. Tirzepatide is not approved for alcohol use disorder.
- Science
GLP-1 scientists pass over again for the Nobel Prize
The 2025 Nobel Prize in Physiology or Medicine went to Mary Brunkow, Frederick Ramsdell and Shimon Sakaguchi for peripheral immune tolerance, leaving GLP-1 as a repeat Nobel contender.
- Business
Lilly commits more than $1 billion to Indian contract manufacturing
The investment covered partners making tirzepatide for India and for export, part of a strategy of serving price-sensitive markets from local capacity.
- Research
Network meta-analysis of 56 obesity drug trials published
Across 60,307 patients, only semaglutide and tirzepatide exceeded 10% total body weight loss; semaglutide alone had proven cardiovascular and knee osteoarthritis benefits, tirzepatide alone had sleep apnea and MASH benefits.
- Research
Study finds cost, not side effects, is the main reason people stop
A Cleveland Clinic study in Obesity reviewed 288 adults who started injectable semaglutide or tirzepatide for obesity and stopped within the first year. Cost or insurance issues were the documented primary reason for 137 patients (47.6%), well ahead of adverse effects (14.6%), shortages (11.8%), switching to a compounded product (2.4%) and inadequate weight loss (1.7%). It reframed stopping in US practice as mostly an access event rather than a clinical decision.
- Safety
EMA opens a tirzepatide warfarin interaction signal
At its September to October 2025 meeting, the EMA's Pharmacovigilance Risk Assessment Committee took up a new signal for tirzepatide: drug interaction with warfarin and other coumarin derivatives leading to decreased international normalised ratio, raised by Spain on four cases. Lilly was required to submit a cumulative review within 90 days and to discuss whether product information should change.
- Science
European obesity specialists recommend semaglutide and tirzepatide as first-line drugs
The European Association for the Study of Obesity said the two incretins should be the starting pharmacotherapy for obesity, one of the first major guideline bodies to rank them ahead of older drugs.
- Research
VA study finds liraglutide comparable to semaglutide on kidney and heart outcomes
A target-trial emulation in JAMA Network Open covering 21,790 veterans with type 2 diabetes finds similar risks of kidney failure, major adverse cardiovascular events and the combined outcome for liraglutide, semaglutide and dulaglutide initiators. Liraglutide had lower all-cause death than semaglutide in intent-to-treat analysis only.
- Safety
All semaglutide labels gain a Severe Gastrointestinal Adverse Reactions warning
A new Warnings and Precautions section was added to Ozempic, Wegovy and the oral semaglutide labels stating that GI adverse reactions are sometimes severe and that semaglutide is not recommended in people with severe gastroparesis. Severe GI reactions occurred in 4.1% of Wegovy-treated adults versus 0.9% on placebo.
- Research
SURPASS-PEDS published: tirzepatide cuts HbA1c 2.23 percent in youth with type 2 diabetes
The Lancet published SURPASS-PEDS, a phase 3 trial in 99 participants with a mean age of 14.7 years across 39 sites in eight countries. Pooled tirzepatide reduced HbA1c by 2.23 percent versus a 0.05 percent increase on placebo at week 30, with BMI falling 7.4 percent on 5 mg and 11.2 percent on 10 mg.
- Prices
Costco begins selling Wegovy and Ozempic for $499 a month cash
Costco announced it would offer Wegovy and Ozempic at $499 per month to cash-paying members, joining a broader retail push into discounted GLP-1s. Walmart rolled out a comparable arrangement with Eli Lilly for Zepbound.
- Safety
MHRA dismantles what it calls the world's largest unlicensed weight-loss drug factory
The UK regulator seized 2,000 injection pens labeled as containing tirzepatide, along with retatrutide-labeled products, tens of thousands of empty pens and raw chemicals, from a facility in central England.
- Business
Severe gastrointestinal reactions warning added to liraglutide labels
A new Warnings and Precautions subsection on Severe Gastrointestinal Adverse Reactions is added to both the Victoza and Saxenda labels in October 2025, stating that liraglutide is not recommended in patients with severe gastroparesis.
- Culture
Surveys show roughly one in eight Americans has used a GLP-1
Industry analysis cited figures indicating about 12% of Americans, roughly 41 million people, had used GLP-1 medicines, with about 20 million currently taking them. Food companies began reformulating around smaller portions as users reported eating far less.
- Research
Viking Therapeutics starts a VK2735 maintenance and reduced-frequency dosing study
Viking began a study testing whether people can hold weight loss on VK2735 given every other week or once a month instead of weekly. It is one of the first formal tests of stepping down dosing frequency in this class. Results were later guided for the third quarter of 2026.
- Policy
White House announces the TrumpRx platform with a Pfizer pricing deal
The Trump administration unveiled TrumpRx, a government-run direct-to-consumer drug pricing website, alongside its first most-favored-nation agreement with Pfizer. The framework set the stage for the GLP-1 pricing deals announced five weeks later.
- Prices
First most-favored-nation manufacturer deal announced
The administration announced the first in a series of MFN pricing agreements with major manufacturers, opening the run of deals that reached 16 companies by February 2026.
- Culture
STEP UP MRI substudy reports body composition on semaglutide 7.2 mg at EASD 2025
An MRI-based substudy of the STEP UP trial presented at EASD 2025 reported the split between adipose and lean tissue loss on semaglutide 7.2 mg and 2.4 mg, giving a lower lean-tissue proportion than DXA-based analyses and sharpening the point that measurement method drives the headline muscle-loss numbers.
- Business
FDA approves Inluriyo (imlunestrant) for ESR1-mutated advanced breast cancer
A new oncology launch in a year dominated by obesity news, and part of Lilly's answer to the concentration question.
- Competition
Lilly halts one bimagrumab plus tirzepatide trial in type 2 diabetes
Lilly stopped a Phase 2b study of the muscle-sparing antibody bimagrumab combined with tirzepatide for what it called strategic business reasons, while continuing other bimagrumab studies.
- Business
Lilly says it will bring its obesity pill to India
Executives said orforglipron would be launched in India, where a pill avoids the cold-chain and injector costs that make injectables expensive to distribute.
- Compounding
Court lets Eli Lilly's "personalized" advertising claim against Henry Meds proceed
A federal judge kept alive Lilly's claim that Henry Meds falsely advertised mass-produced compounded tirzepatide as personalized, while dismissing the broader safe-and-effective theory for now.
- Research
BMJ Group retracts the apple cider vinegar weight-loss trial
After complaints prompted a statistical review, BMJ Group retracts the March 2024 trial that reported roughly 9% weight loss with daily apple cider vinegar, and states that journalists and others should no longer reference or use the study findings in future reporting.
- Culture
Lilly announces a $6.5 billion Houston plant
The second of four new US sites, a next-generation synthetic medicine active pharmaceutical ingredient facility producing small molecule medicines including cardiometabolic products, with 615 permanent and about 4,000 construction jobs.
- Culture
IQVIA publishes its analysis of the tirzepatide launch
The report documented four times as many prescribers as the semaglutide launches at the 12-month mark, about 11 million US GLP-1 patients in Q2 2025, and GLP-1 promotional spending above $7 billion.
- Competition
Pfizer agrees to buy Metsera for up to $7.3 billion
Pfizer announced a deal at $47.50 per share plus a contingent value right of up to $22.50 per share, re-entering obesity through Metsera's long-acting injectable GLP-1 and amylin programs.
- FDA & regulation
FDA issues Import Alert 66-80 on GLP-1 ingredients
Field staff may now detain GLP-1 active ingredient shipments without physical examination unless the manufacturer is on the green list.
- Research
SURPASS-PEDS published: first phase 3 tirzepatide results in children and teens
In 99 participants aged 10 to under 18 with youth-onset type 2 diabetes, pooled tirzepatide lowered HbA1c by 2.23 points versus a 0.05-point rise on placebo (difference -2.28 points; 95% CI -2.87 to -1.69). BMI fell 7.4% at 5 mg and 11.2% at 10 mg.
- Competition
China approves mazdutide for type 2 diabetes
Innovent announced NMPA approval of mazdutide for glycemic control in adults with type 2 diabetes, three months after its weight-management approval.
- Research
Study documents racial inequity in semaglutide prescribing among people with HIV
Diabetes Care published an analysis of 11,617 eligible people with HIV across nine US sites: only 6.7 percent received semaglutide, and eligible Black patients were 20 percent less likely to receive it than White patients, with wider gaps at HbA1c of 8.0 or higher.
- Research
OASIS 4 published: oral semaglutide 25 mg produces 13.6% weight loss
In 307 adults without diabetes, the 25 mg tablet produced 13.6% weight loss at week 64 under the treatment policy estimand (16.6% under the trial product estimand).
- Research
SURPASS-CVOT presented in full at EASD 2025 in Vienna
Stephen Nicholls presented component-level results: myocardial infarction 4.7% versus 5.4%, stroke 3.5% versus 3.8%, cardiovascular death 5.6% versus 6.2%, all-cause death 8.6% versus 10.2%. Independent commentators noted the trial did not achieve superiority and used an active comparator with only modest proven benefit.
- Research
Editorial warns about muscle loss on GLP-1 drugs in older adults
An Annals of Internal Medicine editorial argued adults over 65 have little margin before crossing into frailty, since aging alone removes 12 to 16 percent of skeletal muscle mass, and called for monitoring of nutrition and function during GLP-1 treatment.
- Competition
ACHIEVE-3: Lilly's pill beats Novo's pill head-to-head in type 2 diabetes
Orforglipron produced greater A1C and weight reductions than oral semaglutide in a direct comparison, the first time the two oral GLP-1 programs met in a randomized trial. Full results published in The Lancet in February 2026.
- Science
SURPASS-PEDS results presented and published
At EASD and simultaneously in The Lancet, Lilly reports the first Phase 3 trial of tirzepatide in children and adolescents with type 2 diabetes: 99 participants aged 10 to under 18, a pooled HbA1c reduction of 2.23% versus a 0.05% rise on placebo (estimated treatment difference -2.28%) under the trial's efficacy estimand. The FDA label reports the same trial under the treatment-regimen estimand as a least-squares mean difference of -1.8% (95% CI -2.4 to -1.2).
