GLP‑1 news from 2024
182 dated, sourced GLP-1 developments from 2024: approvals, trial results, prices, lawsuits, compounding and culture.
- Safety
FDA lists NAION as a potential signal for the GLP-1 class, naming Mounjaro and Zepbound
In its October to December 2024 quarterly report of potential signals of serious risks, FDA listed non-arteritic anterior ischemic optic neuropathy for the whole GLP-1 receptor agonist class, with Mounjaro and Zepbound among the fourteen products named. The entry read 'FDA is evaluating the need for regulatory action.' As of September 2026 no NAION warning had been added to any US GLP-1 label.
- FDA & regulation
Japan approves Zepbound for obesity disease
Japan's approval carries tighter entry criteria than the US label, requiring a specific comorbidity plus a BMI of at least 27 with two conditions or at least 35.
- Culture
Elon Musk posts as "Ozempic Santa"
Musk posted a Christmas Day photo of himself in a Santa costume captioned "Ozempic Santa," a marker of how completely the drug had crossed into everyday joke material.
- FDA & regulation
FDA approves the first true generic of Victoza
The FDA approves Hikma Pharmaceuticals USA's abbreviated new drug application for liraglutide injection 18 mg/3 mL, the first generic referencing Victoza. The agency notes liraglutide was in shortage and that it prioritizes generic applications for shortage drugs. Hikma launched on 2024-12-24 and cited roughly $1.3 billion in US liraglutide sales for the 12 months ending October 2024.
- Compounding
Lilly welcomes a trade ruling against imported knockoff tirzepatide
Lilly said a US International Trade Commission decision would help stop the unlawful importation and sale of counterfeit tirzepatide products, one of the few enforcement wins aimed at the overseas supply chain rather than domestic pharmacies.
- Research
CagriSema's first phase 3 readout disappoints investors
Novo Nordisk reported that CagriSema, its combination of semaglutide and the amylin analog cagrilintide, produced about 22.7% weight loss in the REDEFINE 1 trial when all participants stayed on treatment. Analysts had expected closer to 25%, and Novo shares fell sharply.
- Culture
FDA approves Zepbound for obstructive sleep apnea
The FDA cleared Zepbound (tirzepatide) to treat moderate-to-severe obstructive sleep apnea in adults with obesity, making it the first medication approved for the condition. Lilly estimated about 20 million US adults have moderate-to-severe OSA. The approved OSA maintenance dose is 10 mg or 15 mg once weekly.
- Business
FDA declares the tirzepatide shortage resolved for the second time
FDA had first determined the tirzepatide shortage resolved on October 2, 2024; after reconsidering, it reaffirmed that determination on December 19, 2024 and published the enforcement dates. With the shortage declared over, the legal basis for compounding copies began to close. Search demand shifted from 'where to buy compounded tirzepatide' toward 'is compounded tirzepatide still legal', a question whose answer changed several times over the following twenty months and which almost no ranking page keeps current.
- Compounding
FDA reaffirms the tirzepatide shortage resolution and starts the wind-down clocks
A Declaratory Order and Decision Memorandum confirm the shortage is over and set two deadlines: 60 days for state-licensed 503A pharmacies and 90 days for 503B outsourcing facilities to stop compounding copies of tirzepatide.
- Business
Catalent deal closes; Novo Nordisk takes over three sterile fill-finish plants
Novo Nordisk acquired Catalent sites in Anagni (Italy), Brussels (Belgium) and Bloomington, Indiana, employing more than 3,000 people. The cash outflow pushed Novo Nordisk's 2024 free cash flow to negative DKK 14.7 billion.
- FDA & regulation
Europe's regulator says Mounjaro can be used for sleep apnea without a new approval
The EMA said the existing European label already covered treating obstructive sleep apnea in people being treated for obesity, a different regulatory route from the standalone US indication approved a week later.
- Safety
European regulators conclude tirzepatide causes dysesthesia and delayed gastric emptying
Following a PRAC assessment of the tirzepatide periodic safety update report, the CHMP concluded that a causal relationship between tirzepatide and both dysesthesia and delayed gastric emptying was at least a reasonable possibility, and required EU product information to be amended. The US label lists dysesthesia with incidence figures but still does not list delayed gastric emptying as an adverse reaction, placing it only in Clinical Pharmacology. This is a real US-EU divergence.
- Culture
RFK Jr. softens on GLP-1s, saying they "have a place"
After campaigning on the idea that good food three times a day could end obesity overnight, the incoming health secretary told CNBC that lifestyle should come first but GLP-1 drugs "have a place" - the first step in a multi-year reversal.
- FDA & regulation
CHMP recommends adding sleep apnea trial data to the EU Mounjaro label
Variation II/0027 put the SURMOUNT-OSA results into sections 4.1, 4.8 and 5.1 rather than creating a separate EU indication.
- FDA & regulation
EU adds kidney outcome data to the Ozempic label
European regulators cleared kidney disease progression language about six weeks before the equivalent US approval.
- Competition
FDA issues what consultants describe as its only supplement-side GLP-1 warning letter
The agency warns Veronvy over its 'Elily Veronvy' and 'Elily Veronvy 40+' products, treating them as unapproved new drugs under the FDCA because they were intended to prevent, treat or cure disease or affect the structure or function of the body. Regulatory consultants note in 2025 that this remains the only such letter, in contrast with dozens sent to telehealth companies over compounded GLP-1 marketing.
- Business
Lilly announces a $15 billion buyback and a seventh straight 15% dividend increase
Capital returns scaled with the tirzepatide cash flow.
- Business
Lilly puts another $3 billion into the Wisconsin plant it had just bought
The expansion of a plant bought from Nexus Pharmaceuticals brought total Wisconsin investment to about $4 billion and 750 new jobs. Lilly called it its largest US manufacturing investment outside Indiana.
