Peptide news
A running record of approvals, trial results, regulatory actions and safety signals. Every item links to its source.
October 2026
OP18 helps cultured immune cells clear traps formed after radiation exposure
A study in Frontiers in Immunology tested OP18, an experimental peptide with 18 amino acids, in cultured mouse macrophages, a type of immune cell. OP18 increased uptake and breakdown of extracellular traps, webs of DNA and proteins released by macrophages exposed to radiation. Cells clearing these traps showed improved energy metabolism and increased release of the anti-inflammatory signal IL-10. These cell experiments do not establish protection from radiation injury or clinical benefit in people.
MOTS-c protects retinal blood-vessel cells in mouse and laboratory models
A study in Cell Death Discovery examined MOTS-c in cultured human retinal blood-vessel cells and mice with experimentally induced diabetes. The peptide reduced damage to the vascular barrier and improved mitochondrial function in these models. Experiments implicated PLA2G6, an enzyme involved in lipid metabolism, and reducing its expression blocked the protective effect. These preclinical findings do not establish that MOTS-c prevents or treats diabetic eye disease in people.
Oral teriparatide phase 3 study design announced for osteoporosis
Entera Bio announced that it would present the design of a planned phase 3 trial of oral teriparatide (PTH(1-34), development code EB613) at the American Society for Bone and Mineral Research annual meeting. The proposed randomized, double-blind, placebo-controlled trial would study postmenopausal women with osteoporosis. The announcement describes a study plan, not phase 3 efficacy results; the oral formulation remains investigational.
Petrelintide phase 2 trial reports weight loss in adults with type 2 diabetes
Zealand Pharma reported preliminary results from ZUPREME-2, a phase 2 trial of petrelintide in 220 adults with overweight or obesity and type 2 diabetes. At 28 weeks, mean weight loss was 7.4% to 9.2% across study groups versus 2.0% with placebo, using an analysis that assumes participants remained on treatment. Gastrointestinal side effects led 1.9% of petrelintide recipients and 1.7% of placebo recipients to stop treatment. Petrelintide remains investigational, and these findings are a company topline report.
New method builds bicyclic peptide libraries for laboratory screening
Researchers reporting in Nature Communications developed PReP-Bicyc, a method for giving peptides two molecular rings while keeping them compatible with phage display, a laboratory screening technique. The method allowed researchers to screen peptide libraries and identify molecules that bound to the protein PD-1 and reduced its interaction with PD-L1 in laboratory tests. This expands tools for studying peptide structure and target binding. The study did not test a treatment in people.
REMODEL: primary kidney MRI outcomes show no significant difference versus placebo
The REMODEL study, published in Nature Medicine, compared semaglutide with placebo over 52 weeks in 106 adults with type 2 diabetes and chronic kidney disease. It found no statistically significant differences in the primary MRI measures of kidney oxygenation, blood flow and tissue inflammation. Secondary analyses, including smaller kidney biopsy subgroups, suggested effects on resistance to blood flow, markers of scarring and blood-vessel cells. These secondary findings offer possible explanations for kidney protection but do not establish a new clinical benefit.
STEP UP exploratory analysis finds reduced liver fat with semaglutide
Novo Nordisk presented an exploratory, post hoc analysis from a 55-person imaging subgroup of STEP UP at EASD. Among 26 participants with elevated liver fat who received semaglutide, 23 (88.5%) had liver fat below 5% at week 72. The analysis pooled semaglutide treatment groups and was not a prespecified main trial outcome. This small subgroup finding does not establish reversal of liver scarring or long-term clinical benefit.
SYNCHRONIZE-2: survodutide reduces weight in adults with type 2 diabetes
Phase 3 SYNCHRONIZE-2 results were presented at EASD and published in the New England Journal of Medicine, covering 755 adults with overweight or obesity and type 2 diabetes. At 76 weeks, mean weight loss reached 13.1% versus 3.1% with placebo in an analysis that assumes participants remained on treatment. Gastrointestinal side effects caused treatment discontinuation in 18% of survodutide recipients versus 1.2% with placebo. Survodutide remains investigational and has not been approved for use.
September 2026
Eloralintide with tirzepatide reduces weight in phase 2b trial
Eli Lilly reported phase 2b results for investigational eloralintide with tirzepatide in 367 adults with overweight or obesity and type 2 diabetes. At 48 weeks, the combination group with the largest mean weight reduction lost 23.3%, compared with 14.8% for tirzepatide alone and 3.0% for placebo, using an analysis that assumes participants remained on treatment. Adverse events led to treatment discontinuation in 10.8% to 27.0% of combination recipients, versus 2.9% with tirzepatide alone and 16.7% with placebo; stomach and intestinal events were most common. These company-reported conference results concern an investigational combination, with phase 3 studies still planned at the time of the announcement.
TRIUMPH-1 paper reports 25.0% weight loss with retatrutide at 80 weeks
The New England Journal of Medicine published TRIUMPH-1, a phase 3 trial of investigational retatrutide in 2,339 adults with obesity without diabetes. At 80 weeks, mean weight loss reached 25.0% in the highest study group versus 3.9% with placebo, using an intention-to-treat analysis that includes treatment discontinuations. This differs from the 28.3% estimate in Lilly's earlier topline report, which assumed continued treatment. Gastrointestinal adverse events were the most common, and retatrutide remains unapproved.
