GLP‑1 news from 2022
51 dated, sourced GLP-1 developments from 2022: approvals, trial results, prices, lawsuits, compounding and culture.
- FDA & regulation
FDA approves Wegovy for adolescents aged 12 and up
The FDA expanded Wegovy's label to include pediatric patients aged 12 years and older with obesity. The approval followed the STEP TEENS trial and made semaglutide an option for adolescents when lifestyle changes alone were not enough.
- Research
STEP TEENS underpins the adolescent Wegovy approval
The pediatric expansion of Wegovy rested on the STEP TEENS trial in adolescents aged 12 and older with obesity. It was the first time a GLP-1 was cleared for weight management in teenagers.
- FDA & regulation
TGA registers Mounjaro in Australia
Australian registration for type 2 diabetes, decided December 22 and registered December 23, 2022.
- Compounding
FDA adds tirzepatide injection to the drug shortage list
Demand for Mounjaro outstrips supply and tirzepatide goes on FDA's shortage list. Shortage listing is the legal trigger that lets 503A pharmacies and 503B outsourcing facilities compound copies of an approved drug, which is what opened the compounded tirzepatide market.
- Research
STEP TEENS published: semaglutide cuts BMI 16.1 percent in adolescents
The New England Journal of Medicine published STEP TEENS, a 68-week randomized placebo-controlled trial in 201 adolescents aged 12 to 17 with obesity. Mean BMI fell 16.1 percent on semaglutide 2.4 mg versus a 0.6 percent increase on placebo, and 77 percent of the semaglutide group achieved at least a 5 percent BMI reduction versus 20 percent on placebo.
- Business
Lilly says new launches will push 2023 revenue past $30 billion
At its year-ahead briefing the company laid out as many as five launches, with tirzepatide for obesity the one investors cared about. The forecast set the expectations that the Zepbound approval later met.
- Research
FDA expands Wegovy to patients 12 and older with obesity
On the strength of STEP TEENS, the Wegovy injection label established safety and effectiveness for weight reduction and long-term weight maintenance in pediatric patients aged 12 and older with a BMI at or above the 95th percentile for age and sex.
- Research
Setmelanotide phase 3 results published for Bardet-Biedl syndrome
The Lancet Diabetes & Endocrinology reported that 32.3 percent of patients aged 12 and older with Bardet-Biedl syndrome reached at least a 10 percent body weight reduction after 52 weeks of setmelanotide. Results in the small Alstrom syndrome group were inconclusive, which is why the US indication covers Bardet-Biedl syndrome only.
- Research
STEP TEENS reports 16.1 percent BMI reduction in adolescents
A 68-week trial in 201 adolescents aged 12 to 17 with obesity found mean BMI fell 16.1 percent on semaglutide 2.4 mg versus a 0.6 percent increase on placebo. The data supported the FDA's December 2022 expansion of Wegovy to ages 12 and older.
- Research
STEP TEENS extends semaglutide evidence to adolescents
BMI fell 16.1% with semaglutide versus a 0.6% rise on placebo in 201 adolescents, supporting the pediatric Wegovy indication granted in December 2022.
- Business
Mounjaro's first full quarter beats expectations and fuels off-label use
Lilly reported third-quarter Mounjaro sales well above analyst forecasts in only its second quarter on the market. Executives described the launch as spreading by word of mouth, and coverage at the time noted that much of the early demand came from people seeking weight loss rather than diabetes care.
- Business
Sanofi announces it will pull Adlyxin from the US
Sanofi says Adlyxin will no longer be available in the US, citing competition from newer therapies and the product's financial performance. It leaves the market on January 1, 2023, and lixisenatide survives in the US only inside Soliqua 100/33.
- Research
STEP 5 shows two-year durability of semaglutide weight loss
Weight loss reached 15.2% at 104 weeks versus 2.6% on placebo, plateauing rather than reversing while treatment continued.
- FDA & regulation
FDA grants tirzepatide fast track status for obesity
The FDA gave tirzepatide fast track designation for chronic weight management in adults with obesity or overweight with a weight-related condition, a procedural step that allowed Lilly to submit its obesity application in pieces and set up the 2023 Zepbound decision.
- Research
SURPASS-4 post hoc analysis shows slower kidney decline with tirzepatide than insulin
In 1,995 participants at high cardiovascular risk, eGFR fell 1.4 mL/min/1.73 m2 per year on tirzepatide versus 3.6 on insulin glargine. Urine albumin-to-creatinine ratio rose 36.9% on insulin but not on tirzepatide, a between-group difference of -31.9%.
- Culture
Ozempic goes viral as a weight-loss shortcut on social media
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 fueled demand that the supply chain could not meet.