- Competition
SURMOUNT-5 topline: 20.2% on Zepbound against 13.7% on Wegovy
Lilly reported the first randomized head-to-head result between the two leading obesity drugs. Over 72 weeks, adults on tirzepatide lost an average of 20.2% of body weight against 13.7% on semaglutide 2.4 mg, a 47% relative difference. Novo Nordisk shares fell on the news.
- Culture
Conagra puts a 'GLP-1 Friendly' badge on Healthy Choice products
Conagra Brands introduced on-pack badges directing shoppers to GLP-1-friendly options across select Healthy Choice items, using in-house criteria around protein, fiber and portion size. There is no FDA definition of the phrase, making the badge a marketing descriptor rather than a regulated claim.
- Safety
Endoscopy meta-analysis finds four-fold higher odds of retained stomach contents
A systematic review in Gastrointestinal Endoscopy pooled studies of GLP-1 users undergoing endoscopy and reported an odds ratio of 4.54 for residual gastric contents and the same odds ratio for procedures terminated early.
- Compounding
Tennessee officials seize more than 300 counterfeit GLP-1 vials
Authorities in West Tennessee seize over 300 vials of counterfeit semaglutide and tirzepatide from a home in Medina. Lilly's testing of one sample finds only water.
- Business
US GLP-1 prescription volume passes 9 million a month
IQVIA reported that by the end of 2024 total US GLP-1 prescription volume across diabetes and obesity indications had surpassed 9 million per month, up from about 2.5 million before October 2022.
- FDA & regulation
FDA adds a 1.7 mg adolescent dose and a severe GI warning to Wegovy
The supplement created an extra maintenance option for teens and added a Warnings and Precautions subsection on severe gastrointestinal reactions.
- Science
Amgen reports Phase 2 results for MariTide, a monthly GIP-blocking obesity drug
Amgen reported phase 2 data for maridebart cafraglutide, known as MariTide, a candidate designed for monthly or less frequent dosing. Reported weight loss ranged from about 12.3% to 16.2% on an intention-to-treat basis, with a higher range under the efficacy estimand.
- Policy
The outgoing administration proposes letting Medicare cover obesity drugs
The Centers for Medicare and Medicaid Services proposed reinterpreting the statutory exclusion on weight-loss drugs so Part D could cover Wegovy and Zepbound. The proposal was not finalized, and the incoming administration dropped it in April 2025.
- Search trends
Google broadens the site reputation abuse policy to any third-party content borrowing a host domain's signals
Google clarified that publishing third-party pages to exploit a host site's ranking violates the policy regardless of first-party involvement. The update confirmed that properly marked affiliate links are not themselves a violation, which defined the compliance boundary for affiliate-funded health sites.
- Business
Procter & Gamble's Jon Moeller joins the Lilly board; Karen Walker resigns
Moeller was elected effective December 1, 2024 to the audit and governance committees. Walker, a director since 2018, resigned effective December 31, 2024 to work with Lilly on digital commercial activities instead.
- Research
Circulation analysis finds SUMMIT benefits spread across symptoms, function and medication burden
A companion analysis showed consistent gains across the 6-minute walk test, EQ-5D-5L quality of life, New York Heart Association class and number of heart failure medications, with a hierarchical composite win ratio of 1.63.
- Research
SUMMIT mechanistic analysis shows less circulatory overload and less organ injury
A Nature Medicine secondary analysis found tirzepatide reduced estimated blood volume, systolic blood pressure and C-reactive protein while improving kidney filtration and lowering urine albumin, NT-proBNP and troponin T — evidence that the heart failure benefit tracked with reduced volume-pressure overload and less end-organ damage.
- Research
SUMMIT: tirzepatide cuts heart failure events by 38 percent in obesity-related HFpEF
Presented at the American Heart Association Scientific Sessions and published in NEJM, SUMMIT randomized 731 adults with heart failure with preserved ejection fraction and obesity. Cardiovascular death or a worsening heart failure event occurred in 9.9 percent on tirzepatide versus 15.3 percent on placebo. It was the first trial in this population to use heart failure events as a prespecified primary endpoint.
- Culture
Jim Gaffigan says he lost 50 pounds on Mounjaro
The comedian whose stage persona was built on eating told People he used Mounjaro after reaching 270 pounds, and said he was talking about it specifically to remove the stigma.
- Research
Three-year SURMOUNT-1 data show 94 percent lower risk of progressing to type 2 diabetes
Over 176 weeks, 1.3 percent of adults with obesity and prediabetes on tirzepatide developed type 2 diabetes versus 13.3 percent on placebo, with a number needed to treat of nine. Weight loss held at up to 19.7 percent. After 17 weeks off the drug, weight and blood sugar moved back toward baseline.
- Research
Detailed three-year data show 99% of prediabetic patients stayed diabetes-free
Presented at ObesityWeek and published in the New England Journal of Medicine, the 176-week SURMOUNT-1 analysis reported that nearly 99% of participants with prediabetes on tirzepatide had not progressed to type 2 diabetes, against 2.4% progression on placebo.
- FDA & regulation
FDA finalizes the gastrointestinal and aspiration labeling for Mounjaro
Supplements S-010, S-015 and S-022 implemented the September 2024 safety letter and added dysgeusia and dysesthesia.
- Business
Three Mounjaro labeling supplements approved together
NDA 215866 supplements S-010, S-015 and S-022 revised the package insert and Medication Guide.
- FDA & regulation
FDA lists Ozempic and Wegovy as available after two years of shortage
The FDA updated its database to show all doses of Ozempic and Wegovy as available, ending more than two years of listed shortage. The formal declaratory order resolving the shortage came four months later.
- Research
STEP 9 shows semaglutide reduces knee osteoarthritis pain
The New England Journal of Medicine published STEP 9, in which 407 adults with obesity and moderate knee osteoarthritis on semaglutide 2.4 mg lost about 10.5% more body weight than placebo and reported larger reductions in knee pain scores over 68 weeks. Semaglutide is not approved to treat osteoarthritis.
