GLP‑1 news from 2023
96 dated, sourced GLP-1 developments from 2023: approvals, trial results, prices, lawsuits, compounding and culture.
- Policy
FDA alerts public to counterfeit Ozempic lot NAR0074 in US supply chain
The FDA said on Dec. 21, 2023 that counterfeit Ozempic (semaglutide) injection 1 mg had entered the legitimate U.S. drug supply chain, and it named lot NAR0074 and serial number 430834149057. Thousands of units were seized, and the agency said the needles bundled with them were counterfeit, so their sterility cannot be confirmed.
- Science
Lilly to pay Fauna Bio up to $494 million to hunt obesity targets using hibernation biology
Eli Lilly signed a multi-year agreement with Fauna Bio on Dec. 21, 2023, to use the biotech's AI platform, built partly on data from hibernating mammals, to search for new obesity drug targets. Fauna Bio will receive an upfront payment including an equity investment and is eligible for up to $494 million in preclinical, clinical and commercial milestone payments, plus royalties on product sales.
- Business
Ro adds Eli Lilly's Zepbound to its telehealth weight-loss program
On Dec. 13, 2023, the telehealth company Ro said it had added Zepbound (tirzepatide) injection to its Body Program, its weight-loss service. Ro cited a 72-week trial in which people without diabetes lost an average of 48 pounds, about 20% of body weight, on the highest maintenance dose plus diet and exercise, versus about 3% with diet and exercise alone. The move put the Eli Lilly obesity drug alongside Wegovy, Ozempic and Saxenda in Ro's medication list.
- Research and trials
Trial shows weight regain after stopping tirzepatide, continued use adds more loss
SURMOUNT-4, published Dec. 11, 2023 in JAMA, found that adults with obesity who took tirzepatide for 36 weeks lost an average of 20.9% of their body weight, but those switched to placebo for 52 more weeks regained an average of 14.0%. Participants who kept taking tirzepatide lost an additional 5.5%, and 89.5% of them held at least 80% of their original loss, compared with 16.6% on placebo.
- Regulation
European Commission adds weight management to Mounjaro's EU approval
The European Commission added chronic weight management to the existing European Union authorization for Mounjaro (tirzepatide) on December 11, 2023, after the EMA's human medicines committee issued a positive opinion on November 9, 2023. The label now covers weight loss and weight maintenance in adults with a BMI of 30 or higher, or 27 to under 30 with at least one weight-related condition. In the main weight-management study, participants lost at least 15 percent of body weight on average over 72 weeks, compared with about 3 percent on placebo.
- Business
Zepbound reaches US pharmacies with a savings card and early insurer coverage
Eli Lilly said on Dec. 5, 2023 that Zepbound (tirzepatide) is now stocked in U.S. pharmacies, about four weeks after the FDA approved the obesity drug on Nov. 8. The monthly list price is $1,059.87, and Lilly's savings card sets floors of $25 for commercially insured patients whose plans cover the drug and $550 for those whose plans do not.
- Research and trials
SURMOUNT-4 trial finds rapid weight regain after stopping tirzepatide
In the phase 3 SURMOUNT-4 trial, 670 adults with obesity or overweight who had lost a mean 20.9% of their body weight during a 36-week tirzepatide lead-in were randomly assigned to keep taking the drug or switch to placebo. Over the next 52 weeks, the tirzepatide group lost an additional 5.5% while the placebo group regained 14.0%. About 89.5% of those who continued the drug maintained at least 80% of their lead-in weight loss, compared with 16.6% of those switched to placebo.
- Culture
Oprah Winfrey discloses weight-loss medication and steps down from WeightWatchers board
Oprah Winfrey told People in December 2023 that she takes a prescription weight-loss drug she did not name, describing it as "a tool to manage not yo-yoing". In February 2024 she told WeightWatchers she would not seek re-election to its board, a move disclosed alongside a regulatory statement that the decision involved no disagreement with the company. WeightWatchers shares fell 25% in premarket trading on Feb. 29, 2024.
- Research and trials
Study links semaglutide and tirzepatide to lower self-reported drinking
A Scientific Reports paper published Nov. 28, 2023 combined a machine-learning analysis of about 68,250 Reddit posts with a 153-person remote study and found lower self-reported alcohol intake, fewer drinks per episode, lower binge-drinking odds and lower AUDIT scores among people taking semaglutide or tirzepatide. Of 1,580 alcohol-related Reddit posts, 71% described craving reduction, decreased desire to drink or other negative effects of drinking. The authors described it as the first published report of reduced drinking with tirzepatide.
- Compounding
US trade commission opens investigation into imported tirzepatide products
The U.S. International Trade Commission voted on November 20, 2023, to institute Investigation No. 337-TA-1377 into imported products containing or purporting to contain tirzepatide, based on a complaint filed by Eli Lilly and Company on October 19, 2023. The complaint names 11 respondents in the United States, Hong Kong, the United Kingdom, Poland, Spain and China, and asks for exclusion orders and cease and desist orders.
- Science
Real-world analysis finds Mounjaro patients lost more weight than Ozempic patients
A Truveta Research analysis of electronic health records for about 18,000 adults found that 42.3% of those taking tirzepatide, sold as Mounjaro, lost at least 15% of their body weight within a year, compared with 19.3% of those taking semaglutide, sold as Ozempic. After adjusting for risk factors, the Mounjaro group was more than three times as likely to reach that threshold. The results were posted Nov. 27, 2023, on the preprint server medRxiv and had not been peer-reviewed.
