On July 23 and 24, FDA's Pharmacy Compounding Advisory Committee recommended that six peptides be added to the federal list of ingredients that may be used in patient-specific compounding, in which a licensed pharmacist or physician prepares a customized medication for one identified patient. BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax received more yes than no votes. Emideltide, also called DSIP, did not.
This was a nonbinding recommendation from an outside advisory committee, not FDA approval or a change in law. None of the seven FDA reviews contained a well-reported, adequately sized, placebo-controlled human study that established benefit for the exact condition and route under review.
FDA staff had proposed excluding every substance. The committee then disagreed on 12 of the 14 questions put to it. FDA's multidisciplinary staff conducted the literature reviews and wrote the evidence packets. The outside panel reviewed that work, heard public testimony and member discussion, and gave FDA advice.
The committee cast 14 votes, not seven
FDA treated the free base and acetate salt as two separate chemical forms of each peptide. The committee therefore voted twice on every peptide. Both forms received the same tally in every case.
The counts below come from the votes read into the record in the FDA's July 23 recording and July 24 recording.
| Peptide | Use FDA evaluated | Vote on free base | Vote on acetate | Committee recommendation |
|---|---|---|---|---|
| BPC-157 | Ulcerative colitis | 8 yes, 6 no, 1 abstention | 8 yes, 6 no, 1 abstention | Include both forms |
| KPV | Wound healing and inflammatory conditions | 8 yes, 6 no, 1 abstention | 8 yes, 6 no, 1 abstention | Include both forms |
| TB-500 | Wound healing | 8 yes, 6 no, 1 abstention | 8 yes, 6 no, 1 abstention | Include both forms |
| MOTS-c | Obesity and osteoporosis | 7 yes, 5 no, 2 abstentions | 7 yes, 5 no, 2 abstentions | Include both forms |
| Emideltide (DSIP) | Opioid withdrawal, chronic insomnia, and narcolepsy | 6 yes, 7 no, 1 abstention | 6 yes, 7 no, 1 abstention | Do not include either form |
| Epitalon | Insomnia | 7 yes, 4 no, 1 abstention | 7 yes, 4 no, 1 abstention | Include both forms |
| Semax | Cerebral ischemia, migraine, and trigeminal neuralgia | 8 yes, 5 no, 1 abstention | 8 yes, 5 no, 1 abstention | Include both forms |
The number of voters changed by topic because the FDA roster assigned several temporary members to specific peptides. That is why 15 people voted on BPC-157, 14 on Emideltide and Semax, and 12 on Epitalon.
Who reviewed the evidence, and who voted
FDA's Pharmacy Compounding Review Team searched the literature, assessed product quality, animal data, human data, and adverse-event reports, and wrote seven detailed reviews. Staff members from clinical, product-quality, regulatory, and compounding specialties presented the proposal to exclude all 14 forms.
The outside committee did not perform a second systematic review. Its members reviewed FDA's packets, questioned staff, heard public speakers, brought their own experience to the discussion, and then voted. The committee did not overrule FDA, and its members were not a second FDA review division. FDA still owns the regulatory decision.
What the vote did not do
The committee is called the Pharmacy Compounding Advisory Committee. Its recommendation is advice to FDA.
FDA's meeting page states that its recommendations are nonbinding. Every FDA employee on the roster was non-voting. FDA staff wrote and presented the proposal to exclude all 14 forms; outside members cast the votes.
No peptide was approved. No product, dose, route, manufacturer, or medical claim was approved. The current 503A regulation still lists six unrelated substances and none of the seven peptides considered at this meeting.
Even a future place on the 503A list would not make a peptide FDA-approved. The regulation itself says that being on the list does not demonstrate the safety or efficacy of a compounded drug and does not amount to FDA endorsement.
FDA's caution around compounding also has a patient-safety history. In 2012, contaminated drugs made by a Massachusetts compounding pharmacy caused more than 750 infections and more than 60 deaths across 20 states. Congress responded in 2013 with the Drug Quality and Security Act. The law retained and updated 503A and created 503B outsourcing facilities, which are subject to current good manufacturing practice requirements and adverse-event reporting. Qualifying 503A drugs remain exempt from those requirements. That history does not answer whether any of these seven peptides works. It explains why manufacturing quality and enforceable oversight were central to FDA's analysis.
