GLP‑1 news from 2024
180 dated, sourced GLP-1 developments from 2024: approvals, trial results, prices, lawsuits, compounding and culture.
- Safety
FDA flags rare eye condition as possible signal for GLP-1 drugs including Mounjaro and Zepbound
In its quarterly review of side effect reports for October through December 2024, the FDA listed non-arteritic anterior ischemic optic neuropathy (NAION) as a potential signal of a serious risk for the whole GLP-1 receptor agonist class, naming 14 products including Mounjaro and Zepbound. The agency's note, dated as of March 6, 2025, said only that it is evaluating the need for regulatory action. No NAION warning has been added to any US label for these medicines.
- Regulation
Japan approves Zepbound for obesity disease with narrower eligibility than the US
Japan's Ministry of Health, Labour and Welfare approved Zepbound (tirzepatide) on December 27, 2024, for adults with "obesity disease" who also have hypertension, dyslipidemia or type 2 diabetes and do not respond adequately to diet or exercise. Use is limited to a BMI of at least 27 with two obesity-related conditions, or a BMI of at least 35. In the Japanese trial behind the approval, participants on 15 mg lost an average 22.7 percent of body weight at week 72 versus 1.7 percent on placebo.
- Business
Hikma launches first FDA-approved generic of Victoza in the US
Hikma Pharmaceuticals received FDA approval for and launched a generic version of Victoza (liraglutide injection, 6 mg/mL) in the U.S., the company said Dec. 26, 2024. The FDA approved the first generic referencing Victoza on Dec. 23, 2024. U.S. sales of liraglutide injection 6 mg/mL were about $1.3 billion in the 12 months ending October 2024, according to IQVIA.
- Culture
Elon Musk calls himself "Ozempic Santa" and says he takes Mounjaro
Elon Musk posted a Christmas Day photo of himself in a Santa costume captioned "Ozempic Santa," then clarified that the drug he actually takes is Mounjaro. Axios reported the Dec. 25 post on Dec. 26 and described it as a marker of how mainstream weight-loss drugs have become. Musk did not disclose how long he has been taking the drug or at what dose.
- Policy
Britain's NHS will cover Mounjaro for weight management starting in March
Britain's cost-effectiveness watchdog NICE gave final approval on Dec. 23 for Mounjaro (tirzepatide) to be offered through the National Health Service for weight management. About 3.4 million people in England meet the eligibility rules — a BMI above 35 plus at least one weight-related condition — but only around 220,000 are expected to be treated in the first three years under a phased rollout. The NHS will pay 122 pounds ($153) per patient per month for the highest dose.
- Regulation
FDA approves first generic of Victoza, a daily GLP-1 shot for type 2 diabetes
On December 23, 2024, the FDA approved Hikma Pharmaceuticals USA's liraglutide injection 18 mg/3 mL, the first generic referencing Victoza, for blood sugar control in type 2 diabetes. The agency said liraglutide has been in shortage and that it gives priority to generic applications for shortage drugs. Hikma said it launched the product right after approval and pointed to about $1.3 billion in US liraglutide injection sales in the 12 months through October 2024.
- Compounding
Lilly says trade judge ruled Customs should block imported knockoff tirzepatide
A U.S. International Trade Commission judge has ruled that Customs and Border Protection should stop the unlawful import of knockoff tirzepatide, Eli Lilly said on December 23, 2024. The judge found seven entities based in China, Spain, Texas, Florida and Iowa violated federal law by misleading buyers about whether their imported products were genuine Lilly medicine. Lilly said the order covers anyone importing such products.
- Research and trials
CagriSema phase 3 trial shows 22.7% weight loss, below Novo Nordisk's 25% target
Novo Nordisk's CagriSema produced 20.4% average weight loss at 68 weeks in the REDEFINE 1 phase 3 trial, or 22.7% when all participants were counted as staying on treatment. That fell short of the 25% goal Novo Nordisk had set internally for the trial. The company has since submitted a New Drug Application for the drug to the FDA.
- Culture
FDA approves Zepbound for sleep apnea, the first drug cleared for the condition
The FDA approved Zepbound (tirzepatide) on December 20, 2024, to treat moderate-to-severe obstructive sleep apnea in adults with obesity, the first medication approved for the condition. In two 52-week trials of 469 adults, people taking Zepbound had 25 to 29 fewer breathing interruptions per hour than those on placebo and lost 18% to 20% of body weight. The label lists 10 mg or 15 mg once weekly as the maintenance dose for sleep apnea.
- Business
FDA reaffirms tirzepatide shortage is over and sets deadlines for compounded copies
On Dec. 19, 2024, the FDA again determined that the tirzepatide shortage is resolved, replacing the Oct. 2, 2024, decision it had pulled back for review after a lawsuit. State-licensed pharmacies and physicians have until Feb. 18, 2025, and outsourcing facilities until March 19, 2025, before the enforcement discretion tied to the shortage ends.
- Regulation
FDA ends tirzepatide shortage and sets 2025 deadlines for compounders
The FDA issued a declaratory order on December 19, 2024 finding the tirzepatide injection shortage resolved, revoking and replacing its October 2, 2024 decision. The order gives state-licensed pharmacies and physicians until February 18, 2025 and outsourcing facilities until March 19, 2025 before the agency intends to act on violations that depend on the drug's place on the shortage list.
- Compounding
FDA again says tirzepatide shortage is resolved and sets compounding deadlines
On December 19, 2024, the FDA determined again that the tirzepatide injection shortage is over, after a court-ordered re-evaluation of its October 2 decision. State-licensed 503A pharmacies have 60 days, until February 18, 2025, to stop making copies of Mounjaro and Zepbound, and 503B outsourcing facilities have 90 days, until March 19, 2025.
- Business
Novo Nordisk takes over three Catalent plants as $16.5 billion deal closes
Novo Holdings completed its $16.5 billion acquisition of Catalent on Dec. 18, 2024, and transferred three fill-finish plants to Novo Nordisk in Italy, Indiana and Belgium. Reuters reported the sites will be used to fill Novo Nordisk injection pens as the company works to ease supply limits on its GLP-1 drug Wegovy. Novo Nordisk's 2024 free cash flow was negative DKK 14.7 billion, according to its annual report figures.
- Regulation
Europe's regulator says Mounjaro label can cover sleep apnea without a new approval
The European Medicines Agency said Eli Lilly does not need a separate approval to add a sleep apnea benefit to the label of its obesity drug Mounjaro. Lilly had sought EU approval for moderate to severe obstructive sleep apnea in patients with obesity. In two company-reported trials with 469 participants, the drug cut the frequency of irregular breathing by as much as 63%.
- Safety
European regulators link tirzepatide to dysesthesia and delayed gastric emptying
On December 12, 2024, the European Medicines Agency's CHMP concluded that a causal relationship between tirzepatide and both dysesthesia and delayed gastric emptying is at least a reasonable possibility, based on a safety review covering September 14, 2023 to May 13, 2024. The committee said the drug's benefit-risk balance is unchanged but recommended that EU product information be amended.
- 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.
- Regulation
EU committee backs adding sleep apnea trial data to Mounjaro label
The European Medicines Agency's human medicines committee recommended updating the Mounjaro label with results from two obstructive sleep apnea trials, in an opinion issued Dec. 12, 2024. The filing, variation II/0027, revised sections 4.1, 4.8 and 5.1 of the EU product information plus the package leaflet, and a European Commission decision followed on Feb. 14, 2025. The record does not include the trial results themselves.
- Regulation
EU adds kidney disease reduction to Ozempic label, about six weeks before FDA
European regulators cleared Novo Nordisk to add a reduction in kidney disease to the Ozempic label on December 12, 2024. The US Food and Drug Administration followed on January 28, 2025, approving Ozempic (semaglutide) as the only GLP-1 receptor agonist that reduces the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. The two decisions came about six weeks apart.
- Business
Lilly partners with Ro to sell discounted Zepbound vials through telehealth app
Eli Lilly will sell single-dose vials of Zepbound (tirzepatide) through the telehealth company Ro, the first time the lower-priced vials are offered outside Lilly's own direct-to-consumer site. The 2.5-milligram vials cost $399 per month and the 5-milligram vials cost $549 per month before insurance, compared with about $1,000 per month for the autoinjector pen.
- Competition
Veronvy drew the FDA's lone GLP-1 warning letter aimed at a supplement maker
On Dec. 10, 2024, the FDA told Veronvy that its "Elily Veronvy" and "Elily Veronvy 40+" products were unapproved new drugs under the Federal Food, Drug and Cosmetic Act. Consultants said in May 2025 that the letter was still the only GLP-1-related warning letter the agency had sent to a supplement company, and neither the FDA nor the FTC has explained the limited enforcement.
- Regulation
FDA approves reformulated oral semaglutide tablets in three new strengths
On December 9, 2024, the FDA approved a reformulated version of Rybelsus (semaglutide) tablets, adding 1.5 mg, 4 mg and 9 mg strengths along with instructions for switching between the new tablets and the original 3 mg, 7 mg and 14 mg tablets. The same approval added a Durham, North Carolina manufacturing site, updated the lactation labeling, and added dysesthesia and alopecia to the side effects listed from clinical trials.
- Business
Lilly approves $15 billion share buyback and raises its dividend 15%
Eli Lilly's board approved a new $15 billion share repurchase program on Dec. 9, 2024, after completing a prior $5 billion buyback in the fourth quarter of 2024. The board also raised the quarterly dividend by 15% for the seventh year in a row, to $1.50 per share. Lilly said it expects to run the buyback over the next three years.
- Policy
England plans to limit Mounjaro to about 220,000 NHS patients in first three years
NICE, England's health spending watchdog, recommended tirzepatide (Mounjaro) for people with a BMI above 35 plus at least one weight-related illness, a group estimated at 3.4 million people. Under the phased rollout, about 220,000 people would be treated in the first three years, and NHS England asked for the drug to be spread over 12 years.
- Business
Lilly to spend another $3 billion expanding its Wisconsin injectable-drug plant
Eli Lilly said on Dec. 5, 2024, that it will invest $3 billion to expand the Wisconsin plant it bought from Nexus Pharmaceuticals earlier this year. The company said the acquisition, expansion and land purchases bring its total planned investment in the site to $4 billion and will add 750 jobs to a workforce of more than 100.