FDA approves Onswik (efsitora), a second once-weekly basal insulin for type 2 diabetes
The FDA approved Eli Lilly's Onswik (insulin efsitora alfa-gobe), a basal insulin injected once a week, for adults with type 2 diabetes. In each of the four QWINT phase 3 trials, which together evaluated it in more than 3,400 adults, it lowered A1C (average blood sugar) by an amount non-inferior to daily insulin glargine or insulin degludec. It is the second once-weekly basal insulin approved in the US, after Novo Nordisk's Awiqli (insulin icodec) in March 2026, and its label says it should not be used in type 1 diabetes because of a higher risk of severe hypoglycaemia.
Petrelintide enters phase 3 ZUPREME program targeting about 7,000 participants
Zealand Pharma announced the start of the phase 3 ZUPREME program evaluating petrelintide, an investigational peptide that mimics the hormone amylin, against placebo in adults with overweight or obesity. Three trials, ZUPREME-3, ZUPREME-4 and ZUPREME-5, are expected to enroll approximately 7,000 participants across populations without type 2 diabetes, with type 2 diabetes, or with established cardiovascular disease. Their primary outcome is percentage change in body weight at 64 weeks. The announcement concerns trial initiation and planned enrollment, not phase 3 results or regulatory approval.
FDA says compounded GLP-1s with added vitamins are still copies of approved drugs
In a September 18, 2026 warning letter to a large Houston compounding pharmacy, the FDA said its tirzepatide with niacinamide and semaglutide with cyanocobalamin (vitamin B12) injections were essentially copies of FDA-approved drugs. The agency said the volume produced suggested the claimed differences from the approved products were pretextual, and it criticized templated prescription justifications. Under section 503A, pharmacies may not regularly compound copies of approved drugs unless a prescriber documents a significant clinical difference for the individual patient.
TGA finds undeclared semaglutide in counterfeit retatrutide after hospitalization
Australia's TGA reported a hospitalization after severe vomiting from a product sold as retatrutide caused a torn oesophagus. Laboratory testing found no retatrutide and instead detected undeclared semaglutide at approximately 8 times the level in registered semaglutide products. The alert concerns a counterfeit product, not retatrutide administered in a clinical trial. The TGA said retatrutide remains unapproved and warned against using unapproved peptide products.
WADA keeps GLP-1 drugs off its 2027 Prohibited List and continues monitoring
The World Anti-Doping Agency's Executive Committee confirmed that GLP-1 receptor agonists such as semaglutide and tirzepatide will not be banned under the 2027 Prohibited List, which takes effect on January 1, 2027. They stay in WADA's Monitoring Program, which tracks use through testing without sanctions, while the agency gathers data on possible performance effects and misuse. Semaglutide entered the monitoring program in 2024 and tirzepatide in 2026.
Vosoritide speeds growth in children with hypochondroplasia in phase 3 trial
NEJM Evidence published CANOPY-HCH-3, a phase 3 trial of vosoritide (Voxzogo), a C-type natriuretic peptide analogue already approved for achondroplasia, in 81 children with hypochondroplasia, a rare genetic skeletal dysplasia that causes short stature. After 52 weeks, annualised growth velocity rose by 1.95 cm per year with vosoritide and fell by 0.39 cm per year with placebo, a difference of 2.33 cm per year, with no grade 3 or higher adverse events. BioMarin has applied for US approval, with an FDA decision expected by February 28, 2027; no medicine is currently approved by the FDA or EMA for hypochondroplasia.
Redasemtide phase 2 stroke trial misses its primary endpoint
Shionogi reported that a global phase 2 trial of redasemtide, an investigational peptide derived from the HMGB1 protein, did not meet its primary endpoint in acute ischemic stroke. Disability at 90 days, measured using the modified Rankin Scale, did not improve significantly versus placebo in the group that had not received treatment to reopen blocked blood vessels. Exploratory subgroup findings suggested possible benefit in more severe cases, but they do not overturn the negative primary result. The company reported comparable adverse-event rates and said future development would be considered after further analysis.
Mouse study traces peptide preparations' cholesterol effects to TFA
A Nature Communications study found that trifluoroacetate (TFA), a charged component often present in synthetic peptide salts, had metabolic effects of its own in mice and cultured liver cells. Cholesterol reductions seen with several peptide preparations were traced to TFA, and replacing it with chloride in one peptide preparation removed that effect. The findings show why studies need controls that separate a peptide's activity from the effects of accompanying chemicals. These animal and cell results do not establish safety or benefit in people.
Review of 565 studies finds little human evidence for popular injectable peptides
UCLA researchers reviewed 565 studies of six compounds marketed for recovery and performance: BPC-157, TB-500, CJC-1295, ipamorelin, GHK-Cu and the non-peptide MK-677. More than two-thirds of the studies were in animals only, and the few human studies were small, poorly controlled and showed modest benefits at best. Published in The American Journal of Sports Medicine, the review also flagged safety concerns, including heart failure risk seen with MK-677 and possible contamination of unregulated products.
August 2026
ESC heart failure guidelines back semaglutide or tirzepatide in HFpEF with obesity
The European Society of Cardiology published its 2026 heart failure guidelines at ESC Congress 2026. They add a Class IIa recommendation for semaglutide or tirzepatide in people with heart failure with preserved ejection fraction (HFpEF) and obesity. The guidelines also give mineralocorticoid receptor antagonists a Class I recommendation in chronic heart failure regardless of ejection fraction.