- Business
A rare sales miss on Zepbound and Mounjaro knocks Lilly's shares
Third-quarter incretin revenue came in below expectations, which Lilly attributed largely to wholesalers drawing down inventory rather than to weaker demand. The stock fell sharply and the episode became a reference point for how sensitive the shares had become to GLP-1 numbers.
- Safety
Five medical societies reverse course: most patients can keep taking GLP-1 drugs before surgery
The American Society of Anesthesiologists, American Gastroenterological Association, American Society for Metabolic and Bariatric Surgery, ISPCOP and SAGES issued joint guidance recommending individualized risk stratification instead of a blanket hold, with a 24-hour clear liquid diet for higher-risk patients.
- Business
AstraZeneca discontinues Byetta and Bydureon BCise
AstraZeneca notifies the FDA that it has discontinued Byetta on October 25, 2024 and Bydureon BCise on October 28, 2024. Both are commercial decisions, not safety actions. Payers immediately publish preferred alternatives for affected patients.
- Research
SMART trial reports albuminuria reduction in kidney disease without diabetes
A 24-week trial in 101 adults with chronic kidney disease and overweight or obesity but no diabetes found semaglutide 2.4 mg reduced urine albumin-to-creatinine ratio, body weight and systolic blood pressure versus placebo.
- Competition
Lilly launches its obesity drug in Denmark, Novo Nordisk's home market
Lilly began selling tirzepatide for weight loss in Denmark, a symbolic move into the country where Novo Nordisk is the largest company and a major share of the economy.
- Compounding
Novo asks the FDA to bar compounded copies of semaglutide
Novo Nordisk petitioned the FDA to add semaglutide to a "demonstrably difficult to compound" list, arguing the peptide is too complex for compounding pharmacies to reproduce safely. The petition sat unresolved for more than a year before the FDA proposed a rule.
- Research
SOUL trial: oral semaglutide cuts cardiovascular events by 14%
Novo Nordisk reported that oral semaglutide reduced major adverse cardiovascular events by 14% versus placebo in 9,650 adults with type 2 diabetes and established cardiovascular or kidney disease. The company said it would seek a Rybelsus label expansion.
- FDA & regulation
FDA adds SURMOUNT-3 and SURMOUNT-4 data to the Zepbound label
Five supplements approved together also retitled the gastrointestinal warning and removed the Patient Selection subsection.
- Business
Five Zepbound labeling supplements approved at once
NDA 217806 supplements S-005, S-006, S-011, S-015 and S-019 were actioned together, including an efficacy labeling change with clinical data.
- Policy
Lilly funds a UK trial testing whether weight-loss drugs affect employment
A £279 million package included a real-world study in Greater Manchester examining employment and sick days among people treated for obesity. Health economists were skeptical, but the study became a template for arguing indirect benefits to payers.
- FDA & regulation
Court remands the tirzepatide shortage decision to FDA
On the agency's own unopposed motion, the delisting went back for reevaluation.
- Science
Review questions how completely the gastric emptying effect fades
Jalleh et al. publish a JCEM review of delayed gastric emptying with GLP-1 receptor agonists and tirzepatide, finding evidence for tachyphylaxis with long-acting agents but cautioning that the acetaminophen absorption test used in most studies has real limitations.
- Compounding
Outsourcing Facilities Association sues FDA over tirzepatide shortage delisting
The 503B trade group challenged FDA's removal of tirzepatide from the shortage list in the Northern District of Texas, the opening move in the litigation that would decide the fate of mass compounding.
- FDA & regulation
Compounders sue FDA over the tirzepatide delisting
The Outsourcing Facilities Association sued the FDA in the Northern District of Texas after the agency removed tirzepatide from its shortage list. The litigation delayed enforcement deadlines and previewed the fight that followed the semaglutide delisting.
- Compounding
FDA takes tirzepatide off the shortage list, and compounders sue days later
The FDA declared the tirzepatide shortage resolved, which under federal law ends the exemption that lets pharmacies make copies of an approved drug. The Outsourcing Facilities Association sued within a week, and the agency then agreed to reconsider.
- Compounding
FDA first declares the tirzepatide shortage resolved (October 2, 2024)
The first resolution decision, later remanded and then reaffirmed on December 19, 2024. The existing lane timeline dates this event to 2024-12; the precise sequence is October 2 (declared), October 22 (remanded for re-evaluation), December 19 (reaffirmed with wind-down clocks).
- Business
Lilly announces a $4.5 billion 'Medicine Foundry' research and manufacturing center
The Lebanon, Indiana facility was designed to develop manufacturing processes and make clinical supply at the same site, which Lilly said would shorten the path from trial to launch for its obesity pipeline.
- Culture
Kathy Bates pushes back on "she just did it with Ozempic"
Bates said she lost about 100 pounds over seven years, roughly 80 through lifestyle change and the last 15 to 20 with Ozempic started for type 2 diabetes, and objected to the assumption that the drug did everything.
- Science
Multi-society guidance replaces the standalone anesthesia advice on GLP-1 drugs
Anesthesiology, gastroenterology and obesity medicine organizations issued joint clinical practice guidance on managing patients taking GLP-1 receptor agonists before procedures.
- Business
Novo settles US patent challenges with four generic makers
Novo Nordisk settled disputes with Mylan, Dr. Reddy's, Apotex and Sun Pharma over a US patent covering specific semaglutide dosages for type 2 diabetes. The settlements preserved Novo's US exclusivity into the 2030s while leaving other markets exposed.