- Competition
Zepbound beat Wegovy on average weight loss in first head-to-head trial, Lilly says
Eli Lilly reported on Dec. 4, 2024 that Zepbound (tirzepatide) led to an average 20.2% weight loss over 72 weeks, compared with 13.7% for Wegovy (semaglutide), in the first randomized head-to-head trial of the two obesity drugs. That was a 47% greater relative weight loss. Novo Nordisk said it would wait for the full, peer-reviewed data before commenting; full results were published in May 2025.
- Culture
Conagra adds 'GLP-1 friendly' badge to 26 Healthy Choice frozen meals
Conagra Brands said it will begin printing an "On Track" badge on 26 Healthy Choice frozen meals in January 2025, telling shoppers the items are "GLP-1 friendly." The company set its own criteria — high protein, low calories and a good source of fiber — and said the recipes did not change. Café Steamers and Simply Steamers carry suggested retail prices of $3.49 and $3.99.
- Safety
Meta-analysis links GLP-1 drugs to retained stomach contents before endoscopy
A systematic review and meta-analysis of 23 observational studies covering 262,018 patients found that GLP-1 receptor agonist users had about 4.5 times higher odds of residual stomach contents during an upper endoscopy and the same higher odds of the procedure being stopped early. The analysis found no significant difference in aspiration pneumonia between users and non-users. It was published in the April 2025 issue of Gastrointestinal Endoscopy.
- Compounding
Counterfeit semaglutide and tirzepatide vials seized in West Tennessee raid
Officers in West Tennessee found 300-plus vials of counterfeit semaglutide and tirzepatide while searching a home in Medina, the West Tennessee Drug Task Force said. A 41-year-old local woman faces four felonies and a misdemeanor, including impersonating a licensed professional, and her attorney says she will plead not guilty. Officials said the vials were priced at about $100 to $140, while brand-name semaglutide from Novo Nordisk costs roughly $1,000 a month.
- Business
US GLP-1 prescriptions passed 9 million a month by the end of 2024, IQVIA says
Monthly US prescriptions for GLP-1 drugs passed 9 million by the end of 2024, up from about 2.5 million a month before October 2022, according to IQVIA. The class includes the semaglutide brands Ozempic and Wegovy and the tirzepatide brands Mounjaro and Zepbound. IQVIA also reports that 11 million unique patients were using a GLP-1 across indications as of the second quarter of 2025.
- Regulation
FDA adds 1.7 mg adolescent maintenance dose and severe GI warning to Wegovy label
The FDA approved a label update for Wegovy (semaglutide) injection on November 27, 2024, adding a 1.7 mg weekly maintenance dose for adolescents ages 12 to under 18 with obesity. The same supplement adds a Warnings and Precautions subsection on severe gastrointestinal adverse reactions and fulfills a postmarketing requirement to analyze data supporting the 1.7 mg pediatric dose.
- Science
Amgen reports Phase 2 weight loss results for monthly obesity drug MariTide
Amgen said its experimental obesity drug MariTide produced average weight loss of up to about 20% at 52 weeks in people without type 2 diabetes and up to about 17% in people with type 2 diabetes, with no weight-loss plateau reported at either level. The drug is given once a month or less often in a Phase 2 trial of 592 adults. Amgen also announced a Phase 3 program called MARITIME; MariTide is not approved anywhere.
- Policy
White House proposes Medicare and Medicaid coverage of Wegovy and Zepbound for obesity
On Nov. 26, 2024, the Biden administration proposed reinterpreting a law that bars Medicare from covering weight-loss drugs so that Part D could pay for Wegovy and Zepbound in people with obesity, and Medicaid could follow. Medicare already covers the drugs for diabetes and heart disease. The proposal was never finalized, and the incoming Trump administration would have had to complete the rule for it to take effect.
- Business
Generic exenatide from Amneal is listed for US marketing
An FDA drug listing shows Amneal Pharmaceuticals LLC marketing a generic exenatide injection under ANDA 206697, with a marketing start date of Nov. 22, 2024, at a strength of 250 micrograms per milliliter in a 1.2 milliliter cartridge. The FDA said in a Dec. 23, 2024 release that it approved the first generic referencing Byetta (exenatide) the previous month. Pricing, insurance coverage and pharmacy availability have not been disclosed.
- Business
Lilly and Laekna to develop muscle-preserving obesity drug
Eli Lilly and Hong Kong-listed biotech Laekna said on Nov. 20 they will collaborate on LAE102, an experimental obesity drug intended to help patients lose weight while preserving muscle. Lilly will fund development and share resources and expertise, while Laekna keeps global rights and plans an early-stage trial in China. Financial terms were not disclosed.
- Business
Lilly adds P&G chief Jon Moeller to board as director Karen Walker steps down
Eli Lilly and Company said on Nov. 19, 2024, that Procter & Gamble chairman and CEO Jon Moeller was elected to its board effective Dec. 1, 2024. The same announcement said Karen Walker, a Lilly director since 2018, will resign from the board effective Dec. 31, 2024, and will work with the company in 2025 on certain digital commercial activities.
- Research and trials
Tirzepatide improved symptoms, function and medication burden in HFpEF and obesity analysis
An expanded analysis of the SUMMIT trial in Circulation reports that tirzepatide improved heart failure symptoms and exercise capacity and reduced medication use in patients with heart failure with preserved ejection fraction and obesity. At 52 weeks, the Kansas City Cardiomyopathy Questionnaire score rose 6.9 points and six-minute walk distance rose 18.3 meters versus placebo. The trial's hierarchical composite win ratio was 1.63.
- Research and trials
Tirzepatide cut blood volume, blood pressure and inflammation in SUMMIT heart failure analysis
A secondary analysis of the SUMMIT trial found that tirzepatide reduced estimated blood volume by 0.58 liters, systolic blood pressure by 5 mmHg and C-reactive protein by 37.2% versus placebo at 52 weeks in patients with obesity-related heart failure with preserved ejection fraction. Kidney filtration improved and markers of kidney and heart muscle injury fell. Two other markers, NT-proBNP and the 52-week urine albumin change, did not reach statistical significance.
- Research and trials
Tirzepatide cut heart failure events by 38% in obesity-related HFpEF, SUMMIT trial finds
In the SUMMIT trial, tirzepatide lowered the combined risk of cardiovascular death or a worsening heart failure event by 38 percent compared with placebo in 731 adults who had heart failure with preserved ejection fraction and obesity. The composite occurred in 9.9 percent of the tirzepatide group and 15.3 percent of the placebo group over a median of about two years. Patients on tirzepatide also reported bigger improvements in heart failure symptoms and quality of life, while gastrointestinal side effects led more of them to stop treatment.
- Culture
Tori Spelling says she lost about 40 pounds on Mounjaro after her fifth pregnancy
Tori Spelling said on her podcast that she used Mounjaro, whose active ingredient is tirzepatide, to lose weight after her fifth child and that it took off roughly 40 pounds. She said a doctor prescribed hormone therapy at the same time because she was nearing menopause, and that she stopped the drug after reaching the weight she wanted.
- Culture
Jim Gaffigan says he lost 50 pounds on Mounjaro and wants to cut the stigma
Comedian Jim Gaffigan told People he used Mounjaro after his weight reached 270 pounds and has since lost 50 pounds. He said he is speaking about the drug publicly to reduce the stigma around weight-loss medications.
- Research and trials
Three years of tirzepatide cut progression to type 2 diabetes by 94 percent in SURMOUNT-1
In the SURMOUNT-1 trial, adults with obesity and prediabetes who took weekly tirzepatide for 176 weeks were much less likely to develop type 2 diabetes than those on placebo: 1.3 percent versus 13.3 percent, which Lilly reported as a 94 percent reduction in risk and a number needed to treat of nine. Average weight loss at the 15 mg dose was 19.7 percent in the main analysis and sustained across three years. After 17 weeks off treatment, 2.4 percent of the tirzepatide group and 13.7 percent of the placebo group had type 2 diabetes.
- Research and trials
Tirzepatide kept nearly 99% of prediabetic adults diabetes-free at three years, Lilly says
Eli Lilly reported detailed three-year results from its SURMOUNT-1 trial showing that 1.2% of adults with prediabetes and obesity or overweight who took weekly tirzepatide were diagnosed with type 2 diabetes at 176 weeks, versus 12.6% on placebo, a 94% reduction in risk. Average weight loss reached 22.9% at the 15 mg dose and was sustained over three years. The data were published in the New England Journal of Medicine and presented at ObesityWeek 2024.
- Regulation
FDA adds aspiration warning to GLP-1 labels for semaglutide, tirzepatide and liraglutide
Regulators expanded the prescribing information for semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro, Zepbound) and liraglutide (Saxenda, Victoza) to warn that food or fluid can reach the lungs during general anesthesia or deep sedation. The revised labels direct patients to tell their care team about a planned surgery or procedure. The agency said the evidence is not sufficient to say whether pausing a GLP-1 drug or changing fasting instructions beforehand would reduce the risk.
- Regulation
FDA approves Mounjaro labeling update on aspiration risk and gastrointestinal reactions
The FDA approved three supplemental applications for Mounjaro (tirzepatide) injection effective Nov. 1, 2024. The changes add a serious pulmonary aspiration warning tied to general anesthesia or deep sedation, update information on severe gastrointestinal reactions, and add dysgeusia and dysesthesia to the clinical trials section of the label.
- Business
FDA approves three labeling supplements for Mounjaro
On November 1, 2024, the FDA approved three labeling supplements for Mounjaro, the tirzepatide injection from Eli Lilly, according to the agency's Drugs@FDA record for application NDA 215866. The supplements — S-010, S-015 and S-022 — together revised the package insert and the Medication Guide, and FDA published one combined label and one approval letter for all three. The record does not describe what text changed.
- Regulation
FDA database shows every Ozempic and Wegovy dose available as shortage review continues
The FDA's drug shortage database stopped flagging any dose of Ozempic or Wegovy as in short supply in late October 2024, more than two years after the semaglutide injections were first listed. Both products stayed on the shortage list at that point; the declaratory order formally resolving the shortage is dated February 21, 2025.