FDA approves Mounjaro to lower heart attack, stroke and CV death risk in type 2 diabetes
The FDA approved Mounjaro (tirzepatide) to lower the risk of cardiovascular death, non-fatal heart attack and non-fatal stroke in adults with type 2 diabetes who are at high risk of these events, Eli Lilly announced. The approval rests on SURPASS-CVOT, which randomised 13,299 people to tirzepatide or to dulaglutide (Trulicity), a GLP-1 medicine with established cardiovascular benefit, rather than to placebo: tirzepatide was non-inferior, with a hazard ratio of 0.92 (95.3% CI 0.83 to 1.01), so it was not shown to be better than dulaglutide. The EMA's CHMP declined the same indication in June 2026, so the US and EU labels now differ.
FDA approves rusfertide (Mimrylo) for adults with polycythemia vera
The FDA approved Mimrylo (rusfertide) for adults with polycythemia vera, a disorder that causes excess red blood cell production. It is the first approved medicine for this condition that mimics the iron-regulating hormone hepcidin. Approval was based on the 293-participant VERIFY trial, which found a reduced need for blood-removal procedures (phlebotomy) compared with placebo. Injection-site reactions and anemia were the most common adverse reactions.
Appeals court upholds FDA decisions ending the tirzepatide and semaglutide shortages
The US Court of Appeals for the Fifth Circuit rejected the Outsourcing Facilities Association's challenges to the FDA's decisions to take tirzepatide and semaglutide injections off the drug shortage list, affirming lower court rulings for the agency in two unpublished opinions. The court found that any failure to use notice-and-comment procedures was harmless and that the FDA's action was not arbitrary or capricious. The shortage listing had been the legal basis for pharmacies and outsourcing facilities to compound copies of these drugs, so the rulings leave that route closed.
FDA warning letters reject 'research use only' labels on online GLP-1 peptide sales
In warning letters dated August 24, 2026, the FDA told online sellers that products such as retatrutide, tirzepatide, semaglutide, survodutide, mazdutide, bremelanotide (PT-141), tesamorelin and tesamorelin-ipamorelin blends were unapproved new drugs. The agency rejected 'for laboratory, research, and analytical use' disclaimers, citing therapeutic claims, bacteriostatic water for reconstitution and a dosing calculator as evidence of intended human use. Similar letters went to other peptide sellers earlier in 2026, including in March.
Australian regulator seizes illegal peptides allegedly sold by a social media influencer
The TGA and NSW Police executed search warrants at two New South Wales homes on August 4, 2026, seizing more than 120,000 Australian dollars of illicit peptide and anabolic steroid products, including retatrutide, CJC-1295 and a BPC-157 and TB-500 blend. The influencer allegedly imported and relabeled the products and sold them through social media and a website despite a prior TGA warning. The TGA had made unapproved peptides a compliance priority in June 2026.
July 2026
Paradigm Peptides owner sentenced to 70 months for selling unapproved drugs
A federal judge in Indiana sentenced the owner of Paradigm Peptides, an online peptide seller marketed for research use, to 70 months in prison after he pleaded guilty to selling unapproved drugs; his sister, the company's main employee, received 16 months. Prosecutors estimated the company had 54,000 customers in all 50 US states and 80 countries, and the owner agreed to forfeit $5 million. The unapproved drugs he was charged with selling included BPC-157, and he admitted forging laboratory certificates for the products.
Canadian court permanently bars Canlab Research from selling injectable peptides
Health Canada announced that the Superior Court of Québec granted it a permanent injunction on June 11, 2026 against Canlab Research, an online seller of unauthorized injectable peptides, and its representatives. The order bars them from making, testing, distributing, selling or advertising these products, including through websites and social media reachable from Canada. Health Canada said the company kept selling despite earlier enforcement, including a Ministerial Order, and noted that injectable peptides are prescription drugs in Canada that must be authorized before they can be sold.
FDA advisers back compounding of semax and epitalon, narrowly reject DSIP
On the second day of its peptide review, the FDA's Pharmacy Compounding Advisory Committee voted 8 to 5 to recommend semax (reviewed for migraine, cerebral ischemia and trigeminal neuralgia) and 7 to 4 for epitalon (reviewed for insomnia) for the 503A bulk substances list. It voted 6 to 7 against emideltide (DSIP), proposed for opioid withdrawal, chronic insomnia and narcolepsy. FDA staff had recommended against all three, and the agency is not bound by the votes.
FDA advisers vote to allow compounding of BPC-157, KPV, TB-500 and MOTS-c
The FDA's Pharmacy Compounding Advisory Committee voted 8 to 6, with one abstention, to recommend adding BPC-157, KPV and TB-500 to the 503A bulk substances list, and 7 to 5 with two abstentions for MOTS-c, overruling FDA staff who recommended against all four. Agency scientists cited insufficient safety and efficacy data and the lack of a universally accepted chemical specification for these products. The votes are advisory; the FDA makes the final decision through notice-and-comment rulemaking.
Retatrutide succeeds in TRIUMPH-2 and TRIUMPH-3; Lilly plans FDA filing in 2027
Eli Lilly reported two more positive phase 3 trials of retatrutide. In TRIUMPH-2 (1,152 adults with type 2 diabetes and obesity or overweight), weight fell 12.7%, 19.1% and 20.8% on 4, 9 and 12 mg at 80 weeks versus 4.0% on placebo, with A1C down by up to 1.6 points. In TRIUMPH-3 (1,949 adults with severe obesity and cardiovascular disease), weight fell 21.6% on 9 mg and 22.6% on 12 mg versus 3.2% on placebo. Lilly said it plans to submit retatrutide to the FDA in the first quarter of 2027.
