GLP‑1 news from 2022
50 dated, sourced GLP-1 developments from 2022: approvals, trial results, prices, lawsuits, compounding and culture.
- Regulation
FDA adds a pediatric weight-management indication to Wegovy
On Dec. 23, 2022, the FDA extended Wegovy (semaglutide) injection's weight-management indication to patients aged 12 and older with obesity, defined as an initial BMI at or above the 95th percentile standardized for age and sex. The agency based the decision on a 68-week randomized, double-blind, placebo-controlled study in adolescents called STEP TEENS. Wegovy's earlier weight-management approval, from June 4, 2021, covered adults.
- Research and trials
FDA approves Wegovy for obesity in teens aged 12 and older
On Dec. 23, 2022, the FDA approved once-weekly Wegovy (semaglutide) injection for weight management in adolescents aged 12 and older with obesity, extending an adult approval first granted in June 2021. It was the first time a GLP-1 medicine was cleared for weight management in teenagers. The approval covers the injection only; Wegovy tablets are approved for adults.
- Regulation
Australia registers Mounjaro for type 2 diabetes, listing six pen strengths
Australia's Therapeutic Goods Administration approved Mounjaro (tirzepatide) for adults with insufficiently controlled type 2 diabetes, deciding on December 22, 2022, and registering the medicine on December 23, 2022. The registration covers six pre-filled pen strengths, from 2.5 mg to 15 mg per 0.5 mL, and lists the sponsor as Eli Lilly Australia Pty Limited.
- Regulation
FDA adds Eli Lilly's Mounjaro to national drug shortage list
The FDA added Eli Lilly's Mounjaro, known by the common name tirzepatide, to the national drug shortage list on Dec. 16, 2022, about seven months after the type 2 diabetes drug was approved. The agency said pharmacies could see delays in receiving full shipments of the 5-milligram dose through January, and a separate shortage tracker reported intermittent backorders on two other doses. Lilly's older diabetes drug Trulicity was added to the same list a day earlier.
- Compounding
FDA added tirzepatide to its drug shortage list on Dec. 15, 2022
The FDA first added tirzepatide injection products to its national drug shortage list on Dec. 15, 2022, as demand for Mounjaro outpaced supply. The listing lifted federal limits on compounding essentially copies of an approved drug, which opened the compounded tirzepatide market. The shortage was declared resolved on Oct. 2, 2024, and again on Dec. 19, 2024, after a court remanded the earlier decision.
- Research and trials
Semaglutide lowered teen BMI by 16 percent in STEP TEENS trial
The New England Journal of Medicine published STEP TEENS, a 68-week randomized trial of 201 adolescents aged 12 to 17 with obesity. Mean BMI fell 16.1 percent on semaglutide 2.4 mg versus a 0.6 percent rise on placebo, and 73 percent of the semaglutide group lost at least 5 percent of body weight versus 18 percent on placebo.
- Business
Lilly plans up to five 2023 launches, led by tirzepatide for obesity
Eli Lilly said on Dec. 13, 2022 that it hopes to launch as many as five new treatments in 2023, including tirzepatide for obesity, and projected 2023 revenue of $30.3 billion to $30.8 billion. Adjusted profit per share was forecast at $8.10 to $8.30, below analysts' estimate of $9.15, and the shares fell about 1% to $363.59.
- Research and trials
Wegovy's label now covers adolescents aged 12 and older with obesity
The Wegovy prescribing information now includes an obesity indication for pediatric patients aged 12 years and older, in addition to adults. The label states the semaglutide injection is to be used with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term, and it summarizes a pediatric weight-reduction study in patients 12 and older.
- Regulation
Health Canada approves Mounjaro for type 2 diabetes in adults
Health Canada issued a Notice of Compliance for Mounjaro (tirzepatide) to Eli Lilly Canada Inc. on Nov. 24, 2022, clearing the drug for adults with type 2 diabetes. The submission was filed Nov. 29, 2021, and the approval covers six strengths given once weekly by subcutaneous injection.