- Research and trials
Novo Nordisk's STEP 9 trial finds semaglutide eases knee osteoarthritis pain in adults with obesity
Results published Oct. 30, 2024 in the New England Journal of Medicine show that weekly semaglutide 2.4 mg produced a 13.7% average body weight loss over 68 weeks in adults with obesity and moderate knee osteoarthritis, compared with 3.2% on placebo. Knee pain scores on the WOMAC scale fell 41.7 points with semaglutide versus 27.5 points with placebo. Semaglutide is not approved to treat osteoarthritis.
- Business
Eli Lilly's Zepbound and Mounjaro sales miss estimates as wholesalers draw down inventory
Eli Lilly reported third-quarter sales of $1.26 billion for its weight-loss drug Zepbound and $3.11 billion for its diabetes drug Mounjaro, both below analyst estimates. The company blamed wholesalers using existing inventory instead of ordering more, not weaker patient demand, though one analyst estimated the inventory effect explains only about 20% of the shortfall. Lilly shares fell 8%, wiping out nearly $70 billion in market value.
- Safety
Five medical societies back keeping GLP-1 drugs before elective surgery
Joint guidance released October 29, 2024 by five US medical societies says an automatic pause of GLP-1 medications before elective surgery should be replaced by individual risk assessment, and that most patients can stay on the drug. Those at highest risk for delayed stomach emptying are advised to follow a 24-hour liquid-only diet or take other precautions.
- Business
AstraZeneca discontinues Byetta and Bydureon BCise; UnitedHealthcare lists covered alternatives
AstraZeneca has discontinued the diabetes medicines Byetta and Bydureon BCise, according to a notice UnitedHealthcare sent to providers. Byetta was discontinued on Oct. 25, 2024, and Bydureon BCise on Oct. 28, 2024. UnitedHealthcare published preferred covered GLP-1 alternatives that differ by plan type.
- Research and trials
Semaglutide cut albuminuria 52% in non-diabetic kidney disease trial
A 24-week randomized trial in 101 adults with chronic kidney disease, overweight or obesity and no diabetes found that weekly semaglutide 2.4 mg reduced urine albumin-to-creatinine ratio by a placebo-adjusted 52.1%. Participants on semaglutide also lost about 9.1 kg more weight and had 6.3 mmHg lower systolic blood pressure than those on placebo. Gastrointestinal side effects were more common with semaglutide, and the overall safety profile matched earlier studies in people with overweight or obesity.
- Competition
Eli Lilly to sell weight-loss drug Mounjaro in Novo Nordisk's home market of Denmark
Eli Lilly said it will launch its weight-loss drug Mounjaro in Denmark next week, moving into the home market of rival Novo Nordisk. Mounjaro will cost about 2,200 Danish crowns ($318.50) a month, while Novo's Wegovy ranges from 1,313 to 2,353 crowns. Denmark's public health system does not generally reimburse weight-loss drugs.
- Compounding
FDA pulls back its tirzepatide shortage finding for review after compounders sue
After two compounding groups sued over Mounjaro and Zepbound, the FDA agreed in October 2024 to withdraw and re-evaluate its finding that the tirzepatide shortage was over, and reopened the record for new information. On December 19, 2024, the agency again said supply meets demand and set enforcement grace periods of 60 days for 503A pharmacies and 90 days for 503B outsourcing facilities, ending February 18 and March 19, 2025.
- Compounding
Novo Nordisk asks FDA to block compounded semaglutide copies
Novo Nordisk petitioned the FDA on Oct. 22, 2024, to classify semaglutide as too difficult to compound, which would stop pharmacies from making copies of Ozempic and Wegovy even during shortages. The company cited impurities, wrong dosages and batches containing no semaglutide; the FDA said it was reviewing the request. The petition remains unresolved, and a related FDA rule on difficult-to-compound drugs has not been finalized.
- Research and trials
Novo Nordisk says oral semaglutide cut cardiovascular events by 14% in SOUL trial
Novo Nordisk reported that oral semaglutide, sold as Rybelsus, lowered major adverse cardiovascular events by 14% compared with placebo in the Phase III SOUL trial, which enrolled 9,650 adults with type 2 diabetes and established cardiovascular or kidney disease. The company said it will submit the results to regulators around the end of 2024 to support a label expansion, with detailed data due at a scientific conference in 2025.
- Regulation
FDA approves five Zepbound label updates, adding SURMOUNT-3 and SURMOUNT-4 trial data
On October 18, 2024, the FDA approved five supplemental applications for Zepbound (tirzepatide) injection covering trial data, a retitled gastrointestinal warning, two added side effects in the clinical trials section, removal of the patient selection subsection, and a pulmonary aspiration warning. The updates add data from the phase 3 SURMOUNT-3 and SURMOUNT-4 trials.
- Business
FDA clears five Zepbound labeling supplements on the same day
On October 18, 2024, the FDA actioned five labeling supplements for Zepbound (tirzepatide) under New Drug Application 217806, held by Eli Lilly and Co. One of them, S-006, is classified as an efficacy labeling change with clinical data, and all five link to a single updated label. The record does not say which trial supported the change or what the revised label now states.
- Regulation
FDA tells compounders it will hold off on tirzepatide copy enforcement during review
On October 17, 2024, the FDA's compounding office told the Alliance for Pharmacy Compounding that it does not intend to take action against compounders for violations tied to tirzepatide's place on the national shortage list while the agency re-evaluates that decision. The letter followed an October 7 lawsuit by a compounder and a trade association and an October 11 court order remanding the shortage decision to FDA. The pause lasts through the reevaluation and two weeks after FDA decides, or until a court rules on any preliminary injunction motion.
- Policy
Eli Lilly's £279 million UK deal includes a trial tracking weight-loss drug users' employment
Eli Lilly committed £279 million ($364 million) to the United Kingdom, including a five-year real-world study of tirzepatide, the molecule in Mounjaro and Zepbound. The study, run with Health Innovation Manchester, will examine weight loss, diabetes prevention and obesity-related complications, and also participants' employment status and sick days. Lilly said it anticipates an additional £279 million of UK investment in coming years.
- Regulation
Court remands FDA's tirzepatide shortage decision for reevaluation
A federal court in Texas sent the FDA's October 2, 2024 decision removing tirzepatide injection products from the national drug shortage list back to the agency for a second look on October 11, 2024, on the agency's own unopposed motion. The FDA then issued a December 19, 2024 order revoking and replacing that decision and again finding the shortage resolved. The order sets deadlines of February 18 and March 19, 2025 for compounded copies.
- Compounding
FDA agrees to revisit tirzepatide shortage listing after compounders sue
The FDA told a federal court on Oct. 11 that it will reconsider its Sept. 30 decision to remove tirzepatide, the ingredient in Eli Lilly's Mounjaro and Zepbound, from the national shortage list, and will hold off on enforcement against compounders during the review. The reversal followed an Oct. 7 lawsuit by the Outsourcing Facilities Association, which represents compounding pharmacies. A federal judge in Texas put that case on hold.
- Science
Review finds evidence that GLP-1 stomach-slowing effect fades, but flags limits of the test used to measure it
A review published in the Journal of Clinical Endocrinology & Metabolism examined delayed gastric emptying with GLP-1 receptor agonists and tirzepatide. The authors, Jalleh and colleagues, report evidence of tachyphylaxis — a fading of the effect with continued use of long-acting agents — and caution that the acetaminophen absorption test used in most studies has real limitations.
- Compounding
Compounding group sues FDA over tirzepatide shortage list removal
The Outsourcing Facilities Association, a trade group for 503B compounding facilities, sued the FDA on October 8, 2024, over the agency's removal of tirzepatide from the national drug shortage list. The case was filed in the Northern District of Texas. No hearing date, ruling or public FDA response has been reported.
- Regulation
Compounders sue FDA over tirzepatide shortage list removal
The Outsourcing Facilities Association and North American Custom Laboratories sued the FDA in the Northern District of Texas on October 7, 2024, five days after the agency removed tirzepatide injection products from its national drug shortage list. The case forced the FDA to re-evaluate, and on December 19, 2024 the agency again declared the shortage resolved and set 60-day and 90-day compliance windows for compounders. A federal appeals court upheld the FDA's decision on August 27, 2026.
- Compounding
FDA removes Mounjaro and Zepbound from shortage list, and compounders sue the agency
The FDA removed Eli Lilly's tirzepatide drugs, Mounjaro and Zepbound, from its national shortage list on Oct. 2, 2024, ending the exemption that let compounding pharmacies make copies while supplies were short. The Outsourcing Facilities Association sued over the change, and the FDA put its decision on hold before finalizing the removal. Compounding deadlines of Feb. 18, 2025 for 503A pharmacies and March 19, 2025 for 503B facilities are now on hold until a court rules.
- Compounding
FDA declared the tirzepatide shortage resolved, then reaffirmed it after a court remand
The FDA removed tirzepatide injection products, sold as Mounjaro and Zepbound, from its national drug shortage list on October 2, 2024. The decision was remanded for re-evaluation on October 22, 2024 and reaffirmed on December 19, 2024, with wind-down periods ending February 18, 2025 for state-licensed compounders and March 19, 2025 for outsourcing facilities.
- Business
Lilly to spend $4.5 billion on Indiana center combining drug research and manufacturing
Eli Lilly said on Oct. 2, 2024 that it will invest $4.5 billion in a Lebanon, Indiana, facility called the Lilly Medicine Foundry that develops new manufacturing methods and makes clinical trial supply in one place. The company says the site will add 400 full-time jobs and open in late 2027, and that it brings Lilly's total investment in the Lebanon site to more than $13 billion.
- Culture
Kathy Bates says Ozempic accounted for only part of her 100-pound weight loss
Kathy Bates has pushed back on the idea that Ozempic did all the work in her weight loss, saying she lost about 100 pounds over seven years. She has said roughly 80 pounds came from lifestyle changes and the last 15 to 20 pounds came after she started Ozempic for type 2 diabetes.
