Peptide research, regulation, discovery. Every story links to the peptide it’s about.
RSSThe FDA's compounding advisers scheduled a second peptide meeting for before the end of February 2027, covering melanotan II, GHK-Cu, LL-37, dihexa, and PEG-MGF. There is no date and no docket yet, and the panel's last round cleared peptides with zero human trials.
Novo Nordisk ran compounded and follow-on copies of semaglutide and liraglutide through immune-response assays and reported they carry different impurities. The chemistry is real. So is the conflict of interest.
The FDA's compounding advisory committee closed a two-day peptide session Friday by recommending Semax (8 to 5) and Epitalon (7 to 4), then rejecting Emideltide, or DSIP, 6 to 7. It was the only no vote across seven peptides. Six now head toward a rulemaking that could take up to 18 months, every one of them over the objection of the FDA's own scientists.
After BPC-157 and KPV, the compounding committee voted 8-6 for TB-500 and 7-5 for MOTS-c. Both are banned in sport. Neither has ever been tested in a person.
The Pharmacy Compounding Advisory Committee recommended adding BPC-157 and KPV to the 503A bulks list, overruling FDA career scientists who said neither peptide had human safety or efficacy data. The vote is a recommendation, not a final rule.
A JAMA Health Forum secret-shopper study found 75 clinics in West Virginia and Oklahoma still selling compounded copies of Ozempic and Mounjaro after the shortages ended, more than half mixed with B vitamins and nearly one in five suppliers unlicensed to compound sterile injectables.
The FDA approved Merck's LIPFENDRA (enlicitide) on July 16 as the first oral PCSK9 inhibitor, a once-daily macrocyclic peptide tablet that cut LDL cholesterol 56 and 59 percent against placebo in two Phase 3 trials, matching injectable antibodies at a $315-a-month list price, roughly a third of the injections. The approval rests on LDL, not heart-attack prevention; the cardiovascular outcomes trial does not report until 2029. An approved, priced, once-daily macrocyclic peptide is the clearest sign yet the oral-peptide class has cleared its chemistry problem.
Ecnoglutide, from Sciwind Biosciences, is the first GLP-1 drug built to drive one signaling arm and ease off another. China cleared it for diabetes and obesity six weeks apart, and Pfizer paid up to $495 million for the China rights. Its roughly 15 percent weight loss has not yet beaten the incumbents.
The FDA's complete response letter for gallium-68 edotreotide raised no issue with the clinical data, only with the contract facility that makes the dose.
Ahead of the July 23-24 compounding vote, FDA reviewers concluded that none of the seven peptides (BPC-157, KPV, TB-500, MOTS-c, DSIP, Semax, Epitalon) has sufficient evidence for the 503A list, citing missing human data and impurities. Seven of the fourteen panelists who decide have peptide-business ties.
The FDA cleared a single-patient compassionate-use request for Eli Lilly's unapproved triple agonist retatrutide. Eighteen bioethicists and obesity clinicians told STAT the one-person route is the wrong tool for a disease that affects 100 million Americans, when the standard path to the drug is still a clinical trial.
The Pharmacy Compounding Advisory Committee meets July 23 and 24 to decide whether BPC-157, TB-500, MOTS-c, KPV, DSIP, Semax, and Epitalon belong on the 503A list that makes a peptide legal to compound. The seven are voted as one bucket, but their evidence bases are nothing alike.
The TGA made unapproved peptides a 2026 compliance priority and named five: BPC-157, GHK-Cu, TB-500, CJC-1295, and retatrutide. Four have thin human evidence. The fifth is Lilly's Phase 3 obesity drug, swept up because demand outran approval.
On June 19 Japan cleared Wegovy (semaglutide 2.4 mg) for fatty-liver disease with fibrosis, its first approved MASH treatment. The ESSENCE trial cleared inflammation in 62.9 percent of patients versus 34.3 on placebo.
The EMA's first dedicated guideline for synthetic peptide active substances took legal effect on June 1, setting manufacturing and impurity-control standards for the chemistry behind drugs like Wegovy and Mounjaro. It lands as France becomes the first EU country to reimburse them.