- Research
LIBERATE begins: the first randomized test of tirzepatide for binge eating disorder
A Johns Hopkins phase 2 trial run with Lilly began randomizing 105 adults with obesity and binge eating disorder to tirzepatide, lisdexamfetamine or placebo, with guided self-help cognitive behavioral therapy for everyone. The primary endpoint is the change in binge-eating episodes at 52 weeks. Completion is estimated for December 2027.
- Research
STOP KNEE-OA, the first trial of tirzepatide for knee replacement, continues enrolling
A University of Melbourne phase 4 trial with Lilly as collaborator is randomizing 352 adults with obesity and moderate-to-severe knee osteoarthritis who are already eligible for a knee replacement waiting list, to 72 weeks of tirzepatide or placebo. The primary endpoint is the percentage who go on to have the operation. Primary completion is estimated for May 2027.
- Research
Complete ATTAIN-1 results published in NEJM and presented at EASD
The full dataset showed 59.6% of people on the highest dose lost at least 10% and 39.6% lost at least 15%, with waist circumference down 4.4 inches, systolic blood pressure down 6.7 mm Hg and hsCRP down 47.7%. Among 1,127 participants with prediabetes, up to 91% reached near-normal blood sugar.
- Compounding
FDA and HHS issue dozens of warning letters to GLP-1 compounders and telehealth firms
Working with the Department of Health and Human Services, the FDA issued warning letters to compounding pharmacies, telehealth platforms and manufacturers marketing GLP-1 products. The focus was marketing conduct, including claims implying compounded products were equivalent to approved drugs.
- Business
Lilly names Goochland County, Virginia as the first of four new US plants
A $5 billion site for active ingredients and drug product for bioconjugates and monoclonal antibodies, with 650 permanent jobs. It is a cancer and biologics plant, not a GLP-1 plant.
- Research
INFORM survey reports a 46 percent drop in constant food thoughts on semaglutide
Presented at EASD 2025 and later published in Advances in Therapy, a US patient survey found the share of people reporting constant daily thoughts about food fell 46 percent after starting injectable semaglutide, alongside improved mental health measures.
- Research
STEP UP published: semaglutide 7.2 mg pushes weight loss toward 20%
The higher weekly dose produced 18.7% weight loss under the treatment policy estimand (20.7% under the trial product estimand) versus 15.6% for 2.4 mg, with more nausea and more dysesthesia.
- Research
STEP UP T2D reports 13.2% weight loss at the 7.2 mg dose in diabetes
In 512 adults with obesity and type 2 diabetes, semaglutide 7.2 mg beat placebo by 9.3 percentage points on weight and 1.5 points on HbA1c.
- Business
Novo Nordisk announces 9,000 job cuts
Novo Nordisk said it would eliminate about 9,000 positions worldwide, roughly 11.5% of its 78,400-person workforce, with 5,000 cuts in Denmark. The restructuring aimed to save about $1.25 billion a year by the end of 2026 and cut 2025 operating profit growth guidance to 4% to 10%.
- Business
FDA issues Lilly three advertising warning letters, including one over an Oprah special
The letters, dated the day President Trump signed an executive order on drug advertising disclosure, covered two local-television interview segments and "An Oprah Special: Shame, Blame, and the Weight Loss Revolution." The FDA said the materials omitted or minimized risks including the boxed warning for thyroid C-cell tumors. Lilly said the interviews were not advertisements and that it had no editorial control.
- Compounding
FDA sends Hims & Hers a warning letter over compounded semaglutide claims
The agency cited website statements including "weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy" and "clinically proven ingredients" as false or misleading, making the products misbranded.
- Policy
Executive order targets direct-to-consumer prescription drug advertising
President Trump signed an executive order on disclosure in direct-to-consumer prescription drug advertising, and the FDA issued dozens of letters the same day. Commissioner Marty Makary said the agency would send about 100 cease-and-desist notices and thousands of letters.
- Safety
FDA warning letters cite Eli Lilly for minimizing Zepbound and Mounjaro risks
FDA issued multiple warning letters to Eli Lilly over direct-to-consumer promotional videos, including an ABC and Hulu primetime special. The agency said a paid consultant's statements that pancreatitis, gallbladder and thyroid cancer concerns had 'really not been shown in human studies' misleadingly minimized serious risks including the boxed warning, and that the MEN 2 contraindication and several other risks were omitted. Lilly said it had no editorial control over the interviews.
- Culture
FDA warns Novo Nordisk over the Oprah special video
The FDA issued Novo Nordisk a warning letter finding that promotional material including the version of Oprah Winfrey's ABC special posted online failed to present the serious risks of Wegovy, Ozempic and Victoza in a truthful, non-misleading way.
- Competition
FDA warning letter treats compounded retatrutide as an unapproved new drug
The agency warns GLP-1 Solution that its compounded retatrutide products are unapproved new drugs and misbranded drugs under FDCA sections 505(a), 502(f)(1), 301(a) and 301(d), and that its claims about compounded semaglutide and tirzepatide are false or misleading.
- Business
Lilly launches TuneLab, opening its AI drug discovery models to outside biotechs
Built on what Lilly says is more than $1 billion of research investment, TuneLab lets smaller companies use Lilly's models without handing over their data.
- Science
SURMOUNT-MAINTAIN design paper published
Horn et al. publish the rationale, design and baseline characteristics of the first randomized trial testing whether tirzepatide can be reduced to 5 mg for weight maintenance. 441 participants enrolled, mean BMI 40 kg/m2.
- Compounding
FDA creates a GLP-1 API "green list" and Import Alert 66-80
Shipments of GLP-1 active ingredient from facilities not on the green list became subject to detention without physical examination at the border, squeezing the cheap overseas API that fed compounders and gray-market sellers.
- Prices
NC Medicaid announces it will stop covering GLP-1s for weight management
North Carolina Medicaid announced a coverage change ending GLP-1 coverage for weight management while keeping coverage for diabetes, cardiovascular death and event reduction in adults with obesity and cardiovascular disease, noncirrhotic MASH, and severe obstructive sleep apnea. The change took effect in October 2025 and was attributed to a state budget shortfall.
- Prices
Truveta quantifies the switching caused by the Zepbound exclusion
Truveta Research found 9.6% of patients on anti-obesity tirzepatide switched drugs in July 2025, more than a 16-fold increase over the earlier 2025 average, and that 82.8% of those who switched moved to anti-obesity semaglutide. It is the clearest measured evidence of a formulary decision moving patients between molecules.
- FDA & regulation
Novo Nordisk tells the EMA it will stop marketing Victoza in Europe
The European Medicines Agency reports that Novo Nordisk will cease marketing Victoza across the EU and EEA by the end of 2026, for commercial reasons. The US brand continues, but in shortage.
- Policy
Patients file a class action over CVS Caremark's decision to drop Zepbound
The suit argued that moving members off a drug that was working for them, for rebate reasons, breached fiduciary duties under federal benefits law. CVS restored coverage in 2026.
- Culture
Truveta publishes data on what the CVS switch did to prescribing
Using records for more than 1.6 million patients, Truveta found tirzepatide prescribing growth halved in July 2025 while semaglutide prescribing accelerated fivefold, then leveled off.
- Business
Byetta and Bydureon approvals formally cease to exist
The FDA withdrawal of NDA 021773, NDA 022200 and NDA 209210 takes effect. Introducing these products into interstate commerce without an approved application now violates the Federal Food, Drug, and Cosmetic Act.
- Prices
Patients file an ERISA class action over the Zepbound formulary removal
Dennis Larkin and Danielle Gosline sued Caremark RX in the Southern District of New York, alleging the removal of Zepbound was driven by a rebate agreement with Novo Nordisk rather than clinical merit and breached ERISA fiduciary duties. A narrower companion case over sleep apnea coverage was filed in Washington the next day.
- Research
American Academy of Sleep Medicine publishes prescribing guidance for tirzepatide in OSA
The AASM told sleep clinicians that tirzepatide is a tool rather than a cure, that it works best alongside lifestyle change and continued OSA therapy, that CPAP should not be stopped without proper reassessment, and that patients should understand this may be long-term therapy like blood pressure medication.
- Prices
Lilly raises UK Mounjaro list prices by up to 170%
Effective September 1, 2025 Lilly raised UK list prices for the Mounjaro KwikPen, taking 2.5 mg from GBP 92 to GBP 133 and 15 mg from GBP 122 to GBP 330. The Department of Health and Social Care redetermined NHS reimbursement prices to match so pharmacies would not dispense at a loss. Lilly cited pricing inconsistencies versus other developed countries.
- Culture
Gallup reports the US obesity rate falling to 37.0% as GLP-1 use hits 12.4%
Gallup's 2025 wave showed adult obesity down from a 2022 peak of 39.9% to 37.0%, an estimated 7.6 million fewer adults with obesity, alongside 12.4% of adults taking a GLP-1 specifically for weight loss.
- Safety
EADV cohort reports increased hair loss incidence with GLP-1 drugs
A real-world multicenter TriNetX cohort presented at the European Academy of Dermatology and Venereology congress found higher hair loss incidence with GLP-1 receptor agonists, while alopecia areata was consistently higher in controls, suggesting no autoimmune effect.
- Research
Network meta-analysis ranks tirzepatide doses above semaglutide for weight loss
Pooling eight randomized trials in 7,179 non-diabetic adults with obesity, tirzepatide at maximum tolerated dose gave -20.90% versus placebo and tirzepatide 15 mg -18.08%, with semaglutide at maximum tolerated dose at -14.40%. Both drugs at top doses had the highest odds of stopping for adverse events.
- Prices
TRICARE ends weight-loss drug coverage for TRICARE For Life and several other groups
The Defense Health Agency implemented regulatory controls ending coverage of weight-loss medications including Zepbound for TRICARE For Life, direct-care-only, TRICARE Plus, foreign force and NATO beneficiaries. Prior authorizations approved before that date became invalid. Diabetes coverage of Mounjaro continued for all plans.
- Science
Real-world study compares Wegovy and tirzepatide on heart outcomes
Novo Nordisk published a real-world analysis reporting that Wegovy was associated with a 57% lower risk of heart attack, stroke or death compared with tirzepatide in people with obesity and cardiovascular disease. Real-world comparisons are observational and cannot establish cause and effect the way a randomized trial can.
