Evidence audit · Regulatory · 8 min read
Hexarelin (examorelin) is a growth hormone-releasing peptide with dozens of small human studies published from 1994 to 2004. Twice-daily injections for 16 weeks in 12 healthy elderly people blunted its growth hormone response and did not significantly change IGF-1, body fat, lean mass or bone density. It has no FDA approval, is in none of FDA's 503A compounding categories, and is banned in sport.
- PubMed tags 59 records mentioning hexarelin as clinical trials, published 1994 to 2004; single doses released large amounts of growth hormone in healthy adults, along with prolactin and cortisol.
- After 16 weeks of twice-daily injections in 12 healthy elderly people, the growth hormone response was about 45% smaller, recovering after stopping, and IGF-1, body fat, lean mass and bone density did not change significantly.
- pepmg found no FDA approval for hexarelin as of October 27, 2026; it is in none of FDA's three 503A nomination categories, and WADA's 2026 list prohibits it as examorelin.
Published October 27, 2026
Evidence audit · Regulatory · 8 min read
5-Amino-1MQ is a small-molecule NNMT inhibitor, not a peptide, and has no FDA approval. Its weight and muscle results come from five studies in mice given injections, all coauthored by a Texas group whose senior author founded Ridgeline Therapeutics. Oral bioavailability was 3.5% in mice and 38.4% in rats, and FDA cited the compound in a January 2026 warning letter to a compounding outsourcing facility.
- pepmg found no human trial of 5-amino-1MQ on ClinicalTrials.gov or PubMed as of October 26, 2026; it is a small-molecule NNMT inhibitor, not a peptide, with no FDA approval or 503A category.
- Its weight and muscle results come from five injected-mouse studies coauthored by a group whose senior author founded Ridgeline Therapeutics; in the first, 9 treated obese mice lost about 5.1% of body weight in 11 days.
- Oral bioavailability was 3.5% in mice and 38.4% in rats, and FDA's January 2026 warning letter to an outsourcing facility said 5-amino-1MQ was not on the 503B bulks list.
Published October 26, 2026
Evidence audit · Regulatory · 9 min read
FDA approved Isembyld (apitegromab) on September 11, 2026 for spinal muscular atrophy, with a fracture warning. Follistatin, the other myostatin blocker sold online as 1 mg vials, has no FDA approval; its published muscle trials injected a follistatin gene into the thighs of 12 patients without a placebo group, and a third trial in 3 patients posted results only to its registry.
- FDA approved Isembyld (apitegromab-mstn), an antibody that blocks myostatin activation, on September 11, 2026 for spinal muscular atrophy; its label warns of fractures in 9% of patients on the recommended dose versus 2% on placebo.
- Follistatin has no FDA approval or 503A category; its muscle trials with results injected a follistatin gene into 18 patients at one Ohio hospital without a placebo group, and pepmg found no trial of the injected protein alone.
- WADA's 2026 list bans both follistatin and apitegromab at all times; an Austrian-German lab found follistatin in only 9 of 17 black-market products.
Published October 25, 2026
Evidence audit · Human trials · 7 min read
Selank is registered in Russia as 0.15% nasal drops for adults with anxiety. Its three published patient trials, 192 people in all, compared it with or added it to benzodiazepines; in the head-to-head trial pepmg read in full, it cut anxiety scores less than phenazepam by day 14. In the U.S. it has no FDA approval and no compounding category as of October 19, 2026.
- Selank is registered in Russia as 0.15% nasal drops for adults with anxiety states, neurasthenia and adjustment disorders; pepmg found no FDA approval.
- Its three published patient trials, 192 people in all, compared it with or added it to benzodiazepines; in the 2014 trial anxiety scores fell 26.3% on selank and 55% on phenazepam by day 14, and selank did better only a week after both were stopped.
- Selank is not on FDA's 503A bulks list or in any interim-policy category; its category 2 nomination was withdrawn, and FDA says it lacks information on safety in humans.
Published October 19, 2026
Evidence audit · Human trials · 7 min read
AICAR is acadesine, an intravenous drug once developed to protect the heart during bypass surgery. Pooled results from earlier trials looked promising, but the 3,080-patient confirmatory trial found no benefit. The "exercise in a pill" idea comes from injected mice, and pepmg's October 18 searches found no human trial testing it for endurance or fat loss.
- AICAR is acadesine, an intravenous drug tested to protect the heart during bypass surgery; a 1997 pooled analysis of five trials (4,043 patients) reported fewer perioperative heart attacks.
