Evidence audit · Regulation · 12 min read
Afamelanotide was approved in October 2019 as Scenesse — a 16 mg bioresorbable implant a trained clinician inserts every two months, to increase pain-free light exposure in adults with a rare inherited photodermatosis. FDA's own analysis of the pivotal trial's primary endpoint returned a p-value of 0.055. Fifty-four of the 112 vendors in pepmg's index sell the peptide as a powder vial, and one listing in sixty-two names afamelanotide at all.
- Approved since 2019 — as a clinician-inserted implant, for a rare photodermatosis.
- FDA's own imputed analysis of the pivotal endpoint returned p = 0.055.
- No controlled trial of chronic use for cosmetic tanning in healthy people exists.
Published August 15, 2026
Evidence audit · Regulation · 12 min read
Elamipretide was approved in September 2025 as Forzinity, for an ultra-rare genetic disease, under accelerated approval on an intermediate endpoint. The randomized trial was not superior to placebo on either primary endpoint. The strength result the approval rests on comes from an open-label extension with eight patients left in it — and the trial FDA requires to verify it does not complete until 2029.
- Accelerated approval in Sept. 2025 — Barth syndrome only, on an intermediate endpoint.
- The randomized trial in 12 patients was not superior to placebo on either primary endpoint.
- A 218-person phase 3 in mitochondrial myopathy found no effect; the confirmatory trial ends 2029.
Published August 14, 2026
Evidence audit · Regulation · 11 min read
Bremelanotide is approved for premenopausal women with acquired, generalized HSDD, and the label states it is not indicated in men. In the two phase 3 trials, desire and distress scores moved by fractions of a point — and the number of satisfying sexual events did not separate from placebo at all.
- Approved since 2019 — for premenopausal women, and the label rules out men.
- Desire and distress scores moved fractions of a point; satisfying events did not.
- 18% stopped for adverse reactions against 2% on placebo.
Published August 12, 2026
Evidence audit · Regulation · 10 min read
Eighty vendors in pepmg’s index list it as a fat-loss peptide. Behind it sits a 536-person trial whose primary endpoint failed, a development program terminated in 2007, and a December 2024 FDA advisory committee that voted 0 in favor and 12 against adding it to the 503A Bulks List. Every human study FDA found used oral or intravenous dosing.
- A 536-person randomized trial missed its primary endpoint; the program was terminated.
- FDA’s advisory committee voted 0 in favor, 12 against adding it to the 503A Bulks List.
- Every human study used oral or IV dosing; FDA found no human data for the injected route.
Published August 10, 2026
Evidence audit · Regulation · 10 min read
It is the growth-hormone peptide with real Phase 3 trials behind it, and 95 of the 113 vendors in our price index list it. Those trials measured visceral fat in HIV-associated lipodystrophy, and two independent 2026 meta-analyses of the same small RCT set found no significant change in BMI or subcutaneous fat.
- FDA-approved since 2010 — for excess abdominal fat in HIV lipodystrophy only.
- The label calls the effect weight neutral and disclaims weight-loss use.
- Two 2026 meta-analyses: visceral fat down, BMI and subcutaneous fat unchanged.
Published August 9, 2026
Evidence audit · Regulation · 10 min read
China’s regulator cleared mazdutide in June 2025 — at 4 mg and 6 mg. The 20% figure now circulating comes from a 9 mg dose approved nowhere, in a subgroup, in a trial run entirely in China. An independent meta-analysis rates the certainty of that evidence very low to low.
- China approved 4 mg and 6 mg in 2025; the FDA has approved nothing.
- The 20% headline is a subgroup, at a 9 mg dose approved nowhere.
- An independent BMJ meta-analysis rates the evidence very low to low certainty.
Published August 7, 2026
Evidence audit · Clinical trials · 10 min read
The widely quoted 22.7% comes from CagriSema, a two-drug combination. In the same Phase 3 trial, the cagrilintide-only arm reported 11.8% — less than semaglutide alone. Here is what the human trials actually tested, and what is still unapproved.
- The 22.7% headline belongs to the combination, not cagrilintide alone.
- Cagrilintide monotherapy reported 11.8% in the same 68-week trial.
- The combination missed non-inferiority to tirzepatide and is not approved.
Published August 6, 2026
Evidence audit · Regulation · 9 min read
The advisory vote changed the regulatory conversation, not the clinical record. FDA found five small, short human studies, no established efficacy, and no approved BPC-157 product anywhere.
- FDA found five small, short human studies across unrelated conditions.
- The only controlled efficacy result was a 53-person meeting abstract.
- An advisory vote does not establish efficacy, approval, or product equivalence.
Published July 31, 2026
Clinical trials · Regulation · 10 min read
Two new sponsor-reported trials put the triple agonist near 21–23% average weight loss at 80 weeks. Here is what the topline data establish, what remains unpublished, and why a planned BLA is not an approval.
- Topline results report 20.8% and 22.6% average weight loss at 80 weeks.
- Full trial reports and detailed subgroup tables are not yet published.
- Lilly plans a BLA in early 2027; submission is not approval.
Published July 29, 2026
Breaking · Regulation · 12 min read
A federal panel backed BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon for the 503A Bulks List. The votes were consequential—but they did not approve a drug, validate online vials, or immediately rewrite compounding law.
- PCAC recommended six peptide families; emideltide/DSIP fell short.
- The votes are advice—not FDA approval or a final legal change.
- FDA staff had proposed excluding every free-base and acetate form reviewed.
Published July 29, 2026
Testing · Market audit · 11 min read
There is no standard 7x or 8x peptide-testing panel. We audited the claim, mapped the tests that actually answer different quality questions, and built a COA checklist that is harder to game.
- No regulator or pharmacopeia defines “7x tested.”
- Seven counts can mean seven methods—or five vials plus two assays.
- A lot-matched COA with methods and results matters more than the multiplier.
Published July 28, 2026
Science · Regulation · 13 min read
BPC-157, GLP-1 drugs, thymosin β4 and other peptides are attracting veterinary interest. Here is what animal studies actually show—and why an RUO label does not turn a research vial into a veterinary drug.
- Veterinary evidence varies sharply by peptide class.
- RUO labeling does not convert a reagent into an animal drug.
- Equine competition adds a separate anti-doping rulebook.
Published July 28, 2026