- Safety
Reporting finds gym users already taking unapproved retatrutide
Business Insider documented bodybuilders buying research-grade retatrutide online years before any approval, an early look at a gray market that Lilly sued to shut down in 2026.
- Business
Denmark halves its 2025 growth forecast, citing Novo Nordisk
The Danish economy ministry cut its 2025 GDP growth forecast from 3% to 1.4%, blaming weaker prospects for Novo Nordisk and US tariffs. Export growth expectations fell from 4.3% to 0.9%.
- Safety
Court finds no proximate cause in Lilly's suit against a compounded tirzepatide telehealth platform
The Central District of California held in Eli Lilly & Co. v. Willow Health Services that the requirement for a physician's prescription defeated proximate causation on Lilly's false advertising claims. A different court would reach the opposite conclusion eight months later.
- Business
Lilly partners with JD Health to sell obesity and diabetes drugs directly in China
The deal extended the LillyDirect idea to the largest online pharmacy in China, giving Lilly a consumer channel in a market where incretin prices are a fraction of US levels.
- Business
Teva launches the first generic GLP-1 approved for weight loss
Teva announces FDA approval and same-day US launch of a generic Saxenda (liraglutide injection) under ANDA214568, making liraglutide the first and so far only GLP-1 receptor agonist available as a generic for weight management in the United States. Teva cites Saxenda annual sales of $165 million as of June 2025.
- Research
Obesity Pillars publishes the most concrete US nutrition numbers for GLP-1 therapy
A narrative review by Fitch, Gigliotti and Bays in the Obesity Medicine Association's journal set out usable targets: protein 1 to 1.5 g/kg/day, fluid above 2 to 3 L/day noting that GLP-1 therapy may reduce thirst perception, fiber 21-25 g/day for women and 30-38 g/day for men, regular eating schedules with planned portions, and limits on high-fat and spicy foods. It also stated that many patients on GLP-1 therapy receive no nutrition advice at all.
- Business
ATTAIN-2 succeeds, completing the obesity filing package
In 1,613 adults with obesity or overweight plus type 2 diabetes, the highest dose produced 10.5% (22.9 pounds) weight loss and a 1.8-point A1C reduction at 72 weeks. With ATTAIN-2 complete, Lilly had the full data package to begin global regulatory submissions for obesity.
- Safety
Eli Lilly asks the JPML to centralize GLP-1 vision loss cases
Lilly moved under 28 U.S.C. section 1407 to centralize 21 NAION actions before Judge Marston in the Eastern District of Pennsylvania, or alternatively to fold them into MDL 3094. It is an unusual posture: the defendant, not the plaintiffs, sought the second MDL.
- Prices
Novo lowers the cash price of Ozempic to $499 a month
Novo Nordisk extended its $499 self-pay price from Wegovy to Ozempic for patients paying without insurance. The move matched competitive cash pricing as the market shifted toward consumers paying directly.
- Research
FDA grants accelerated approval of Wegovy for MASH
The FDA's accelerated approval of Wegovy for noncirrhotic MASH with moderate to advanced fibrosis added an indication that almost no consumer health page covered. Queries began appearing for the unfamiliar MASH acronym and for whether insurance covers Wegovy for liver disease.
- Safety
MDL 3094 court requires objective gastric emptying testing for gastroparesis claims
Judge Karen S. Marston ruled that any plaintiff claiming gastroparesis must show the diagnosis rests on a properly performed gastric emptying study, and excluded two plaintiff diagnostic experts. The ruling applies equally to the Eli Lilly and Novo Nordisk tracks and reshaped case qualification across the entire docket.
- Prices
Lilly raises the UK list price of Mounjaro by about 170%
Responding to White House pressure to equalize prices across rich countries, Lilly said it would raise European prices so American ones could come down. British private patients faced the steepest increase, and the company briefly paused UK shipments two weeks later after stockpiling.
- Business
Lilly signs a $1.3 billion AI drug-discovery deal with Superluminal
The agreement targets G-protein coupled receptors, the family that includes GLP-1 and amylin receptors, using machine learning to find small molecules. It was part of a run of AI partnerships Lilly funded with incretin cash.
- Compounding
Novo Nordisk expands its legal campaign against compounded semaglutide sellers
Novo announced a new round of lawsuits against compounders, telehealth companies and medical spas, part of a campaign that would reach more than 130 suits across about 40 states.
- Business
Lilly's chief executive buys $1 million of stock after the obesity pill selloff
The open-market purchase followed the double-digit drop on the orforglipron obesity data, and was widely read as a signal of confidence in the pill's prospects.
- Search trends
Texas sues Eli Lilly, adding a state-litigation layer to Lilly brand queries
The Texas attorney general sued Lilly over prescribing inducements. Company-level legal news reliably produces navigational searches that the site's Lilly hub can capture and that Lilly's own properties cannot answer.
- Safety
Texas sues Lilly over alleged kickbacks tied to its drugs
The Texas attorney general accused Lilly of paying inducements to prescribers, and the company said it would defend itself vigorously. The case was one of several state actions touching the incretin business.
- Safety
Target trial emulation finds semaglutide or tirzepatide linked to higher optic nerve disorder risk
A JAMA Network Open study emulated a target trial in 159,398 propensity-matched adults with type 2 diabetes. Over two years, NAION occurred in 0.04% of the semaglutide-or-tirzepatide group versus 0.02% of comparators, hazard ratio 1.76. Other optic nerve disorders had a hazard ratio of 1.65. The exposure group combined both drugs, so the study cannot attribute the finding to tirzepatide specifically.
- Safety
Texas attorney general sues Eli Lilly over Mounjaro and Zepbound prescribing inducements
Texas and co-plaintiff Health Choice Alliance sued Eli Lilly in the 71st Judicial District Court in Harrison County, alleging that a 'Free Nurse Program' and a 'Support Services Program' amounted to illegal inducements that tainted Texas Medicaid claims for drugs including Mounjaro and Zepbound. The state seeks more than $1 million plus civil penalties and an injunction. Lilly denies the allegations and has said it will vigorously defend.
- Research
ATTAIN-1 topline: 27.3 pounds lost on the highest dose
Lilly announced that in the first of two pivotal obesity trials, adults on the highest dose of orforglipron who stayed on treatment lost an average of 27.3 pounds, or 12.4%, over 72 weeks.
- Business
Lilly raises guidance on incretin demand even as the obesity pill lands with a thud
Second-quarter revenue and profit beat expectations and the company lifted full-year forecasts, but shares dropped double digits the same morning because the first phase 3 obesity result for orforglipron came in at about 12.4% weight loss, below what investors had priced in.
- Competition
Lilly's orforglipron posts about 12.4% weight loss in phase 3
Eli Lilly reported phase 3 ATTAIN results for orforglipron showing roughly 12.4% average weight loss, less than injectable options but delivered in a daily pill with no food or water restrictions. The data supported the filing that led to approval in April 2026.
- Business
Orforglipron delivers 27.3 pounds of average weight loss in its first pivotal obesity trial
ATTAIN-1 results moved Lilly's oral GLP-1 toward filing and set up the 2026 launch race against Novo Nordisk's Wegovy pill.
- Business
Novo Nordisk cuts its 2025 profit outlook again
Novo Nordisk lowered full-year operating profit growth guidance to 10% to 16% at constant currencies, down from 16% to 24% set in May. It was the company's second guidance cut of the year, with a third to follow in September.
- Research
SURMOUNT-OSA patient-reported outcomes show sleep and quality-of-life gains
Beyond the apnea-hypopnea index, tirzepatide improved PROMIS sleep disturbance and sleep-related impairment scores, EQ-5D-5L, most SF-36v2 domains, and the Epworth Sleepiness Scale in the group not using positive airway pressure.
- Business
FDA withdraws the Byetta and Bydureon approvals
A Federal Register notice withdraws approval of 39 new drug applications at the applicants' request because the products are no longer marketed. Byetta, Bydureon, Bydureon Pen and Bydureon BCise are on the list. Withdrawal takes effect September 3, 2025, though product already in inventory can be dispensed until depleted or expired.
- Safety
Novo Nordisk files suits against 12 compounding defendants
The manufacturer expanded its civil campaign against compounded semaglutide, part of a reported total of more than 130 lawsuits across 40 states by mid-2025 against telehealth companies, med spas and pharmacies.
- Safety
MDL judge rules on what evidence supports a gastroparesis claim
Judge Marston issued a detailed decision on the medical documentation required to support gastroparesis allegations in MDL 3094. Defendants had argued each plaintiff needs a gastric emptying study; the ruling reshaped which claims are viable and pushed new filings toward objective scintigraphy.
- Safety
Wegovy label adds an acute kidney injury warning
The Wegovy Recent Major Changes section records an August 2025 addition of Warnings and Precautions on acute kidney injury due to volume depletion, after postmarketing reports of kidney injury, some requiring hemodialysis, in patients who became dehydrated from GI side effects.
- Policy
Wegovy's indications section is rewritten without BMI numbers
A labeling update changed the Wegovy indications and usage section to describe the eligible population as adults with obesity, or adults with overweight plus at least one weight-related comorbid condition, rather than naming BMI 30 and BMI 27 thresholds. A further indications revision followed in December 2025. The practical effect is that the familiar BMI numbers now come from the trial entry criteria and from guidelines rather than from the label's own indication text.
- FDA & regulation
Novo files a higher 7.2 mg dose of Wegovy with the FDA
Novo Nordisk submitted semaglutide injection 7.2 mg for US approval after STEP UP showed greater weight loss than the 2.4 mg dose. The application was later accelerated under the Commissioner's National Priority Voucher program.
- Research
Lilly announces SURPASS-CVOT topline: non-inferior on heart events, 16% lower all-cause death
Tirzepatide met the non-inferiority endpoint versus dulaglutide for cardiovascular death, heart attack or stroke (hazard ratio 0.92; 95.3% CI 0.83 to 1.01). All-cause mortality was 16% lower (hazard ratio 0.84; 95.0% CI 0.75 to 0.94), but that endpoint was not controlled for multiple comparisons.