BMJ study links GLP-1 diabetes drugs to a higher risk of non-scarring hair loss
A target trial emulation in The BMJ, using University of Pennsylvania health records, compared adults with type 2 diabetes who started a GLP-1 receptor agonist with those who started an SGLT-2 or DPP-4 inhibitor. GLP-1 drug use was associated with a higher risk of alopecia (hazard ratio 1.37 versus SGLT-2 inhibitors and 1.68 versus DPP-4 inhibitors), and the excess was in non-scarring hair loss. Absolute rates were low, 6.91 versus 5.04 cases per 1,000 person-years in the first comparison, and the study is observational, so it cannot show that the drugs cause hair loss.
BMJ review of 262 trials: semaglutide the only obesity drug linked to lower mortality
A network meta-analysis in The BMJ pooled 262 randomised trials with 99,791 adults with overweight or obesity, comparing 19 drugs. At one year, tirzepatide and cagrilintide-semaglutide (CagriSema) produced the largest weight loss with moderate to high certainty evidence, but larger benefits generally came with more side effects and discontinuation. Subcutaneous semaglutide was the only drug associated with lower all-cause mortality (risk ratio 0.81, 95% CI 0.72 to 0.93), an estimate driven largely by cardiovascular outcome trials in high-risk people, and most drugs did not meaningfully improve quality of life.
Medicare GLP-1 Bridge starts, covering obesity drugs for a $50 monthly copay
A temporary Medicare GLP-1 Bridge began letting eligible beneficiaries get Wegovy (injection and pill), Zepbound KwikPens and the non-peptide pill Foundayo for obesity at a $50 monthly copay, with prior authorization based on BMI and clinical criteria. Manufacturers supply the drugs at a net price of $245 a month, mirroring the November 2025 pricing agreements between the Trump administration, Eli Lilly and Novo Nordisk. The Bridge now runs to December 31, 2027 after CMS dropped plans to launch its BALANCE model in Medicare in 2027.
June 2026
Health Canada approves first generic semaglutide for weight loss
Health Canada authorized a generic semaglutide injection from Apotex, a copy of Wegovy, for once-weekly chronic weight management in people aged 12 and older. It was the third generic semaglutide product approved in Canada, which on April 28, 2026 became the first G7 country to approve one (a Dr. Reddy's version of Ozempic for type 2 diabetes). Health Canada said six more generic semaglutide submissions were under review.
EMA declines new heart-risk indication for Mounjaro but adds trial data to label
The EMA's CHMP finished assessing an application to extend tirzepatide (Mounjaro) to reducing the risk of serious cardiovascular events in adults with type 2 diabetes and established cardiovascular disease. The committee did not recommend the new indication but agreed to add the relevant trial data to the product information. Lilly had said it would submit data from SURPASS-CVOT, in which tirzepatide was non-inferior to dulaglutide, to regulators by the end of 2025.
American College of Physicians names semaglutide and tirzepatide first-line obesity drugs
The American College of Physicians issued a living clinical guideline on medicines for adults with overweight or obesity, published in Annals of Internal Medicine. For adults with obesity it ranks semaglutide and tirzepatide first-line (moderate-certainty evidence), phentermine-topiramate second, liraglutide third and naltrexone-bupropion fourth, all alongside lifestyle changes and all as conditional recommendations. It also advises counselling patients about unintended effects of weight loss, including nutritional deficiencies and loss of muscle and bone density, especially in older adults.
Mazdutide phase 3 GLORY-2 in JAMA: 16.65% average weight loss at 60 weeks
JAMA published GLORY-2, a phase 3 trial of a higher dose of mazdutide, a weekly GLP-1 and glucagon receptor agonist approved in China, in Chinese adults with obesity. Among 461 participants, body weight fell by 16.65% at 60 weeks with mazdutide versus 1.50% with placebo, and 84.3% versus 33.1% lost at least 5% of their weight. Vomiting, nausea and diarrhoea were common, and the trial enrolled only Chinese adults.
Survodutide phase 3 SYNCHRONIZE-1 published: up to 16.6% weight loss at 76 weeks
Full results of Boehringer Ingelheim's SYNCHRONIZE-1 trial of survodutide, a once-weekly glucagon and GLP-1 dual agonist, were presented at the ADA meeting and published in the New England Journal of Medicine. Among 725 adults with obesity without diabetes, weight loss at 76 weeks reached up to 16.6% in people who stayed on treatment versus 3.2% on placebo, or about 13% versus 5% regardless of adherence. Gastrointestinal side effects were common, affecting 90% of the 6.0 mg group versus 48% on placebo.
Retatrutide lowers HbA1c by up to 1.94% in its first type 2 diabetes phase 3 trial
The Lancet published TRANSCEND-T2D-1, the first phase 3 trial of retatrutide (a weekly GIP, GLP-1 and glucagon receptor agonist) in type 2 diabetes, as the results were presented at the ADA Scientific Sessions. In 537 adults whose diabetes was not controlled by diet and exercise, HbA1c fell by 1.69% to 1.94% across three doses after 40 weeks, versus 0.81% with placebo, and body weight fell by up to 15.3% versus 2.6%. Side effects were mainly gastrointestinal, and retatrutide remains investigational and unapproved.
Amycretin, now named zenagamtide, cuts A1C and weight in phase 2 diabetes trial
Novo Nordisk presented phase 2 results at the American Diabetes Association meeting for zenagamtide, the new name for amycretin, a single-molecule GLP-1 and amylin receptor agonist. In 262 adults with type 2 diabetes given weekly injections for 36 weeks, A1C fell by up to 1.71 percentage points from a baseline of 7.8%, and body weight fell by up to 14.6% on 40 mg versus 2.1% on placebo. An oral form is being studied separately.