- Science
Anesthesiology, GI and obesity groups say most patients can continue GLP-1 drugs before elective surgery
Five medical organizations released joint clinical practice guidance on October 29, 2024, saying most patients should keep taking GLP-1 receptor agonists before elective surgery, while those at highest risk for gastrointestinal side effects should follow a liquid diet for 24 hours before the procedure. About one in eight U.S. adults uses a GLP-1 drug such as Ozempic or Wegovy (semaglutide). The guidance replaces the approach of routinely pausing these drugs, saying the decision belongs with the patient's anesthesia, surgical and prescribing teams.
- Business
Novo Nordisk settles US semaglutide patent disputes with four generic makers
In October 2024, Novo Nordisk settled US patent disputes with Mylan, Dr Reddy's, Apotex and Sun Pharma over a patent covering specific semaglutide doses for type 2 diabetes. The settlements leave the US market closed to those generics for now, while Dr Reddy's plans launches in 87 countries in 2026, starting with Canada, India, Brazil and Turkey. Dr Reddy's CEO Erez Israeli said the US and Europe will open later, with other Western markets open between 2029 and 2033.
- Culture
Sanders questions Novo Nordisk CEO over US prices for Ozempic and Wegovy
Sen. Bernie Sanders pressed Novo Nordisk CEO Lars Fruergaard Jørgensen at a Senate hearing on Sept. 24, 2024, saying Americans pay a $969 list price for Ozempic against $59 in Germany. Sanders said the net price after rebates is still nearly $600, more than nine times Germany's, while Jørgensen said the company pays back about 75% of sales in rebates and that past list-price cuts reduced patient access.
- Business
Novo Nordisk CEO defends Ozempic and Wegovy prices at Senate hearing
Novo Nordisk CEO Lars Fruergaard Jørgensen testified before the Senate HELP Committee on Sept. 24, 2024, where Chairman Bernie Sanders pressed him on U.S. prices for Ozempic and Wegovy. Sanders said Ozempic has a U.S. list price of $969 a month versus $59 in Germany, and Wegovy $1,349 versus $92 in the United Kingdom. Jørgensen did not commit to cutting list prices and said he would work with lawmakers on broader policy changes.
- Compounding
FDA warns companies selling semaglutide and tirzepatide as research chemicals
The FDA has sent warning letters to companies marketing semaglutide and tirzepatide as "research chemicals," saying evidence shows the products are intended for human use. Between August 2021 and mid-July 2024, the agency reviewed 288 reports of bad reactions to compounded semaglutide and 108 for tirzepatide, and some patients were hospitalized. The FDA and the drugmakers say some unapproved versions contained bacteria, high impurity levels or different chemical structures.
- Business
Lilly adds $1.8 billion to Irish plants making tirzepatide and Alzheimer's ingredients
Eli Lilly announced $1.8 billion in Irish manufacturing spending on Sept. 12, 2024: a $1 billion expansion at its Limerick site, which is still under construction, and an $800 million expansion already completed at Kinsale. Limerick will make biologic active ingredients, including for Lilly's Alzheimer's drug, and Kinsale makes the tirzepatide medicines Mounjaro and Zepbound.
- Regulation
Australia registers Mounjaro for chronic weight management
Australia's Therapeutic Goods Administration registered Mounjaro (tirzepatide) for chronic weight management on 10 September 2024. The TGA lists the evaluation as 255 working days, opening on 3 October 2023 and closing with a decision date of 9 September 2024. The registered indication covers adults with a BMI of 30 or higher, or a BMI of 27 to under 30 with at least one weight-related condition.
- Business
Lilly names Lucas Montarce chief financial officer as weight loss drug demand grows
Eli Lilly appointed Lucas Montarce as executive vice president and chief financial officer, effective Sept. 9, 2024, succeeding Anat Ashkenazi, who left to join Google parent Alphabet. Montarce, who joined Lilly in 2001, will receive a $1 million base salary and is eligible for a $1 million annual target bonus. The change comes as Lilly invests billions to expand manufacturing for Mounjaro and Zepbound, which remain on the FDA's shortage list.
- Regulation
FDA orders class-wide GLP-1 anesthesia warning and approves first label change for Ozempic
The FDA notified Novo Nordisk on September 6, 2024, that labels for GLP-1 receptor agonist products must describe the serious risk of pulmonary aspiration during general anesthesia or deep sedation. Novo Nordisk submitted a labeling supplement for Ozempic on October 4, 2024, and the FDA approved it effective November 1, 2024.
- Regulation
FDA orders aspiration warning for GLP-1 labels; Mounjaro update approved Nov. 1
The FDA wrote to Eli Lilly on September 6, 2024, saying that labels for GLP-1 receptor agonist drugs, including Mounjaro, must carry information about the serious risk of pulmonary aspiration during general anesthesia or deep sedation. Lilly's tirzepatide labeling change for that warning was approved November 1, 2024, alongside two other Mounjaro updates covering severe gastrointestinal reactions, dysgeusia and dysesthesia.
- Science
Three GLP-1 scientists, including Novo Nordisk's Lotte Bjerre Knudsen, win 2024 Lasker Award
The 2024 Lasker~DeBakey Clinical Medical Research Award went to Joel Habener, Svetlana Mojsov and Lotte Bjerre Knudsen for discovering and developing GLP-1-based obesity drugs. Habener and Mojsov identified the active form of the hormone GLP-1 in the 1980s; Knudsen's team at Novo Nordisk later engineered versions that last hours instead of minutes, leading to liraglutide and semaglutide.
- Business
Liraglutide lowered BMI in children aged 6 to under 12 in phase 3 trial
In the 82-child SCALE Kids trial, once-daily liraglutide plus lifestyle interventions produced a mean BMI change of −5.8% over 56 weeks, compared with +1.6% for placebo, an estimated difference of 7.4 percentage points. Body weight rose 1.6% with liraglutide versus 10.0% with placebo, and 46% versus 9% of children cut BMI by at least 5%. Gastrointestinal adverse events were reported in 80% of children on liraglutide and 54% on placebo; no medication is approved for obesity in children under 12.
- Research and trials
Pooled analysis links semaglutide to fewer heart failure events in HFpEF
A pooled analysis of four randomized trials found that once-weekly injectable semaglutide reduced the combined risk of cardiovascular death or a worsening heart failure event by 31% among 3,743 participants with heart failure with preserved ejection fraction (HFpEF). Worsening heart failure events alone fell by 41%. The effect on cardiovascular death by itself was not statistically significant.
- Prices
Lilly starts selling $399 Zepbound vials to cash-paying patients
Eli Lilly began selling single-dose vials of Zepbound (tirzepatide) directly to self-paying patients on Aug. 27, 2024, at $399 a month for the 2.5 mg starter dose and $549 for the 5 mg dose. Lilly said the prices are at least 50% below the list price of other GLP-1 obesity medicines, while Reuters reported the starter vial is $250 less than the $650 Lilly charges self-payers for the pen version.
- Business
Sanders calls Lilly's Zepbound vial price cut a 'modest step forward'
Eli Lilly started selling the two lowest doses of Zepbound in single-dose vials for cash-paying patients at $399 and $549 a month. Sen. Bernie Sanders called the move a "modest step forward" but said Lilly raised its savings-card price for pens from $550 to $650 and left Mounjaro's US price at $1,069 a month.
- Science
GIP receptor agonist cut gut side effects of GLP-1 therapy in early Lilly trial
A single dose of LY3537021, an experimental long-acting GIP receptor agonist, reduced gastrointestinal side effects in 32 healthy volunteers who were rapidly escalated onto the GLP-1 drug liraglutide. Total gastrointestinal adverse events fell from 75 with placebo to 41 with LY, and reflux events dropped from 14 to 5. The Phase 1 crossover trial was published August 27, 2024, in Diabetes, Obesity and Metabolism.
- Research and trials
Lilly says tirzepatide cut type 2 diabetes risk by 94% in three-year trial
Eli Lilly reported that adults with prediabetes and obesity or overweight who took tirzepatide for 176 weeks were 94% less likely to progress to type 2 diabetes than those on placebo. Average weight loss reached 22.9% at the 15 mg dose. During a 17-week period after treatment stopped, participants regained weight and the risk reduction fell to 88%.
- Compounding
FTC rule banning fake and undisclosed reviews takes effect, covering GLP-1 marketing content
The Federal Trade Commission finalized 16 CFR Part 465 on August 14, 2024, a rule that bans fake reviews, undisclosed insider reviews, review hijacking and company-run sites that pose as independent. The rule took effect on October 21, 2024, and applies to reviews and testimonials used in advertising, including the kind of content common around weight-loss and GLP-1 products.
- Compounding
Lilly sends cease-and-desist letters to providers selling compounded Zepbound and Mounjaro
Eli Lilly sent cease-and-desist letters to U.S. telehealth companies, wellness centers and medical spas telling them to stop promoting compounded versions of Zepbound and Mounjaro, the company said on August 14, 2024. The drugs were in short supply, which allowed licensed pharmacies to produce compounded copies; the FDA has listed all doses as available but has not removed them from its shortage list. Lilly and Novo Nordisk have previously sued more than three dozen sellers in total.
- Research and trials
Novo Nordisk withdraws Wegovy heart failure application and plans 2025 resubmission
Novo Nordisk pulled its FDA application to approve Wegovy for heart failure on Aug. 7, 2024, after the agency said the company's trials were too small to confirm an effect on heart-related events. Novo said a combined analysis of two trials showed a 69% reduction in cardiovascular death or heart failure hospitalization, but it will resubmit in early 2025 with added data from its FLOW kidney trial.
- Regulation
FDA lists every Mounjaro and Zepbound dose as available, keeping both on shortage list
On Aug. 2, 2024, the FDA's drug shortage database showed all doses of Eli Lilly's Mounjaro and Zepbound as available in the U.S. Mounjaro had been on the list since late 2022 and Zepbound since April 2024, and neither drug has been removed from the list yet.
- Research and trials
Lilly says tirzepatide cut heart failure events by 38% in phase 3 trial
Eli Lilly reported on Aug. 1, 2024 that tirzepatide reduced a composite of heart failure outcomes by 38% compared with placebo in adults with heart failure with preserved ejection fraction (HFpEF) and obesity. The phase 3 SUMMIT trial enrolled 731 patients and followed them a median of 104 weeks, and also showed a 15.7% body weight reduction versus 2.2% for placebo. Tirzepatide is not approved for heart failure, and Lilly said it plans to file with the FDA starting later this year.