- Business
SURPASS-CVOT reports: Mounjaro non-inferior to Trulicity on cardiovascular events
The first cardiovascular outcomes trial to compare two incretin medicines head to head rather than against placebo. Across 13,299 people with type 2 diabetes and established heart disease, tirzepatide met its non-inferiority objective against dulaglutide, with an 8% lower rate of cardiovascular death, heart attack or stroke (hazard ratio 0.92, 95.3% CI 0.83 to 1.01). Superiority was not established. The trial later produced the August 2026 cardiovascular risk-reduction indication.
- Business
Administration sends MFN pricing letters to leading drugmakers
The President sent letters to leading pharmaceutical manufacturers outlining steps required to bring US prices in line with the lowest price offered in other developed nations, setting off a year of company-by-company negotiations.
- Business
Profit warning wipes about $70 billion off Novo Nordisk's value; Doustdar named CEO
Novo Nordisk cut 2025 sales growth guidance to 8-14% from 13-21% and operating profit growth to 10-16%, blaming compounded GLP-1s, slower market expansion and competition. Shares fell more than 20% in the company's worst trading day on record. The same announcement named Maziar Mike Doustdar as CEO.
- Competition
Dr. Reddy's plans generic semaglutide launches in 87 countries
Dr. Reddy's Laboratories said it planned to launch generic semaglutide in 87 countries during 2026, starting with Canada, India, Brazil and Turkey as patents expired. The company said Western markets would open between 2029 and 2033.
- FDA & regulation
FDA approves Lupin's generic Victoza
Lupin received approval for ANDA215421, a Victoza-referenced liraglutide, according to the FDA Drugs@FDA database. The product first appeared in the FDA drug code directory on 2025-10-02.
- Culture
Lilly ties a Zepbound campaign to a summer movie release
The partnership put obesity-care messaging into mainstream entertainment marketing, part of a year in which GLP-1 advertising became one of the largest categories on US television.
- FDA & regulation
Ohio pharmacy board publishes GLP-1 compounding guidance
Ohio treated semaglutide and tirzepatide as no longer compoundable copies, banned retatrutide and cagrilintide, and required in-state licensed API distributors.
- Policy
Senators accuse Lilly and Pfizer of 'shady tactics' in their telehealth platforms
A Senate investigation disclosed what the companies paid telehealth partners and argued that manufacturer-run platforms steer patients toward branded drugs. Lilly said LillyDirect uses independent prescribers and does not pay for prescriptions.
- Research
SURMOUNT-1 analysis shows most slow starters still succeed on tirzepatide
Of 1,545 adherent participants, 18% lost less than 5% of body weight by week 12. Of those slow starters, 70% reached 5% by week 24 and 90% did by week 72, though their average total loss was 11.0% versus 22.5% for early responders.
- Culture
Kinsey Institute finds GLP-1s are changing sex and dating for most users
A Kinsey Institute survey found 50% to 60% of GLP-1 users reported at least one change in their dating or sex life, with men roughly three times more likely than women to report more confidence and more dating-app matches.
- FDA & regulation
Canada approves the Zepbound KwikPen, the first multi-dose tirzepatide pen
A single pen carrying four weekly doses launched in Canada more than six months before the US version, which the FDA cleared in February 2026.
- FDA & regulation
Zepbound KwikPen approved and launched in Canada
Health Canada authorized the multi-dose pen for chronic weight management; Canada uses the US two-brand split.
- Safety
Endocrine Society review finds real-world databases do not show more aspiration
A review in the Journal of the Endocrine Society concluded that although GLP-1 drugs slow gastric emptying, retrospective cohort studies using large real-world databases have not consistently identified an increased risk of aspiration or pneumonia around elective surgical and endoscopic procedures.
- Prices
All six Zepbound doses become available through LillyDirect self-pay
Lilly opened self-pay vial access across the full dose range, with 2.5 mg at $349 and the higher doses at $499 under the 45-day refill condition. The channel stopped being a starter-dose offer and became a complete alternative to insurance.
- Research
Pilot study reports tirzepatide raises testosterone and improves erectile function in men with obesity
A two-month controlled pilot in 83 men with obesity and functional low testosterone found that the tirzepatide group had greater weight loss and higher LH, FSH, SHBG and testosterone than either lifestyle alone or transdermal testosterone, with erectile function scores improving more than with lifestyle alone. Allocation was by patient preference rather than randomization.
- Research
CVS Caremark forces the largest molecule switch in the class to date
CVS Caremark removed Zepbound from its standard, advanced control and value commercial template formularies, making Wegovy the preferred weight-management GLP-1 and affecting roughly a third of the people it covers. Existing Zepbound prior authorizations were transitioned so members did not have to repeat the process, and CVS reported that after July 1 more than 95% of prescriptions filled by affected members were for Wegovy. A formulary exception route existed for members who had already tried Wegovy with severe side effects or insufficient weight loss.
- Prices
CVS Caremark's Zepbound exclusion takes effect
Roughly a third of the lives Caremark manages lost preferred coverage of Zepbound for weight management. Patients already stable on the drug were told to switch to Wegovy or pay cash. An exception process required trying and failing Wegovy first, including for people with an approved sleep apnea authorization.
- Competition
FTC charges telehealth company NextMed over deceptive GLP-1 weight-loss marketing
The FTC alleges Southern Health Solutions, doing business as Next Medical and NextMed, used deceptive cost and weight-loss claims, fake reviews and fake testimonials to sell GLP-1 weight-loss membership programs. A final order approved in December 2025 requires a $150,000 payment expected to fund consumer refunds.
- Compounding
WeightWatchers emerges from bankruptcy with its clinical business intact
The 42-day case cut roughly $1.15 billion of debt. Reporting later put WW Clinic revenue growth at 57 percent year over year with about 135,000 clinical members by early 2026.
- Safety
FDA lists intestinal obstruction and fecal impaction as a class signal covering both tirzepatide brands
In the April to June 2025 quarterly report, FDA added intestinal obstruction and fecal impaction as a potential signal of a serious risk for the entire GLP-1 receptor agonist class, naming Mounjaro and Zepbound. As of the June 2026 update the agency was still evaluating the need for regulatory action. Both items already appear in the postmarketing section of both tirzepatide labels.
- Safety
WHO issues a global statement on semaglutide and NAION
The World Health Organization published guidance on semaglutide and the risk of non-arteritic anterior ischemic optic neuropathy, echoing the EMA's recommendation that patients with sudden vision changes seek care without delay.
- Research
Lilly starts the COMMIT trials pairing tirzepatide with a biologic in inflammatory bowel disease
Two phase 3b trials began testing tirzepatide added to the IL-23 inhibitor mirikizumab in people with inflammatory bowel disease and obesity or overweight. COMMIT-UC enrolls 350 adults with moderately to severely active ulcerative colitis, with a week-52 primary endpoint combining clinical remission and at least 10 percent weight reduction. COMMIT-CD enrolls 290 adults with Crohn's disease and adds endoscopic remission to the composite. Obesity is associated with worse response to biologic therapy in IBD, which is the stated rationale. Primary completion is April and May 2028.
- Safety
MHRA and Genomics England start hunting for a genetic cause of GLP-1 pancreatitis
The Yellow Card Biobank began asking people who report pancreatitis on a GLP-1 medicine for a saliva sample, to test whether some patients are genetically more susceptible. It is one of the first regulator-run pharmacogenomic investigations of a GLP-1 safety signal.
- Science
New data show most patients now stay on Wegovy or Zepbound past a year
An analysis shared with Reuters found one-year persistence had improved markedly from earlier estimates, undercutting the argument that high discontinuation would cap the market. Lilly cited the trend in later earnings calls.
- Compounding
Novo Nordisk terminates its Hims & Hers partnership
Eight weeks after launching the collaboration, Novo Nordisk ended it, accusing Hims & Hers of illegal mass compounding under "the false guise of personalization" and deceptive marketing. Hims & Hers shares fell more than 30% on the news.
- Research
ADJUST-T1D: first randomized evidence for semaglutide in type 1 diabetes
In 72 adults with type 1 diabetes and obesity using automated insulin delivery, 36 percent on semaglutide met a composite of time in range, low hypoglycemia and at least 5 percent weight loss, versus none on placebo, with average weight loss of about 18.5 pounds.
- Research
Amgen reports 52-week Phase 2 data for MariTide and redesigns Phase 3 dosing
MariTide produced roughly 12% to 20% average weight loss at 52 weeks depending on dose, with no plateau at the end of the study. Amgen said it would titrate more slowly in Phase 3 to reduce nausea. MariTide is the leading candidate for monthly or less-frequent dosing.
- Prices
More than 60 insurers pledge to simplify prior authorization
HHS and CMS announced a voluntary industry pledge covering commitments including reducing the scope of services subject to prior authorization by January 1, 2026, standardizing electronic prior authorization using FHIR APIs by January 1, 2027, answering at least 80 percent of electronic approvals in real time in 2027, honoring existing authorizations for 90 days when patients change plans, and continuing clinical review of all non-approvals by medical professionals.
- Research
BELIEVE shows an activin-pathway drug can protect muscle during incretin weight loss
At the American Diabetes Association meeting, the phase 2b BELIEVE trial reported that adding bimagrumab to semaglutide produced 22.1 percent weight loss with 92 percent of it from fat and only 2.9 percent lean mass loss, compared with 7.4 percent lean mass loss on semaglutide alone. Investigators said trials combining bimagrumab with tirzepatide were underway.
- Culture
England begins mass NHS rollout of tirzepatide through GPs
About 220,000 patients were expected to receive Mounjaro over three years. Because the UK has no Zepbound brand, British weight-loss coverage says "Mounjaro," which regularly confuses American readers.
- Research
EU regulators back an Ozempic label update for peripheral artery disease
The EMA's CHMP adopted a positive opinion based on STRIDE, making semaglutide the first glucose-lowering drug with proven functional benefit in peripheral artery disease.
- Prices
NHS primary care funding mandate for tirzepatide begins in England
One hundred eighty days after NICE guidance, Integrated Care Boards became required to fund tirzepatide for obesity in primary care for prioritized patient cohorts, with NHS England targeting about 220,000 patients over the first three years.