- The confirmatory RED-CABG trial was stopped for futility after 3,080 of a planned 7,500 patients: the primary outcome occurred in 5.1% on acadesine and 5.0% on placebo (odds ratio 1.01).
- The endurance claim comes from mice injected with 500 mg/kg a day; in men, oral AICAR was under 5% bioavailable, and pepmg found no human trial of it for endurance or fat loss. WADA prohibits it at all times.
Published October 18, 2026
Evidence audit · Safety · 7 min read
FDA's review found three adverse event reports for BPC-157 through December 4, 2025. FDA's public data shows five more naming it as a suspect product, received from January to May 2026, most from consumers and most also coded for product-quality problems. A health-records preprint and a new systematic review fill in who uses it, but neither measures how often harm happens.
- FDA's July briefing found three FAERS reports for BPC-157 through December 4, 2025; openFDA data shows five more naming it as a suspect product, received January through May 2026.
- Of those eight reports, six came from consumers and six also carry product-quality coding such as contamination, sterility or labeling problems; FDA says it cannot be certain a reported event was caused by the suspect product.
- A preprint of de-identified clinical notes found 1,039 documented BPC-157 users from 2020 to 2026, and a new systematic review rated the human evidence very low certainty; neither measures how often harm occurs.
Published October 17, 2026
Breaking · Regulation · 6 min read
A White House review list shows it received FDA's "Interim Access Policy for Compounding Using Certain Peptides" on October 14, 2026. Reports citing unnamed people say it would let pharmacies temporarily compound some peptides, including BPC-157. It is not a drug approval or a final rule, and FDA's staff had proposed that none of the seven peptides reviewed in July be added to the compounding list.
- The White House's regulatory review list shows FDA submitted an "Interim Access Policy for Compounding Using Certain Peptides" (RIN 0910-ZD94), received October 14, 2026; no text or list of peptides is public.
- The AP, citing two unnamed people, reports it would let pharmacies temporarily compound some popular peptides, including BPC-157; it is not a drug approval or a final 503A rule.
- FDA's July briefing proposed adding none of the seven peptides reviewed; as of October 16, none of them is in category 1 of FDA's 503A nominations document.
Published October 16, 2026
Evidence audit · Regulatory · 7 min read
GHRP-2 is pralmorelin. Japan approved it in October 2004 as a single intravenous dose to diagnose growth hormone deficiency, and pepmg found no approval anywhere else. When researchers tested a twice-daily nasal spray in 126 children with growth hormone deficiency at its Japanese maker's request, growth hormone rose but height did not improve against placebo over 48 weeks. FDA lists GHRP-2 among bulk substances that may present significant safety risks for outsourcing facilities.
- GHRP-2 (pralmorelin) was approved in Japan on October 22, 2004 only to diagnose growth hormone deficiency, as one slow intravenous dose; pepmg found no FDA approval.
- In a sponsor-requested, double-blind trial of 126 children with growth hormone deficiency, a twice-daily GHRP-2 nasal spray raised growth hormone peaks but height did not improve against placebo over 48 weeks.
- FDA lists injectable and nasal GHRP-2 among bulk substances that may present significant safety risks for outsourcing facilities; WADA prohibits it at all times.
Published October 15, 2026
Regulatory · Evidence audit · 8 min read
On August 3, 2026, FDA approved new labeling for Lilly's teriparatide pen Forteo after an April notice to makers of parathyroid hormone products: anaphylaxis, angioedema and hives are now a named warning, with permanent discontinuation after a severe reaction. pepmg found the same August 2026 warning on four related labels. The osteosarcoma boxed warning, based on tumors in rats, came off in November 2020 after human surveillance studies found no excess cases. The fracture evidence for the approved 20 mcg daily injection comes from randomized trials in postmenopausal women.
- On August 3, 2026, FDA approved Forteo labeling that makes hypersensitivity reactions, including anaphylaxis, the first warning, after an April notice to makers of parathyroid hormone products.
- pepmg found the same August 2026 warning on Bonsity, Almaject's teriparatide, Tymlos and Yorvipath.
- The osteosarcoma boxed warning, based on rat studies, was removed in November 2020; human surveillance found no excess cases, with wide uncertainty.
Published October 13, 2026
Safety · Evidence audit · 9 min read
At least four Texas compounding pharmacies posted recalls of injectable glutathione over elevated or potentially elevated endotoxin between August 5 and October 1, 2026. FDA has reports of at least 30 patients with adverse events after IV glutathione made from one supplement-grade Medisca lot, and CDC counts over 25 people sick in at least four states. Glutathione has no FDA approval as a medicine; pharmacies compound it under FDA's interim policy while it is evaluated. Its placebo-controlled injection trials for skin lightening and Parkinson's disease were small and did not show a significant difference, while two hospital trials, in chemotherapy nerve damage and heart attack, reported benefits.