May 2026
EMA committee recommends oral Wegovy tablets for weight management in the EU
The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended extending Wegovy's EU marketing authorization to add a once-daily oral semaglutide tablet as an alternative to weekly injections for adults with obesity, or overweight with at least one weight-related condition. The EMA described it as the first GLP-1 receptor agonist developed for oral use in weight management. A CHMP opinion is followed by a European Commission decision.
Retatrutide TRIUMPH-1: 28.3% average weight loss at 80 weeks on highest dose
In Eli Lilly's pivotal phase 3 TRIUMPH-1 trial of 2,339 adults with obesity, once-weekly retatrutide produced average weight loss of 19.0% on 4 mg, 25.9% on 9 mg and 28.3% on 12 mg at 80 weeks, versus 2.2% on placebo. Among 532 participants with a BMI of 35 or more who continued to 104 weeks, those on 12 mg lost 30.3% on average. Discontinuation due to adverse events was 11.3% on 12 mg versus 4.9% on placebo.
April 2026
FDA proposes barring outsourcing facilities from compounding semaglutide and tirzepatide
The FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound them from bulk ingredients when FDA-approved versions are available. If finalized, the decision would close the remaining large-scale route for making these GLP-1 peptides from raw ingredients outside a shortage. The notice was published in the Federal Register on May 1, 2026, and the comment period was later extended.
Semaglutide cuts heavy drinking days in trial of alcohol use disorder with obesity
A randomized, double-blind trial published in The Lancet gave once-weekly semaglutide or placebo for six months to 108 adults with obesity seeking treatment for alcohol use disorder at a Danish mental health center, alongside cognitive behavioral therapy. Heavy drinking days fell from about 17 to 5 per 30 days with semaglutide versus 17 to 9 with placebo. The authors noted the trial was small and had no follow-up after treatment ended.
FDA removes BPC-157 and 11 other peptides from its compounding safety-risk list
The FDA announced it would remove 12 peptides, including BPC-157, TB-500, KPV, MOTS-c, semax, epitalon, DSIP, injectable GHK-Cu, LL-37, dihexa and melanotan II, from Category 2 of its 503A bulk substances list (substances flagged for significant safety risks) because the nominators withdrew their nominations. Removal is not approval and does not by itself permit compounding: the agency scheduled Pharmacy Compounding Advisory Committee reviews for July 2026 and before the end of February 2027. The move followed HHS Secretary Robert F. Kennedy Jr.'s February 2026 pledge to widen lawful access to about 14 peptides.
Australia's TGA warns of severe reactions to unapproved injectable peptides
Australia's Therapeutic Goods Administration issued a safety alert on the growing import and use of unapproved peptide products such as BPC-157, GHK-Cu, TB-500, retatrutide and CJC-1295, often sold as injectables through social media and overseas websites. It cited reports of severe allergic reactions requiring hospital care, severe inflammation, whole-body itching, palpitations and blurred vision. The TGA stressed that these products have not been evaluated for safety, quality or effectiveness and that supplying them is unlawful.
Health Canada warns against injecting peptides bought online and names seized products
Health Canada warned Canadians not to inject peptides bought online, saying unauthorized injectable products can seriously harm health. The seized products it listed as examples include BPC-157, CJC-1295, DSIP, epitalon, GHK-Cu, ipamorelin, KPV, melanotan I and II, MOTS-c, SS-31 (elamipretide), TB-500 and retatrutide. It said that labels such as 'For Research Use Only' do not make these products legal or exempt from regulatory requirements.
FDA approves Foundayo (orforglipron), a non-peptide GLP-1 pill for obesity
The FDA approved Eli Lilly's orforglipron (Foundayo), a once-daily oral GLP-1 receptor agonist for adults with obesity, or overweight with weight-related conditions. Unlike semaglutide, orforglipron is a small molecule rather than a peptide, so it can be taken at any time of day without food or water restrictions. In its 72-week phase 3 trial, users lost about 11% of body weight on average, and Lilly set self-pay prices starting at $149 a month for the lowest dose.
March 2026
Generic semaglutide launches in India on the day the core patent expires
Indian drugmakers including Dr Reddy's, Sun Pharma, Glenmark, Zydus and Alkem launched generic semaglutide injections on March 21, 2026, as soon as Novo Nordisk's core Indian patent expired. Prices ranged from about INR 325 to 440 a week for the cheapest brand to about INR 4,200 a month for a prefilled pen. The launches made India one of the first large markets with generic semaglutide.
FDA approves setmelanotide (Imcivree) for acquired hypothalamic obesity
The FDA expanded the label of Rhythm Pharmaceuticals' setmelanotide (Imcivree), an MC4R agonist, to treat acquired hypothalamic obesity in adults and children aged 4 and older, the first approved therapy for the condition. Acquired hypothalamic obesity usually follows damage to the hypothalamus from tumors such as craniopharyngioma or their treatment. In the phase 3 TRANSCEND trial of 142 patients, BMI fell 15.8% on setmelanotide versus a 2.6% rise on placebo at 52 weeks, an 18.4% placebo-adjusted difference.
FDA approves Wegovy HD, a 7.2 mg semaglutide dose, under priority voucher program
The FDA approved a higher 7.2 mg weekly dose of semaglutide (Wegovy HD) for weight loss and long-term maintenance in adults with obesity, or overweight with a weight-related condition, 54 days after filing under the Commissioner's National Priority Voucher pilot. In the 72-week STEP UP trial, people who stayed on treatment lost about 21% of body weight on 7.2 mg versus about 18% on 2.4 mg and 2% on placebo. Altered skin sensations (dysesthesia) were more common at the higher dose: 22% versus 6% on 2.4 mg.