- Research
SURMOUNT-MMO design published: the first incretin outcome trial covering primary prevention
The peer-reviewed design paper for SURMOUNT-MMO described a 15,374-participant, event-driven trial in adults with obesity but without diabetes, at 664 sites across 27 countries. Its five-component primary endpoint includes all-cause death, and it is the first incretin outcome trial to enroll people who have not yet developed cardiovascular disease.
- Research
Full ACHIEVE-1 results publish at the ADA meeting
The New England Journal of Medicine published the complete orforglipron diabetes data, and Lilly said obesity results would follow in the third quarter. Coverage highlighted that the pill avoided the liver signal that had ended Pfizer's danuglipron program.
- Research
Higher-dose semaglutide 7.2 mg delivers about 21% weight loss
Novo Nordisk reported STEP UP results showing once-weekly semaglutide 7.2 mg produced roughly 21% average weight loss in adults with obesity, with about a third of participants losing 25% or more. The data supported a later FDA filing for Wegovy HD.
- Culture
Lizzo admits she tried Ozempic after months of denials
Having credited diet and exercise for a widely publicized transformation, Lizzo told the Just Trish podcast she had tried Ozempic and found it unsustainable for her. The reversal reset the credibility standard for celebrity denials.
- Business
Lilly files the Mounjaro pediatric supplement
NDA 215866 supplement S-039 was received, carrying results from trial I8F-MC-GPGV in 99 patients aged 10 and older and satisfying the pediatric postmarketing requirement from the 2022 approval.
- Science
Scholar Rock reports that its antibody preserves muscle during Zepbound treatment
In a phase 2 trial, adding apitegromab to tirzepatide shifted the composition of the weight lost toward fat and away from lean mass. The result kept the muscle-preservation question at the center of obesity research through 2026.
- Research
ASMBS head-to-head study finds bariatric surgery far outperforms GLP-1s in the real world
A study of more than 50,000 patients presented at the ASMBS annual meeting reports 24% total weight loss at two years with sleeve gastrectomy or gastric bypass versus 4.7% for patients prescribed a GLP-1 for at least six months, and 7% for those on continuous therapy for a full year. The lead author notes that as many as 70% of patients may discontinue GLP-1 treatment within one year.
- Business
Lilly offers every Zepbound dose as a single-dose vial through LillyDirect
The 12.5 mg and 15 mg vials became prescribable from July 7, 2025 and shipped in early August, at $499 a month through the Journey Program against regular prices of $849 and $1,049. Every strength was then available self-pay regardless of insurance status.
- Science
Diabetes runs a point-counterpoint on agonizing versus antagonizing GIP
The journal publishes paired arguments plus a Campbell and Drucker commentary. The commentary concludes there is no current evidence that tirzepatide attenuates activity in the GIP-receptor-positive neurons that regulate food intake, weakening the desensitization explanation of the paradox.
- Safety
EMA concludes NAION is a very rare side effect of semaglutide
The European Medicines Agency's safety committee concluded that non-arteritic anterior ischemic optic neuropathy should be listed as a very rare side effect of Ozempic, Rybelsus and Wegovy. EMA advised patients with sudden vision loss to contact a doctor immediately and said semaglutide should be stopped if NAION is confirmed.
- Compounding
Federal judge rules for FDA and Novo on the merits in the semaglutide shortage case
The ruling, unsealed June 17, 2025, confirmed that semaglutide would stay off the shortage list, closing the door on shortage-based 503B compounding.
- Safety
Kidney analysis of SURMOUNT-1 and SURMOUNT-2 finds no adverse eGFR signal
A prespecified analysis published in the Journal of the American Society of Nephrology reported acute kidney injury in 0.3% to 0.6% of tirzepatide groups versus 0.2% on placebo in SURMOUNT-1, and 1% on the 10 mg dose versus 0.3% on placebo in SURMOUNT-2. Tirzepatide reduced albuminuria and did not produce adverse changes in estimated GFR. The label's kidney warning remains a dehydration warning rather than a direct nephrotoxicity warning.
- Research
Lilly's amylin drug eloralintide posts more than 11% weight loss in a phase 1 trial
Early data on Lilly's amylin analog showed roughly 11.3% weight loss over 12 weeks with what analysts described as a clean tolerability profile. Amylin became the industry's next target class after GLP-1 and GIP.
- Business
Novo Nordisk briefly regains the title of Europe's most valuable company
A short-lived recovery in the share price put Novo Nordisk back at the top of the European market before the slide resumed.
- Research
SURPASS-CVOT completes after more than four years of follow-up
The largest and longest tirzepatide trial, with 13,299 participants randomized across 640 sites in 30 countries, reached its completion date. It compared tirzepatide against dulaglutide 1.5 mg rather than placebo, an unusual design for a cardiovascular outcomes trial.
- Research
SURMOUNT-CN follow-up measures regain 26 weeks after tirzepatide stopped
Life Metabolism published a real-world follow-up of phase 3 SURMOUNT-CN participants after tirzepatide was stopped. Twenty-six weeks post-cessation, regain was 9.1% for the 10 mg group and 12.3% for the 15 mg group, leaving net losses from baseline of 8.7% and 10.6% at week 78, with waist circumference still about 10.5 cm below baseline. It added a non-Western dataset to a withdrawal literature dominated by US and European trials.
- Business
Lilly commits up to $650 million to Juvena for muscle-boosting drugs
The deal was the third Lilly transaction aimed at preserving or rebuilding muscle during incretin treatment, a problem the company had decided to own rather than cede to rivals.
- Research
Cleveland Clinic study explains the trial-versus-real-world weight-loss gap
Average one-year weight loss was 8.7% across 7,881 patients, but 11.9% among those who stayed on treatment and 3.6% among those who stopped within three months; 80.8% were on low maintenance doses.
- FDA & regulation
EMA adds sudden vision loss to European semaglutide labels
The PRAC concluded that NAION is a very rare side effect of semaglutide, affecting up to 1 in 10,000 people, and ordered product information updates for Ozempic, Rybelsus and Wegovy.
- Safety
EMA declares NAION a very rare side effect of semaglutide
The PRAC concluded after reviewing non-clinical, trial, postmarketing and literature data that non-arteritic anterior ischemic optic neuropathy is a very rare adverse reaction, affecting up to 1 in 10,000 people, and recommended adding it to the Ozempic, Rybelsus and Wegovy product information. Large studies suggested roughly a two-fold relative risk increase in type 2 diabetes.
- Safety
UK regulator issues its first contraception alert covering Mounjaro
The MHRA issued its first public alert to UK patients on contraception and weight-loss medicines after receiving 40 reports relating to pregnancies in people using GLP-1 drugs including Mounjaro. It stated that Mounjaro may reduce the effectiveness of oral contraceptives in people who are overweight and advised barrier contraception.
- Competition
China approves mazdutide, the world's first GLP-1/glucagon dual agonist
China's National Medical Products Administration approved Innovent Biologics' mazdutide for chronic weight management, making it the first approved drug anywhere to combine GLP-1 and glucagon receptor activity. Eli Lilly holds the rights outside China and has not filed in the United States.
- Competition
Regeneron licenses a Phase 3-ready GLP-1/GIP agonist from Hansoh Pharma
Regeneron paid $80 million upfront with up to about $1.93 billion in milestones for rights outside mainland China, Hong Kong and Macau, adding an incretin to a pipeline previously centered on muscle-preservation antibodies.
- Science
Review lays out the evidence behind both GIP directions
Douros, Mowery and Knerr publish 'The Premise of the Paradox' in the Journal of Clinical Medicine, proposing a unified theory in which GIP receptor agonism acts on GABAergic neurons while antagonism releases a brake on GLP-1 action in glutamatergic ones.
- Search trends
Alopecia is added to the Mounjaro label, validating a long-running search query
Hair loss had been one of the highest-volume tirzepatide side-effect searches for two years while ranking pages described it as anecdotal. Its arrival in the label is the kind of change a monthly verification cycle catches and a static page does not.
- FDA & regulation
FDA adds alopecia to the Mounjaro label and drops two Limitations of Use
The supplement also removed the statements that Mounjaro is not indicated in type 1 diabetes and has not been studied after pancreatitis.
- Business
Lilly agrees to acquire SiteOne Therapeutics for up to $1 billion
A non-opioid pain pipeline covering acute, neuropathic, visceral and musculoskeletal pain.
- Compounding
Deadline passes for 503B outsourcing facilities to stop compounding semaglutide copies
The FDA's 90-day grace period for 503B outsourcing facilities ended, completing the federal wind-down of mass-compounded semaglutide. Novo Nordisk announced new access initiatives the same day to move patients to the approved product.
- Culture
FDA's compounding allowance for semaglutide expires
The shortage-period authorization that let pharmacies compound semaglutide lapsed, but a large gray market persisted; Novo Nordisk later complained that copycat sales continued "under the false guise of 'personalisation.'"
- Compounding
Connecticut's Attorney General warns clinics and spas about tirzepatide products
The letter names salt forms of semaglutide and tirzepatide sourced from overseas manufacturers and tells clinics that oral GLP-1 products made by compounding pharmacies have not been shown to deliver safe or effective doses.
- Prices
Cigna's Evernorth caps out-of-pocket cost for Wegovy and Zepbound at $200
The pharmacy benefit manager offered employers a program capping member cost at $200 a month for either drug, an early sign that payers were looking for ways to keep covering obesity treatment rather than exclude it.
- Competition
Lilly publishes an open letter attacking insurers that drop obesity coverage
After the CVS formulary decision, Lilly published a letter arguing that switching patients between obesity drugs for rebate reasons is bad medicine. Novo Nordisk made the mirror-image argument when the roles reversed a year later.
- Business
Novo Nordisk ousts CEO Lars Fruergaard Jorgensen
Novo Nordisk announced that Lars Fruergaard Jorgensen would step down as chief executive after eight years, citing market challenges and the share price decline. Lars Rebien Sorensen, chair of the Novo Nordisk Foundation, joined the board as an observer, signaling a shift in control.
- Science
New SELECT analysis finds heart benefit appears before major weight loss
An analysis of the SELECT trial found that reductions in cardiovascular events with Wegovy emerged early, before clinically meaningful weight change. The finding supported the idea that semaglutide's heart benefit is not only a consequence of losing weight.