- At least four Texas pharmacies recalled injectable glutathione for elevated or potentially elevated endotoxin between August 5 and October 1, 2026.
- FDA links at least 30 patients' adverse events to IV glutathione made from one supplement-grade Medisca lot; CDC counts over 25 sick in at least four states.
- Glutathione is not FDA-approved; its small placebo-controlled injection trials for skin lightening and Parkinson's showed no significant benefit.
Published October 12, 2026
Regulatory audit · Compounding · 10 min read
On May 1, 2026 FDA proposed not to add semaglutide, tirzepatide or liraglutide to the 503B Bulks List, the bulk ingredients outsourcing facilities may compound from, tentatively finding no basis to say any approved product is medically unsuitable. Comments closed July 30, and a Federal Register search on October 11 found no final notice. The notice answers the nominators' dose arguments with the studies they cited, including a 245-person phase 2 trial in which 16 mg of weekly semaglutide did not significantly lower HbA1c more than 2 mg in its primary analysis. Liraglutide injection is still on FDA's shortage list, which the notice does not mention.
- FDA's May 1, 2026 proposal to keep semaglutide, tirzepatide and liraglutide off the 503B Bulks List had no final notice as of October 11.
- FDA found no approved product medically unsuitable and never reached the safety or effectiveness of compounded versions.
- In the 245-person trial FDA cited, 16 mg weekly semaglutide did not significantly beat 2 mg on HbA1c in the primary analysis; liraglutide remains in shortage.
Published October 11, 2026
Evidence audit · Regulatory · 9 min read
FDA says it has not identified any human exposure data on products containing pegylated mechano growth factor, and its compounding advisory committee is due to discuss the substance before the end of February 2027. No study on ClinicalTrials.gov lists any form of MGF as an intervention; the human studies that mention it measured the body's own MGF gene activity in muscle. Researchers at two drug companies could not reproduce the muscle-cell effect the idea rests on, and doping laboratories that analyzed black-market and seized "MGF" found three different molecules.
- FDA says it has found no human exposure data on PEG-MGF products; its compounding panel is due to discuss PEG-MGF before the end of February 2027.
- No ClinicalTrials.gov study gives any form of MGF; the human papers measured the body's own MGF gene activity, mostly after exercise.
- Two drug companies could not reproduce MGF's muscle-cell effect, and doping labs found three different molecules in products sold as MGF.
Published October 10, 2026
Evidence audit · Regulatory · 10 min read
FDA says it has not identified any human exposure data on products containing dihexa acetate, and its compounding advisory committee is due to discuss the substance before the end of February 2027. FDA's own substance registry lists dihexa as the active metabolite of fosgonimeton, a daily injection that missed its primary and secondary endpoints in a 26-week Alzheimer's trial whose primary analysis covered 287 people. The developer's lab work found dihexa's molecule largely degraded in simulated gut fluids, and the paper that set out its proposed mechanism was retracted in 2025 for falsified or fabricated data.
- No registered trial tests dihexa under its own name; FDA says it has found no human exposure data on dihexa acetate products.
- Its phosphate prodrug, fosgonimeton, missed its primary and secondary endpoints in the 26-week LIFT-AD trial (primary analysis 287 people).
- The 2014 paper behind dihexa's proposed HGF/MET mechanism was retracted in 2025 for falsified or fabricated data.
Published October 9, 2026
Product analysis · Evidence audit · 11 min read
Twelve of the 14 vials held full-length activin receptor IIB rather than the receptor-Fc fusion protein that went into clinical trials, 11 of those still carrying a histidine purification tag and apparently made in bacteria. One held follistatin 344. One held no protein at all. The human record behind the name is four registered trials, 153 people, finished in June 2011, and the Duchenne programme was stopped after nosebleeds and telangiectasias in 5 of 9 boys on the higher regimen. The most recent ACE-031 paper, published in February 2026, is a marmoset study.
- Of 14 products bought and analysed by a doping control laboratory, none contained ACE-031.
- Twelve held full-length activin receptor IIB, 11 of those still tagged; one held follistatin 344, one no protein.
- The human record is 153 people in four trials that ended in 2011; the Duchenne study stopped after nosebleeds and telangiectasias in 5 of 9 boys on the higher regimen.