- Business
Novo Nordisk commits 2.1 billion euros to expand Chartres plant in France
Novo Nordisk said on Nov. 24, 2023, that it would spend 2.1 billion euros to expand its manufacturing site in Chartres, France. The move was one of a string of capacity announcements from the Danish drugmaker as it worked to keep up with demand for its semaglutide medicines. No capacity, staffing or completion figures for the project were disclosed.
- Business
Eli Lilly to build $2.5 billion injectable drug plant in Germany
Eli Lilly said on Nov. 17, 2023 that it will build its first German manufacturing plant, a 2.3 billion euro ($2.5 billion) site in Alzey that will make injectable incretin medicines such as Mounjaro and Trulicity. Construction is set to begin in 2024, with operations starting in 2027, and the site is expected to employ up to 1,000 people.
- Business
FDA approves Eli Lilly's Zepbound KwikPen, a four-dose tirzepatide pen, in application filed in 2023
The FDA approved a supplemental application from Eli Lilly for Zepbound KwikPen (tirzepatide), adding six pen presentations that each hold four doses for once-weekly use. Lilly dated and filed the application, NDA 217806/S-002, on November 15, 2023, and the approval letter is signed January 20, 2026. The review included a January 29, 2025 action letter and a December 2, 2025 amendment that FDA called a complete response.
- Research and trials
Semaglutide 2.4 mg cut cardiovascular events 20% in adults with obesity and heart disease, SELECT trial finds
In the SELECT trial, weekly semaglutide 2.4 mg reduced the combined risk of cardiovascular death, nonfatal heart attack or nonfatal stroke by 20% compared with placebo in 17,604 adults who had overweight or obesity and existing cardiovascular disease but no diabetes. A primary endpoint event occurred in 6.5% of the semaglutide group versus 8.0% of the placebo group. Adverse events leading to stopping the drug were twice as common with semaglutide, 16.6% versus 8.2%.
- Regulation
European regulator recommends Mounjaro for weight management
Europe's human medicines committee recommended on Nov. 10, 2023, that Eli Lilly's Mounjaro (tirzepatide) be approved for weight loss, two days after US and UK regulators cleared the same drug for that use. The recommendation now goes to the European Commission, which has not yet granted the change to Mounjaro's marketing authorization.
- Regulation
EU committee backs Mounjaro for chronic weight management
On Nov. 9, 2023, a European Medicines Agency committee recommended extending Mounjaro's European Union authorization to chronic weight management in adults with obesity, or with overweight plus at least one weight-related condition. The recommendation rested on the phase 3 SURMOUNT-1 trial and five supportive phase 3 SURPASS studies, and the European Commission issued the final decision on Dec. 11, 2023.
- Culture
FDA approves Zepbound, giving tirzepatide a second brand name for weight loss
The FDA approved Zepbound (tirzepatide) on November 8, 2023, for chronic weight management, creating a second U.S. brand for a molecule already sold as Mounjaro for type 2 diabetes. In the SURMOUNT-1 trial, adults taking the 15 mg dose lost an average of 48 pounds over 72 weeks, compared with 7 pounds on placebo. Lilly later said Zepbound was the most prescribed injectable weight-management medication in 2025, and a four-dose KwikPen version was approved in February 2026.
- Safety
Zepbound's 2023 launch carried a suicidal ideation warning that lasted two years
The FDA approved tirzepatide as Zepbound for chronic weight management on Nov. 8, 2023, with a Suicidal Behavior and Ideation warning on the label, matching Wegovy and Saxenda. The warning stayed on the label for just over two years. The same label later added warnings about severe gastrointestinal reactions (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1% versus 1% for placebo) and acute kidney injury from volume depletion.
- Regulation
FDA approves Zepbound (tirzepatide) for chronic weight management
The FDA approved Zepbound (tirzepatide) on Nov. 8, 2023, for chronic weight management in adults with obesity, or adults who are overweight with at least one weight-related condition. In the SURMOUNT-1 trial, people taking the highest 15 mg dose lost an average of 48 lb over 72 weeks, compared with 7 lb on placebo. Lilly set the list price at $1,059.87 a month, about 20% below Wegovy's list price at the time, with a savings card offering some commercially insured patients a payment as low as $25.
- Business
UK regulator authorizes Mounjaro for weight loss, giving tirzepatide two brand names
Britain's Medicines and Healthcare products Regulatory Agency authorized Mounjaro (tirzepatide) for weight loss and weight management on November 8, 2023, for adults 18 and over with a BMI of 30 kg/m² or higher, or 27 to 30 with a weight-related condition such as prediabetes or high blood pressure. The FDA cleared the same drug for weight loss hours later under the name Zepbound. In SURMOUNT-1, average weight change over 72 weeks was -22.5% at the 15 mg weekly dose versus -2.4% on placebo.
- Prices
Zepbound's price started at a flat $1,059 a month and now varies by dose and seller
Eli Lilly's Zepbound (tirzepatide) came to market with a list price of $1,059 for a 28-day supply that was the same at every dose, from 2.5 milligrams to 15 milligrams. In August 2024, Lilly cut the two lowest doses to $399 and $549 a month, but only as cash-pay vials sold through its own telehealth platform, with no insurance coverage and no access to the company's savings card. Lilly now lists a list-price range of $499 to $1,086.37 per fill and direct-to-patient self-pay prices of $299 to $699 depending on dose.
- Safety
EMA asked 11 GLP-1 drugmakers for suicidal-thought data in November 2023
In November 2023, the European Medicines Agency's safety committee requested additional data from the companies that hold authorisations for 11 GLP-1 medicines, including Ozempic, Wegovy, Rybelsus, Victoza, Saxenda and Trulicity, about reports of suicidal thoughts and self-harm. The request came during a review opened in July 2023, with roughly 150 reports under analysis, and the committee concluded on 12 April 2024 that no causal link was supported and no product information update was warranted.