- Policy
Executive order sets a most-favored-nation drug pricing target
President Trump signed an executive order directing efforts to bring US prescription drug prices in line with those paid abroad, promising reductions of up to 59%. The order became the framework for the November 2025 GLP-1 pricing agreements and TrumpRx.
- Research
SURPASS-T1D-2 adds a 20-month long-term arm in type 1 diabetes
The long-term companion to SURPASS-T1D-1 began, randomizing 465 adults with type 1 diabetes and obesity or overweight to tirzepatide or placebo over about 20 months, with the same week-40 HbA1c primary endpoint. Together the two trials enroll 1,370 people, by far the largest test of a dual GIP/GLP-1 agonist in type 1 diabetes. Primary completion is listed as November 2026.
- Research
SURMOUNT-5 gives the first randomized head-to-head of tirzepatide and semaglutide for obesity
The only randomized head-to-head trial of the two drugs, 751 adults over 72 weeks, found tirzepatide produced more weight loss (20.2% versus 13.7%) without worse tolerability. Discontinuation for adverse events was 6.1% versus 8.0%, and for gastrointestinal events 2.7% versus 5.6%. Vomiting was lower on tirzepatide (15.0% versus 21.3%) and reflux was lower too (6.1% versus 10.6%). The one clear reversal was injection site reactions: 8.6% on tirzepatide versus 0.3% on semaglutide.
- Culture
Wellness companies pivot to weight-loss drugs to avoid WeightWatchers' fate
Reuters reported that health and wellness businesses were rapidly rebuilding around GLP-1 medicines after the WeightWatchers filing. The drugs had already dented demand at some large food retailers.
- FDA & regulation
Court upholds FDA authority over the tirzepatide shortage list
The Northern District of Texas held that the FDA acted within its statutory authority, reasoning that applied equally to semaglutide.
- Competition
Generic phentermine/topiramate ER launches in the US
Teva begins distributing generic Qsymia in all four strengths, bringing coupon prices to roughly $59 to $63 per month against $249 to $276 average retail for the brand. Dr. Reddy's Laboratories receives approval on 2025-06-12.
- Culture
WeightWatchers files for Chapter 11 as GLP-1s undercut the diet-program model
WW International, the company that defined commercial dieting for sixty years, filed a prepackaged Chapter 11 in Delaware. It emerged as a private company on June 24, 2025, having eliminated roughly $1.15 billion of about $1.6 billion in debt, and pivoted to clinical weight management including GLP-1 prescribing.
- Compounding
Novo Nordisk announces permanent injunctions against compounders
The company reported court rulings permanently prohibiting a compounding pharmacy from selling knockoff Wegovy or Ozempic, along with profit forfeiture orders.
- Research
Lilly withdraws its US heart failure application for tirzepatide
Lilly's chief scientific officer told investors the company had pulled its US HFpEF application after the FDA said an additional confirmatory trial would be required. He noted every patient who would qualify is already covered by the obesity indication, and warned the decision could discourage future outcome trials in HFpEF.
- Prices
CVS Caremark announces it will drop Zepbound from its standard commercial formularies
Caremark told clients it would make Wegovy the preferred weight-management GLP-1 and remove Zepbound from its standard, advanced control and value template formularies effective July 1, 2025, under a rebate agreement with Novo Nordisk. CVS said the change would save employer clients 10% to 15% year over year.
- Prices
CVS Caremark names Wegovy its preferred obesity GLP-1, excluding Zepbound
Novo Nordisk announced that Wegovy would become the preferred GLP-1 for obesity on CVS Caremark's largest commercial formularies from July 1, 2025, with Zepbound excluded. The deal also let CVS sell Wegovy to cash payers for $499 at more than 9,000 stores.
- Search trends
CVS Caremark announces the Zepbound formulary removal, producing the year's largest forced-switching query spike
The announcement that Zepbound would come off standard commercial formularies drove an enormous volume of searches about switching to Wegovy, appealing the change and finding cash alternatives. It is the clearest demonstration that formulary news, not clinical news, drives the biggest query spikes in this category.
- Business
Lilly's first-quarter revenue rises 45%, but the CVS news overshadows it
Revenue climbed to $12.7 billion on Mounjaro and Zepbound, yet shares fell after CVS Caremark named Wegovy its preferred obesity drug for the largest commercial formulary. It was the clearest demonstration to date that pharmacy benefit managers, not prescribers, decide which drug patients get.
- Business
Liraglutide labels drop the pregnancy contraindication
The Recent Major Changes blocks on the Victoza and Saxenda labels record a May 2025 revision to Indications and Usage, removal of the Saxenda 'Patient Selection' dosing subsection, and removal of the Pregnancy contraindication. Pregnancy is now addressed in Use in Specific Populations, which directs discontinuation when a pregnancy is recognized.
- Research
Meta-analysis flags thyroid and colorectal cancer signals in GLP-1 trials
A meta-analysis of randomized trials found no overall cancer increase but reported elevated odds for thyroid cancer (1.55) and colorectal cancer (1.27), a counterweight to observational studies showing lower obesity-related cancer risk.
- Research
ESSENCE Part 1 shows semaglutide reverses liver inflammation in MASH
Steatohepatitis resolved without worsening fibrosis in 62.9% of participants versus 34.3% on placebo, and fibrosis improved in 36.8% versus 22.4%.
- Safety
FDA logs 520 adverse event reports tied to compounded semaglutide
By the end of April 2025 the FDA had received 520 adverse event reports connected to compounded semaglutide. The count was cited as justification for the enforcement deadlines that followed.
- Science
GIP receptor blockade shown to work through a different pathway than activation
A Nature Metabolism study finds the weight effects of GIP receptor antagonism vanish in mice lacking the GLP-1 receptor but survive deletion of GIP receptors in GABAergic neurons - the opposite pattern to agonism. Sequencing shows blockade, not activation, mimics GLP-1 receptor activation in the hindbrain.
- Research
SURPASS-T1D-1 begins: the first properly powered incretin trial in type 1 diabetes
Lilly started a phase 3 trial randomizing 905 adults with type 1 diabetes and obesity or overweight to tirzepatide once weekly or placebo, with HbA1c change to week 40 as the primary endpoint over about 49 weeks. It dwarfs the 24-person phase 2 trial that generated the existing evidence. Liraglutide's ADJUNCT program in type 1 diabetes previously raised hypoglycemia and ketosis concerns and never led to an approval, so the safety readout matters as much as the efficacy one. Primary completion is listed as November 2026.
- Compounding
Legal trade press tallies the scale of Lilly's tirzepatide litigation
Texas Lawyer reports a rapid series of filings across multiple districts, marking a shift from individual med-spa suits to a coordinated campaign against pharmacies and platforms.
- Safety
Texas federal court leaves the FDA shortage decision in place, ending mass compounding of semaglutide
The court denied a compounding trade association's motion to freeze the FDA determination that Ozempic and Wegovy were fully available, which ended the legal basis for most compounded semaglutide and triggered a wave of enforcement and civil suits.
- Compounding
FDA sends a warning letter to a Texas outsourcing facility named in Lilly's suit
The action linked federal enforcement to Lilly's private litigation, hitting a 503B facility that had been making tirzepatide copies.
- Safety
Eli Lilly sues four telehealth platforms over compounded tirzepatide
Lilly filed suits against Mochi Health, Fella Health and Delilah, Willow Health Services and Henry Meds in California federal courts, alleging they deceived consumers about untested, unapproved drugs. The safety-relevant allegations were specific: an under-the-tongue oral tirzepatide, and injectable tirzepatide mixed with additives including niacinamide, glycine and l-arginine, none of which has been studied in any clinical trial.
- Compounding
Reporting puts compounded tirzepatide as low as $99 a month
NPR's coverage of the Lilly suits documents compounded tirzepatide selling for as little as $99 a month against a Zepbound list price above $1,086 — the price gap that built the industry.
- Business
Novo expands its GLP-1 partnership with Humana's CenterWell Pharmacy
Novo Nordisk widened its arrangement with CenterWell Pharmacy to handle prescription fulfillment and home delivery of Wegovy for direct-to-patient customers. The move extended the NovoCare distribution network beyond the telehealth partners announced weeks earlier.
- Compounding
Deadline passes for 503A pharmacies to stop compounding semaglutide copies
The FDA's grace period for state-licensed 503A compounding pharmacies to stop making semaglutide products that are essentially copies of approved drugs expired. Patient-specific compounding for documented clinical needs remained allowed.
- Culture
Zepbound reaches nearly 339,000 weekly US prescriptions
IQVIA figures reported in trade coverage showed Zepbound clearly ahead of Wegovy in total weekly scripts, not just new starts, by the spring of 2025.
- Research
ACHIEVE-1: the first Phase 3 win for an oral small-molecule GLP-1
Topline results from ACHIEVE-1 showed orforglipron lowered A1C by 1.3 to 1.6 points from a baseline of 8.0% in 559 adults with type 2 diabetes, with more than 65% on the top dose reaching A1C of 6.5% or below and 16.0 pounds of weight loss. It was the first Phase 3 trial of an oral small-molecule GLP-1 receptor agonist to succeed anywhere.
- Competition
Lemme GLP-1 Daily federal class action voluntarily dismissed
Robins v. Lemme Inc., No. 1:25-cv-01938 (S.D.N.Y.), filed 2025-03-09 over claims that the Lemme GLP-1 Daily supplement boosted GLP-1 and reduced hunger, is terminated after the parties file a stipulation of voluntary dismissal without prejudice under Rule 41(a)(1)(A)(ii). Lemme had moved to dismiss on 2025-04-08. No court ruled on the merits, so the allegations were never tested. A parallel California state action (No. 25STCV04635, filed 2025-02-19 in Los Angeles Superior Court) was brought by the same plaintiff.
- Safety
Anaesthesia meta-analysis: more retained stomach contents, no measurable increase in aspiration
Pooling 28 observational studies covering 185,414 patients and 471 aspiration cases, researchers found no association between GLP-1 use and pulmonary aspiration (odds ratio 1.04) despite a clear increase in residual gastric contents across 165,522 patients. The evidence was rated low certainty.