Published October 8, 2026
Evidence audit · Clinical trials · 10 min read
Influencers say retatrutide is different from other GLP-1 drugs: raise the dose until appetite suppression kicks in, then stay there instead of climbing to the top dose. We read the phase 2 and phase 3 record. Every published trial assigned fixed doses, weight loss rose with dose, hunger scores fell even at doses that produced far less weight loss, and no registered study we found tests the appetite rule.
- Every published retatrutide efficacy trial assigned fixed doses; weight loss rose with dose.
- Phase 2 hunger scores fell even at 1 mg, which gave about a third of the 12 mg weight loss.
- No trial we found tests appetite-guided dosing; TRIUMPH-6 and TRIUMPH-9 are estimated to complete in 2028.
Published October 8, 2026
Evidence audit · Regulation · 10 min read
FDA has named Melanotan II for a compounding advisory meeting before the end of February 2027, with no date yet noticed. The published placebo-controlled human evidence is three studies from one lab: a three-man pilot in which two men's skin darkened, and two 10-man erectile dysfunction trials. It is not approved, sits in none of FDA's 503A categories, and keeps an FDA safety entry citing case reports. Its approved near-twin, bremelanotide, lists focal hyperpigmentation in 38% of patients dosed daily for eight days.
- Not approved and in none of FDA's 503A categories; an FDA panel is due to consider it by Feb. 2027.
- Published controlled human evidence: 23 men in three studies from one lab, 1996 to 2000.
- Only a three-man pilot measured tanning; the label of its approved near-twin, bremelanotide, records pigment changes.
Published September 19, 2026
Evidence audit · Regulation · 12 min read
Cibinetide has what most of this index lacks: randomized, placebo-controlled human trials. The ClinicalTrials.gov intervention search identified four records. The biggest was 64 people across four arms, and it did move corneal nerve fiber area at the 4 mg dose (P = 0.012) — an endpoint its own authors call a surrogate. On the results the sponsor posted to ClinicalTrials.gov, placebo did numerically better on skin nerve fiber density and on how much pain interfered with daily life. The newest registered trial was terminated at nine participants because the study drug expired.
- The primary endpoint was corneal nerve fiber area — a surrogate, by the authors' own description.
- On the sponsor's posted results, placebo led on pain interference and on skin nerve fiber density.
- Four records in the cited ClinicalTrials.gov search; the last-started trial stopped at nine when its drug expired.
Published September 18, 2026
Evidence audit · Clinical trials · 12 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 September 18, 2026
Evidence audit · Research integrity · 12 min read
The randomized evidence includes large trials — 1,070 patients in one stroke trial, seven trials and 1,773 participants in Cochrane's review. Cochrane's moderate-certainty reading is that it probably does not prevent death after stroke, and probably increases non-fatal serious adverse events. Between January 2025 and June 2026, seven Cerebrolysin papers carried retraction notices. Every one of them was an animal study.
- Real randomized human trials — the largest, 1,070 patients, missed its primary endpoint.
- Cochrane: probably no effect on death, probably more non-fatal serious adverse events.
- Seven Cerebrolysin animal papers were retracted between January 2025 and June 2026.
Published September 18, 2026
Evidence audit · Regulation · 12 min read
FDA evaluated five CJC-1295 substances and its advisers took five separate votes on December 4, 2024 — one yes in the sixty-five cast. The published human record is three studies in 63 healthy volunteers, none of them with growth hormone deficiency, and FDA can say only that the molecule they used “appears” to have been the DAC form. In pepmg’s index, 103 of 177 CJC-1295 listings name the other one.
- FDA's advisers took five separate votes and cast one yes in sixty-five.
- FDA’s review counted 63 exposed healthy volunteers across three publications; none had GHD.
- 103 of 177 listings sell the no-DAC form, which FDA found no human study of.
Published September 18, 2026
Evidence audit · Regulation · 11 min read
Emideltide, sold as DSIP, was the only one of seven peptide families FDA's compounding advisers declined to recommend in July, by 6 votes to 7. It does have placebo-controlled human trials. They date from 1981 to 1992, every dose FDA found was intravenous, and the two run by other research groups found little or no benefit.
- The only one of seven peptide families the July panel did not recommend: 6 for, 7 against, 1 abstention.
- FDA found 209 people dosed in small studies, every one of them intravenously.
- Placebo-controlled insomnia studies by two other research groups found little or no benefit.
Published September 18, 2026
Evidence audit · Regulation · 12 min read
FDA's own review found three studies in which epitalon was given to people — two sublingual, one an eye injection — and none in the condition it was nominated for. The mortality result quoted across the market belongs to epithalamin, a cattle pineal extract FDA says in writing is a different substance. FDA's reviewers proposed not adding epitalon to the 503A list; its advisers voted 7–4 to add it anyway.gov searches returned no intervention record.