February 2026
CagriSema misses non-inferiority goal against tirzepatide in REDEFINE 4
In the open-label phase 3 REDEFINE 4 trial of 809 adults with obesity, CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg) produced 23.0% average weight loss at 84 weeks versus 25.5% with tirzepatide 15 mg among people adhering to treatment, or 20.2% versus 23.6% regardless of adherence. The trial therefore did not meet its primary goal of showing CagriSema was not inferior to tirzepatide. Novo Nordisk had filed CagriSema with the FDA in December 2025.
FDA vows crackdown on compounded GLP-1s after Hims markets a semaglutide pill
The FDA said it would use all available compliance and enforcement tools, including restricting GLP-1 active ingredients destined for non-approved compounded drugs and acting on misleading advertising, against companies mass-marketing copies of approved GLP-1 medicines. The statement named Hims & Hers, which on February 5 had launched a compounded oral semaglutide pill as an alternative to the newly approved Wegovy pill. Hims said on February 7 that it would stop offering the product.
January 2026
UK regulator strengthens GLP-1 warnings on severe, necrotising and fatal pancreatitis
The MHRA said the product information for all GLP-1 and dual GLP-1/GIP receptor agonists authorised in the UK (dulaglutide, exenatide, liraglutide, semaglutide and tirzepatide) now highlights the risk of severe acute pancreatitis, including rare necrotising and fatal cases. Between 2007 and October 2025 it received 1,296 Yellow Card reports of pancreatitis with these medicines, 19 of them fatal and 24 necrotising, against an estimated 25.4 million packs dispensed in the past 5 years. Clinicians are told to stop the medicine if pancreatitis is suspected, not to restart it if the diagnosis is confirmed, and to ask patients about privately prescribed GLP-1 use.
FDA asks makers to drop suicidal-thoughts warning from GLP-1 weight-loss drug labels
In an updated drug safety communication, the FDA said its review found no increased risk of suicidal ideation or behavior with GLP-1 receptor agonists and asked manufacturers to remove the warning from the labels of Saxenda (liraglutide), Wegovy (semaglutide) and Zepbound (tirzepatide). The review included a meta-analysis of 91 placebo-controlled trials with 107,910 patients and a claims-data study of more than 2.2 million people comparing GLP-1 drugs with SGLT2 inhibitors.
December 2025
FDA approves Wegovy pill, the first oral GLP-1 drug for weight loss
The FDA approved once-daily oral semaglutide 25 mg (Wegovy pill) for chronic weight management and to reduce the risk of major cardiovascular events, the first oral GLP-1 receptor agonist approved for obesity. In the OASIS 4 trial, average weight loss was about 14% versus about 2% on placebo regardless of adherence, and about 17% versus 3% among people who stayed on treatment. Novo Nordisk set a self-pay price of $149 a month for the 1.5 mg starting dose ahead of a January 2026 launch.
Retatrutide's first phase 3 trial: 28.7% weight loss and less knee pain
Eli Lilly reported the first phase 3 results for retatrutide, a once-weekly injection that activates GIP, GLP-1 and glucagon receptors. In TRIUMPH-4, which enrolled 445 adults with obesity or overweight and knee osteoarthritis, those on the 12 mg dose lost an average of 28.7% of body weight at 68 weeks, and WOMAC knee pain scores fell by up to 75.8%. Dysesthesia (altered skin sensation) was reported by 20.9% on 12 mg versus 0.7% on placebo.
WHO issues first guideline on GLP-1 medicines for obesity, with conditional backing
The World Health Organization published its first guideline on GLP-1 therapies (liraglutide, semaglutide and tirzepatide) for treating obesity as a chronic, relapsing disease. It conditionally recommends them for long-term treatment in adults other than pregnant women, and suggests adding intensive behavioural support based on low-certainty evidence. WHO called the recommendation conditional because long-term efficacy and safety data are limited and costs and health-system readiness are concerns, and it projected that the drugs will reach fewer than 10% of those who could benefit by 2030.
November 2025
Semaglutide fails to slow Alzheimer's disease in phase 3 evoke and evoke+ trials
Novo Nordisk said its two phase 3 trials of oral semaglutide in 3,808 adults aged 55 to 85 with mild cognitive impairment or mild dementia due to Alzheimer's disease did not show slower progression than placebo on the Clinical Dementia Rating Sum of Boxes after two years. Semaglutide improved some Alzheimer's-related biomarkers, but this did not translate into a delay in disease progression. Safety was consistent with earlier semaglutide trials.
October 2025
UK regulator raids first illegal weight-loss pen factory, seizing retatrutide pens
The UK Medicines and Healthcare products Regulatory Agency (MHRA) raided a Northampton warehouse on October 22 and 23, 2025, seizing more than 2,000 unlicensed pens labeled as retatrutide and tirzepatide, tens of thousands of empty pens, raw ingredients and about 20,000 pounds in cash. The MHRA called it the largest single seizure of trafficked weight-loss medicines recorded by any law enforcement agency and the first illicit production site of its kind found in the UK. Retatrutide was still in clinical trials and not licensed anywhere.