- Culture
Novo Nordisk's CEO is grilled by Bernie Sanders over US GLP-1 prices
Sen. Bernie Sanders led a Senate HELP Committee hearing with Novo Nordisk CEO Lars Fruergaard Jørgensen on a solo panel, arguing Americans pay nine times the German net price for Ozempic. It set the political frame that persists today.
- Compounding
FDA sends warning letters to sellers of counterfeit GLP-1 ingredients
The FDA issued warning letters to companies marketing semaglutide and tirzepatide as "research chemicals" while evidence showed the products were intended for human use. The agency said some counterfeits contained bacteria, high impurity levels or different chemical structures from approved medicines.
- FDA & regulation
TGA registers Mounjaro for chronic weight management in Australia
Australia added the weight indication to the existing single brand after a 255-working-day evaluation.
- FDA & regulation
FDA orders a class-wide anesthesia warning for GLP-1 drugs
FDA notified manufacturers under section 505(o)(4) that labels must describe the risk of pulmonary aspiration during general anesthesia or deep sedation.
- FDA & regulation
FDA issues a section 505(o)(4) letter on pulmonary aspiration
The class-wide safety letter required GLP-1 labels, including tirzepatide, to warn about aspiration during general anesthesia or deep sedation.
- Business
SCALE Kids reports liraglutide results in children aged 6 to under 12
A phase 3a trial in 82 children finds BMI fell 5.8% with liraglutide versus a 1.6% rise with placebo over 56 weeks, an estimated difference of 7.4 percentage points. Gastrointestinal adverse events occurred in 80% versus 54%. No FDA approval for this age group followed; the Saxenda label still stops at age 12.
- Research
Pooled analysis suggests semaglutide cuts heart failure events
Across SELECT, FLOW and the two STEP-HFpEF trials, semaglutide reduced cardiovascular death or worsening heart failure by 31% in 3,743 participants with HFpEF.
- Prices
Lilly launches $399 Zepbound vials and starts the cash-pay price war
Lilly began selling single-dose vials of the two lowest Zepbound doses directly to self-paying patients at $399 and $549 a month, roughly half the list price of the autoinjector pens. The move was aimed squarely at compounded tirzepatide, which had been selling for a few hundred dollars a month.
- Business
Sanders calls Lilly's Zepbound vial pricing a "modest step forward"
Lilly had cut the starter dose to $399 and the second dose to $549 in single-dose vials sold through LillyDirect. Sanders noted Lilly had simultaneously raised its savings-card price from $550 to $650 and had not cut Mounjaro, which he said cost $1,069 in the United States, $485 in the United Kingdom and $94 in Japan.
- Science
Evidence that GIP receptor agonism eases GLP-1 gut side effects
Knop et al. publish a Phase 1 crossover trial in 32 healthy volunteers: pretreatment with a selective GIP receptor agonist cut total gastrointestinal adverse events during a rapid liraglutide escalation from 75 to 41, and reflux events from 14 to 5.
- Research
Three-year SURMOUNT-1 data show a 94% cut in progression to type 2 diabetes
Lilly reported that adults with prediabetes and obesity who stayed on tirzepatide for 176 weeks were 94% less likely to develop type 2 diabetes than those on placebo, with average weight loss of about 22% maintained. Detailed results followed in November.
- Compounding
FTC finalizes its rule on consumer reviews and testimonials
The FTC published 16 CFR Part 465, banning fake reviews, insider reviews without disclosure, review hijacking and company-controlled sites posing as independent. The rule took effect October 21, 2024 and applies squarely to GLP-1 affiliate content.
- Compounding
Lilly tells physicians to stop selling compounded copies of its drugs
In letters to prescribers, the company said clinicians who sold compounded tirzepatide risked their licenses and patient safety. It marked a shift from suing sellers to pressuring the doctors who wrote for them.
- Research
Novo Nordisk withdraws its FDA heart failure application for Wegovy
After FDA feedback that the HFpEF trials were too small to substantiate a treatment effect on events, Novo Nordisk pulled its supplemental application and said it would resubmit with additional data.
- FDA & regulation
FDA says every dose of Mounjaro and Zepbound is available again
The agency's shortage database moved all tirzepatide presentations to available, the first step toward removing the drug from the shortage list two months later and, with it, the legal basis for most compounding.
- Research
SUMMIT topline: tirzepatide cuts heart failure events by 38% in HFpEF
Lilly reported that in adults with heart failure with preserved ejection fraction and obesity, tirzepatide reduced a composite of cardiovascular death and worsening heart failure by 38% over a median of two years. HFpEF had no good drug options, and the result opened a new indication path.
- Compounding
Novo Nordisk files 11 more compounding lawsuits across seven states
Novo Nordisk filed 11 new lawsuits against medical spas, weight-loss clinics and telehealth companies advertising compounded semaglutide, bringing its total to 34 legal actions with six permanent injunctions. Eli Lilly told investors that samples it obtained from compounders often were not tirzepatide at all.
- Research
STEP 10 reverses prediabetes in 81% of participants
After 52 weeks, 81% of adults with obesity and prediabetes returned to normal blood sugar versus 14% on placebo, with 13.9% weight loss.
- FDA & regulation
FDA alerts patients and prescribers to overdoses from compounded semaglutide unit-conversion errors
FDA reported adverse events, some requiring hospitalization, from overdoses of compounded semaglutide dispensed in multiple-dose vials. Most reports involved patients drawing up 5 to 20 times the prescribed dose. FDA named the cause directly: unfamiliarity with withdrawing medicine from a vial and confusion between milliliters, milligrams and 'units.' Documented examples included patients told to draw 5 units who drew 50, a prescriber who wrote 25 units instead of 0.25 mg, and a prescriber who wrote 20 units instead of 2. Reported harms included acute pancreatitis, gallstones, fainting and dehydration.
- Culture
Lilly builds a Mounjaro television campaign around Simone Biles
The gymnast fronted a diabetes awareness campaign in an Olympic year, part of a marketing push that made Lilly one of the biggest direct-to-consumer advertisers in the country.