- Culture
Sharon Osbourne says she dropped under 100 pounds on Ozempic and warns against teenage use
Sharon Osbourne, 71, said she started Ozempic in December 2022, lost 42 pounds, and ended up under 100 pounds, a weight she said she could not put back on. In a November 2023 interview she warned against giving the drug to teenagers, calling it "just too easy" and saying weight loss can become addictive. She later said she does not regret taking it.
- Business
Ozempic and Wegovy sales reach $4.7 billion in a quarter
Novo Nordisk's Ozempic and Wegovy combined for $4.7 billion in third-quarter sales, about 57% of the company's revenue, while Eli Lilly's Mounjaro reached $1.4 billion in the same period. The quarter also brought the industry's largest year-over-year revenue increases, with Lilly up 38% and Novo up 29%.
- Competition
Gelesis, maker of weight-loss pill Plenity, files for Chapter 7 liquidation
Gelesis Holdings, Inc. and its two U.S. subsidiaries ceased operations and filed for Chapter 7 liquidation on October 30, 2023, in the U.S. Bankruptcy Court for the District of Delaware. The petition lists assets of $50 million to $100 million and liabilities of $44.34 million. Gelesis sold Plenity, a prescription weight-loss capsule dispensed through telehealth consultations.
- Compounding
Eli Lilly files trade complaint seeking to block tirzepatide imports from 11 sellers
Eli Lilly and Company filed a complaint with the U.S. International Trade Commission on Oct. 19, 2023, asking the agency to stop imports of products that contain or claim to contain tirzepatide, the ingredient in Mounjaro and Zepbound, and naming 11 sellers. The Commission opened Investigation No. 337-TA-1377 on Nov. 20, 2023. Five of the 11 respondents are based in the United States.
- Compounding
Lilly asks trade panel to block imports of unapproved tirzepatide sold online
Eli Lilly said on Oct. 19, 2023 that it filed a complaint with the U.S. International Trade Commission against 11 online pharmacies, seeking to keep products claiming to contain tirzepatide, the active ingredient in its diabetes drug Mounjaro, out of the country. Lilly said testing of one seller's product showed it was "nothing more than sugar alcohol." Lilly is the only company with FDA approval to sell tirzepatide products.
- Safety
Mounjaro can reduce absorption of birth control pills, report warns of unintended pregnancies
CBS Boston reported that Mounjaro can reduce absorption of oral contraceptive pills in the gut, and that its label suggests people using the pill switch to a non-oral birth control method. The report described unintended pregnancies in some patients taking the drug along with oral contraceptives, and said many doctors may not be counseling patients about the interaction. It did not say how many pregnancies were reported or how much the drug lowers absorption, and it noted that it is not clear whether other hormonal birth control methods or similar drugs such as Ozempic and Wegovy carry the same risk.
- Research and trials
Lilly starts phase 3 tirzepatide weight trial in teenagers
Eli Lilly has started a phase 3 trial of tirzepatide for weight in teenagers aged 12 to 17, the first tirzepatide weight trial in that age group. The study, SURMOUNT-ADOLESCENTS (NCT06075667), plans to enroll 160 participants with obesity or with overweight plus at least one weight-related condition, and its main measure is percent change in BMI at week 72. Primary completion is listed as June 2, 2026, and no results have been posted.
- Research and trials
Tirzepatide added to a lifestyle program produced further weight loss in SURMOUNT-3 trial
In the phase 3 SURMOUNT-3 trial, 579 adults who had already lost at least 5% of their body weight during a 12-week intensive lifestyle program were randomly assigned to weekly tirzepatide or placebo for 72 more weeks. The tirzepatide group lost an additional 18.4% of body weight on average, while the placebo group gained 2.5%, a difference of 20.8 percentage points. Total average weight loss from study entry over 84 weeks was 26.6% with tirzepatide and 3.8% with placebo.
- Safety
JAMA letter links weight-loss use of semaglutide and liraglutide to three gastrointestinal risks
A research letter in JAMA reports that adults prescribed semaglutide or liraglutide for weight loss in a US claims database were more likely than bupropion-naltrexone users to be diagnosed with gastroparesis, pancreatitis and bowel obstruction, with adjusted hazard ratios of 3.67, 9.09 and 4.22. The number of events behind those ratios was small and the confidence intervals were wide. Biliary disease was not significantly elevated.
- Culture
Walmart data shows GLP-1 shoppers buy less food, US chief says
John Furner, who runs Walmart's U.S. business, said in an Oct. 4, 2023, Bloomberg interview that customers filling GLP-1 prescriptions at its pharmacies buy "less units, slightly less calories" than similar shoppers who do not. He said the finding is too early to support firm conclusions. Trilliant Health data cited by NBC News show prescriptions for the medicines quadrupled from late 2020 to 2022, with 9 million filled in the final quarter of 2022.
- Business
Lilly names Patrik Jonsson to lead diabetes and obesity unit as Mike Mason retires
Eli Lilly announced on Oct. 4, 2023, that Mike Mason, who led the diabetes and obesity division through the launch of Mounjaro, will retire and be replaced by Patrik Jonsson starting Jan. 1. The change comes as Mounjaro, or tirzepatide, awaits a regulatory decision on use as a weight-loss treatment and recorded $979.7 million in quarterly sales. Jonsson will also oversee late-stage development of Lilly's next-generation obesity drug retatrutide and its obesity pill orforglipron.