- Research and trials
Setmelanotide phase 3 trial reports weight loss in Bardet-Biedl syndrome
Setmelanotide produced at least a 10 percent body weight reduction in 32.3 percent of patients aged 12 and older with Bardet-Biedl syndrome after 52 weeks of treatment, according to phase 3 results published Nov. 7, 2022, in The Lancet Diabetes & Endocrinology. Results in the small Alström syndrome group were inconclusive. The trial enrolled 38 patients and was funded by Rhythm Pharmaceuticals.
- Research and trials
Semaglutide cut teen BMI 16.1 percent in STEP TEENS, supporting Wegovy approval for ages 12 and up
The 68-week STEP TEENS trial found that adolescents with obesity taking weekly semaglutide 2.4 mg injections had a mean BMI reduction of 16.1 percent, while those taking placebo had a 0.6 percent increase, investigators reported. On a secondary measure, 77 percent of the semaglutide group had a BMI reduction of at least 5 percent, compared with 20 percent on placebo. The data supported expanding the Wegovy label to patients 12 and older.
- Research and trials
Semaglutide 2.4 mg cut BMI 16.1% in adolescents in STEP TEENS trial
In the STEP TEENS trial, 201 adolescents aged 12 to under 18 with obesity or overweight received once-weekly semaglutide 2.4 mg or placebo for 68 weeks, both alongside a lifestyle intervention. Mean BMI fell 16.1% with semaglutide and rose 0.6% with placebo. At week 68, 73% of the semaglutide group had lost at least 5% of body weight, compared with 18% of the placebo group.
- Business
Mounjaro's first full quarter beats forecasts as weight-loss interest grows
Eli Lilly's new type 2 diabetes drug Mounjaro posted $97 million in U.S. sales in the third quarter of 2022, its first full quarter on the market, the company reported Nov. 1. Global revenue reached $187 million, well above analyst forecasts of roughly $80 million. Lilly said demand was driven partly by interest in the drug's weight-loss effects, even though it is not approved for weight loss.
- Business
Sanofi withdraws Adlyxin from the US as lixisenatide injection is listed discontinued
Sanofi says Adlyxin (lixisenatide), its once-daily injectable GLP-1 receptor agonist for type 2 diabetes, will no longer be available in the United States. The FDA's drug shortages tracker lists lixisenatide (Adlyxin) injection as discontinued; that entry was accessed on February 6, 2023. Adlyxin was approved by the FDA in 2016.
- Research and trials
STEP 5 trial reports two-year semaglutide weight loss of 15.2%
In the STEP 5 trial, adults with overweight or obesity who took weekly semaglutide 2.4 mg lost an average of 15.2% of their body weight at 104 weeks, compared with 2.6% for placebo. More than three-quarters of the semaglutide group lost at least 5% of starting weight, versus about a third on placebo. Gastrointestinal side effects were more common with the drug but were mostly mild to moderate.
- Regulation
FDA grants fast track status to tirzepatide for obesity
The FDA granted Fast Track designation to tirzepatide for chronic weight management in adults with obesity, or overweight with a weight-related condition, Eli Lilly said on Oct. 6, 2022. Lilly said it planned to begin a rolling submission of a new drug application in 2022, based mainly on the SURMOUNT-1 and SURMOUNT-2 trials. SURMOUNT-2 was expected to finish by the end of April 2023.
- Culture
Elon Musk credits Wegovy for his weight loss in a post that put a GLP-1 drug in front of millions
Elon Musk said on Twitter that he used Wegovy, Novo Nordisk's injectable semaglutide, along with fasting, to lose weight. His one-word reply "Fasting" drew 82,978 likes, and the follow-up "And Wegovy" drew 1,543. Novo Nordisk said it was not aware of his use before he posted it.