- Compounding
Novo Nordisk files 11 more compounded semaglutide lawsuits, bringing total to 34
Novo Nordisk filed 11 new lawsuits in August 2024 against medical spas, weight loss clinics and telehealth companies advertising compounded semaglutide, bringing its total to 34 legal actions, six of which have ended in permanent injunctions. Eli Lilly separately told investors that samples it obtained from compounders often were not tirzepatide at all, and the FDA has reviewed 288 reports of adverse reactions to compounded semaglutide and 108 for compounded tirzepatide between August 2021 and mid-July 2024.
- Research and trials
Semaglutide 2.4 mg returns 81% of adults with obesity and prediabetes to normal blood sugar in STEP 10
In the phase 3 STEP 10 trial, 81% of adults with obesity and prediabetes who took weekly semaglutide 2.4 mg injections for 52 weeks returned to normal blood sugar, compared with 14% of those on placebo. Participants on the drug lost 13.9% of body weight versus 2.7% on placebo. The trial ran at 30 sites in five countries outside the United States and was funded by Novo Nordisk.
- Regulation
FDA warns of overdoses from compounded semaglutide dosing errors
The FDA alerted patients, prescribers and compounders on July 26, 2024, that it has received reports of overdoses tied to dosing errors with compounded injectable semaglutide, some requiring hospitalization. Most reports involved multiple-dose vials, where patients drew up five to 20 times the prescribed dose, and documented cases include a patient told to draw 5 units who drew 50.
- Regulation
China approves tirzepatide for weight management, weeks after semaglutide
China's health regulator approved Eli Lilly's tirzepatide for chronic weight management, the company said in a social media post on July 19, 2024. Novo Nordisk's semaglutide had won a Chinese weight-loss approval in June. In the China trial behind the decision, patients on the 15 mg dose lost an average of 17.5% of their body weight at 52 weeks, versus 2.3% on placebo.
- Culture
Lilly puts Simone Biles and her mother at the center of a Mounjaro TV campaign
Eli Lilly has partnered with seven-time Olympic medalist Simone Biles and her mother Nellie on a television ad for Mounjaro, its type 2 diabetes drug, timed to the Paris Olympics. The gymnast does not have type 2 diabetes and her mother, who does, does not take Mounjaro. Lilly is running the campaign while it still faces supply constraints on the drug.
- Science
Tirzepatide beats semaglutide for weight loss in large real-world study
A study published July 8, 2024 in JAMA Internal Medicine found that adults prescribed tirzepatide lost more weight on average than adults prescribed semaglutide during routine care. At 12 months, tirzepatide patients had lost 15.3% of body weight compared with 8.3% for semaglutide, and they were significantly more likely to reach 5%, 10% and 15% weight-loss thresholds. The analysis covered 18,386 matched patients drawn from U.S. health system records.
- Business
Lilly completes $3.2 billion acquisition of Morphic to add oral IBD drug candidate
Eli Lilly agreed on July 8, 2024 to buy Morphic Holding for $57 a share in cash, about $3.2 billion, adding oral integrin therapies for inflammatory bowel disease to its pipeline. The tender offer drew about 92.8% of Morphic's shares and the acquisition closed on Aug. 16, 2024.
- Safety
Harvard study links semaglutide to rare optic nerve condition, prompting reviews
A matched cohort study from Massachusetts Eye and Ear, published in JAMA Ophthalmology in July 2024, found higher rates of non-arteritic anterior ischemic optic neuropathy (NAION) in patients prescribed semaglutide than in patients taking other medications. The reported hazard ratios were 4.28 for people with type 2 diabetes and 7.64 for people with overweight or obesity, though the referral-center design drew criticism and later studies reported mixed results.
- Business
Biden and Sanders op-ed names Lilly and Novo Nordisk over GLP-1 prices
President Joe Biden and Sen. Bernie Sanders published a joint op-ed on July 2, 2024, calling out Eli Lilly and Novo Nordisk over the prices of their GLP-1 drugs. The piece said Mounjaro costs roughly $1,100 a month and that Ozempic and Wegovy can cost several times more in the U.S. than in other countries, and warned the companies to cut prices or face action. It announces no specific penalty and no price cut.
- Regulation
China approves Novo Nordisk's Wegovy for long-term weight management
China's National Medical Products Administration approved Novo Nordisk's Wegovy (semaglutide) on June 25, 2024, for long-term weight management in adults with a body mass index of at least 30, or between 27 and 30 with one weight-related risk factor. In China the drug will be sold as NovoCare, the same compound used in Ozempic. Novo's semaglutide patent there is set to expire in about two years, and at least 15 GLP-1 biosimilar candidates are in development in China.
- Regulation
First generic Qsymia reaches US pharmacies after June 2024 FDA approval
The FDA approved the first generic version of the weight-loss pill Qsymia (phentermine and topiramate extended-release) on June 25, 2024, but the product did not launch in the U.S. until May 7, 2025. GoodRx lists the generic at a cash price as low as $59.05 at certain pharmacies, compared with $149.10 for a 30-day supply of brand-name Qsymia at its exclusive cash price.
- Business
Teva launches authorized generic of Victoza, the first generic GLP-1 sold in the U.S.
Teva Pharmaceuticals began selling an authorized generic of Victoza (liraglutide injection 1.8 mg) in the United States on June 24, 2024, and described it as the first generic GLP-1 product on the U.S. market. Victoza recorded $1.656 billion in annual sales as of April 2024, according to IQVIA data cited by Teva, and reported launch list prices were $469.60 for a two-pack and $704.40 for a three-pack. The medicine is approved for type 2 diabetes and for lowering cardiovascular risk in adults with type 2 diabetes and established heart disease, not for weight loss.
- Business
Novo Nordisk commits $4.1 billion to North Carolina plant making Ozempic and Wegovy
Novo Nordisk said on June 24, 2024 that it will invest $4.1 billion in a second fill-and-finish plant in Clayton, North Carolina, adding 1.4 million square feet of production space and 1,000 jobs. FiercePharma reported the site will produce the semaglutide injections Ozempic and Wegovy, with construction finished in stages between 2027 and 2029. Novo plans to spend about $6.8 billion on production in 2024, up from $3.9 billion in 2023.
- Research and trials
Tirzepatide sharply reduced sleep apnea events in two 52-week trials
Two phase 3 trials published June 21, 2024 found that tirzepatide lowered the apnea-hypopnea index by an average of 25.3 events per hour in adults with obstructive sleep apnea and obesity who were not using PAP therapy, and by 29.3 events per hour in those who were, compared with about 5 events per hour on placebo. Gastrointestinal symptoms were the most commonly reported side effects, and two cases of acute pancreatitis were adjudicated, both in tirzepatide recipients in the PAP-therapy trial.
- Business
Hybio liraglutide listing shows a marketing start date six months before FDA approval
An FDA drug directory lists a single-pen Hybio Pharmaceutical liraglutide 18 mg/3 mL product under ANDA215503 with a marketing start date of June 21, 2024, while Drugs@FDA records that application as approved on December 23, 2024. Hybio's two- and three-pen cartons start on December 24, 2024, making the June date a listing-record anomaly rather than evidence of a generic sold before approval. The first generic liraglutide a US patient could buy was Teva's authorized generic, dated June 24, 2024.
- Compounding
Lilly warns about counterfeit and compounded tirzepatide, files new lawsuits
On June 20, 2024, Eli Lilly published an open letter stating it never sells Mounjaro or Zepbound on social media and does not supply tirzepatide to compounding pharmacies, med-spas or online retailers. Lilly said testing of products advertised as tirzepatide found bacteria, high impurity levels, a pink rather than colorless solution, a completely different chemical structure and, in at least one case, only sugar alcohol. The company also said it is filing several legal actions against med-spas and wellness centers selling unapproved compounded products.
- Compounding
Lilly sues med-spas over compounded tirzepatide marketing
Eli Lilly filed new lawsuits on June 20, 2024 against med-spas, wellness centers and other sellers of compounded products they advertise as tirzepatide, alleging the sellers wrongly used the names Mounjaro and Zepbound and borrowed Lilly's clinical trial results. Lilly also disclosed a May 2024 settlement with Totality Medispa that included a monetary payment. The suits follow cases Lilly filed in September and October 2023.
- Science
Study maps how tirzepatide's GIP receptor acts on human fat cells
A paper in Cell Metabolism reports that activating the GIP receptor in human fat cells increased their uptake of glucose and lipids when insulin was present, and increased fat breakdown when insulin was absent. Tirzepatide, sold as Mounjaro and Zepbound, is a long-acting GIP receptor activator; semaglutide (Ozempic, Wegovy, Rybelsus) does not act on that receptor. The work is laboratory research and reports no patient outcomes.
- Research and trials
Tirzepatide resolved MASH in up to 62% of patients in a 52-week phase 2 trial
In the SYNERGY-NASH trial, 190 adults with biopsy-confirmed MASH and stage F2 or F3 liver fibrosis received weekly tirzepatide at 5 mg, 10 mg or 15 mg, or placebo, for 52 weeks. MASH resolved without worsening fibrosis in 44%, 56% and 62% of the tirzepatide groups, compared with 10% on placebo. About half of treated participants also improved by at least one fibrosis stage, versus 30% on placebo.
- Research and trials
Lilly starts second phase 3 adolescent obesity trial with comorbidity endpoint
Eli Lilly has begun SURMOUNT-ADOLESCENTS-2, a phase 3 trial that plans to enroll 300 adolescents aged 12 to 17 who have obesity and multiple weight-related conditions. The study has two co-primary endpoints: percent change in BMI at week 72 and a composite requiring improvement in at least two predefined comorbidities without any new ones. Primary completion is listed as October 2027.
- Safety
FDA and Novo Nordisk warn of counterfeit Ozempic in U.S. supply chain
The FDA and Novo Nordisk warned in December 2023 that counterfeit Ozempic had been found in the legitimate U.S. drug supply chain, and named lot NAR0074 and serial number 430834149057 in a 1 mg injected dose. Thousands of units were seized, but the FDA said some may still be in circulation. Five users of products from the lot reported side effects that matched Ozempic's known ones, and Novo Nordisk said it could not guarantee the counterfeit product's quality or safety.
