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PeptideSorted

News

Short updates on FDA actions, trial results and price changes. Each one links to the primary source and to the guide it changes, and the biggest one leads Sorted on Tuesday.

  1. PolicyHHS says it will not act against compounding of six peptides, with conditionsHHS will not act against 503A compounding of BPC-157, TB-500, MOTS-c, KPV, epitalon and semax under ten conditions. None is FDA-approved.
  2. SafetyNSW Health reports a sharp rise in emergency visits linked to unapproved peptides, mostly retatrutideNSW Health counted 1,180 emergency visits mentioning unapproved peptides from July 2025 to September 2026, mostly retatrutide. About 18% led to admission.
  3. PolicyFDA sends an interim policy on compounding certain peptides to White House reviewAn FDA notice on compounding certain peptides reached White House review on October 14, 2026. HHS issued it on October 28 as an enforcement policy.
  4. Trial resultFirst retatrutide phase 3 results published in NEJM and The LancetTRIUMPH-1 (NEJM) and TRIUMPH-2 (Lancet) are the first peer-reviewed phase 3 results. Weight loss on 12 mg was 25.0% and 18.8% at 80 weeks.
  5. FDANovo Nordisk expects an FDA decision on CagriSema in the fourth quarter of 2026Novo Nordisk expects an FDA decision on CagriSema, its cagrilintide and semaglutide combination for weight management, in Q4 2026. It is not yet approved.
  6. SafetyFDA warns online sellers of research-use-only GLP-1 and peptide productsFDA letters dated August 24, 2026 told online sellers that research-only semaglutide, tirzepatide, retatrutide and tesamorelin are unapproved new drugs.
  7. PolicyFDA advisory committee recommends six peptides, including BPC-157, for the 503A bulks listFDA advisers voted July 23-24, 2026 to recommend BPC-157, KPV, TB-500, MOTS-c, Semax and epitalon for the 503A bulks list, against FDA staff advice.
  8. Trial resultRetatrutide succeeds in two more phase 3 trials; Lilly plans FDA submission in early 2027Lilly reported topline TRIUMPH-2 (type 2 diabetes) and TRIUMPH-3 (heart disease) results for retatrutide and plans to file with the FDA in Q1 2027.
  9. PriceMedicare GLP-1 Bridge begins: $50 a month for certain weight-loss drugsFrom July 1, 2026 through December 31, 2027, eligible Medicare Part D enrollees can get certain GLP-1 weight-loss drugs for $50 a month under a CMS pilot.
  10. PolicyFDA proposes keeping semaglutide, tirzepatide and liraglutide off the 503B bulks listFDA proposed leaving semaglutide, tirzepatide and liraglutide off the 503B bulks list, finding no clinical need for outsourcing facilities to make them.
  11. FDAFDA approves Foundayo (orforglipron), a once-daily GLP-1 pill for weight managementThe FDA approved Foundayo (orforglipron), a daily pill for chronic weight management in adults. It is a small-molecule GLP-1 with no empty-stomach rule.