Peptide news
Zepbound label updated in August 2026 after the SURPASS-CVOT heart trial, as Mounjaro gains a cardiovascular indication
On 26 August 2026 the FDA approved a revision to the US label for Zepbound, the weight-management brand of tirzepatide, using data from the SURPASS-CVOT cardiovascular trial. The change rewrote the diabetic retinopathy warning; it did not add a new Zepbound indication. A day later, Mounjaro, the diabetes brand of the same drug, gained a new indication to reduce the risk of major cardiovascular events.
FDA warns sellers of semaglutide, tirzepatide and retatrutide labelled "for research purposes"
FDA has sent warning letters to online companies selling semaglutide, tirzepatide and retatrutide with "research use only" labels, most recently on 24 August 2026. In each letter FDA said the labels did not stop the products being unapproved new drugs, because the sellers' own websites showed they were meant for human use. Retatrutide remains unapproved.
Retatrutide phase 3 results so far: one peer-reviewed trial and four company-reported TRIUMPH readouts
The first peer-reviewed phase 3 trial of retatrutide, TRANSCEND-T2D-1, was published in The Lancet in June 2026. Eli Lilly has also reported topline results from four TRIUMPH obesity trials by press release, most recently on 23 July 2026. Retatrutide is still not approved anywhere, and the head-to-head TRIUMPH-5 trial against tirzepatide is still running.
FDA advisory committee reviews BPC-157, TB-500 and five other peptides for compounding
On 23 and 24 July 2026 the FDA's Pharmacy Compounding Advisory Committee met to consider whether seven peptides, including BPC-157 and TB-500, should be added to the list of bulk substances US pharmacies may compound with. FDA's own briefing papers proposed that none of them be added. The committee's advice is not binding, and FDA has not announced a decision.
Medsafe warns New Zealanders that unapproved peptides are illegal to import, sell or use
On 21 May 2026 Medsafe, New Zealand's medicines regulator, issued a consumer advisory on unapproved peptide products and SARMs, naming BPC-157, retatrutide, TB-500 and others. It said many of these products are prescription medicines, that "for research purposes only" labels have no legal effect, and that Medsafe continues to seize them.
FDA proposes keeping semaglutide, tirzepatide and liraglutide off the 503B bulks list
On 30 April 2026 FDA proposed not to add semaglutide, tirzepatide or liraglutide to the 503B bulks list, saying it found no clinical need for outsourcing facilities to compound them from bulk ingredients. The comment period was later extended to 30 July 2026. As of 24 September 2026 we have found no final decision.
BPC-157, TB-500 and other peptides leave FDA's category 2 list after nominations are withdrawn
FDA's list of compounding substances that "may present significant safety risks" now has a separate section for 17 substances, including BPC-157, TB-500 and CJC-1295, whose nominations were withdrawn. The move reflects what the nominators did, not a finding by FDA that the peptides are safe. None of them is approved or on the list of substances pharmacies may compound with.
FDA approves Wegovy tablets, the first oral semaglutide for weight management
On 22 December 2025 the FDA approved Wegovy tablets (NDA 218316), a once-daily oral form of semaglutide for chronic weight management. The approval rests mainly on the OASIS 4 trial, in which a 25 mg daily tablet produced an average weight loss of 13.6% at 64 weeks against 2.2% on placebo. It is the first semaglutide tablet licensed in the US for weight rather than type 2 diabetes.
FDA grants accelerated approval to elamipretide (SS-31) as Forzinity for Barth syndrome
On 19 September 2025 the FDA granted accelerated approval to Forzinity, the brand name for elamipretide, the peptide sold online as SS-31. The approval, under NDA 215244, covers improving muscle strength in adults and children with Barth syndrome who weigh at least 30 kg. It rests on an intermediate end point, so the company must run a confirmatory trial to keep it.
SURMOUNT-5: tirzepatide beat semaglutide for weight loss in the first head-to-head obesity trial
SURMOUNT-5, published online in the New England Journal of Medicine on 11 May 2025, compared weekly tirzepatide with weekly semaglutide in 751 adults with obesity but without diabetes. After 72 weeks, average weight loss was 20.2% with tirzepatide and 13.7% with semaglutide. It is the first randomised trial to compare the two drugs directly for obesity.