- Culture
Eli Lilly files six more lawsuits over compounded tirzepatide sold by med spas
In late June 2024, Eli Lilly filed six new lawsuits against medical spas and wellness centers in Ohio, Texas, Hawaii and Washington, DC, alleging they misled customers into thinking compounded tirzepatide products were FDA-approved. The filings follow a May 2024 settlement with Totality Medispa and a June 20 open letter in which Lilly said it does not supply tirzepatide to compounding pharmacies, med spas or online retailers.
- Safety
Federal GLP-1 lawsuits over Ozempic and others reassigned to Judge Karen Marston in June 2024
MDL 3094, the federal consolidation of product liability lawsuits over GLP-1 drugs, was reassigned in June 2024 to Judge Karen S. Marston in the Eastern District of Pennsylvania. She has overseen both the gastrointestinal injury docket and the later NAION vision-loss docket. The consolidated litigation covered 4,022 lawsuits as of September 2026, and no global settlement has been announced.
- Compounding
Novo Nordisk files nine more lawsuits over compounded semaglutide
Novo Nordisk filed nine new lawsuits against medical spas, weight-loss clinics and pharmacies in six states over products marketed as compounded semaglutide, adding to 12 earlier cases. The company said testing of some compounded products found no semaglutide at all and impurities as high as 24%, and cited 442 adverse event reports linked to compounded products claiming to contain semaglutide as of March 31, 2024, including 99 hospitalizations and 7 deaths.
- Research and trials
Tirzepatide produced 13.6% and 17.5% weight loss in Chinese obesity trial
In a 52-week phase 3 trial called SURMOUNT-CN, 210 Chinese adults with obesity or overweight who took weekly tirzepatide injections lost an average of 13.6% of body weight on the 10 mg dose and 17.5% on the 15 mg dose, compared with 2.3% on placebo. At least 5% weight loss was reached by 87.7% and 85.8% of the tirzepatide groups versus 29.3% on placebo. The most common side effects were gastrointestinal and mostly mild to moderate, with fewer than 5% of participants stopping treatment because of them.
- Research and trials
Weekly semaglutide cut major kidney disease events 24% in FLOW trial, NEJM reports
The New England Journal of Medicine published the FLOW trial on May 24, 2024, in which 3,533 adults with type 2 diabetes and chronic kidney disease had a 24% lower risk of major kidney disease events on weekly semaglutide than on placebo. The trial was stopped early after an interim analysis recommended cessation.
- Business
Lilly adds $5.3 billion to Indiana plant making tirzepatide ingredients
Eli Lilly said on May 24, 2024, that it will invest an additional $5.3 billion at its Lebanon, Indiana, manufacturing site, raising its total commitment there to $9 billion. The plant will make active pharmaceutical ingredients for tirzepatide, sold as Zepbound and Mounjaro. Lilly says it has committed more than $18 billion to manufacturing since 2020.
- Compounding
Australia bans compounded tirzepatide, and Lilly cites the move in U.S. warnings
On May 21, 2024, the Australian government announced a complete ban on compounded tirzepatide and other compounded diabetes and weight-loss medicines, pointing to reports of patients being harmed. Eli Lilly cited the Australian action in a June 20, 2024 open letter warning U.S. patients about compounded and counterfeit versions of its tirzepatide medicines, Mounjaro and Zepbound.
- Regulation
China clears Eli Lilly's tirzepatide for type 2 diabetes
Chinese regulators approved Eli Lilly's tirzepatide for type 2 diabetes on May 21, 2024, the company said, opening a market where Novo Nordisk's Ozempic has been sold since 2021. Novo Nordisk's greater China revenue from that weekly semaglutide injection doubled to 4.8 billion Danish Krone, or roughly $698 million, last year. Lilly gave no timetable for a China launch and no figure for how much supply it would send.
- Regulation
FDA flags compounded injectable labels tied to 5- to 50-fold dosing errors
The FDA says differences in how compounders and conventional manufacturers print drug strength on small-volume injectable labels have led clinicians to give patients 5 to 50 times the intended dose. The agency recommends that strength per total volume be the primary, prominent number on the label, with strength per milliliter in parentheses. The alert page carries a May 21, 2024 update date and describes case reports dated September 24, 2018 involving fentanyl and ketamine.
- Research and trials
Novo Nordisk to test semaglutide and two other drugs in alcohol-related liver disease
Novo Nordisk plans to begin a trial in alcohol-related liver disease testing semaglutide, cagrilintide and an experimental drug called zalfermin, alone and in combination, with about 240 participants and a May 20 start date listed in a government database. Liver scarring is the primary measure, assessed over 28 weeks, while changes in alcohol consumption are a secondary endpoint. The company says the focus is liver disease, not addiction.
- Compounding
Lilly settles with med spa over misleading tirzepatide claims
Eli Lilly said on May 14, 2024 that it settled a lawsuit against Totality Medispa, which it accused of selling compounded tirzepatide while misleading consumers into thinking the products were Lilly's FDA-approved Mounjaro or Zepbound. The settlement requires a monetary payment, whose amount was not disclosed, and bars the spa from using Lilly branding or claiming its products are FDA-approved. Totality must also report patient adverse events to the FDA and post a disclaimer on its website and advertisements.
- Culture
Kelly Clarkson says she takes a weight-loss drug that is not Ozempic
Kelly Clarkson said on the May 13 episode of her talk show that a prescription medicine helped her lose weight and that it is not Ozempic. She said her bloodwork had gotten bad and that she had resisted treatment for about two years, but she did not identify the drug. She said she weighed 203 pounds at her heaviest.
- Research and trials
Semaglutide weight loss held for four years in SELECT trial analysis
A prespecified analysis of the SELECT trial found that adults with heart disease and overweight or obesity but no diabetes lost a mean 10.2% of body weight after 208 weeks on semaglutide, compared with 1.5% on placebo. Waist circumference fell 7.7 cm versus 1.3 cm. Serious adverse events were less common with semaglutide, but more participants stopped the trial product.
- Culture
Johann Hari's Magic Pill, a mass-market book on GLP-1 drugs, arrives as semaglutide goes mainstream
Johann Hari's Magic Pill: The Extraordinary Benefits and Disturbing Risks of the New Weight-Loss Drugs was published May 7, 2024, in hardcover, large print, ebook and audiobook formats. Penguin Random House lists the 320-page hardcover, priced at $30.00, as a best seller. A Washington Post review describes the book's conclusion as mixed, quoting Hari saying he will not deliver either an uncritical championing or a damning of the drugs.
- Compounding
Hims & Hers began selling compounded semaglutide injections in May 2024
Hims & Hers started offering compounded semaglutide injections in May 2024, using a rule that lets pharmacies compound copies of drugs on the FDA's shortage list. Ten days later, Novo Nordisk said it was escalating legal action against compounded semaglutide. The FDA declared the shortage resolved in February 2025, closing that route, and Novo has since sued Hims seeking a permanent ban on compounded versions of its drugs.
- Culture
KFF survey estimates 12% of US adults have taken a GLP-1 drug
A KFF Health Tracking Poll published May 10, 2024 found that 12% of US adults have taken a GLP-1 agonist at some point and 6% were taking one at the time of the survey. Among people who had used the drugs, 62% took them to treat a chronic condition such as diabetes or heart disease, while 38% used them only for weight loss. Just over half of users, 54%, said paying for the drugs was hard.
- Culture
Nestlé launches Vital Pursuit frozen meals aimed at GLP-1 users
Nestlé has rolled out Vital Pursuit, a frozen-food brand built for people taking GLP-1 medications and others managing their weight, starting with 12 products reaching select stores nationwide by the fourth quarter at a suggested price of $4.99 or less. Nestlé describes it as the first food brand it has created for GLP-1 users, and Food Dive reported it was the company's first new major U.S. brand in nearly three decades.
- Research and trials
Study links semaglutide to about half the rate of alcohol use disorder diagnoses
A retrospective study of electronic health records from 83,825 patients with obesity found that those prescribed semaglutide were 50% to 56% less likely to receive a new or recurrent alcohol use disorder diagnosis over 12 months than patients taking other anti-obesity medications. The researchers replicated the finding in 598,803 patients with type 2 diabetes. The authors say randomized trials are needed to confirm the link.
- Culture
Billie Jean King says she took GLP-1 injections for binge eating, not weight loss
Tennis champion Billie Jean King said on the Wiser Than Me podcast that she is a binge eater and took "a few injections" of a GLP-1 medication at her doctor's recommendation to quiet her preoccupation with food. She did not name the drug, and her dose and how long she used it have not been reported. Most celebrity disclosures about this drug class have centered on weight loss or diabetes instead.
- Business
Lilly to buy Wisconsin injectables plant as tirzepatide shortages continue
Eli Lilly agreed on April 22, 2024, to acquire Nexus Pharmaceuticals' 84,000-square-foot injectables plant in Pleasant Prairie, Wisconsin, for an undisclosed price. Lilly expects production at the site could begin by the end of 2025. The purchase adds capacity while the FDA lists Mounjaro and Zepbound doses as in shortage.
- Regulation
EU clears six Mounjaro KwikPen strengths for multidose tirzepatide pen
The European Commission authorized six additional Mounjaro strengths — 2.5, 5, 7.5, 10, 12.5 and 15 mg per dose — for a multidose pre-filled pen called the KwikPen, in a decision dated April 19, 2024. The move followed a European Medicines Agency opinion on Feb. 22, 2024. Mounjaro's active ingredient is tirzepatide.
- Research and trials
Semaglutide improves heart failure symptoms and weight in adults with type 2 diabetes and obesity-related HFpEF
In a 52-week trial of 616 adults with obesity-related heart failure with preserved ejection fraction (HFpEF) and type 2 diabetes, once-weekly semaglutide 2.4 mg improved heart failure symptom scores by an estimated 7.3 points more than placebo and produced 6.4 percentage points more weight loss. Walking distance, a composite heart failure measure, and C-reactive protein also favored semaglutide. Serious adverse events were reported in 17.7% of the semaglutide group and 28.8% of the placebo group.