September 2025
FDA grants accelerated approval to elamipretide (Forzinity) for Barth syndrome
The FDA granted accelerated approval to Stealth BioTherapeutics' elamipretide (Forzinity) for Barth syndrome, an ultra-rare inherited mitochondrial disease, in patients weighing at least 30 kg. It is the first treatment for the disease and the first FDA-approved therapy aimed at mitochondria, where the peptide binds cardiolipin in the inner membrane. Approval was based on improved knee extensor muscle strength in the TAZPOWER trial, and continued approval depends on confirmatory evidence of clinical benefit.
WHO adds semaglutide, tirzepatide and other GLP-1 drugs to its essential medicines list
The World Health Organization's updated Model List of Essential Medicines (24th edition) added the GLP-1 receptor agonists semaglutide, dulaglutide and liraglutide and the dual GIP/GLP-1 receptor agonist tirzepatide. The listing is only for glucose-lowering treatment in adults with type 2 diabetes who have both obesity (body mass index of 30 or more) and either established cardiovascular disease or chronic kidney disease; it does not cover obesity or weight loss on their own. WHO said high prices of medicines such as semaglutide and tirzepatide are limiting access to them.
August 2025
FDA approves first generic GLP-1 for weight loss, a copy of Saxenda (liraglutide)
Teva received FDA approval for, and launched, a generic version of Saxenda (liraglutide injection), the first generic GLP-1 receptor agonist indicated for chronic weight management, for adults and for adolescents aged 12 to 17 weighing more than 60 kg. It followed the FDA's December 2024 approval of the first generic of Victoza, the type 2 diabetes version of liraglutide, from Hikma. Teva put branded Saxenda's annual US sales at about $165 million.
FDA grants accelerated approval to Wegovy for MASH with moderate to advanced fibrosis
The FDA approved semaglutide 2.4 mg (Wegovy) for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH, an inflammatory fatty liver disease) with stage F2 to F3 fibrosis, the first GLP-1 drug approved for the condition. In part 1 of the ESSENCE trial of 1,197 people, 63% on semaglutide had resolution of steatohepatitis without worsening fibrosis versus 34% on placebo, and 37% versus 22% had improved fibrosis at 72 weeks. Continued approval depends on part 2 of ESSENCE, which tracks liver-related clinical events.
July 2025
SURPASS-CVOT: tirzepatide matches dulaglutide on heart outcomes in type 2 diabetes
Eli Lilly's SURPASS-CVOT trial randomized 13,299 adults with type 2 diabetes and atherosclerotic cardiovascular disease to tirzepatide (Mounjaro) or dulaglutide (Trulicity) and followed them for a median of four years. Tirzepatide met the non-inferiority goal, with 8% fewer major adverse cardiovascular events (hazard ratio 0.92, 95.3% CI 0.83 to 1.01), and all-cause death was 16% lower in an analysis not adjusted for multiple testing. More people stopped tirzepatide because of side effects (13.3% versus 10.2%).
June 2025
China approves mazdutide, first dual glucagon and GLP-1 agonist for weight loss
China's National Medical Products Administration approved Innovent's mazdutide for chronic weight management in adults with a BMI of at least 28, or at least 24 with a weight-related condition. It is the first approved drug that activates both the glucagon and GLP-1 receptors. In the 48-week GLORY-1 trial in Chinese adults, weight fell by 12.0% on 4 mg and 14.8% on 6 mg versus 0.5% on placebo. Innovent develops mazdutide in China under a license from Eli Lilly.
EMA lists NAION optic nerve damage as a very rare side effect of semaglutide
The EMA's safety committee (PRAC) concluded that non-arteritic anterior ischemic optic neuropathy (NAION), a loss of blood flow to the optic nerve that can permanently damage vision, is a very rare side effect of Ozempic, Rybelsus and Wegovy, affecting up to 1 in 10,000 users. Large observational studies in type 2 diabetes suggested about a doubling of risk, roughly one extra case per 10,000 person-years of treatment. Product information was updated: patients with sudden vision loss should contact a doctor, and semaglutide should be stopped if NAION is confirmed.
April 2025
FDA warns of counterfeit Ozempic 1 mg pens found in the US drug supply chain
The FDA warned patients, pharmacies and wholesalers not to use counterfeit Ozempic (semaglutide) 1 mg injection after Novo Nordisk reported several hundred fake units in the US supply chain, and the agency seized the identified products. The counterfeits carry the genuine lot number PAR0362 with serial numbers beginning 51746517, so both must be checked. It followed a December 2023 alert about thousands of fake Ozempic pens with counterfeit needles, and a further alert followed in December 2025.
March 2025
Novo Nordisk launches NovoCare Pharmacy selling Wegovy at $499 a month to cash payers
Novo Nordisk opened NovoCare Pharmacy, a direct-to-patient channel offering every dose of Wegovy (semaglutide) for $499 a month with home delivery, for uninsured people and those whose insurance excludes obesity drugs. The company presented it as a way to get the FDA-approved product instead of compounded semaglutide as shortage-era compounding wound down. It followed Eli Lilly's August 2024 launch of lower-priced Zepbound (tirzepatide) vials through its own LillyDirect self-pay pharmacy.
February 2025
FDA declares semaglutide shortage resolved, ending mass compounding of copies
The FDA determined that the shortage of semaglutide injection products (Ozempic, Wegovy), listed since 2022, was resolved. It gave state-licensed compounding pharmacies until April 22, 2025 and outsourcing facilities until May 22, 2025 to stop making what are essentially copies of the approved drugs. Together with the earlier tirzepatide decision, this ended the shortage exception that had allowed large-scale sales of compounded GLP-1 injections.
