Breaking developments across peptide therapeutics: trial launches, regulatory actions, and industry moves, reported with primary sourcing.
Two newly posted ClinicalTrials.gov records show Viking Therapeutics has begun a Phase 3 program, SUNRISE-1 and SUNRISE-2, testing an oral once-daily formulation of VK2735, a dual GIP/GLP-1 receptor agonist, for weight management in adults with and without type 2 diabetes.
A JAMA Medical News feature published October 9, 2026 lays out the enforcement record, product-testing findings and physician concerns behind the online market for retatrutide and zenagamtide, two investigational weight-loss peptides not approved by any regulator.
Topline results announced at the company's Capital Markets Day show once-weekly CagriSema produced greater weight loss than a 5 mg dose of tirzepatide in adults with type 2 diabetes, and greater weight loss than placebo in a separate obesity trial called REDEFINE 9.
Topline results announced September 7, 2026 showed 40.4% of children treated with once-weekly semaglutide were no longer classified as having obesity at week 68, versus none on placebo, in a 165-participant trial where most had severe obesity at baseline.
A propensity-matched cohort study of more than 98,000 patient pairs, published online August 27, 2026 in Diabetes, Obesity and Metabolism, found GLP-1 receptor agonist use associated with a modest increase in diabetic retinopathy compared with DPP-4 inhibitors, but no statistically significant increase in the rare optic nerve condition NAION.
TRIUMPH-2 tested the investigational triple agonist in adults with type 2 diabetes and obesity, while TRIUMPH-3 studied adults with severe obesity and established cardiovascular disease. Both trials met their weight-loss goals; a cardiovascular-event analysis in TRIUMPH-3 did not reach statistical significance.
The Pharmacy Compounding Advisory Committee voted over two days to recommend BPC-157, KPV, TB-500, MOTS-c, semax and epitalon for the Section 503A bulk drug substances list, and voted against emideltide. The votes are advisory and non-binding, and the FDA had not announced a final decision as of publication.
Australia's Therapeutic Goods Administration updated product warnings for every GLP-1 receptor agonist sold in the country after adverse-event reports linked the drugs to non-arteritic anterior ischaemic optic neuropathy, a rare condition that can cause permanent vision loss.
The Pharmacy Compounding Advisory Committee's two-day vote on seven nominated peptides came over the written objections of the FDA's own career scientists. The recommendations are non-binding, and none of the peptides is an FDA-approved drug.
A target trial emulation study of more than 50,000 Penn Medicine patients, published in The BMJ on July 22, 2026, found GLP-1 receptor agonist users had a 37 to 68 percent higher relative risk of clinically recorded hair loss than patients on two other diabetes drug classes, though absolute risk remained low.
The July 15, 2026 decision authorizes a once-daily 25 mg semaglutide tablet as the first oral GLP-1 receptor agonist for weight management across the European Union, following a CHMP recommendation adopted in May.
The Pharmacy Compounding Advisory Committee is scheduled to review seven peptides for the Section 503A bulk drug substances list on July 23-24, part of a broader reconsideration of substances the agency flagged in 2023.
Career reviewers at the agency posted documents finding little human evidence for BPC-157, TB-500 and five other peptides, setting up a clash with Health Secretary Robert F. Kennedy Jr., who has pushed to widen access before the July 23-24 advisory meeting.
A TGA decision added the experimental peptide BPC-157 to Schedule 4 of the Poisons Standard effective June 1, 2024, amid warnings about a growing market for unapproved peptide products.
The company submitted a New Drug Application on December 18, 2025 for the once-weekly injection combining semaglutide and the amylin analogue cagrilintide for chronic weight management.
The August 15, 2025 decision made semaglutide 2.4 mg the first GLP-1 receptor agonist cleared to treat noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate-to-advanced fibrosis.
Topline results from TRIUMPH-1, the first pivotal trial of the investigational triple-hormone agonist, showed average weight reductions of roughly 19% to 28% across three doses over 80 weeks.