- Research and trials
Lilly says tirzepatide cut sleep apnea events by up to 63% in two phase 3 trials
Eli Lilly reported April 17 that tirzepatide, sold as Zepbound, reduced the apnea-hypopnea index by as much as 62.8% over 52 weeks in adults with moderate-to-severe obstructive sleep apnea and obesity, compared with about 6% for placebo. The two phase 3 SURMOUNT-OSA trials enrolled 469 people and also met their weight-loss endpoints. Lilly said it plans to file for a new sleep apnea indication with the FDA beginning mid-year.
- Regulation
FDA says most Zepbound and Mounjaro doses will stay in short supply through June
The FDA's drug shortage database lists every dose strength except the 2.5-milligram versions of Eli Lilly's Zepbound and Mounjaro as in limited supply through June 2024, extending an earlier estimate that ran through April. Lilly blames demand that is outpacing production and says it does not know when supply will return to normal.
- Safety
European regulator finds no link between GLP-1 drugs and suicidal thoughts
The European Medicines Agency's safety committee said on April 12, 2024 that available evidence does not support a causal link between GLP-1 receptor agonists, including semaglutide, and suicidal or self-injurious thoughts and actions. The committee reviewed clinical trials, post-marketing surveillance data and two studies based on electronic health records, and said no update to the medicines' product information is warranted.
- Compounding
Florida judge dismisses Lilly's tirzepatide suit against a compounding pharmacy
A federal judge in Florida dismissed Eli Lilly's lawsuit against RXCompoundStore.com, a compounding pharmacy selling its own version of tirzepatide. Judge Roy Altman ruled that Lilly cannot use state law to enforce the federal Food, Drug, and Cosmetic Act, saying that job belongs mainly to the FDA. The dismissal is an early setback in Lilly's legal campaign against pharmacies selling compounded copies of its diabetes and weight-loss drug.
- Science
Semaglutide eases heart failure symptoms in people with obesity and type 2 diabetes
A 616-person trial found that weekly semaglutide 2.4 mg improved heart failure symptoms, physical function and weight more than placebo over 52 weeks in people with obesity-related heart failure with preserved ejection fraction who also have type 2 diabetes. Symptom scores rose 13.7 points versus 6.4 with placebo, and weight fell 9.8% versus 3.4%. Wegovy is not approved for heart failure.
- Culture
Costco members can join Sesame weight-loss program with Ozempic and Wegovy access
Costco expanded its partnership with telehealth provider Sesame to offer members a weight-loss program that can include prescriptions for the GLP-1 drugs Ozempic and Wegovy. Members pay $179 for three months, compared with $195 for non-members. The subscription fee does not cover the cost of medication or lab work.
- Compounding
FDA added Zepbound to its drug shortage list in April 2024
In April 2024, the FDA added Zepbound, the weight-management brand of tirzepatide, to its national drug shortage list because of high demand. The listing meant compounded tirzepatide could be made under shortage-related exemptions. FDA later declared the tirzepatide shortage resolved on December 19, 2024, and enforcement discretion for compounders ended in early 2025.
- Culture
SNL's "Ozempic for Ramadan" sketch turns the GLP-1 boom into a fake commercial
On March 30, 2024, "Saturday Night Live" aired a parody commercial called "Ozempic for Ramadan," pitched by host Ramy Youssef as a pork-free semaglutide injection for Muslims fasting during the holiday. The sketch described the fictional product as "100% halal food" and carried the branding of real Ozempic maker Novo Nordisk, and it closed with the slogan "Yeah, it's just Ozempic."
- Regulation
FDA approves single-dose vial version of Zepbound in corrected letter
The FDA approved a single-dose vial presentation of Zepbound (tirzepatide) through supplement NDA 217806/S-003, which Lilly submitted on November 20, 2023, with an effective action date of March 28, 2024. A corrected letter fixed an error in the original March 28 letter, which had listed a Medication Guide version that is now superseded by the March 2024 Medication Guide covering both the single-dose pen and single-dose vial.
- Business
FDA approves first labeling revision for Zepbound since 2023 clearance
The FDA approved revisions to Zepbound's carton labels, Medication Guide and package insert on March 28, 2024, as supplement S-003 to New Drug Application 217806. It is the first labeling change for the tirzepatide product since its Nov. 8, 2023 approval. The FDA record does not describe what text changed or why the revision was filed.
- Culture
'The View' hosts Whoopi Goldberg and Sunny Hostin say they used Mounjaro to lose weight
On the March 19, 2024, episode of ABC's "The View," Whoopi Goldberg and Sunny Hostin each said they used Mounjaro, a tirzepatide injection, to lose weight. Goldberg said she weighed almost 300 pounds while filming the 2022 movie "Till" after steroid treatment for back pain, and Hostin said she gained about 40 pounds during the pandemic and then lost it. The segment aired one day after Oprah Winfrey's ABC special about weight-loss medicines.
- Culture
FDA warned Lilly and Novo Nordisk over Oprah Winfrey weight-loss special
The FDA told Eli Lilly and Novo Nordisk in warning letters dated Sept. 9, 2025, that "An Oprah Special: Shame, Blame, and the Weight Loss Revolution" was false or misleading. The ABC prime-time special, hosted by Oprah Winfrey, first aired March 18, 2024, and streamed on Hulu the next day. The two letters were among dozens issued that day, including one to Hims & Hers about compounded semaglutide.
- Competition
Zepbound overtakes Wegovy in new US prescriptions for first time
Eli Lilly's Zepbound recorded 77,590 new US prescriptions in the week ending March 8, moving ahead of Novo Nordisk's Wegovy in new starts for the first time since the Lilly drug reached the market, according to IQVIA data published by JPMorgan. Wegovy's total was about 6,000 lower that week, but it kept a lead of 25,307 in overall prescriptions, which include refills.
- Business
Lilly adds Amazon Pharmacy as a delivery option for Zepbound through LillyDirect
Eli Lilly said on March 13, 2024 that Amazon Pharmacy will deliver certain Lilly prescriptions, including the obesity drug Zepbound, ordered through its LillyDirect site. Amazon Pharmacy is the second online pharmacy partner on the platform, after Truepill, and offers two-day delivery to Amazon Prime members. Lilly has not disclosed how many prescriptions LillyDirect has filled.
- Culture
Lilly buys Oscars airtime to say Mounjaro and Zepbound aren't for vanity
Eli Lilly ran two commercials during the March 10 Academy Awards telling viewers its medicines treat disease, not appearance. The 30-second "Big Night" aired on E!'s red-carpet coverage and the 60-second "Shame" ran inside the broadcast, part of the company's Get Better campaign. Mounjaro revenue topped $2.2 billion in Lilly's latest quarter, and Zepbound brought in nearly $176 million in its first quarter on the market.
- Regulation
FDA approves Wegovy to lower heart attack and stroke risk in adults with heart disease plus obesity
The FDA approved a new use for Wegovy (semaglutide) injection on March 8, 2024: lowering the risk of cardiovascular death, heart attack and stroke in adults who already have cardiovascular disease and are also obese or overweight. In the trial behind the decision, major cardiovascular events occurred in 6.5% of participants taking Wegovy compared with 8% of those on placebo, among more than 17,600 people. The approval was granted to Novo Nordisk A/S.
- Culture
Zepbound tops Wegovy in weekly new US prescriptions for the first time
Zepbound filled 77,590 new US prescriptions in the week ending March 8, 2024, moving ahead of Wegovy for the first time since the Lilly drug's launch, according to IQVIA data published by JPMorgan. Wegovy had about 6,000 fewer fills that week but still held a lead of 25,307 in total weekly prescriptions.
- Business
Novo Nordisk's market value passes $600 billion after early amycretin data
Novo Nordisk's market capitalization passed $600 billion on March 8, 2024, reaching about $604 billion and ranking it as the twelfth most valuable company in the world, after early trial data for the experimental obesity drug amycretin. Amycretin is not an approved medicine, and the trial's size and results have not been disclosed.
- Prices
Cigna's Evernorth caps yearly GLP-1 spending growth at 15% for participating employers
Evernorth Health Services, the Cigna Group subsidiary that includes pharmacy benefit manager Express Scripts, introduced a financial guarantee on March 7, 2024 that holds annual GLP-1 spending increases to 15% for employers and health plans in its EncircleRx program. Clients can choose a cost cap or a savings guarantee, and the cap applies to spending on Novo Nordisk's Wegovy and Eli Lilly's Zepbound. Cigna said health plans have been seeing annual cost trend increases of 40% to 50% for weight loss drugs.
- Compounding
Lilly reports bacteria and impurities in compounded tirzepatide products
Eli Lilly said on March 7, 2024 that its testing found bacteria, high impurity levels and, in some samples, a different chemical structure in products sold as compounded tirzepatide, the active ingredient in Mounjaro and Zepbound. Lilly said one sample was nothing more than sugar alcohol and that it does not supply tirzepatide to compounding pharmacies. The company has sued sellers; a compounding industry group said it is unclear whether the products came from state-licensed pharmacies.
- Research and trials
FLOW results show injectable semaglutide 1 mg slowed kidney disease progression
In the FLOW trial, injectable semaglutide 1 mg significantly improved a composite kidney outcome in people with type 2 diabetes and chronic kidney disease, with a hazard ratio of 0.76, a 24% relative reduction. A later trial of oral semaglutide, SOUL, found a 14% reduction in major cardiovascular events but no significant difference in major kidney disease events.
- Science
Semaglutide reduced severity of a common liver disease in people with HIV, researchers reported
Researchers reported on March 5, 2024, that semaglutide reduced the severity of a common liver disease in people living with HIV. The finding adds to evidence that semaglutide affects the liver through pathways beyond weight loss alone. The study's size, dose, duration and the specific liver diagnosis have not been reported.
- Research and trials
Supervised exercise plus liraglutide kept more weight off a year after treatment, trial follow-up finds
The S-LiTE trial's one-year post-treatment analysis, published in eClinicalMedicine in March 2024, followed adults who had used the GLP-1 drug liraglutide, a supervised exercise program, both, or placebo for one year of weight-loss maintenance. A year after treatment stopped, the combination group weighed 5.1 kg less on average than the liraglutide-only group, and more of them held onto at least a 10% weight loss.