- FDA found three studies giving epitalon to humans; none in the nominated use, none by the sold route.
- The quoted mortality result is for epithalamin, a pineal extract FDA calls a different substance.
- FDA staff proposed not adding it; the advisory panel voted 7–4 to add it anyway.
Published September 18, 2026
Evidence audit · Regulation · 11 min read
FDA removed GHK-Cu from category 1 on April 22, 2026, then added it back on May 5 as “GHK-Cu (except for injectable routes of administration)” — a nominator had meant to withdraw only the injection. The injectable nomination now sits on FDA’s significant-safety-risks page instead. GHK-Cu is the second most widely carried compound in pepmg’s index, in 103 of 108 vendors, and 222 of its 231 listings are lyophilized vials. One registered trial specifically tests a single-ingredient GHK-Cu formulation: a topical gel, 60 healthy adults, no results yet.
- FDA's category 1 entry now reads “GHK-Cu (except for injectable routes of administration).”
- The injectable nomination was previously in category 2, and its nominator withdrew it.
- One randomized human study of the peptide alone: 13 patients, no objective endpoint met.
Published September 18, 2026
Evidence audit · Regulation · 11 min read
Before it lists a single indication, the prescribing information states that HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity — in full capitals, on more than one marketed label. Behind that sentence are randomized human trials from 1976 and 1990 that found no advantage over the diet, and a 24-trial meta-analysis that found none either. Since March 23, 2020 the compound has also been a licensed biologic, which puts it outside the compounding lists the peptide market spent 2026 arguing about.
- The label states the obesity finding in capitals, before its three indications.
- Randomized trials in 51 and 40 women found no advantage over the same diet.
- A licensed biologic since March 2020 — outside the 503A and 503B compounding lists.
Published September 18, 2026
Evidence audit · Regulation · 11 min read
Fifty-five of the 104 vendors in pepmg's index stock it — wider coverage than melanotan-1 or SS-31. The molecule was published in 1992 as a laboratory reagent, ClinicalTrials.gov returns no registered study that gives it to anyone, and a June 2026 review places it in the tier defined by having no peer-reviewed human studies. The IGF-1 drug that is FDA-approved is a different molecule, licensed for children, and its label contraindicates use once the growth plates have closed.
- The ClinicalTrials.gov intervention search found no human IGF-1 LR3 study.
- The approved IGF-1 drug is a different molecule, for children, contraindicated once growth plates close.
- Animal studies do not establish a human benefit, dose or safety profile.
Published September 18, 2026
Evidence audit · Regulation · 12 min read
One hundred and one of the 112 vendors in pepmg's index stock it — sixth of 83 compounds by coverage. Behind it sit two Phase 2 trials in patients recovering from bowel resection: one published without significant benefit on its overall efficacy endpoints, one that enrolled 320 people and has no results posted in the registry. The human trials identified by FDA used intravenous dosing, and in October 2024 an FDA advisory committee voted 12 to 0 against it, twice.
- The published bowel-surgery trial treated 114 patients; its primary result was not significant.
- A 320-patient phase 2 completed in 2014 has no results posted in its registry record.
- FDA advisers voted 0 in favor, 12 against — on each salt form, at one meeting.
Published September 18, 2026
Evidence audit · Clinical trials · 11 min read
Sixty-eight of the 112 vendors in pepmg’s index list kisspeptin, mostly as 10 mg vials of kisspeptin-10. The studies that built the reputation — egg maturation in IVF, two randomized crossovers in hypoactive sexual desire disorder — used kisspeptin-54. An August 2026 study recruited fifteen healthy men across several infusion experiments, including twelve-day intermittent dosing; outcomes were hormone concentrations.
- The IVF and sexual-desire trials used kisspeptin-54; the market sells kisspeptin-10.
- An August 2026 study recruited 15 men across infusion protocols, including 12-day intermittent dosing.
- The newer chronic kisspeptin-10 study measured hormones, not long-term clinical outcomes.
Published September 18, 2026
Evidence audit · Regulation · 13 min read
Sixty-seven of the 112 vendors in pepmg's index carry it, almost always as a 5 or 10 mg vial. The human record is real and it is serious — but repeated exposure has produced both desensitization and sustained responses, depending on the dosing pattern and hormone measured. FDA's 2024 review found a single clinical study that had given kisspeptin-10 under the skin, to about 35 healthy women, and its advisory committee voted 0 in favor, 11 against.
- Continuous and intermittent dosing produced different hormone responses; desensitization is not universal.
- FDA's advisory committee voted 0 in favor, 11 against adding kisspeptin-10 to the 503A Bulks List.