- Science
A JAMA Internal Medicine study finds more weight loss on tirzepatide in routine care
Researchers using Truveta records for more than 18,000 matched adults reported that people on tirzepatide were significantly more likely to reach 5%, 10% and 15% weight loss than people on semaglutide. It was the strongest observational comparison before the randomized head-to-head arrived.
- Safety
Harvard eye researchers report a NAION signal with semaglutide
A matched cohort study from Massachusetts Eye and Ear published in JAMA Ophthalmology reported hazard ratios of 4.28 for non-arteritic anterior ischemic optic neuropathy in people with type 2 diabetes prescribed semaglutide and 7.64 in people with overweight or obesity. The referral-center design drew immediate criticism, but the signal set off worldwide regulatory review.
- Business
President Biden and Senator Sanders publish a joint op-ed naming Lilly and Novo Nordisk over GLP-1 prices
The op-ed said Lilly was charging "unconscionably high prices" for Mounjaro at roughly $1,100 a month and warned that if the companies did not cut prices, "we will do everything within our power to end it for them."
- FDA & regulation
China approves Wegovy for long-term weight management
The NMPA cleared semaglutide 2.4 mg for adults with a BMI of 30 or above, or 27 to 30 with a weight-related risk factor.
- Business
Teva launches the first generic GLP-1 in the US, an authorized generic of Victoza
Teva announces the US launch of an authorized generic of Victoza (liraglutide injection 1.8 mg) under Novo Nordisk's own application, the first generic GLP-1 product in the US market. Teva cites Victoza annual sales of $1.656 billion as of April 2024. Reported launch list pricing was $469.60 for a two-pack and $704.40 for a three-pack.
- Business
Novo Nordisk announces a $4.1 billion plant in Clayton, North Carolina
The second fill-and-finish facility in Johnston County adds 1.4 million square feet and about 1,000 jobs to a 2,500-person workforce, with completion between 2027 and 2029. It was called the largest life-sciences capital investment in North Carolina history.
- Research
SURMOUNT-OSA gives tirzepatide a sleep apnea result semaglutide does not have
The two sleep apnea trials in 469 adults were published in the New England Journal of Medicine. Gastrointestinal events dominated, as in the weight trials. Serious adverse events occurred in 7.5% overall and were similar between arms. There were two adjudicated acute pancreatitis cases, both on tirzepatide in the PAP-therapy trial, no medullary thyroid cancer, and no deaths. Five severe or serious depressive or suicidal events split two on tirzepatide to three on placebo.
- Business
An FDA listing anomaly: a Hybio liraglutide pen is recorded as marketed six months before its application was approved
Hybio Pharmaceutical's single-pen liraglutide 18 mg/3 mL presentation under ANDA215503 records a marketing start date of 2024-06-21 in the FDA drug code directory. Drugs@FDA records ANDA215503 (applicant: Hikma) as approved on 2024-12-23, and Hybio's two- and three-pen cartons start on 2024-12-24. The June date is therefore a listing-record anomaly, not evidence that a true ANDA generic was sold before approval. The first generic liraglutide a US patient could buy was Teva's authorized generic on 2024-06-24.
- Compounding
Lilly publishes its open letter on counterfeit and compounded tirzepatide
The letter states that Lilly never sells Mounjaro or Zepbound on social media, that Lilly does not supply tirzepatide to compounders or med-spas, and that testing of products advertised as tirzepatide has found bacteria, high impurity levels, a pink rather than colorless solution, a completely different chemical structure, and in one case only sugar alcohol. It also publishes the authentic-pen identifiers: purple injection button, tri-lobular gray base cap, and the script Lilly logo in black ink on Mounjaro and red ink on Zepbound.
- Compounding
Lilly files further legal actions against med-spas and wellness centers
Filed alongside the open letter, the suits allege that defendants misleadingly called their compounded products Mounjaro or Zepbound, borrowed Lilly's clinical trial results in advertising, and implied FDA approval. Lilly also discloses a May 2024 settlement with Totality Medispa.
- Science
Cell Metabolism paper maps tirzepatide's effects on fat cells
Regmi et al. show GIP receptor activation in human adipocytes enhances glucose and lipid uptake when insulin is present but increases lipolysis when insulin is absent - a nutrient-partitioning model for the receptor that GLP-1 drugs cannot reach.
- Research
SYNERGY-NASH shows tirzepatide resolves fatty liver disease in a phase 2 trial
In 190 adults with biopsy-confirmed MASH and stage F2 or F3 fibrosis, 44 to 62 percent of those on tirzepatide had MASH resolution without worsening fibrosis at 52 weeks versus 10 percent on placebo. About half improved fibrosis by at least one stage. Presented at EASL 2024 and published simultaneously in NEJM.
- Research
SURMOUNT-ADOLESCENTS-2 begins with a comorbidity-resolution endpoint
Lilly started a second phase 3 adolescent obesity trial, this one enrolling 300 participants aged 12 to 17 with obesity and multiple weight-related conditions. Alongside BMI percent change at week 72, it carries a co-primary composite endpoint requiring normalization or clinically meaningful improvement in at least two predefined comorbidities without developing new ones. Primary completion is listed as October 2027.
- Safety
Counterfeit semaglutide spreads through illegal online sales
Novo Nordisk warned of a significant increase in illegal online sales of products claiming to contain semaglutide, after fake Ozempic pens surfaced in both US and European supply chains. Regulators in several countries issued parallel alerts.
- Culture
Lilly files six more lawsuits against med spas selling compounded tirzepatide
Lilly expanded its legal campaign against medical spas and wellness centers in Ohio, Texas, Hawaii and Washington, DC. Over time the company sued more than two dozen sellers.