- Business
FDA seizes counterfeit Ozempic lot PAR0362
Novo Nordisk warned consumers about counterfeit Ozempic injection 1 mg carrying lot number PAR0362 and illegitimate serial numbers. The FDA seized the identified counterfeit product and said it was aware of five adverse events tied to the lot.
- Competition
Pfizer discontinues its oral GLP-1 danuglipron after a liver injury case
Pfizer ended development of danuglipron after one asymptomatic trial participant had potential drug-induced liver injury that resolved on stopping the drug. The decision left Pfizer without a late-stage obesity asset and set up its later acquisition of Metsera.
- Compounding
ITC issues a general exclusion order on infringing tirzepatide imports
The Commission bars importation of products containing or purporting to contain tirzepatide that infringe Lilly's trademark or carry a false designation of origin, plus cease and desist orders against Arctic Peptides, Triggered Brand and Strate Labs. A general exclusion order binds any importer, not just the named parties.
- Safety
FDA seizes counterfeit Ozempic from the US supply chain
After Novo Nordisk alerted the agency on April 3, the FDA seized several hundred counterfeit Ozempic 1 mg units labeled with lot PAR0362 and serial numbers beginning 51746517 that had been distributed outside the authorized supply chain.
- Research
SURPASS-SWITCH finds switching beats dose escalation for people on dulaglutide
In 282 adults with type 2 diabetes not at target on dulaglutide 0.75 mg or 1.5 mg, switching to tirzepatide lowered HbA1c by 0.77 points more and weight by 6.9 kg more than escalating dulaglutide to 4.5 mg over 40 weeks.
- Research
Meta-analysis quantifies weight regain after stopping GLP-1 drugs
Across eight randomized trials and 2,372 participants, pooled regain was 9.69 kg for semaglutide or tirzepatide and 2.20 kg for liraglutide, proportional to the original loss.
- Policy
The administration drops the plan to have Medicare cover obesity drugs
The Trump administration declined to finalize the Biden-era proposal that would have let Medicare Part D cover Wegovy and Zepbound for weight loss, citing cost. Coverage returned in a different form through the November 2025 pricing deal.
- Business
Novo Nordisk reshuffles executive management
A leadership reorganization trimmed the executive team to ten members ahead of the far larger changes that would follow in the summer.
- Compounding
FDA issues two warning letters to Empower Pharmacy
One letter went to Empower's 503A pharmacy and one to its 503B outsourcing facility, both citing insanitary conditions in sterile drug production and deficient corrective actions at one of the largest suppliers of compounded GLP-1s.
- Business
Meitheal launches liraglutide injection during the Victoza shortage
Meitheal Pharmaceuticals receives FDA approval and launches liraglutide injection 18 mg/3 mL under ANDA218115, its first injector-pen product. The company notes branded Victoza was in active shortage on both the FDA and ASHP lists as of 2025-03-24.
- Compounding
Lilly sues Strive and Empower over compounded tirzepatide
Fella Health, Willow Health, Henry Meds and Mochi Health were sued in California federal courts for false advertising under the Lanham Act, unfair competition and, for some, unlicensed practice of medicine. The core claim was that mass-produced formulations were sold as "personalized."
- Business
Hims & Hers adds branded Zepbound, and Lilly publicly disowns the company
Hims & Hers said it would sell Zepbound on its platform. Lilly posted a statement saying it had no affiliation with Hims & Hers and did not endorse how the telehealth firm marketed GLP-1 products, an unusually blunt public break with a distribution partner.
- Research
ESSENCE published: semaglutide resolves MASH in most treated patients
The New England Journal of Medicine published Part 1 of ESSENCE. At 72 weeks, 63 percent of semaglutide-treated adults had resolution of steatohepatitis with no worsening of fibrosis versus 34 percent on placebo, and 37 percent had fibrosis improvement versus 22 percent.
- Policy
Obesity Medicine Association and ACOFP publish a primary care roadmap
A joint clinical perspective in Obesity Pillars laid out how family physicians should diagnose and treat obesity, naming the four pillars of nutrition, physical activity, behavior modification and medical intervention. It identified the barriers that keep primary care from starting anti-obesity medication, including insufficient visit time, weak reimbursement, weight bias, and the staff training needed to handle prior authorization.
- Culture
WeightWatchers relaunches its GLP-1 offering as a tailored companion program
WeightWatchers introduced a GLP-1-tailored plan inside its app, positioning the platform as behavioral support alongside medication rather than as an alternative to it — part of a broader pivot by consumer weight-loss brands toward companion programs.
- Science
SOUL full results presented at ACC 2025 and published in NEJM
Full SOUL results showed 12.0% of patients on oral semaglutide had a primary cardiovascular endpoint event versus 13.8% on placebo over nearly four years. Secondary kidney and limb outcomes were not significantly different, and gastrointestinal side effects drove a 20% to 30% discontinuation rate.
- Research
STRIDE shows semaglutide improves walking distance in peripheral artery disease
At the American College of Cardiology meeting, Novo Nordisk presented STRIDE, showing semaglutide 1 mg improved maximum walking distance by 13% versus placebo in adults with type 2 diabetes and symptomatic peripheral artery disease. It was the first dedicated functional-outcomes trial of a GLP-1 in PAD, and the results were published in The Lancet.
- Research
SUMMIT analysis flags a measurement problem with kidney function during rapid weight loss
A SUMMIT analysis found baseline cystatin C-based eGFR ran about 9 mL/min/1.73 m2 lower than creatinine-based eGFR, with the two formulas often disagreeing for individual patients. Chronic kidney disease did not reduce the relative benefit of tirzepatide on heart failure events.
- Prices
England's ICBs must start funding tirzepatide in specialist weight management services
Ninety days after NICE published TA1026, Integrated Care Boards became required to fund tirzepatide for obesity in NHS specialist weight management services for anyone meeting NICE's criteria. NHS England estimated 3.4 million people would be eligible and phased access over up to 12 years.
- FDA & regulation
Washington regulator issues a stop service order over GLP-1 compounding
The state's Pharmacy Quality Assurance Commission placed a limited stop service on a pharmacy's license, one of the first visible state enforcement actions.
- FDA & regulation
FDA confirms the tirzepatide compounding timeline after the ruling
The agency said the 503A period had ended and the 503B period would close on March 19, 2025.
- Competition
First class action filed over Lemme GLP-1 Daily supplement claims
Robins v. Lemme Inc. is filed in the Southern District of New York (1:25-cv-01938) alleging that the capsules cannot effectively reduce hunger or promote weight loss by raising the body's own GLP-1. The complaint notes that the underlying Eriomin research, which reported a roughly 17.5% average GLP-1 increase, did not show reductions in body weight, BMI, waist-to-hip ratio or calorie intake. A second class action follows in California.
- Research
REDEFINE 2: CagriSema produces about 16% weight loss in type 2 diabetes
Novo Nordisk reported that CagriSema achieved nearly 16% weight loss in adults with obesity or overweight and type 2 diabetes, well above placebo. The company said it planned to file for approval in 2026.
- Safety
Claims study reports increased hair loss risk with semaglutide in women
A preprint from the same University of British Columbia group behind the 2023 GI study reported an adjusted hazard ratio of 1.52 for hair loss overall and 2.08 in women compared with bupropion-naltrexone. The paper was a preprint and not peer reviewed at the time.
- Research
First trial of tirzepatide in polycystic kidney disease starts enrolling
A NIDDK-supported phase 2 trial led by the University of Colorado Denver, with Washington University and Mayo Clinic, began randomizing 126 adults with autosomal dominant polycystic kidney disease and a BMI of at least 27 to tirzepatide titrated to 5 mg weekly or placebo for 12 months. The primary outcome is change in height-adjusted total kidney volume on MRI, the standard marker of ADPKD progression, with adiponectin, leptin, interleukin-6, TNF-alpha, hs-CRP and 8-isoprostane measured as mechanistic markers. Diabetes and tolvaptan use are exclusions. Primary completion is June 2029.
- Business
Telehealth firms start switching patients from compounded copies to branded Zepbound
As the compounding deadlines closed in, LifeMD and Teladoc agreed to sell Lilly's discounted vials, and Lilly expanded LillyDirect's roster of telehealth partners. The shift moved a large block of cash-paying patients back into the branded channel.
- Prices
Novo launches NovoCare Pharmacy with Wegovy at $499 a month
Novo Nordisk opened NovoCare Pharmacy, a direct-to-patient channel offering all doses of FDA-approved Wegovy at $499 per month for cash-paying patients. The list price remained above $1,300, so the offer was a large discount aimed at people without coverage.
- FDA & regulation
Court refuses to block the tirzepatide delisting
A preliminary injunction was denied, letting the FDA's tirzepatide compounding deadlines take effect.
- Research
SURMOUNT-J reports Japanese obesity results
In 225 Japanese adults with obesity disease as defined locally, placebo-adjusted weight change at week 72 was -16.1% at 10 mg and -21.1% at 15 mg. Japan defines obesity at a lower BMI threshold than the United States.
- Compounding
Lilly launches an advertising campaign against copycat weight-loss drugs
The campaign told consumers that products sold as tirzepatide outside the approved supply chain are not FDA approved and may not contain what the label claims, a consumer-facing complement to the company's lawsuits.
- Culture
Scott Disick confirms Mounjaro use on "The Kardashians"
Nearly a year after viewers spotted the box in his refrigerator, Disick addressed it on camera and refused to apologize. The clip became one of the most-circulated celebrity GLP-1 moments of the year.
- Prices
Lilly pledges $27 billion for four new US plants, taking total US commitments past $50 billion
At a Washington press conference Lilly announced four new US manufacturing sites, three of them producing active pharmaceutical ingredients including tirzepatide. CEO David Ricks cited a real gap in US active-ingredient supply. Total US capital commitments since 2020 passed $50 billion.
- Prices
Lilly cuts Zepbound vial prices and adds 7.5 mg and 10 mg with a 45-day refill condition
The 2.5 mg vial fell from $399 to $349 and the 5 mg from $549 to $499. Lilly added 7.5 mg and 10 mg vials at $499 per month, but only on a first fill or a refill within 45 days of the previous delivery, otherwise $599 and $699. The 45-day rule enters the program here.