- Research and trials
BMJ Group retracts apple cider vinegar weight-loss trial
BMJ Group has retracted a March 2024 trial that reported weight loss of as much as 7 kilograms in 12 weeks from small daily doses of apple cider vinegar. Statistical experts could not replicate the results and found multiple analytical errors, and the authors agreed with the retraction.
- Prices
West Virginia ends state employee GLP-1 obesity pilot, citing $1.3 million monthly cost
West Virginia's Public Employees Insurance Agency ended a pilot that had covered GLP-1 medications for obesity for about 1,000 state employees, citing roughly $1.3 million a month in costs even after manufacturer rebates. The program, started in 2019, was paused on March 15, 2024, and existing authorizations were honored through June 30 or the end of their term. Two bills that would have restored coverage failed to advance in the legislature.
- Culture
Oprah Winfrey leaves WeightWatchers board, donates her shares and cites conflict of interest
Oprah Winfrey told WeightWatchers she will not stand for re-election to its board, the company said on Feb. 29, 2024, and WW International stock fell 25% in premarket trading. She is donating her roughly 1.1 million shares, a 1.43% stake, to the National Museum of African American History and Culture. On March 15 she said she left to avoid the appearance of a conflict of interest before her ABC special on weight-loss drugs.
- Research and trials
Review finds thin evidence on semaglutide and other weight drugs in PCOS
A systematic review published February 14, 2024 in Obesity Reviews found only 11 trials, with 545 participants in intervention arms, testing anti-obesity medications in women with polycystic ovary syndrome. Meta-analysis was possible for just two comparisons, and neither showed a benefit for androgen outcomes. The authors called published data in this group "very limited" and a high research priority.
- Science
Tirzepatide's half-life is about five days, Lilly researchers report, explaining once-weekly dosing
A population pharmacokinetic analysis pooled data from 19 clinical studies and found that tirzepatide has a half-life of roughly five days, with a mean of 5.4 days and 1.7-fold accumulation on repeated weekly doses. The two-compartment model, published February 14, 2024, also found no need for dose adjustments based on kidney function, liver function, body weight, sex, age, race or ethnicity.
- Policy
CMS finalizes faster prior authorization deadlines, but drugs like GLP-1s are left out
The Centers for Medicare & Medicaid Services published a final rule on Feb. 8, 2024, requiring Medicare Advantage, Medicaid, CHIP and Federally-Facilitated Exchange plans to decide standard prior authorization requests within 7 calendar days and expedited requests within 72 hours starting Jan. 1, 2026. The rule applies to items and services and excludes drugs, so its faster deadlines do not cover GLP-1 prior authorizations.
- Business
Zepbound sales reach $175.8 million in its first partial quarter as Lilly's Mounjaro revenue climbs
Eli Lilly reported $175.8 million in Zepbound sales for the fourth quarter of 2023, the first period to include the weight loss drug, which was approved in early November. Mounjaro brought in $2.21 billion for the quarter, up from $279.2 million a year earlier, and total company revenue rose 28% to $9.35 billion.
- Business
Novo Holdings agrees to buy Catalent for $16.5 billion to expand Wegovy supply
Novo Holdings, the investment arm of the Novo Nordisk Foundation, agreed on February 5, 2024 to acquire contract manufacturer Catalent for about $16.5 billion, or $63.50 a share in cash. After the deal closes, Novo Holdings will sell three Catalent fill-finish plants — in Anagni, Italy; Brussels, Belgium; and Bloomington, Indiana — to Novo Nordisk for $11 billion. Novo Nordisk expects the added capacity to increase its filling capacity from 2026.
- Science
Tirzepatide lowered 24-hour blood pressure in SURMOUNT-1 substudy
A planned substudy of the SURMOUNT-1 trial found that weekly tirzepatide reduced 24-hour systolic blood pressure by 7.4 mmHg at 5 mg, 10.6 mmHg at 10 mg and 8.0 mmHg at 15 mg compared with placebo in adults with overweight or obesity. Heart rate rose modestly at each dose, and diastolic reductions were smaller. Researchers said it is not known whether the blood pressure effect comes from the drug itself or from the weight loss it causes.
- Research and trials
Semaglutide 2.4 mg led to 12.1% average weight loss in East Asian population trial
The STEP 7 trial, published in The Lancet Diabetes & Endocrinology, found that once-weekly semaglutide 2.4 mg produced an average 12.1% weight loss over 44 weeks in a predominantly East Asian population, compared with 3.6% for placebo. Among participants taking semaglutide, 85% lost at least 5% of their body weight, versus 31% on placebo. Gastrointestinal disorders were the most common side effect, reported by 67% of the semaglutide group and 36% of the placebo group.
- Safety
GLP-1 stomach injury lawsuits consolidated into MDL 3094
A federal judicial panel consolidated lawsuits alleging that GLP-1 medications caused gastroparesis, intestinal obstruction and ileus into one proceeding, MDL 3094, in the Eastern District of Pennsylvania on February 2, 2024. The cases are now before Judge Karen S. Marston. As of September 2026, about 4,022 cases were pending, and no case has settled or gone to trial.
- Safety
GLP-1 injury lawsuits against Novo Nordisk and Eli Lilly centralized in Philadelphia federal court
The Judicial Panel on Multidistrict Litigation has centralized 37 lawsuits alleging gastrointestinal injuries from GLP-1 medications into MDL 3094 in the Eastern District of Pennsylvania. The proceeding covers Novo Nordisk's Ozempic, Wegovy and Rybelsus and Eli Lilly's Trulicity and Mounjaro. Both manufacturers deny the allegations.
- Business
Novo Nordisk full-year 2023 sales rose 31% to DKK 232.3 billion
Novo Nordisk reported 2023 net sales of DKK 232.3 billion, up 31% as reported and 36% at constant exchange rates, with operating profit up 37% to DKK 102.6 billion and net profit up 51% to DKK 83.7 billion. Diabetes and obesity care sales rose 38% to DKK 215.1 billion, led by GLP-1 diabetes sales growth of 48% and obesity care growth of 147%.
- Regulation
FDA says preliminary review finds no evidence GLP-1 drugs cause suicidal thoughts
The FDA said its preliminary review of side-effect reports and trial data found no evidence that GLP-1 receptor agonists cause suicidal thoughts or actions, a class of 13 approved medicines that includes Ozempic, Wegovy, Mounjaro and Zepbound. The agency said the small number of such events in both treated and comparison groups means a small risk cannot be definitively ruled out, and that it is continuing to review the question.
- Regulation
FDA lists Mounjaro 12.5 mg dose as limited through February
The FDA's website shows Eli Lilly's Mounjaro in limited supply at the 12.5 milligram dose through February 2024, while other doses remain available. Lilly says it is still shipping all doses of the tirzepatide injection to wholesalers and warns of possible regional pharmacy stock outages.
- Prices
North Carolina State Health Plan drops weight-loss coverage of Wegovy and Zepbound
The board of the North Carolina State Health Plan voted in January 2024 to stop covering GLP-1 drugs for weight loss beginning in April 2024. Roughly 23,000 members were taking the medicines at a net cost above $800 per member per month after rebates, and the plan projected more than $170 million in spending for 2024. Diabetes coverage continued, including for Mounjaro.
- Safety
FDA review finds no sign GLP-1 medicines such as Wegovy cause suicidal thoughts
The FDA said on January 11, 2024 that a preliminary evaluation of reports of suicidal thoughts or actions in people taking GLP-1 receptor agonists turned up no evidence the drugs cause them. The agency reviewed adverse event reports plus trial and observational data, and said that because so few events occurred it could not entirely exclude a small risk. It said it will keep investigating through a pooled analysis of trials and a review of postmarketing data.
- Business
Eli Lilly opens LillyDirect to route patients to telehealth and home delivery
Eli Lilly launched LillyDirect on Jan. 4, 2024, a website where U.S. patients with obesity, diabetes or migraine can reach independent telehealth providers and have select Lilly medicines delivered to their homes. Zepbound, Lilly's weight-loss drug, is eligible for delivery; shipping is free and savings cards are applied automatically for patients who qualify, but the site offers no price discounts and Zepbound's list price is above $1,000 for a month's supply. The American College of Physicians and several ethicists questioned whether a drugmaker steering patients to prescribers creates at least the appearance of a conflict of interest.
- Business
Lilly opens LillyDirect, pairing telehealth visits with home delivery of its medicines
On Jan. 4, 2024, Eli Lilly launched LillyDirect, a U.S. website that connects patients to independent telehealth providers and to home delivery of select Lilly medicines for obesity, migraine and diabetes. The company said shipping is free through the site's pharmacy service and that savings card opportunities are applied automatically for patients who qualify. Lilly said the telehealth vendors listed on the site are independent and make their own prescribing decisions.
- Culture
Lilly tells the public its tirzepatide drugs are not for cosmetic weight loss
Eli Lilly published an open letter on January 4, 2024 saying Mounjaro and Zepbound are not approved for cosmetic weight loss and are intended for type 2 diabetes or for obesity at a BMI of 30 or higher, or 27 or higher with a weight-related condition. The letter also warned about compounded and counterfeit tirzepatide, which the company said has not been reviewed by the FDA for safety, quality or efficacy.
- Business
Eli Lilly's LillyDirect opens a cash-pay route to obesity drugs
Eli Lilly began selling obesity medicines directly to cash-paying patients through LillyDirect in January 2024, later adding discounted single-dose Zepbound vials, and Novo Nordisk launched its own direct channel about a year later. Cash prices now anchor the market: as of January 2026, Novo Nordisk says the two lowest doses of its new Wegovy pill cost $149 a month and the two higher doses $299 a month for cash payers, while the lowest-dose Wegovy injection runs $349 a month.
- Science
Large records study links semaglutide to lower risk of suicidal ideation
A Nature Medicine analysis of electronic health records from 240,618 patients with overweight or obesity found semaglutide was associated with a lower risk of first-time suicidal ideation (hazard ratio 0.27) and recurrent suicidal ideation (hazard ratio 0.44) than other anti-obesity medicines. The results replicated in 1,589,855 patients with type 2 diabetes, and the authors said their findings do not support higher risks of suicidal ideation with semaglutide.