- Safety
MDL 3094 reassigned to Judge Karen S. Marston
Judge Marston took over the GLP-1 products liability MDL in the Eastern District of Pennsylvania and would go on to handle both the gastrointestinal and the later NAION dockets.
- Compounding
Novo Nordisk files nine more lawsuits over compounded semaglutide
Novo Nordisk announced nine new lawsuits against med spas, weight-loss clinics and pharmacies in six states, on top of 12 earlier cases. The company said testing of some compounded products found no semaglutide at all and impurities as high as 24%.
- Research
SURMOUNT-CN reports China obesity trial results in JAMA
In 210 Chinese adults with obesity or overweight and a weight-related condition, tirzepatide 10 mg and 15 mg produced 13.6% and 17.5% weight loss at week 52 versus 2.3% on placebo.
- Research
FLOW published: semaglutide cuts kidney disease progression by 24 percent
The New England Journal of Medicine published FLOW, in which 3,533 adults with type 2 diabetes and chronic kidney disease saw a 24 percent reduction in the composite of kidney failure, sustained eGFR decline and cardiovascular death. The trial was stopped early for efficacy.
- Business
Lilly adds $5.3 billion in Lebanon, Indiana, taking the site to $9 billion
Ricks called it the largest manufacturing investment in the company's history and, he believed, the single largest investment in synthetic medicine active ingredient manufacturing in US history. Lilly had by then committed more than $18 billion to new sites since 2020.
- Compounding
Australia bans compounded tirzepatide and other compounded incretins
Australia's government announces a complete ban on compounded GLP-1 and GIP weight-loss medicines, citing increasing reports of patient harm. Lilly cites the ban in its own counterfeit and compounding warnings to U.S. patients.
- FDA & regulation
China approves tirzepatide for type 2 diabetes
China's regulator approved tirzepatide for type 2 diabetes, opening the second-largest pharmaceutical market. An obesity approval followed two months later.
- FDA & regulation
FDA warns that compounded-label strength expression can cause 5x to 50x dosing errors
FDA issued a compounding risk alert about differences in how compounders and conventional manufacturers display strength on small-volume injectable labels. Compounders often lead with strength per mL while conventional manufacturers lead with strength per total volume, and clinicians reading the wrong number have given 5 to 50 times the intended dose of drugs including fentanyl and ketamine. FDA recommended strength per total volume as the primary, prominent expression with strength per mL in parentheses. The alert is the regulatory origin of the advice that a compounded GLP-1 vial reading only '10 mg' cannot be dosed from safely.
- Research
Novo Nordisk starts a trial touching alcohol use, framed around liver disease
Novo Nordisk began a phase 2 trial of semaglutide, cagrilintide and an experimental agent in alcohol-related liver disease, with change in alcohol consumption as a secondary endpoint. The company said its focus was liver disease, not addiction.
- Compounding
Lilly settles with a med spa selling knockoff tirzepatide
Lilly entered a settlement with Totality Medispa requiring a monetary payment and prohibiting conduct that misled consumers into believing it sold Lilly's Mounjaro or Zepbound, or an FDA-approved alternative. Similar settlements followed with other med spas and wellness centers.
- Search trends
Google begins enforcing its site reputation abuse policy, reshaping commercial health SERPs
Google started issuing manual actions against third-party affiliate and coupon content published on large host domains. The enforcement removed many big-publisher affiliate pages from commercial queries, including health and drug-pricing terms, and opened room for specialist sites.
- Compounding
Hims & Hers launches compounded semaglutide injections
Hims & Hers added compounded GLP-1 injections to its platform at prices well under $200 a month, sending its stock sharply higher and making it the most visible consumer face of the compounded GLP-1 market.
- Culture
Nestlé launches Vital Pursuit for GLP-1 users
Nestlé introduced its first major new US brand in nearly three decades: portion-controlled, protein- and fiber-rich frozen meals built for people taking GLP-1 medications. It was the first time a global food company built a brand around a drug class.
- Research
Real-world study links semaglutide to about half the rate of alcohol use disorder
A retrospective cohort of 83,825 patients with obesity found semaglutide was associated with a 50 to 56 percent lower risk of new and recurrent alcohol use disorder compared with other anti-obesity medications, helping motivate randomized trials.
- Culture
Billie Jean King ties her GLP-1 use to binge eating disorder
On the Wiser Than Me podcast, King said she is a binge eater who has taken "a few injections" at her doctor's recommendation, hoping the drug would quiet food preoccupation. Hers was a rare disclosure framed around disordered eating.
- Business
Lilly buys a Wisconsin injectables plant to add fill-finish capacity
Lilly agreed to acquire a Nexus Pharmaceuticals facility in Pleasant Prairie, Wisconsin. Filling and finishing injector pens, not making the drug substance, had become the binding constraint on tirzepatide supply.
- FDA & regulation
EU approves six additional Mounjaro strengths for the multi-dose pen
Line extension X/0015 brought the KwikPen presentation to Europe almost two years before the US version.
- Research
STEP-HFpEF DM extends heart failure benefit to people with type 2 diabetes
A companion trial in 616 adults with obesity-related HFpEF and type 2 diabetes reported the same pattern of symptom and physical-function improvement plus greater weight loss at one year.
- Research
SURMOUNT-OSA topline: tirzepatide cuts sleep apnea events by up to two thirds
Lilly reported that in two trials of adults with moderate to severe obstructive sleep apnea and obesity, tirzepatide reduced the apnea-hypopnea index by up to about 63%, and said it would file for a new indication. It was the first strong evidence that an obesity drug could treat a downstream condition directly.
- FDA & regulation
FDA says most Zepbound and Mounjaro doses will stay tight through June
The FDA's shortage database showed limited availability for most strengths of both brands, and Lilly said there was no immediate end in sight. The stretch of 2024 shortage was the legal basis for mass compounding of tirzepatide.