- Business
US GLP-1 prescriptions pass 2.5 million a month before demand inflects
IQVIA recorded roughly 2.5 million GLP-1 prescriptions per month across all indications before Elon Musk's October 2022 post about Wegovy. Volume more than doubled over the following year.
- FDA & regulation
Japan approves Mounjaro for type 2 diabetes
Eli Lilly Japan and Mitsubishi Tanabe Pharma announced Japanese approval of the first sustained-release GIP and GLP-1 receptor agonist for type 2 diabetes there.
- Business
GRADE puts liraglutide through an independent five-year test
The NIH-funded GRADE trial randomized 5,047 US adults on metformin to add insulin glargine, glimepiride, liraglutide or sitagliptin. Over five years glargine and liraglutide were the most effective at holding A1C under 7%, and liraglutide produced the most weight loss and the most gastrointestinal side effects.
- Research
SURPASS-4 post hoc analysis reports slower kidney function decline with tirzepatide
A post hoc analysis of 1,995 adults with type 2 diabetes and high cardiovascular risk found kidney filtration declined 2.2 mL/min/1.73 m2 per year more slowly on tirzepatide than on insulin glargine, urine albumin rose on insulin but not on tirzepatide, and a composite kidney endpoint was 42 percent less common. It was the first signal that tirzepatide might protect the kidney.
- FDA & regulation
European Commission authorizes Mounjaro
EU-wide marketing authorization for type 2 diabetes, held by Eli Lilly Nederland B.V.
- Business
Analysts flag unusually strong early demand for Mounjaro
Four months after launch, prescription trackers showed Mounjaro ramping faster than most diabetes drugs ever had. Lilly told investors the uptake was driven partly by prescribing for weight loss, which the label did not yet cover.
- FDA & regulation
Australia registers Wegovy on the ARTG
The TGA entered Wegovy on the Australian Register of Therapeutic Goods, though the product did not reach pharmacies until August 2024.
- Business
Novo Nordisk acquires Forma Therapeutics for $1.1 billion
The deal added sickle cell disease candidate etavopivat and expanded the rare blood disorders portfolio.
- Research
SURPASS J-mono and J-combo report Japanese phase 3 results
SURPASS J-mono (n=636) found HbA1c reductions 1.1 to 1.5 points greater than dulaglutide 0.75 mg at week 52, with weight loss of 5.8 to 10.7 kg. SURPASS J-combo (n=443) reported one-year safety data with tirzepatide added to a single oral diabetes drug.
- FDA & regulation
Ozempic added to the FDA drug shortage list
The FDA listed Ozempic as being in shortage in August 2022, five months after Wegovy. Off-label prescribing of Ozempic for weight loss contributed to the supply squeeze that left some people with type 2 diabetes unable to fill prescriptions.
- FDA & regulation
CHMP adopts a positive opinion on Mounjaro
The EU committee recommended authorization of tirzepatide for type 2 diabetes.
- Competition
Qsymia approved for patients aged 12 and older
In a 56-week trial of 223 adolescents, Qsymia 7.5/46 mg and 15/92 mg reduced BMI by 4.8% and 7.1% respectively, while the placebo group gained 3.3% of BMI.
- Research
SURMOUNT-1 reports 20.9% average weight loss and reshapes the obesity field
In 2,539 adults with obesity and without diabetes, tirzepatide produced mean weight changes of -15.0%, -19.5% and -20.9% versus -3.1% on placebo at week 72. More than half of the 15 mg group lost at least 20% of their body weight, a result no prior obesity drug had matched in a phase 3 trial.
- Research
SURPASS-4 analysis shows tirzepatide slowing kidney decline in type 2 diabetes
A prespecified analysis of the SURPASS-4 cardiovascular safety trial, presented at the American Diabetes Association meeting, reported that tirzepatide slowed the loss of kidney function and reduced new or worsening albuminuria compared with insulin glargine in adults with type 2 diabetes at high cardiovascular risk.
- Research
SURPASS-3 MRI sub-study reports a large drop in liver fat with tirzepatide
In 296 SURPASS-3 participants with a fatty liver index of at least 60, pooled tirzepatide 10 mg and 15 mg reduced liver fat content by 8.09 percentage points versus 3.38 on insulin degludec, an estimated difference of -4.71% (95% CI -6.72 to -2.70).
- Business
Lilly announces its first $2.1 billion for the LEAP District in Lebanon, Indiana
Lilly announced two new manufacturing sites in Boone County, Indiana, an early move in what became the largest factory build-out in the company's history. The plants were tied to demand for its incretin medicines, which at that point meant Mounjaro and Trulicity.
- Science
STEP 1 extension shows two-thirds of lost weight returns after stopping
One year after both semaglutide 2.4 mg and the structured lifestyle program were withdrawn, participants had regained on average two-thirds of the weight they lost, and cardiometabolic gains largely reversed with it.