- Routes and schedules vary; the newer study used subcutaneous kisspeptin-10 infusions.
Published September 18, 2026
Evidence audit · Regulation · 10 min read
In July an FDA advisory committee voted 8 to 6 to recommend KPV for pharmacy compounding, for wound healing and inflammatory conditions, over a staff proposal not to add it. The nomination was for a 0.1% skin cream. FDA's review found no study, case report or adverse-event report of KPV in a human, by any route.
- Recommended 8 to 6 for compounding, over an FDA staff proposal not to add it.
- FDA found no human study, case report or adverse-event report for KPV by any route.
- The nomination was a 0.1% cream; in a lab test, KPV did not get through untreated human skin.
Published September 18, 2026
Evidence audit · Regulation · 10 min read
FDA has named cathelicidin LL-37 for a compounding advisory committee meeting before the end of February 2027, after its nomination left the agency’s significant-safety-risk category. The human record is small and almost entirely topical: in a 148-patient phase IIb in venous leg ulcers, 26.5% and 24.7% of patients on LL-37 reached confirmed wound closure against 25.3% on placebo, and the company that ran it initiated voluntary liquidation in 2023.
- FDA plans an advisory panel on LL-37 before the end of February 2027. That is advice on compounding, not approval.
- The 148-patient phase IIb in leg ulcers matched placebo on wound closure: 26.5% and 24.7% vs 25.3%.
- Every controlled trial of the synthetic peptide applied it to wounds; we found none of subcutaneous injection.
Published September 18, 2026
Evidence audit · Trial reporting · 11 min read
Both numbers come from the same 725-person Phase 3 trial, both are correct, and the trial met its endpoints under both. The 16.6% is the sponsor's April topline figure under the efficacy estimand; the −13.0% against −5.4% on placebo is the prespecified primary analysis published in The New England Journal of Medicine in June. Gastrointestinal adverse events reached 89.7% in the higher-dose arm, and in the Phase 2 trial 60.4% of all treated participants, including placebo, finished. No FDA approval for survodutide was identified, and sixteen of the 112 vendors pepmg tracks already list it.
- The prespecified primary analysis: −13.0% against −5.4% on placebo at 76 weeks, in 725 adults.
- The 16.6% headline is the same trial read under the efficacy estimand.
- Gastrointestinal adverse events reached 89.7% at 6.0 mg; approved in no country.
Published September 18, 2026
Evidence audit · Regulation · 11 min read
The approved US product is a 1 mg/kg infusion for acquired methemoglobinemia, and its label warns of serious or fatal serotonin syndrome alongside common antidepressants and opioids. The newest randomized human trials give it intravenously during surgery. A completed trial of daily oral use across healthy aging and cognitive-impairment groups posted group averages with no statistical comparison, and 43 of the 98 people who started it did not finish.
- Approved in the US since 2016 as a 1 mg/kg IV antidote, under a serotonin syndrome boxed warning.
- The newest randomized trials gave it by IV during surgery: three trials, 779 patients, lower reported delirium.
- The one completed daily oral trial in healthy older adults posted no statistical comparison.
Published September 18, 2026
Evidence audit · Regulation · 12 min read
LUM-201 — which a peer-reviewed paper identifies as “ibutamoren, formerly MK-0677” — began a 150-child randomized Phase 3 in growth hormone deficiency on May 20, 2026. The adult record runs the other way: a 563-patient Alzheimer’s trial found no clinical effect, a two-year trial in 65 healthy older adults raised fat-free mass without changing strength or function, and a 123-patient hip-fracture trial was terminated early for a congestive-heart-failure signal FDA still quotes by name. It is also not a peptide.
- A 563-patient Alzheimer's trial found no clinical effect; a 123-patient hip-fracture trial stopped early.
- Fat-free mass rose 1.1 kg over two years in 65 older adults — strength and function did not.
- The same molecule, as LUM-201, began a 150-child Phase 3 in growth hormone deficiency in May 2026.
Published September 18, 2026
Evidence audit · Regulation · 9 min read
In July an FDA advisory committee voted 7 to 5 to recommend MOTS-c for pharmacy compounding, against FDA staff’s proposal. The agency’s review found no clinical study of it, no in vivo pharmacokinetic study in any species and no toxicology study. The closest human drug data belong to CB4211, a company’s analogue, from a four-week, 20-person placebo-controlled stage reported by press release. The first placebo-controlled trial of MOTS-c itself began recruiting in China in February 2026. It is listed by 101 of the 108 vendors in pepmg’s index.