- Culture
Goldman Sachs forecasts $100 billion global market for anti-obesity drugs by 2030
Goldman Sachs Research forecast on Oct. 30, 2023, that the global market for anti-obesity medications could grow to $100 billion by 2030, up from about $6 billion on an annualized basis earlier that year. The projection assumes roughly 15 million U.S. adults will be treated with the drugs by 2030, about 13% of the eligible obese or overweight adult population. The analysts wrote that the market is "still in its early stages" and that the estimate is sensitive to small changes in its underlying assumptions.
- Safety
UK and EU regulators warn of falsified Ozempic pens in wholesale channels
In October 2023, health authorities in the United Kingdom and Europe warned pharmacies and distributors that falsified Ozempic pens were circulating in wholesale channels. German regulators later described complex cross-border trades in the fake product. Novo Nordisk, which makes Ozempic and Wegovy, also warned of a surge in counterfeit versions of its medicines.
- Business
FDA approves Mounjaro KwikPen, adding four-dose pens to Lilly's tirzepatide line
The FDA approved Mounjaro KwikPen on January 20, 2026, adding six presentations of Eli Lilly's tirzepatide injection that each hold four once-weekly doses. Lilly filed the supplemental application on September 28, 2023; the FDA issued an action letter on January 29, 2025, and Lilly answered with a complete response amendment dated December 2, 2025. The approval letter does not disclose the dose strengths or a launch date.
- Regulation
FDA adds ileus to the Ozempic label after postmarketing reports
The FDA added ileus, a blockage of normal movement in the intestines, to the adverse reactions section of the Ozempic label after postmarketing reports of the condition. The same day, the agency added labeling about low blood sugar risk when semaglutide is used with insulin or a sulfonylurea. The label notes that voluntary reports cannot establish how often the reaction occurs or whether the drug caused it.
- Safety
Eli Lilly opens legal push against sellers of compounded tirzepatide
Eli Lilly filed lawsuits on Sept. 19, 2023 against 10 medical spas, wellness clinics and compounding pharmacies in the U.S., accusing them of selling unauthorized versions of its diabetes drug Mounjaro. The complaints went to federal courts in seven states and sought orders blocking the sales plus money damages in an amount Lilly did not specify. In June 2024 the company published an open letter saying some products sold as compounded tirzepatide contained bacteria, high impurity levels, or in one case nothing but sugar alcohol.
- Competition
ConsumerLab finds lead in two goldenseal supplements and little berberine in a third
Independent testing of 10 berberine and goldenseal products found that five of six berberine supplements passed quality checks, with one short on berberine, while all three goldenseal supplements failed. One goldenseal product contained almost none of the expected berberine and two were contaminated with lead, ConsumerLab reported for products tested in 2023.
- Policy
England's NICE backs Mounjaro for type 2 diabetes after earlier rejection
England's National Institute for Health and Care Excellence recommended tirzepatide, sold as Mounjaro, for adults with poorly controlled type 2 diabetes on Sept. 8, 2023, reversing an earlier decision not to cover it. NICE estimates about 180,000 people could benefit. Final guidance is due Oct. 11, with NHS availability planned within 90 days after that, pending supply.
- Business
Novo Nordisk briefly passes LVMH as Europe's most valuable company on Ozempic and Wegovy demand
On Sept. 1, 2023, Novo Nordisk briefly overtook LVMH as Europe's most valuable listed company, ending the French luxury group's two-and-a-half-year run at the top. Novo's market value was about $424.7 billion at Friday's close, against $420.1 billion for LVMH, after its shares rose roughly 17% since an Aug. 8 report that Wegovy cut cardiovascular risk by 20% in a large trial.
- Compounding
Eli Lilly sues 10 med spas and compounders over copycat tirzepatide
Eli Lilly sued 10 U.S. medical spas, wellness centers and compounding pharmacies in September, saying they sold products they claimed were its diabetes drug Mounjaro. The suits followed similar legal action by Novo Nordisk, which sued two Florida compounders in November. The cases come as the FDA and Novo warn of counterfeit Ozempic found in the legitimate U.S. supply chain.
- Compounding
Lilly sues med-spas and wellness centers over compounded tirzepatide
Eli Lilly and Company began filing lawsuits in September and October 2023 against med-spas, wellness centers and other sellers that advertised compounded products as tirzepatide, Mounjaro or Zepbound. In a June 20, 2024 release, Lilly announced another round of legal actions and an open letter warning patients about counterfeit and compounded versions of its medicines, and said it settled with Totality Medispa in May 2024.
- Science
Semaglutide 2.4 mg eases obesity-related heart failure symptoms in trial
In the STEP-HFpEF trial, published in the New England Journal of Medicine, 529 patients with obesity-related heart failure with preserved ejection fraction received weekly semaglutide 2.4 mg or placebo for 52 weeks. Symptom scores improved 16.6 points with semaglutide versus 8.7 with placebo, body weight fell 13.3 percent versus 2.6 percent, and six-minute walk distance rose 21.5 meters versus 1.2 meters.
- Prices
Analysis finds US list prices for semaglutide far above peer nations
The Peterson-KFF Health System Tracker published a comparison on August 17, 2023, showing a month of Ozempic listed at $936 in the US against $169 in Japan and $93 in the United Kingdom. Wegovy was listed at $1,349 in the US versus $328 in Germany, and Mounjaro at $1,023 versus $444 in the Netherlands. The authors cautioned that list prices are not the same as what insurers or patients actually pay.