- Research and trials
Tirzepatide slowed kidney function decline versus insulin glargine in SURPASS-4 analysis
A post-hoc analysis of the SURPASS-4 trial found that adults with type 2 diabetes and high cardiovascular risk taking tirzepatide lost kidney filtration more slowly than those taking insulin glargine, about 1.4 versus 3.6 mL/min/1.73 m2 per year. Urine albumin-to-creatinine ratio climbed 36.9% with insulin glargine but did not climb with tirzepatide, a gap of -31.9% between groups. A combined kidney endpoint occurred less often on tirzepatide, with a hazard ratio of 0.58.
- Culture
Ozempic went viral in late 2022 as demand outran supply
Through late 2022, Ozempic became a mainstream cultural reference, driven by TikTok videos, celebrity speculation and coverage of off-label use for cosmetic weight loss. The attention pushed demand past what the supply chain could meet. Ozempic is a brand of semaglutide, a prescription-only medicine in the United States that is also sold as Rybelsus and Wegovy.
- Business
GLP-1 prescriptions reached 2.5 million a month before Musk's 2022 Wegovy post
GLP-1 medications were already at about 2.5 million US prescriptions a month in October 2022, when Elon Musk said on Twitter that he used Wegovy, according to IQVIA. Prescription volume more than doubled over the next year, and by the end of 2024 it had passed 9 million.
- Regulation
Japan approves Mounjaro (tirzepatide) for type 2 diabetes, a first for its drug class
Japan's Ministry of Health, Labour and Welfare approved Mounjaro (tirzepatide) for type 2 diabetes on September 26, 2022, Eli Lilly Japan and Mitsubishi Tanabe Pharma announced. The once-weekly injection was cleared in autoinjector strengths from 2.5 mg to 15 mg, based mainly on four phase 3 trials, two of them run in Japan. The same drug was approved in the United States on May 13, 2022, and launched there on June 7.
- Business
Five-year GRADE trial finds liraglutide and insulin glargine hold A1C best when added to metformin
The NIH-funded GRADE trial randomly assigned 5,047 US adults with type 2 diabetes who were already taking metformin to add insulin glargine, glimepiride, liraglutide or sitagliptin, and followed them for a mean of 5.0 years. Confirmed A1C of 7.0% or higher occurred at 26.5 per 100 participant-years with glargine and 26.1 with liraglutide, compared with 30.4 for glimepiride and 38.1 for sitagliptin. Liraglutide produced the most weight loss and the most gastrointestinal side effects, and a companion report found no material differences among the four drugs in microvascular complications or death.
- Research and trials
Tirzepatide slowed kidney function decline in SURPASS-4 analysis
A post hoc analysis of the SURPASS-4 trial found that adults with type 2 diabetes and high cardiovascular risk who took tirzepatide lost kidney filtration 2.2 mL/min/1.73 m2 per year more slowly than those taking insulin glargine. Urine albumin rose on insulin but not on tirzepatide, and a composite kidney endpoint was 42 percent less common with tirzepatide. The analysis was published September 21, 2022, in The Lancet Diabetes & Endocrinology and was funded by Eli Lilly.
- Regulation
European Commission authorizes Mounjaro for type 2 diabetes across the EU
The European Commission granted Mounjaro (tirzepatide) a marketing authorization valid throughout the European Union on September 15, 2022, for type 2 diabetes. Regulators weighed five main studies in more than 6,000 adults in which the once-weekly injection lowered HbA1c by up to 2.6 percentage points; the EU label now also covers weight management in certain adults.
- Business
Mounjaro early demand sits at high end of Lilly's expectations, analysts say
Morgan Stanley analysts who met with Eli Lilly executives said Mounjaro (tirzepatide) is tracking at the highest end of Lilly's demand expectations about four months after its U.S. approval for type 2 diabetes. Lilly said it is prepared to fully supply the U.S. market and plans to double incretin manufacturing capacity by the end of 2023. Insurance coverage stood at just over 20%, with most patients relying on copay cards.