- Prices
FDA approves Mounjaro, and the tirzepatide pricing clock starts
Eli Lilly's tirzepatide was approved for type 2 diabetes as Mounjaro at a US list price of roughly $1,023 per month. The approval date also set the five-year New Chemical Entity exclusivity running to May 13, 2027 and the NCE-1 challenge date of May 13, 2026.
- Safety
Mounjaro approved with a thyroid C-cell boxed warning
FDA approved tirzepatide as Mounjaro for type 2 diabetes. It arrived with the same boxed warning the GLP-1 class carries, based on dose-dependent thyroid C-cell tumors in rats, and the same absolute contraindication in people with a personal or family history of medullary thyroid carcinoma or with MEN 2. Those two items have never come off either tirzepatide label.
- FDA & regulation
Mounjaro's first label sets a six-dose ladder from 2.5 mg to 15 mg
The FDA approved Mounjaro under priority review as the first dual GIP and GLP-1 receptor agonist for adults with type 2 diabetes. The label the agency posted that day describes a starting dose of 2.5 mg once weekly, stepping up over months to a maximum of 15 mg, and carries a boxed warning about thyroid C-cell tumors seen in rodents.
- Search trends
Mounjaro approval creates a US brand term that means one thing here and another abroad
FDA approved Mounjaro for type 2 diabetes. Because the same brand name was later licensed for weight management in the United Kingdom, US searches for 'Mounjaro weight loss' have been served UK content ever since. This is the single most persistent disambiguation problem in the tirzepatide query set and the reason a US Mounjaro hub has to open by stating what the US label covers.
- Safety
Mounjaro launches with an oral contraceptive warning no semaglutide product carries
Because tirzepatide slows stomach emptying more sharply than GLP-1 agonists after the first dose, its label told people using oral hormonal contraceptives to switch to a non-oral method or add a barrier method for four weeks after starting and after every dose increase. Semaglutide labeling has never carried that instruction. It remains the clearest labeled difference between the two drugs.
- Research
Lilly reports up to 22.5% weight loss in the first SURMOUNT-1 topline
Eli Lilly said tirzepatide, then approved nowhere, had produced average weight loss of 16.0% to 22.5% over 72 weeks in SURMOUNT-1, a trial of 2,539 adults with obesity or overweight without diabetes. The readout reset expectations for how much weight a drug could take off and pushed Lilly shares higher.
- Science
Mechanism-of-action trial compares tirzepatide with semaglutide using glucose clamps
Heise et al. publish a 28-week Phase 1 trial in Lancet Diabetes & Endocrinology comparing tirzepatide 15 mg, semaglutide 1 mg and placebo. Tirzepatide produced greater improvements in clamp-derived insulin sensitivity and insulin secretion.
- Research
STEP 1 extension shows most weight comes back after semaglutide stops
Diabetes, Obesity and Metabolism published the off-treatment extension of STEP 1, following 327 participants for a year after both semaglutide 2.4 mg and the structured lifestyle program stopped at week 68. Mean weight loss at week 68 was 17.3%; by week 120 the semaglutide group had regained 11.6 percentage points, ending 5.6% below baseline. Cardiometabolic measures reverted toward baseline. This is the source of the widely quoted 'about two-thirds comes back in a year' figure.
- Science
PNAS paper explains the structural basis of tirzepatide's dual agonism
Sun et al., working with Brian Kobilka's group, publish cryo-EM and molecular dynamics work showing tirzepatide activates the GIP receptor much as native GIP does but engages the GLP-1 receptor differently, producing less agonist-induced desensitization. The fatty acid chain and the GIP-derived N-terminal tyrosine both contribute.
- FDA & regulation
Wegovy added to the FDA drug shortage list
The FDA added semaglutide injection products for weight management to its drug shortage list in March 2022 as demand outstripped Novo Nordisk's ability to supply pens. The shortage listing later opened the legal door for compounding pharmacies to make their own semaglutide.
- Science
First cryo-EM structures of tirzepatide bound to both incretin receptors
Zhao and colleagues publish structures in Nature Communications of tirzepatide bound to human GIPR-Gs and GLP-1R-Gs at 3.4 angstrom resolution (PDB 7FIY and 7FIM), alongside triagonist peptide 20 complexes.
- Business
STEP 8 puts a number on the gap: semaglutide 15.8% versus liraglutide 6.4%
JAMA publishes the only head-to-head phase 3b trial of weekly semaglutide 2.4 mg against daily liraglutide 3.0 mg. Over 68 weeks in 338 adults, mean weight change was -15.8% versus -6.4%. Gastrointestinal adverse events were nearly identical at 84.1% and 82.7%, but 27.6% of the liraglutide arm discontinued versus 13.5% of the semaglutide arm.
- FDA & regulation
European Commission authorizes Wegovy
Wegovy received an EU-wide marketing authorization for weight management.