- Prices
Mounjaro listed at $1,023 a month in the U.S. versus $444 in the Netherlands, analysis finds
An analysis published August 17, 2023 by the Peterson-KFF Health System Tracker found list prices for weight-loss and diabetes drugs were far higher in the United States than in peer nations. A month of Mounjaro (tirzepatide, 15 mg) was listed at $1,023 in the U.S., $444 in the Netherlands and $319 in Japan; Ozempic and Rybelsus were listed at $936 in the U.S., and Wegovy at $1,349.
- Culture
Tracy Morgan says Ozempic is behind his weight loss
Comedian Tracy Morgan said on TODAY with Hoda & Jenna that his weight loss came from Ozempic, saying, "That's Ozempic. That's how this weight got lost." He also joked that he had "out-eaten Ozempic" and gained 40 pounds. His admission adds to a short list of celebrities who have publicly named the GLP-1 drugs they use.
- Business
Novo Nordisk says Wegovy starter-dose supply limits will last into 2024
Novo Nordisk said on Aug. 10, 2023, that supply limits on the lower, starting doses of its weight-loss drug Wegovy will continue into 2024, months later than the company had previously signaled. The restriction affects people trying to begin treatment rather than those already on a maintenance dose. The specific starter strengths affected, the number of patients waiting and a month for relief were not disclosed.
- Business
Novo Nordisk paid up to $1 billion for Inversago, then ended its monlunabant program
Novo Nordisk agreed on Aug. 10, 2023, to buy Inversago Pharma, a Montreal drug developer, for up to $1 billion, gaining a CB1 receptor program that became the experimental medicine monlunabant. Novo Nordisk ended that program in 2026. How much was paid upfront and why the program was stopped have not been disclosed.
- Research and trials
Novo Nordisk reports semaglutide 2.4 mg cut cardiovascular events by 20% in SELECT
Novo Nordisk announced on Aug. 8, 2023 that semaglutide 2.4 mg reduced the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity and established cardiovascular disease in a trial called SELECT. Full results were presented in November 2023 and published in the New England Journal of Medicine. In March 2024, the FDA approved Wegovy for cardiovascular risk reduction in that same population.
- Business
Eli Lilly shares hit record as Mounjaro sales drive 85% profit jump
Eli Lilly said second-quarter profit rose 85% from a year earlier and raised its full-year forecasts, powered by $979.7 million in Mounjaro sales. Shares rose as much as 18% on August 8, 2023, and closed nearly 15% higher. The company also said supply of certain Mounjaro doses will likely stay tight for months.
- Safety
First lawsuit says Ozempic and Mounjaro caused stomach paralysis
A 44-year-old Louisiana woman sued Novo Nordisk and Eli Lilly on Aug. 2, 2023, alleging the companies failed to warn that Ozempic and Mounjaro can cause gastroparesis, or stomach paralysis. The 26-page complaint is the first to claim the drugs cause gastrointestinal injuries. Her attorney says about 400 people have come forward and he expects thousands of cases.
- Regulation
FDA approved Mounjaro single-dose vials in 2023, but Lilly never sold them
On July 28, 2023, the FDA approved supplements to the Mounjaro application that added single-dose glass vials in all six strengths, plus labeling changes on anaphylaxis and angioedema. The Mounjaro vials are not marketed in the United States and have never been on the FDA drug shortage list, the agency said in a December 19, 2024 order.
- Regulation
FDA approves first labeling changes for Mounjaro since its 2022 approval
On July 28, 2023, the FDA approved two labeling supplements for Mounjaro, the first changes to the drug's Medication Guide, carton labels and package insert since it was cleared in May 2022. Supplements S-002 and S-006 under New Drug Application 215866 were approved the same day, and the FDA record shows the label was revised repeatedly afterward.
- Research and trials
Lilly says tirzepatide drove 26% weight loss in two trials, with regain after stopping
Eli Lilly reported topline results from the SURMOUNT-3 and SURMOUNT-4 trials on July 27, 2023. In SURMOUNT-3, people who had already lost weight through an intensive lifestyle program lost an additional 21.1% of body weight on tirzepatide, for 26.6% total. In SURMOUNT-4, people switched to placebo after 36 weeks on tirzepatide regained 14.8% of their weight, while those who kept taking it lost 6.7% more.
- Business
FDA added liraglutide injection to its drug shortage list on July 18, 2023
Liraglutide injection was first posted to the FDA's drug shortage database on July 18, 2023, and the agency still lists it as currently in shortage. On December 23, 2024, the FDA approved the first generic version, referencing Victoza, and said it prioritizes reviews of generic applications for drugs in shortage.
- Business
Lilly completes $1.925 billion acquisition of Versanis and its muscle-preservation drug bimagrumab
Eli Lilly and Company agreed on July 14, 2023, to acquire Versanis Bio, whose lead drug bimagrumab is being studied with semaglutide in adults who are overweight or obese. Shareholders could receive up to $1.925 billion in cash, including an upfront payment and later milestone payments tied to development and sales. The deal closed on August 14, 2023.
- Business
Lilly to buy Versanis Bio and its muscle-sparing drug bimagrumab for up to $1.93 billion
Eli Lilly and Co. agreed on July 14, 2023, to acquire privately held Versanis Bio, whose experimental drug bimagrumab is being tested for weight loss that preserves muscle. The deal could pay Versanis shareholders up to about $1.93 billion in cash, including an undisclosed upfront payment and later payments tied to development and sales milestones.
- Safety
Tirzepatide label added ileus in July 2023, two months before semaglutide
The Mounjaro (tirzepatide) prescribing information was updated in July 2023 to add ileus to its list of reported adverse reactions, and the Ozempic (semaglutide) label gained the same entry in September 2023. Both additions came from postmarketing reports rather than clinical trial data, and the label says the frequency of ileus cannot be reliably estimated.