- Safety
EMA finds no causal link between GLP-1s and suicidal thoughts
The European Medicines Agency's safety committee concluded that available evidence did not support a causal association between GLP-1 receptor agonists, including semaglutide, and suicidal or self-harming thoughts and actions. The committee said no product information update was warranted.
- Compounding
A court hands Lilly an early loss against a compounding pharmacy
A judge declined to give Lilly the relief it sought against a compounder selling tirzepatide, an early sign that the company's suits would turn on advertising and safety claims more than on the compounding itself.
- Science
STEP-HFpEF DM extends the heart failure finding to type 2 diabetes
Results presented at the American College of Cardiology's 2024 meeting showed semaglutide produced greater reductions in heart failure symptoms, physical limitations and body weight than placebo in people with obesity-related HFpEF and type 2 diabetes. Wegovy is not approved for heart failure.
- Culture
Costco adds a members' weight-loss program including GLP-1 access
Costco expanded its partnership with telehealth provider Sesame to offer members a weight-loss program including prescriptions for Ozempic and Wegovy at $179 for three months, moving GLP-1 access into warehouse-club retail.
- FDA & regulation
FDA approves Zepbound single-dose vials
FDA approved single-dose vials of Zepbound. The vial introduced a second presentation with different handling, different pricing and a syringe the patient draws up themselves, and generated a durable query family around 'zepbound vial vs pen' that most brand and drug-database pages still cover incompletely.
- Business
Zepbound carton, Medication Guide and insert revisions approved
NDA 217806 supplement S-003, the first labeling change after launch.
- Culture
Whoopi Goldberg and Sunny Hostin disclose Mounjaro use on "The View"
A day after Oprah Winfrey's ABC special, two co-hosts of a daytime network show said on air that they had used Mounjaro. Hostin said she gained about 40 pounds during the pandemic and called the medicines life-saving.
- Culture
Oprah Winfrey's prime-time GLP-1 special airs on ABC
"An Oprah Special: Shame, Blame, and the Weight Loss Revolution" aired on ABC and later streamed on Hulu. The 42-minute program featured paid consultants for Novo Nordisk and Eli Lilly, and the FDA would cite it in warning letters 18 months later.
- Competition
New Zepbound prescriptions pass Wegovy for the first time
Weekly prescription data showed new US starts for Zepbound overtaking Wegovy about four months after launch, helped by Wegovy's own supply limits. Total prescriptions still favored Wegovy, and would for more than a year.
- Culture
Lilly runs "Big Night" and "Shame" on Oscar night
Eli Lilly bought Oscar-night airtime to tell viewers its medicines are not for fitting into a smaller dress or tux, and to argue that obesity is a health condition. A drugmaker publicly rebuking its most fashionable customers was new.
- FDA & regulation
FDA approves Wegovy to cut heart attack and stroke risk
The FDA approved Wegovy to reduce the risk of cardiovascular death, heart attack and stroke in adults with established cardiovascular disease and either obesity or overweight. It was the first obesity medicine cleared to prevent heart events, which opened a path to Medicare Part D coverage for that use.
- Culture
Zepbound passes Wegovy in weekly new US prescriptions for the first time
IQVIA data reported by Reuters showed 77,590 new Zepbound prescriptions in the week ending March 8, 2024, ahead of Wegovy. Four months after launch, the challenger had taken the lead among new patients.
- Business
Market capitalization passes $600 billion on amycretin data
Novo Nordisk's valuation reached about $604 billion, making it the twelfth most valuable company in the world, after early trial data for the experimental obesity drug amycretin.
- Prices
Evernorth launches the first PBM financial guarantee for GLP-1 spend
Evernorth, part of The Cigna Group, expanded its EncircleRx program to offer employers and health plans either a 15 percent annual cap on GLP-1 cost increases or a 3-to-1 savings guarantee, with qualifying patients enrolled in an Omada Health lifestyle-modification program. The cost cap applies only to existing Express Scripts clients with prior GLP-1 coverage and more than 1,000 lives, in year one.
- Compounding
Lilly says lab tests found bacteria and impurities in knockoff tirzepatide
Lilly said testing of products sold as tirzepatide found bacteria, high impurity levels and in some cases different molecules entirely. The company used the findings to press regulators and state boards to act against compounders and gray-market sellers.
- Research
FLOW trial: semaglutide slows kidney disease progression
Novo Nordisk announced headline results from FLOW, showing injectable semaglutide 1.0 mg reduced the risk of kidney disease progression and kidney or cardiovascular death in people with type 2 diabetes and chronic kidney disease. The trial was stopped early for efficacy.
- Science
Semaglutide shown to reduce liver disease severity in people with HIV
Researchers reported that semaglutide reduced the severity of metabolic dysfunction-associated liver disease in people living with HIV. The finding added to evidence that semaglutide affects the liver beyond weight loss alone.
- Research
S-LiTE reports the only controlled test of exercise around GLP-1 cessation
eClinicalMedicine published the one-year post-treatment follow-up of S-LiTE, which had randomized participants to exercise, liraglutide, both, or placebo. A year after treatment stopped, the combination group retained more of their weight loss than either single intervention. It remains the closest thing to controlled evidence that building an exercise habit during treatment changes what happens after it ends, and its supervised program is not something most people can replicate.
- Research
BMJ journal publishes the apple cider vinegar weight-loss trial that goes global
BMJ Nutrition, Prevention and Health publishes a randomized, double-blind, placebo-controlled trial reporting roughly 9% weight loss over 12 weeks in 120 overweight Lebanese adolescents and young adults. The press release generates enormous international coverage and drives a wave of ACV product marketing.
- Culture
Oprah Winfrey leaves the WeightWatchers board
Winfrey announced her departure from the WW International board and donated her shares to the National Museum of African American History and Culture, saying she did not want the appearance of a conflict of interest before her ABC special. WW stock fell.