- Regulation
Australia's TGA publishes assessment report for Wegovy in adolescents 12 and older
Australia's Therapeutic Goods Administration has published its public assessment report for Wegovy, the semaglutide injection, covering approval for weight management in adolescents ages 12 and older. The report lists a decision date of 3 January 2024 and entry onto the Australian Register of Therapeutic Goods on 29 February 2024 under five ARTG numbers. The approved wording requires a body weight above 60 kg and says treatment should be discontinued if BMI has not dropped at least 5% after 12 weeks.
- Business
Novo Nordisk buys Forma Therapeutics for $1.1 billion
Novo Nordisk agreed to acquire Forma Therapeutics for $1.1 billion in a deal dated September 1, 2022. The purchase added etavopivat, a sickle cell disease candidate, and expanded the Danish company's rare blood disorders portfolio. Novo Nordisk is best known in the US for its diabetes and obesity medicines, including Ozempic and Wegovy.
- Research and trials
Tirzepatide beats dulaglutide on A1c and weight in two Japanese phase 3 trials
Two phase 3 trials in Japan reported that weekly tirzepatide lowered A1c by 2.4 to 2.8 points at 52 weeks, compared with 1.3 points for dulaglutide 0.75 mg, and cut body weight by 5.8 to 10.7 kg versus 0.5 kg. A second trial found tirzepatide was generally tolerated as an add-on to a single oral diabetes drug, with gastrointestinal side effects being most common.
- Regulation
FDA added Ozempic to its drug shortage list on August 23, 2022
Ozempic (semaglutide) was added to the FDA's drug shortage list on August 23, 2022, about five months after Wegovy was listed on March 31, 2022. Both semaglutide injection products were declared resolved on February 21, 2025, when FDA said Novo Nordisk's supply was meeting or exceeding demand.
- Regulation
European regulators recommend Mounjaro (tirzepatide) for type 2 diabetes
A European Medicines Agency committee adopted a positive opinion on July 21, 2022, recommending authorization of Mounjaro (tirzepatide) for type 2 diabetes in adults and children aged 10 and older. The European Commission then granted the EU-wide marketing authorization on September 15, 2022. In studies reviewed by the agency, the drug lowered HbA1c by up to 2.1 to 2.6 percentage points depending on the comparison.
- Competition
FDA approves Qsymia for chronic weight management in adolescents 12 and older
The FDA approved Qsymia (phentermine and topiramate extended-release capsules) for chronic weight management in patients aged 12 and older who are obese. In a 56-week trial of 223 adolescents, BMI fell by an average of 4.8% at the 7.5/46 mg dose and 7.1% at the 15/92 mg dose, while the placebo group gained an average of 3.3%. The drug is available only through a restricted program because it can cause birth defects, and its warnings include slowed linear growth in adolescents.
- Research and trials
Tirzepatide produced 15% to 21% average weight loss in 72-week obesity trial
In the phase 3 SURMOUNT-1 trial, 2,539 adults with obesity but without diabetes were assigned to weekly tirzepatide at 5 mg, 10 mg or 15 mg, or to placebo, for 72 weeks. Average weight change was -15.0%, -19.5% and -20.9% for the three doses versus -3.1% for placebo, and 57% of the 15 mg group lost at least 20% of body weight.
- Research and trials
Tirzepatide slowed kidney function decline in SURPASS-4 analysis of adults with type 2 diabetes
A prespecified analysis of the SURPASS-4 trial, presented at the American Diabetes Association's 2022 Scientific Sessions, found that adults with type 2 diabetes and high cardiovascular risk assigned tirzepatide had a 41% lower risk of a composite kidney outcome than those assigned insulin glargine (HR 0.59; 95% CI, 0.43-0.8). New-onset macroalbuminuria fell by nearly 60% (HR 0.41; 95% CI, 0.26-0.66). The analysis covered 1,995 participants followed for up to 104 weeks.
- Research and trials
Tirzepatide lowered liver fat more than insulin degludec in SURPASS-3 MRI substudy
An MRI substudy of the phase 3 SURPASS-3 trial found that pooled tirzepatide 10 mg and 15 mg reduced liver fat content by 8.09 percentage points after 52 weeks in adults with type 2 diabetes and a fatty liver index of at least 60, compared with 3.38 points on insulin degludec. The estimated difference between the groups was -4.71 percentage points (95% CI -6.72 to -2.70; p<0.0001) among 296 participants.