- Safety
Anesthesiologists group advises holding GLP-1 drugs such as semaglutide before elective procedures
The American Society of Anesthesiologists issued consensus-based guidance on June 29, 2023, advising that weekly injectable GLP-1 drugs be held for a week before elective procedures and daily versions held on the day of the procedure. The group cited case reports of food left in the stomach despite standard fasting and said the supporting evidence is sparse, limited to several case reports.
- Compounding
Case series describes 10-fold dosing errors with compounded semaglutide
A case series in the Journal of the American Pharmacists Association describes three patients who had adverse reactions after wrongly administering compounded semaglutide for weight loss, including two who self-administered 10 times the intended dose. All three had nausea, vomiting and abdominal pain, with most symptoms lasting for days. The authors tied the errors to vials and syringes that allow large overdoses and to dosing instructions given in milliliters and units instead of milligrams.
- Research and trials
Lilly's retatrutide produced up to 24.2% weight loss at 48 weeks in phase 2 trial
Eli Lilly published phase 2 results for retatrutide, an investigational drug that acts on three hormone receptors, in The New England Journal of Medicine on June 26, 2023. In the 338-person trial, mean weight reduction reached up to 17.5% at 24 weeks and up to 24.2%, or 57.8 pounds, at 48 weeks. Side effects were mostly mild-to-moderate gastrointestinal problems, similar to other incretin-based therapies.
- Research and trials
Phase 3 trial finds once-daily oral semaglutide 50 mg produced 15.1% weight loss
In the phase 3 OASIS 1 trial, adults with overweight or obesity but without type 2 diabetes who took oral semaglutide 50 mg once daily lost an average of 15.1% of their body weight over 68 weeks, compared with 2.4% for placebo. About 85% of participants on the drug lost at least 5% of body weight, versus 26% on placebo. Gastrointestinal side effects were more common with the drug, reported by 80% of participants compared with 46% on placebo, and were mostly mild to moderate.
- Research and trials
Tirzepatide produced 12.8% to 14.7% weight loss at 72 weeks in adults with type 2 diabetes
In the phase 3 SURMOUNT-2 trial, adults with type 2 diabetes and a BMI of 27 or higher lost an estimated 12.8% to 14.7% of their body weight over 72 weeks on weekly tirzepatide injections, compared with 3.2% on placebo. Between 79% and 83% of participants on the drug lost at least 5% of body weight, versus 32% on placebo. The trial did not compare tirzepatide with semaglutide or any other weight-management drug.
- Research and trials
Lilly's oral orforglipron led to up to 14.7% weight loss in phase 2 trial
Eli Lilly reported on June 23, 2023 that its experimental once-daily pill orforglipron produced average weight loss of up to 14.7% at 36 weeks in adults with obesity or overweight, in phase 2 results published in the New England Journal of Medicine. At the 26-week primary endpoint, weight loss ranged from 8.6% to 12.6% depending on dose, compared with 2.0% for placebo. A separate 26-week phase 2 trial in adults with type 2 diabetes showed A1C reductions of up to 2.1 percentage points.
- Research and trials
Orforglipron Phase 2 obesity results show up to 14.7% weight loss at 36 weeks
Eli Lilly's orforglipron, an experimental once-daily oral GLP-1 pill, produced average body weight reductions of 8.6% to 12.6% at 26 weeks and 9.4% to 14.7% at 36 weeks in a Phase 2 trial of adults with obesity or overweight, compared with 2.0% and 2.3% for placebo. The results were published in the New England Journal of Medicine on June 23, 2023. The drug was later approved by the FDA as Foundayo on April 1, 2026.
- Compounding
Novo Nordisk sues med spas and compounders over semaglutide marketing and sales
Novo Nordisk said on June 20, 2023 that it had begun legal proceedings against certain US medical spas, weight-loss and wellness clinics and compounding pharmacies over false advertising, trademark infringement and sales of compounded products claiming to contain semaglutide. The company did not identify the businesses targeted or say how many actions it filed. The FDA had warned in May 2023 about some compounded versions of semaglutide, saying it had received reports of adverse events and that patients should not use a compounded drug when an approved drug is available.
- Science
Eli Lilly's LY3537021, a GIP-only drug, produced weight loss without nausea in an early trial
Eli Lilly's experimental drug LY3537021, which acts only on the GIP receptor, produced 1.1 to 3.1 kg of weight loss over four weekly doses in a phase 1 trial, while placebo groups lost about 0.4 kg. No participants who received the drug reported nausea or vomiting, and the drug did not delay gastric emptying. The results, presented at the American Diabetes Association's 2023 Scientific Sessions and published in the journal Diabetes, suggest GIP activity can contribute to weight loss on its own.
- Culture
Celebrities describe using semaglutide and tirzepatide, from 52 pounds lost to treatment stopped
A growing group of celebrities has publicly described using GLP-1 medications, including Ozempic, Wegovy, Mounjaro and Zepbound. Reported results range from a 52-pound loss on Mounjaro to a podcast host's account of suicidal thoughts while taking a GLP-1, and one singer said she stopped because she disliked how the drug changed her appetite.
- Culture
Gracie McGraw says she takes Mounjaro for PCOS, spotlighting off-label GLP-1 use
Gracie McGraw, the 26-year-old daughter of Tim McGraw and Faith Hill, said on Instagram that she takes a "low dose" of Mounjaro for polycystic ovary syndrome after previously using Ozempic. Neither drug is FDA-approved for PCOS, which affects about 1 in 10 women of childbearing age, and doctors reported growing difficulty getting prescriptions covered by insurance.