- Research
Guideline evidence review finds almost no data on weight drugs in PCOS
The systematic review commissioned to inform the anti-obesity medication section of the 2023 International Evidence-based PCOS Guideline was published in Obesity Reviews. Its search, which closed in July 2022, found only eleven trials with 545 participants in intervention arms. Meta-analysis was possible for just two comparisons, neither of which showed benefit on androgen or metabolic outcomes. The authors called published data on anti-obesity agents in PCOS 'very limited' and a high research priority. No tirzepatide data existed at the time of the search, which is why no PCOS guideline mentions the drug.
- Science
Population pharmacokinetic model pins tirzepatide's half-life at 5.4 days
Schneck and Urva publish a two-compartment model built from 19 pooled studies, reporting a mean half-life of 5.4 days, apparent clearance of 0.061 L/h and 1.7-fold accumulation. The same paper provides the simulation behind the label's 4-day missed-dose window.
- Policy
CMS finalizes prior authorization timelines that exclude drugs
The CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) was published, requiring affected Medicare Advantage, Medicaid, CHIP and Exchange plans to decide standard prior authorization requests within 7 calendar days and expedited requests within 72 hours, with specific denial reasons, beginning January 1, 2026. The rule applies to items and services excluding drugs, so the faster clock does not cover a GLP-1 prior authorization.
- Business
Zepbound books $175.8 million in its first partial quarter
Lilly's fourth-quarter 2023 results included Zepbound's first reported sales after about seven weeks on the market, alongside $2.2 billion of Mounjaro revenue for the quarter. The company also reported positive mid-stage results for tirzepatide in MASH.
- Business
Novo Holdings agrees to buy Catalent for $16.5 billion
Novo Holdings, the investment arm of the Novo Nordisk Foundation, agreed to acquire contract manufacturer Catalent for $16.5 billion and to sell three fill-finish sites to Novo Nordisk. The deal was aimed squarely at the Wegovy supply bottleneck.
- Research
STEP 7 reports 12.1% weight loss in a predominantly East Asian population
A 44-week trial in China, Hong Kong, Brazil and South Korea supported approval in Asian markets.
- Safety
Federal court consolidates GLP-1 stomach injury lawsuits into MDL 3094
The Judicial Panel on Multidistrict Litigation consolidated lawsuits alleging that GLP-1 medicines caused gastroparesis, intestinal obstruction and ileus into MDL 3094 in the Eastern District of Pennsylvania. Judge Karen S. Marston was assigned to oversee it.
- Safety
JPML creates MDL 3094 with Eli Lilly as a named defendant
The Judicial Panel on Multidistrict Litigation centralized 37 gastrointestinal injury actions in the Eastern District of Pennsylvania. The class of medications covered includes Trulicity and Mounjaro from Eli Lilly alongside the Novo Nordisk semaglutide products. The court-approved short-form complaint names Eli Lilly and Company and Lilly USA, LLC as default defendants. Both manufacturers deny the allegations.
- Business
Full-year 2023 results: sales up 31% to DKK 232.3 billion
Operating profit rose 37% to DKK 102.6 billion and net profit jumped 51% to DKK 83.7 billion. North America Operations grew 50% in Danish kroner.
- FDA & regulation
FDA finds no evidence GLP-1 drugs cause suicidal thoughts
A Drug Safety Communication reported that FDA's preliminary review of trial and postmarketing data did not show a causal link, while noting remaining uncertainty.
- FDA & regulation
Some Mounjaro doses go to limited availability again
Lilly told the FDA that certain Mounjaro doses would be in limited supply, a pattern that repeated through the first half of 2024 as demand outran fill-finish capacity.
- Prices
North Carolina State Health Plan votes to drop GLP-1 weight-loss coverage
The board of a plan covering more than 750,000 teachers, state employees and retirees voted to end coverage of GLP-1s including Zepbound for weight loss, effective April 2024. About 23,000 members were using them at a net cost above $800 per member per month after rebates. Diabetes coverage, including Mounjaro, continued.
- Safety
FDA finds no evidence GLP-1s cause suicidal thoughts
The FDA issued a drug safety communication saying its preliminary evaluation of reports of suicidal thoughts or actions in GLP-1 users had not found evidence that the medicines cause them. The agency said it would continue monitoring.
- Business
Lilly launches LillyDirect, the first direct-to-patient platform from a major drugmaker
LillyDirect combined a self-pay pharmacy, a list of independent telehealth providers and an in-person care search tool for obesity, diabetes and migraine. The American College of Physicians and several academic ethicists objected that a manufacturer routing patients to prescribers created at least the appearance of conflict.
- Business
LillyDirect opens, and doctors push back on a drugmaker selling to patients
Lilly launched LillyDirect, a website connecting patients to independent telehealth prescribers and home delivery for Zepbound, insulin and migraine drugs. Physician groups objected that a manufacturer steering patients toward its own products blurs a line, and the debate over pharma-owned telehealth started here.
- Culture
Lilly publishes an open letter telling people not to use its drugs for cosmetic weight loss
On the same day it launched LillyDirect, Lilly published a letter saying Mounjaro and Zepbound are not for cosmetic weight loss and should not be used by people who are not eligible under the label. The company repeated the message in a March 2024 Oscars-week campaign.
- Business
Eli Lilly launches LillyDirect, opening the direct-to-consumer era
Eli Lilly began selling its obesity medicines directly to cash-paying patients through LillyDirect, later adding discounted single-dose Zepbound vials. Novo Nordisk followed with its own direct channel a year later.
- Science
Large records study finds lower suicidal ideation among semaglutide users
A Nature Medicine analysis of electronic health records from more than 240,000 people with overweight or obesity found semaglutide was associated with a lower risk of first-time and recurrent suicidal ideation than other anti-obesity or anti-diabetes medicines. The authors said the findings do not support concerns of increased suicidality.