- Business
Lilly commits $2.1 billion to two Indiana plants weeks after Mounjaro approval
Eli Lilly said in May 2022 that it would spend $2.1 billion on two new Indiana manufacturing plants in the LEAP research district in Boone County. The company said the plants would support as many as 500 corporate jobs and about 1,500 temporary construction jobs. The announcement came about two weeks after the FDA cleared Mounjaro (tirzepatide) for type 2 diabetes, and Lilly later expanded the same site past $13 billion.
- Science
STEP 1 extension finds two-thirds of lost weight returns a year after stopping semaglutide
In the STEP 1 trial extension, people who stopped weekly semaglutide 2.4 mg and a structured lifestyle program regained on average about two-thirds of the weight they had lost within one year. The cardiometabolic improvements that had accompanied the weight loss largely reversed along with it. The extension was published in the journal Diabetes, Obesity and Metabolism on April 19, 2022.
- Prices
Mounjaro's 2022 approval set a $1,023 list price and exclusivity running to 2027
The FDA approved Eli Lilly's tirzepatide as Mounjaro for type 2 diabetes in May 2022, and the drug's US list price has been about $1,023 a month. The approval also started new chemical entity exclusivity that runs to May 13, 2027, while patents listed with the FDA run to 2036 and 2039.
- Safety
Mounjaro still carries a boxed warning on thyroid C-cell tumors and an MTC contraindication
Tirzepatide came to the U.S. market in 2022 as Mounjaro with a boxed warning that it causes thyroid C-cell tumors in rats and a contraindication for people with a personal or family history of medullary thyroid carcinoma or MEN 2. The prescribing information dated August 27, 2026 still contains both, while the label has meanwhile gained a pediatric indication and a cardiovascular indication.
- Regulation
FDA approves Mounjaro, first dual-hormone diabetes drug from Eli Lilly
The FDA approved Mounjaro (tirzepatide) on May 13, 2022, for adults with type 2 diabetes, making it the first US-approved drug that acts on both the GIP and GLP-1 hormone receptors. The once-weekly injection comes in six dose strengths from 2.5 mg to 15 mg and carries a boxed warning about thyroid C-cell tumors seen in rodents. In the SURPASS trials, average A1C reductions ranged from 1.8% to 2.4% depending on dose, and participants lost 12 lb to 25 lb on average, though the drug is not indicated for weight loss.
- Safety
Mounjaro label carries a four-week oral contraceptive warning semaglutide labels lack
Mounjaro (tirzepatide) has carried an oral-contraceptive instruction since its 2022 U.S. approval that semaglutide products do not: patients using oral hormonal contraceptives should switch to a non-oral method or add a barrier method for four weeks after starting the drug and for four weeks after each dose increase. The label ties the advice to delayed gastric emptying, and doses rise in 2.5 mg steps at least four weeks apart, up to 15 mg weekly for adults.
- Business
Wegovy joined FDA's shortage list in March 2022, ten months after approval
Wegovy (semaglutide) was added to the FDA's national drug shortage list on March 31, 2022, and Ozempic followed on August 23, 2022, as demand outran supply. The agency declared the semaglutide injection shortage resolved on February 21, 2025, and gave compounding pharmacies 60 and 90 days to stop making copies of the approved products.
- Research and trials
Tirzepatide produced up to 22.5% weight loss in Lilly's phase 3 SURMOUNT-1 trial
Eli Lilly reported on April 28, 2022 that tirzepatide, an unapproved once-weekly injection, produced average weight loss of 16.0% to 22.5% over 72 weeks across three doses in the phase 3 SURMOUNT-1 trial of 2,539 adults with obesity or overweight and no diabetes. Placebo participants lost 2.4% on average, and 63% of those on the 15 mg dose lost at least 20% of their body weight. Lilly shares rose about 3%.