- Research and trials
Tirzepatide kidney benefit holds in cystatin C analysis of SURPASS-4
A post hoc analysis of the SURPASS-4 trial found that tirzepatide's kidney benefit remained when kidney function was measured with cystatin C, a marker not affected by muscle mass. At 52 weeks, cystatin C–based eGFR fell by 3.5 mL/min/1.73 m2 with tirzepatide and 5.3 with insulin glargine, a between-group difference of 1.8 mL/min/1.73 m2 (95% confidence interval 0.8 to 2.8). The authors say this supports a kidney-protective effect, though the analysis did not measure hard kidney outcomes.
- Safety
Novo Nordisk confirms counterfeit Ozempic pens found at a US pharmacy
In June 2023, Novo Nordisk confirmed that counterfeit Ozempic pens had been found at a US retail pharmacy, the first time fake versions of the drug were detected inside the legitimate US supply chain. The company warned patients to check the lot and serial numbers on their pens.
- Compounding
FDA warns compounded semaglutide may contain unapproved salt forms
On May 31, 2023, the FDA alerted the public that some compounded semaglutide products may contain salt forms — semaglutide sodium or semaglutide acetate — which the agency treats as different active ingredients from the semaglutide in Ozempic, Wegovy and Rybelsus. The agency said it is not aware of any lawful basis for using the salts in compounding, and that their properties have not been established.
- Culture
Charles Barkley says he lost 62 pounds on Mounjaro
Charles Barkley said on May 26, 2023, that he lost 62 pounds over about six months while taking Mounjaro, the brand name for tirzepatide. He said he went from 352 pounds to 290 pounds and hoped to reach 270, crediting a weekly shot along with healthy diet and exercise.
- Research and trials
Tirzepatide beats insulin glargine in Asia-Pacific type 2 diabetes trial
In the phase 3 SURPASS-AP-Combo trial, 917 insulin-naive adults with type 2 diabetes in China, South Korea, Australia and India took weekly tirzepatide or daily insulin glargine for 40 weeks. Tirzepatide lowered HbA1c by 1.29 to 1.54 percentage points more than insulin, and produced 5.0 to 7.2 kg of weight loss while the insulin group gained an average of 1.5 kg.
- Business
Novo Nordisk limited Wegovy starter doses for new US patients in May 2023
Novo Nordisk withheld the lowest starter doses of Wegovy from new US patients in May 2023, aiming to keep supply flowing to people already taking the drug. The company described the step on a June 20, 2023 earnings call, the same day it announced legal proceedings against some US med spas, clinics and compounding pharmacies selling non-FDA-approved products that claimed to contain semaglutide. The FDA has warned it does not review compounded versions for safety, effectiveness or quality.
- Research and trials
Exenatide lowered intracranial pressure in women with IIH in a placebo-controlled trial
A randomized, placebo-controlled trial reported in May 2023 found that exenatide, a GLP-1 drug, lowered intracranial pressure in women with active idiopathic intracranial hypertension. Pressure was measured with telemetric catheters placed in the body. The number of participants, the dose used and the size of the pressure change have not been reported.
- Research and trials
Tirzepatide cut body weight up to 15.7% in adults with type 2 diabetes, Lilly says
Eli Lilly reported on April 27, 2023 that tirzepatide produced average weight loss of 13.4% at the 10 mg dose and 15.7% at the 15 mg dose over 72 weeks in adults who had both type 2 diabetes and obesity or overweight, compared with 3.3% for placebo. The phase 3 trial, called SURMOUNT-2, enrolled 938 adults. Lilly said it plans to complete its US submission for weight management in the coming weeks.
- Competition
Lilly starts first head-to-head weight loss trial of tirzepatide against Wegovy
Eli Lilly registered SURMOUNT-5 on April 21, 2023, the first phase 3 trial to compare its drug tirzepatide directly with semaglutide 2.4 mg (Wegovy) for weight loss. The study plans to enroll 700 adults at 61 sites and measure percentage weight loss at 72 weeks, with an estimated primary completion date in February 2025.
- Business
Lilly raises Lebanon, Indiana, plant investment to $9 billion for tirzepatide
Eli Lilly said it will add $5.3 billion to its Lebanon, Indiana, manufacturing site, lifting its total commitment there from $3.7 billion to $9 billion. The plant is intended to make active pharmaceutical ingredients for Zepbound and Mounjaro, both tirzepatide. Lilly expects to add 200 full-time jobs and to begin making medicines at the site toward the end of 2026.
- Business
Novo Nordisk suspended from UK drug trade body for two years over marketing
Novo Nordisk was suspended from the Association of the British Pharmaceutical Industry for two years over marketing practices characterized as inducements to prescribe, according to reporting dated March 16, 2023. Two royal colleges ended their corporate partnerships with the company after the suspension.
- Culture
Kimmel opens Oscars with Ozempic joke as the drug dominates Hollywood talk
Jimmy Kimmel asked whether Ozempic was "right for me" during his opening monologue at the 95th Academy Awards on March 12, 2023, a line that arrived less than two minutes into the broadcast. Coverage at the time described surging weight-loss interest in the diabetes drug, a shortage that affected patients who depend on it, and warnings from doctors about facial aging after rapid weight loss.