- An FDA panel voted 7 to 5 to recommend it for compounding, against FDA staff's proposal. That is advice, not approval.
- FDA's review found no clinical, in vivo pharmacokinetic or toxicology study of MOTS-c.
- The first placebo-controlled trial of MOTS-c itself began in 2026; primary completion is estimated for February 2027.
Published September 18, 2026
Evidence audit · Regulation · 10 min read
The biggest randomized trial of intravenous NAD+ pepmg could find gave 180 heart-failure patients in China 10 mg a day for a week and reported a modest ejection-fraction gain. High-dose infusion studies were small and reported tolerability concerns. A newer injection preprint includes just 15 NAD+ recipients across three routes; neither body of work establishes longevity benefits. And FDA proposed in 2019 not to include NAD on the 503A bulks list; that rule is still unfinished, and NAD remains in category 1 under FDA’s conditional interim enforcement policy.
- The largest randomized IV trial found: 180 heart-failure patients, 10 mg a day for seven days.
- The high-dose infusion studies are small (11, 53 and 14 people), two tied to a rival product's maker.
- FDA’s 2019 proposal to exclude NAD from the 503A bulks list remains unfinished.
Published September 18, 2026
Evidence audit · Regulation · 12 min read
FDA approved Foundayo on April 1, 2026 — the first new molecular entity cleared under the agency's National Priority Voucher pilot, and by FDA's own account the fastest approval of a new molecular entity since 2002. The approved product is a once-daily tablet in six strengths, none of them 6 mg: the label presents the phase 3 trials' 6, 12 and 36 mg arms as 5.5, 9 and 17.2 mg, because those trials ran on a formulation it calls investigational.8 mg starting dose.
- Approved April 1, 2026 — a once-daily tablet, and a small molecule, not a peptide.
- The trials' 6, 12 and 36 mg arms appear on the label as 5.5, 9 and 17.2 mg.
- FDA ordered a medullary thyroid carcinoma registry reporting through 2043.
Published September 18, 2026
Evidence audit · Regulation · 12 min read
Pitocin is indicated to induce contractions and to control postpartum bleeding, and its label opens by saying it is not indicated for elective induction of labour. FDA did once approve an intranasal oxytocin — Syntocinon, to assist initial postpartum milk ejection — and Drugs@FDA now records it as discontinued. A 2026 meta-analysis of 42 double-blind randomized trials in mental disorders, pooling 1,922 participants, found a small, non-significant overall effect.
- Approved as an obstetric injection — the label rules out elective induction.
- The one approved nasal spray was for milk let-down, and is discontinued.
- 42 pooled randomized trials, 1,922 people: g = 0.17, and the interval crosses zero.
Published September 18, 2026
Evidence audit · Clinical trials · 10 min read
Two phase 3 trials, published in The Lancet in March 2026, gave people with early Alzheimer’s oral semaglutide up to 14 mg daily or placebo for two years. Neither trial found a statistically significant difference in decline on its primary scale. Some spinal-fluid markers moved by 10% or less in a small substudy; the observational signal that launched the program was about preventing dementia in diabetes, and that question is still untested.
- Two phase 3 trials, 3,808 people with early Alzheimer’s: no slowing on the primary scale.
- Spinal-fluid markers moved 10% or less in a small substudy; blood markers did not.
- Treatment failed. Prevention in diabetes, the original observational signal, is still untested.
Published September 18, 2026
Evidence audit · Regulation · 12 min read
FDA's May 2026 evaluation identified no human pharmacokinetic data for semax by any route, no safety data at all for the injectable route the nominations proposed, and two clinical references it could evaluate — both uncontrolled, both intranasal — which it said demonstrated a lack of effectiveness. FDA proposed not listing the peptide. On July 24 the advisory committee voted 8–5 the other way.
- FDA proposed not listing it; the advisory committee voted 8–5 the other way.
- The evaluable human record: one 1996 study of 37 people and one meeting abstract.
- No human pharmacokinetics by any route, and no data at all for the injected route.
Published September 18, 2026
Evidence audit · Regulation · 13 min read
GEREF was approved in 1990 as a pituitary provocative test and in 1997 for growth failure in children with idiopathic growth hormone deficiency. EMD Serono discontinued both products in 2008 and asked FDA to withdraw the applications; FDA did, effective June 18, 2009. A 2013 FDA determination found the withdrawal was not for reasons of safety or effectiveness — which opened the door to generic applications; the FDA records checked for this note list no approved generic. The adult case underneath today's market is three studies from the 1990s that dosed forty older adults between them.
- Approved in 1990 and 1997; both approvals withdrawn effective June 18, 2009.