Phase 3 trial finds exenatide does not slow Parkinson's disease
The Exenatide-PD3 trial, published in The Lancet, randomized 194 people with Parkinson's disease at six UK hospitals to weekly extended-release exenatide 2 mg or placebo for 96 weeks. Exenatide was safe and well tolerated but did not slow the worsening of movement symptoms and showed no benefit on other clinical measures or on DaT-SPECT brain imaging. In 2026 The Lancet added an expression of concern to the paper after a UK regulatory inspection raised trial-conduct concerns at one site.
January 2025
FDA approves Ozempic to slow kidney disease in adults with type 2 diabetes
The FDA approved semaglutide (Ozempic) to reduce the risk of kidney disease worsening, kidney failure and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. The label expansion was based on the FLOW trial of 3,533 adults, stopped early for efficacy after a median 3.4 years, in which Ozempic 1 mg lowered the risk of the primary kidney and cardiovascular endpoint by 24% relative to placebo. It is the first GLP-1 receptor agonist approved for this use.
Novo's amycretin injection shows 22% weight loss at 36 weeks in early-stage trial
Novo Nordisk reported topline results from a phase 1b/2a trial of once-weekly subcutaneous amycretin, a single molecule that activates both GLP-1 and amylin receptors, in 125 people with overweight or obesity. Estimated weight loss was 9.7% on 1.25 mg at 20 weeks, 16.2% on 5 mg at 28 weeks and 22.0% on 20 mg at 36 weeks, while placebo groups gained 1.9% to 2.3%. Side effects were mostly mild to moderate gastrointestinal events, and full results were later published in The Lancet.
Veterans study maps GLP-1 drug benefits and risks across 175 health outcomes
A Nature Medicine study using US Department of Veterans Affairs records compared 215,970 people with diabetes who started a GLP-1 receptor agonist with people starting other diabetes drugs and with about 1.2 million on usual care. Compared with usual care, GLP-1 drugs were linked to lower risk for 42 of 175 outcomes, including substance use disorders, dementia and clotting disorders, and higher risk for 19, mainly gastrointestinal problems, kidney stones and low blood pressure. As an observational analysis, it shows associations rather than proof of cause.
December 2024
FDA approves Zepbound as first drug for obstructive sleep apnea in adults with obesity
The FDA approved tirzepatide (Zepbound) for moderate to severe obstructive sleep apnea in adults with obesity, used with a reduced-calorie diet and more physical activity, making it the first medicine approved for the condition. Approval was based on two 52-week trials in 469 adults without type 2 diabetes, including people who did and did not use positive airway pressure therapy. Tirzepatide significantly reduced apnea and hypopnea events versus placebo, and more participants reached remission or mild sleep apnea.
CagriSema delivers 22.7% weight loss in REDEFINE 1, below Novo's 25% expectation
Novo Nordisk reported that CagriSema, a once-weekly combination of the amylin analogue cagrilintide 2.4 mg and semaglutide 2.4 mg, produced 22.7% average weight loss at 68 weeks in the phase 3 REDEFINE 1 trial of 3,417 adults with obesity or overweight. Cagrilintide alone gave 11.8%, semaglutide alone 16.1% and placebo 2.3%. The result fell short of the roughly 25% the company had signaled, and Novo shares fell about 20% that day.
FDA confirms tirzepatide shortage is over, starting wind-down of compounded copies
After re-evaluating its October 2, 2024 decision, which a compounding industry group had challenged in court, the FDA again determined that the national shortage of tirzepatide injection (Mounjaro, Zepbound) was resolved. Because copies of approved drugs can only be compounded routinely during a shortage, the agency set grace periods ending February 18, 2025 for state-licensed pharmacies (503A) and March 19, 2025 for outsourcing facilities (503B).
SURMOUNT-5: tirzepatide beats semaglutide on weight loss in head-to-head trial
Eli Lilly reported topline results from the open-label phase 3b SURMOUNT-5 trial in 751 adults with obesity or overweight without diabetes. At 72 weeks, tirzepatide (10 or 15 mg) produced an average weight loss of 20.2% versus 13.7% with semaglutide (1.7 or 2.4 mg), a 47% greater relative reduction. It was the first head-to-head obesity trial of the two leading incretin drugs, and full results were later published in the New England Journal of Medicine.
July 2024
FDA warns of overdoses from dosing errors with compounded semaglutide vials
The FDA alerted clinicians, compounders and patients to adverse events linked to dosing errors with compounded semaglutide supplied in multiple-dose vials. Some patients drew up five to 20 times the intended dose, and some clinicians miscalculated conversions between milligrams and units, leading to doses five to 10 times too high. Reported harms included nausea, vomiting, fainting, dehydration, acute pancreatitis and gallstones, and some patients were hospitalized.
April 2024
EMA safety committee finds no causal link between GLP-1 drugs and suicidal thoughts
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the available evidence does not support a causal association between GLP-1 receptor agonists (dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide) and suicidal or self-injurious thoughts and actions. The review weighed non-clinical studies, clinical trials, post-marketing reports and two large electronic health record studies. No update to EU product information was required.
March 2024
FDA approves Wegovy to cut heart attack and stroke risk in adults with obesity
The FDA approved Wegovy (semaglutide 2.4 mg) to reduce the risk of cardiovascular death, heart attack and stroke in adults with established cardiovascular disease and obesity or overweight. The decision rested on the SELECT trial of more than 17,600 people, in which major cardiovascular events occurred in 6.5% of those on Wegovy versus 8% on placebo. It made Wegovy the first weight-loss medicine also approved to help prevent cardiovascular events.