- Science
Tirzepatide shows greater improvements than semaglutide in 28-week islet function trial
A 28-week Phase 1 trial published April 22, 2022 in The Lancet Diabetes & Endocrinology compared tirzepatide 15 mg with semaglutide 1 mg and placebo in adults with type 2 diabetes. Using glucose clamps, the study reported greater improvements in insulin sensitivity and insulin secretion with tirzepatide. The trial measured laboratory markers of pancreatic islet function, not long-term clinical outcomes.
- Research and trials
STEP 1 extension finds most lost weight returns within a year of stopping semaglutide
An off-treatment extension of the STEP 1 trial followed 327 participants for one year after weekly semaglutide 2.4 mg and a lifestyle program stopped at week 68. Mean weight loss of 17.3% fell to a net 5.6% below starting weight by week 120, and cardiometabolic improvements reverted toward baseline.
- Regulation
FDA approves higher-dose Ozempic 2 mg pen for type 2 diabetes
On March 28, 2022, the FDA approved a 2 mg dose of Ozempic (semaglutide), a higher-strength weekly injection for adults with type 2 diabetes than the 0.5 mg and 1 mg doses already on the market. The 2 mg dose comes in an 8 mg/3 mL pen containing four doses, and the label allows it after at least four weeks at 1 mg. The approval announcement did not include A1C figures comparing 2 mg with 1 mg.
- Science
Study maps how tirzepatide binds its two target receptors
A paper published in March 2022 in PNAS reported cryo-EM structures of tirzepatide bound to the GIP receptor at 3.1-angstrom resolution and to the GLP-1 receptor at 2.9 angstroms, plus the GIP receptor bound to native GIP at 3.2 angstroms. Tirzepatide activated the GIP receptor much as native GIP does, but at the GLP-1 receptor its N-terminal tyrosine made only a weak contact, its affinity was about fivefold weaker than GLP-1's, and its signaling was biased toward cAMP with less receptor desensitization.
- Regulation
FDA added Wegovy to its drug shortage list in March 2022, opening the door to compounded semaglutide
The FDA put Wegovy on its national drug shortage list on March 31, 2022, after demand outstripped Novo Nordisk's supply of semaglutide pens. Ozempic, the same molecule, followed on August 23, 2022. The listing let compounding pharmacies make their own semaglutide copies until the FDA declared the shortage resolved on February 21, 2025.
- Science
Study maps how tirzepatide grips its two hormone receptors
In February 2022, researchers published cryo-electron microscopy structures of tirzepatide bound to the human GIPR and GLP-1R receptors, plus structures of the experimental triagonist peptide 20 bound to GIPR, GLP-1R and GCGR — five structures in all. The tirzepatide-bound GIPR complex was deposited in the Protein Data Bank as 7FIY. The authors say the images show, at near-atomic detail, how dual and triple agonists act differently from single-receptor drugs such as semaglutide.
- Business
Trial finds weekly semaglutide outperforms daily liraglutide on weight loss
A head-to-head phase 3b trial published Jan. 11, 2022, in JAMA found that weekly semaglutide 2.4 mg produced a mean 15.8% weight loss over 68 weeks, compared with 6.4% for daily liraglutide 3.0 mg, in 338 adults with overweight or obesity who did not have diabetes. Gastrointestinal side effects were reported at nearly identical rates in both groups, but 27.6% of the liraglutide group discontinued treatment versus 13.5% of the semaglutide group.
- Regulation
European Commission authorizes Wegovy for weight management across the EU
The European Commission granted Wegovy an EU-wide marketing authorization on 6 January 2022, clearing the semaglutide medicine for weight management alongside diet and physical activity. In trials summarized by the European Medicines Agency, adults using the weekly injection lost an average of 15% to 16% of body weight over 68 weeks, compared with 2% to 6% on placebo. A daily tablet form averaged about 14% loss over 64 weeks versus about 2% on placebo.