- FDA found the withdrawal was not for safety or effectiveness — no generic has followed.
- The adult evidence is three 1990s studies dosing forty older adults in total.
Published September 18, 2026
Evidence audit · Regulation · 12 min read
FDA's May 2026 review searched PubMed, Embase, ClinicalTrials.gov, FAERS and six other databases and found no article in which TB-500 was administered to humans — then recommended against letting compounders use it. In July its advisory committee voted the other way. TB-500 is a seven-amino-acid fragment; the thymosin β4 trials cited in its place tested the 43-amino-acid protein, and 64 of the 183 listings in pepmg's index put the protein's name on the fragment's vial.
- FDA's May 2026 review found no article in which TB-500 was administered to humans.
- It proposed not listing the substance; in July the advisory committee voted in favor anyway.
- TB-500 is a 7-amino-acid fragment — the human trials people cite tested the 43-amino-acid protein.
Published September 18, 2026
Evidence audit · Regulation · 11 min read
Gattex has been approved since December 2012 for short bowel syndrome in people who depend on intravenous feeding, and its record is genuinely strong: randomized, placebo-controlled trials in 86 and 83 adults, plus a pediatric phase 3. The same label warns that the drug can accelerate neoplastic growth, and one of its two tested doses missed.
- Approved since 2012 for short bowel syndrome in people dependent on IV feeding.
- Pivotal trial: 63% cut IV volume by at least 20%, against 30% on placebo.
- The label asks adults for a colonoscopy before starting, at 1 year, then at least every 5.
Published September 18, 2026
Evidence audit · Regulation · 13 min read
A ClinicalTrials.gov search on September 7, 2026 returned 13 interventional tesofensine studies enrolling 1,513 people — every one of them phase 1 or phase 2. The trial the market quotes is a 203-patient, 24-week phase 2 from 2008 whose own authors asked for phase 3 confirmation, and which has carried an unresolved expression of concern from The Lancet since 2013. The 372-patient phase 3 described in company statements is in neither the registry nor the literature.
- 13 registered studies, 1,513 participants — all phase 1 or 2, none phase 3.
- The 2008 Lancet trial still carries an unresolved expression of concern.
- A tropane small molecule, not a peptide, and approved by no regulator pepmg could verify.
Published September 18, 2026
Evidence audit · Regulation · 12 min read
It is one of the few compounds in pepmg's index with a properly powered Phase 3 behind it: 1,106 adults with sepsis, 22 centres, double-blind, placebo-controlled. Twenty-eight-day mortality was 23.4% against 24.1% on placebo, hazard ratio 0.99. Six weeks before that trial published, FDA's advisory committee voted 4 in favour and 17 against adding the peptide to the 503A Bulks List.
- A 1,106-patient, double-blind phase 3 in sepsis returned a hazard ratio of 0.99.
- FDA's advisers voted 4 in favour, 17 against — on both salt forms.
- The pooled mortality benefit disappears in the high-quality and multi-centre subgroups.
Published September 18, 2026
Evidence audit · Regulation · 14 min read
A ClinicalTrials.gov query on September 8, 2026 returned 231 interventional tirzepatide studies with a combined registry enrollment of 89,135 participants, 46 of them phase 3 — a mixture of actual and planned enrollment, not a count of people who all completed treatment. The pivotal studies reviewed here do not validate vendor products. Shortage-based compounding discretion ended in March 2025, subject to the court-related extension for 503A; other patient-specific statutory conditions still apply, and FDA has since told sellers that a research-use-only label does not decide what a product is. Four of the 108 vendor domains in pepmg's index match websites named in those letters.
- The Sept. 8 registry snapshot included actual and planned enrollment; it does not validate vendor vials.
- SURPASS-CVOT met noninferiority in 13,299 patients; the superiority test returned P = 0.09.
- Shortage-based compounding discretion ended in March 2025; other statutory conditions still apply.
Published September 18, 2026
Evidence audit · Regulation · 12 min read
Aviptadil, the synthetic form of vasoactive intestinal peptide, is half of Invicorp — an ampoule holding 25 micrograms, given by intracavernous injection, licensed in the UK since April 2015 for erectile dysfunction. The largest randomised trial of the peptide itself, 461 adults in American intensive care, returned an odds ratio of 1.11 and was stopped for futility.
- Licensed in the UK since 2015 — 25 micrograms per ampoule, for erectile dysfunction.
- The largest randomised trial, 461 ICU patients, was stopped for futility (OR 1.11).
- The UK-approved intracavernous combination does not establish benefits for other routes or uses.
Published September 18, 2026
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 · 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