- Research
SURMOUNT-1 DXA sub-study puts numbers on tirzepatide lean mass loss
In 160 participants scanned at baseline and week 72, tirzepatide reduced body weight 21.3 percent, fat mass 33.9 percent and lean mass 10.9 percent. About 75 percent of weight lost was fat and 25 percent lean tissue — the same proportion as placebo — and that ratio held across age, sex and weight-loss subgroups.
- Compounding
FDA declares the semaglutide shortage resolved
FDA announced that the injectable semaglutide shortage was resolved and set wind-down dates for compounding: April 22, 2025 for 503A pharmacies and May 22, 2025 for 503B outsourcing facilities. For hundreds of thousands of people on compounded semaglutide, this began a forced transition to an FDA-approved product, a new prescription, and a dose their prescriber had to map by hand because compounded strengths were never standardized.
- Compounding
Compounders sue over the semaglutide shortage delisting
The Outsourcing Facilities Association challenged the FDA's declaratory order resolving the semaglutide shortage. The FDA said it had weighed information from telehealth companies, compounders, trade groups and individuals as well as Novo Nordisk data.
- Business
Lilly stockpiles about $550 million of its unapproved obesity pill
Regulatory filings showed Lilly had built roughly $548 million of orforglipron inventory more than a year before any approval, an unusual bet meant to avoid repeating the tirzepatide shortage at launch. The stockpile grew to about $1.5 billion by early 2026.
- FDA & regulation
Enforcement discretion ends for 503A pharmacies compounding tirzepatide
The window during which the FDA said it did not intend to act against state-licensed pharmacies compounding tirzepatide closed, following the district court's denial of a preliminary injunction in Outsourcing Facilities Association v. FDA.
- Business
Novo Nordisk alleges fraud in the $1.3 billion KBP Biosciences deal
After the hypertension drug ocedurenone failed a trial, Novo Nordisk sued KBP Biosciences and its founder, seeking up to $830 million and winning an asset freeze at the Singapore International Commercial Court.
- FDA & regulation
European Commission adopts the Mounjaro sleep apnea labeling variation
Commission decision on variation II/0027.
- Research
Tirzepatide linked to less papilledema and vision loss in idiopathic intracranial hypertension
A propensity-matched analysis of 193 tirzepatide-treated patients versus 193 controls reported a 68 percent lower risk of papilledema and a 73.9 percent lower risk of visual disturbance or blindness at 24 months. The findings are observational and rest on diagnosis codes rather than standardized eye examinations.
- Research
First randomized trial of semaglutide for alcohol use disorder published
In 48 adults not seeking treatment, low-dose semaglutide reduced laboratory alcohol self-administration and weekly craving over nine weeks, with medium to large effect sizes, though it did not change average drinks per calendar day.
- Safety
JAMA Psychiatry trial finds low-dose semaglutide cuts lab alcohol intake
A phase 2 randomized trial of nine weeks of low-dose semaglutide in adults with alcohol use disorder reported medium to large reductions in alcohol consumed during a post-treatment self-administration task, in a small sample.
- FDA & regulation
FDA clarifies the tirzepatide compounding deadlines
The agency said the 503A and 503B windows ran to February 18 and March 19, 2025 or the court's injunction ruling, whichever was longer.
- Compounding
FDA extends enforcement discretion for compounded tirzepatide pending a court ruling
The FDA said it would hold off on enforcement against compounded tirzepatide until a district court ruled on the compounders' preliminary injunction motion. The move showed how litigation was shaping the pace of the compounding wind-down.
- Business
Lilly signs back-to-back deals in liver disease and cancer
The agreements extended the pattern of using incretin revenue to buy optionality elsewhere, with MASH the closest adjacent market to obesity.
- Culture
Two senators ask the FDA to act on Hims & Hers' Super Bowl ad
Sens. Dick Durbin and Roger Marshall wrote to the FDA before the ad aired, saying it risked misleading patients by omitting safety information and flashed the "not FDA-approved" disclaimer for about three seconds in small type.
- FDA & regulation
FDA approves a four-pack Zepbound vial presentation
Supplement S-020 packaged a month of single-dose vials in one carton.
- Business
Lilly reports 2024 revenue of $45.0 billion, up 32%
Mounjaro delivered $11.54 billion, up 124%, and Zepbound $4.93 billion in its first full year. Reported diluted earnings per share doubled to $11.71.
- Research
SCALE Kids published: liraglutide lowers BMI in children aged 6 to under 12
The New England Journal of Medicine published SCALE Kids, which randomized 82 children aged 6 to under 12 with obesity 2:1 to liraglutide or placebo for 56 weeks. Mean BMI change was -5.8 percent with liraglutide versus +1.6 percent with placebo, a difference of -7.4 percentage points. No GLP-1 drug is FDA-approved for obesity under age 12.
- Business
Lilly's fourth-quarter 2024 results reassure investors on obesity demand
Revenue rose sharply on Mounjaro and Zepbound even as the two drugs missed consensus, and management said underlying prescription demand remained strong. The company also signaled it would test incretins in neurology and immunology.
- Research
Exenatide fails to slow Parkinson's disease in a phase 3 trial
The UK Exenatide-PD3 trial reports no difference between weekly exenatide and placebo on motor scores at 96 weeks in 194 participants. The Lancet later issues an Expression of Concern about the paper, on June 22, 2026.
- Business
FDA issues action letters on both tirzepatide KwikPen applications
On the same day, FDA sent action letters on the Mounjaro KwikPen (S-009) and the Zepbound KwikPen (S-002). Lilly did not submit complete responses until December 2025, delaying the multi-dose pen by roughly a year.
- Research
FDA adds a kidney indication to Ozempic based on FLOW
Semaglutide 1.0 mg became the only GLP-1 receptor agonist approved to reduce the risk of worsening kidney disease, kidney failure and cardiovascular death in type 2 diabetes with chronic kidney disease.
- FDA & regulation
FDA approves Ozempic for chronic kidney disease in type 2 diabetes
The FDA approved Ozempic to reduce the risk of worsening kidney disease, kidney failure and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. The approval was based on the FLOW trial and made Ozempic the only GLP-1 with a kidney indication.
- Prices
Colorado moves to limit GLP-1 coverage for state employees
Colorado announced it would cover GLP-1s for its roughly 40,000 state employees only for type 2 diabetes, cardiovascular disease and obstructive sleep apnea from July 1, 2025, a change projected to save nearly $17 million a year. About 1,100 state employees were on Zepbound at the time.
- Policy
Semaglutide is selected for Medicare drug price negotiation
The Biden administration named semaglutide, covering Ozempic, Rybelsus and Wegovy, among 15 drugs in the second round of Medicare price negotiation under the Inflation Reduction Act. Negotiated prices were set to take effect January 1, 2027.
- Competition
High-dose Wegovy data fall short of Zepbound's numbers
Novo Nordisk's 7.2 mg semaglutide trial produced substantial weight loss but less than tirzepatide had in its own studies, sharpening the sense that Lilly held the efficacy lead going into 2025.
- Research
Lancet Commission proposes replacing BMI-based eligibility with clinical obesity
A 58-member Lancet Diabetes & Endocrinology Commission, endorsed by 76 organizations, defined clinical obesity as a chronic systemic illness with documented organ dysfunction and preclinical obesity as excess adiposity with preserved organ function. It recommended BMI be used as a population screen rather than an individual measure of health, and argued clinical obesity should not require a second disease to justify treatment or coverage, directly challenging the BMI-27-plus-comorbidity model used by US payers.
- Business
Lilly warns on 2024 revenue and has its worst trading day since 2021
In a pre-announcement before the J.P. Morgan healthcare conference, Lilly said fourth-quarter incretin sales would miss forecasts and set 2025 guidance below expectations. Executives blamed slower-than-expected growth in the obesity market and channel inventory.
- Business
Lilly agrees to acquire Scorpion Therapeutics' PI3K-alpha program
An oncology asset purchase reported at up to $2.5 billion, opening a deal year that would run for the next 20 months.
- Compounding
Lilly sues two more med spas over copycat weight-loss drugs
The company filed suits in Florida and Texas against businesses selling products described as tirzepatide, continuing a quarterly pattern of enforcement actions through 2025.
- Research
Three-year SURMOUNT-1 data show a 93% relative drop in progression to type 2 diabetes
Among 1,032 SURMOUNT-1 participants with obesity and prediabetes treated for 176 weeks, 1.3% developed type 2 diabetes on tirzepatide versus 13.3% on placebo (hazard ratio 0.07). Weight loss at three years was 12.3% to 19.7% by dose. This is the longest randomized tirzepatide follow-up published.
- Research
Analysis defines when tirzepatide weight loss plateaus
A post hoc analysis of SURMOUNT-1 and SURMOUNT-4 found median time to weight plateau ranged from 24.3 weeks in participants with overweight to 36.1 weeks in class III obesity. By week 72, 87.6% to 90.2% had plateaued. Higher doses, younger age and female sex predicted a later plateau.
- Policy
Medicare can cover Zepbound for sleep apnea, CMS confirms
CMS said Part D plans could cover Zepbound when it is prescribed for obstructive sleep apnea, because the statutory exclusion applies to drugs used for weight loss rather than to a medically accepted indication. It was the first crack in the Medicare wall for any obesity drug.
- Culture
Cornell and Numerator quantify the GLP-1 grocery effect
Early findings from Cornell's S.C. Johnson College of Business with Numerator showed households cut grocery spending by roughly 6% within six months of starting a GLP-1 - about $416 a year - with chips, bakery, sides and cookies falling hardest.
- Compounding
Lilly asks to join the compounders' lawsuit against the FDA
Lilly moved to intervene in the Outsourcing Facilities Association case, arguing it should be able to defend the FDA's finding that the tirzepatide shortage was over. Courts granted the request, and Lilly stayed a party through the appeals that ran into 2026.
- Safety
Ozempic label updated to say it is not recommended in severe gastroparesis
Novo Nordisk updated the Ozempic label to state the drug is not recommended in patients with severe gastroparesis. The label did not say the drug causes the condition, a distinction at the center of the MDL 3094 litigation.