- Business
Lilly cuts Humalog and Humulin list prices by 70% and caps patient costs at $35 a month
Eli Lilly and Company announced on March 1, 2023 that it will lower list prices for Humalog and Humulin by 70% in the fourth quarter of 2023 and cut the list price of non-branded Insulin Lispro Injection to $25 a vial starting May 1, 2023. The company also began capping out-of-pocket costs at $35 a month for people with commercial insurance at participating retail pharmacies and pointed uninsured patients to a savings card offering the same monthly price.
- Regulation
Japan approves Wegovy for obesity with narrow eligibility rules
Japan's Ministry of Health, Labour and Welfare has approved Novo Nordisk's Wegovy for obesity, but only for patients with hypertension, dyslipidemia or type 2 diabetes who have not responded adequately to diet and exercise. Patients must also have a BMI of at least 27 kg/m2 plus at least two obesity-related health disorders, or a BMI of at least 35 kg/m2. The approval was reported on April 10, 2023.
- Culture
Rosie O'Donnell's Mounjaro TikTok posts marked an early public GLP-1 account
Rosie O'Donnell began posting on TikTok about taking Mounjaro in March 2023, becoming one of the first entertainers to describe a GLP-1 experience in real time on social media, and she kept posting weight updates for three years. In the years since, celebrities including Oprah Winfrey, Charles Barkley and Serena Williams have described their own use of these drugs, with the amount of weight lost, the reason for use and the outcome differing from person to person.
- Business
Lilly's Mounjaro sales miss forecasts as shares fall 6%
Eli Lilly reported fourth-quarter Mounjaro sales of $279.2 million, below the roughly $319 million analysts expected, and the stock fell about 6% on Feb. 2, 2023. Insurance access for the type 2 diabetes drug rose only slightly, to just over 50% of commercial and Medicare plans from 45% the prior quarter, while Lilly's 2023 profit forecast of $8.35 to $8.55 per share beat expectations.
- Business
Novo Nordisk 2022 sales rise 26% to DKK 177 billion on GLP-1 demand
Novo Nordisk reported full-year 2022 sales of DKK 177.0 billion, up 26% in Danish kroner, and operating profit of DKK 74.8 billion, up 28%. GLP-1 diabetes sales rose 56% in kroner and obesity care sales rose 101%, with North America Operations sales up 35%.
- Culture
Chelsea Handler says she was prescribed Ozempic without knowing what it was
Chelsea Handler said on the Call Her Daddy podcast that her anti-aging doctor "just hands it out to anybody," and that she did not realize she was taking Ozempic until a friend described the same nausea. Ozempic is approved for Type 2 diabetes and is often prescribed off-label for weight loss; its active ingredient, semaglutide, is also approved for obesity as Wegovy. Novo Nordisk has said it does not support off-label use of its medications.
- Business
Lilly adds $450 million to North Carolina plant as tirzepatide obesity decision nears
Eli Lilly said it will invest an additional $450 million and create at least 100 jobs at its Research Triangle Park, North Carolina, manufacturing site to expand capacity for its incretin medicines. The company said it is on track to double incretin capacity by the end of 2023, and it expects a US obesity approval for tirzepatide (Mounjaro) sometime that year.
- Regulation
FDA label update allows Rybelsus as a first-line type 2 diabetes treatment
Novo Nordisk announced on January 12, 2023 that the FDA approved a label update allowing Rybelsus (semaglutide) to be used as a first-line treatment for adults with type 2 diabetes, rather than only after other medicines had been tried. Rybelsus is an oral GLP-1 tablet first approved in 2019 and taken once daily in the morning on an empty stomach.
- Business
Judge rules Mylan's proposed generic semaglutide does not infringe one Novo Nordisk patent
A Delaware federal court ruled on July 22, 2025 that Mylan does not infringe U.S. Patent No. 9,764,003, one of five patents Novo Nordisk asserted against Mylan's application to market a generic version of semaglutide, the drug in Wegovy. The court entered judgment for Mylan on direct, contributory and induced infringement claims tied to that patent.
- Research and trials
American Academy of Pediatrics issues first childhood obesity guideline, backing weight-loss drugs for teens 12 and up
In January 2023, the American Academy of Pediatrics published its first clinical practice guideline for treating children and adolescents with obesity. Key Action Statement 12 says providers should offer adolescents 12 and older with obesity weight-loss medication alongside health behavior and lifestyle treatment, with a weaker recommendation for children aged 8 through 11. The guideline states no evidence supports medication as monotherapy.
- Culture
"Ozempic face" enters mainstream vocabulary as semaglutide coverage spreads
In January 2023, the phrase "Ozempic face" moved into everyday American vocabulary, used to describe rapid facial fat loss among people using semaglutide and to frame a wider conversation about appearance and weight. Ozempic, Wegovy and Rybelsus are all brand names for semaglutide, which is prescription-only in the US and available both as an injection under the skin and as an oral tablet. There is no clinical definition for the term, and how often such facial changes occur has not been reported.
- Culture
Remi Bader says her binge eating worsened after she stopped taking Ozempic
The plus-size fashion creator Remi Bader said she was prescribed Ozempic while she was prediabetic and that her binge eating became significantly worse after she stopped the drug, in an interview with People in January 2023. Her account was one of the earliest widely read descriptions connecting GLP-1 medications to disordered eating.
- Competition
Berberine, sold as "nature's Ozempic," lacks rigorous evidence, reviewers say
Berberine, an over-the-counter herbal supplement, went viral in 2023 as a low-cost substitute for semaglutide. UCLA Health calls the weight-loss evidence inconclusive, the American Academy of Family Physicians says the fad lacks rigorous data and carries potential harms, and the Defense Department's supplement program found that a reported weight reduction of 0.84 kg (almost 2 lbs) disappeared once low-quality studies were excluded.