The votes did not rank the human evidence
The amount and quality of human evidence did not track the vote results.
| Peptide | Human evidence FDA found | What that evidence can establish |
|---|---|---|
| BPC-157 | A placebo-controlled early safety study using an enema, an ulcerative-colitis study that assigned treatments by chance and kept participants and investigators unaware of the assignment, and three small reports without comparison groups using knee, bladder, or IV administration | Short-term exposure in small groups. It does not establish effectiveness for ulcerative colitis or safety for the oral, subcutaneous, nasal, and transdermal routes FDA evaluated. |
| KPV | No human administration study or human exposure data | Cell and animal findings support further research. They cannot establish human benefit or human safety. |
| TB-500 | No human administration study of the seven-amino-acid TB-500 fragment. The 43-amino-acid parent protein, thymosin beta-4, has been tested in placebo-controlled Phase II and III eye-drop trials sponsored by ReGenTree. | The 72-person Phase II trial missed both primary endpoints but reported favorable secondary outcomes and no adverse events. In the 18-person Phase III trial, complete corneal healing occurred in 6 of 10 treated participants and 1 of 8 placebo participants; the primary endpoint missed statistical significance (p=0.0656), and no significant adverse effects were observed. These eye-drop studies of the parent protein do not establish the safety or effectiveness of injected TB-500. |
| MOTS-c | No study administering MOTS-c to a person | Human studies measuring naturally occurring MOTS-c are not tests of an administered drug. The treatment evidence remained preclinical. |
| Epitalon | Three reports of human administration. One randomized placebo-controlled study gave sublingual peptide to 20 of 40 women with low melatonin production and measured a melatonin metabolite and gene expression. | The controlled study measured biomarkers, not treatment of insomnia, and did not report safety data. FDA found no human safety data for the proposed subcutaneous route. |
| Semax | Intranasal use in several human reports, many with incomplete methods or safety reporting | The evidence was route-specific and weak for the uses under review. A 12-person migraine study had no control group or blinding and did not define its rating scale adequately. |
| Emideltide | Several IV studies totaling 209 people, including small placebo-controlled insomnia experiments and withdrawal studies without comparison groups | FDA described human exposure to more people than for the other five peptides besides Semax, but the studies were small, inconsistent, and did not test the proposed subcutaneous route. |
The BPC-157 packet contained real preclinical signals. Nominators submitted 25 nonclinical papers, 24 of which described pharmacologic effects in cells or animals. That was the nomination packet, not the full published literature. A 2025 systematic review of musculoskeletal evidence identified 544 search records and included 36 studies: 35 preclinical studies and one retrospective human report. Its authors found no reported harm across several organ systems in the animal safety literature, but they found no clinical safety data. The papers reported smaller gastrointestinal lesions in rodent injury models, kidney protection, tendon healing, and neuroprotective effects. FDA also identified recurring weaknesses: absent dose-response testing, limited tissue analysis, short follow-up, and models or administration routes that did not match the proposed human use. In 28-day intramuscular studies in rats and dogs, researchers reported no gross or microscopic injury to major organs, while FDA flagged clotting and liver-associated findings that needed longer and better-matched studies. Those findings do not establish clinical benefit or safety.
FDA's BPC-157 review also describes the only controlled ulcerative-colitis result it found. Fifty-three people were assigned by chance to a BPC-157 enema or placebo for two weeks, and 46 completed the study. The average disease-activity score moved farther in the BPC-157 group, but the range of results compatible with the data included no difference between the groups. The abstract omitted key details about eligibility, the main outcome, statistical methods, and follow-up. This study did not establish that BPC-157 beat placebo.
The Emideltide review describes more human use than the vote result suggests. In one insomnia experiment, six people received both IV Emideltide and placebo in a randomly assigned order, and neither the participants nor the investigators knew which one was being given at each point. The study found tendencies toward fewer awakenings and higher sleep efficiency, but no difference in sleep onset or final waking time. The sample was too small and the sequence too short for a reliable clinical conclusion.
In the largest withdrawal study, all 107 people received Emideltide and there was no placebo group. Nine experienced temporary effects including headache, nausea, perspiration, or vertigo. Three experienced serious adverse effects, including low blood pressure at the start of an infusion. Whether Emideltide caused every event, and whether it helps withdrawal, remained uncertain without a comparison group.
The committee rejected Emideltide while recommending KPV, TB-500, and MOTS-c, for which FDA found no human administration data. The vote was not a ranking of the peptides by the number or rigor of their human studies.
An observed problem is not the same as a possible one
FDA repeatedly raised aggregation, impurities, and immunogenicity. Immunogenicity is an immune response against a therapeutic peptide. Aggregates and manufacturing impurities can increase that risk.
The briefing documents generally describe these as potential risks that have not been ruled out. They do not report that KPV, TB-500, MOTS-c, or Epitalon caused immune injury in people. For several of those substances, nobody had run the human study that could answer the question.
- No reported immune injury is not proof of safety when there are no human studies.
- A plausible immune mechanism is not an observed adverse event.
- A positive cell or mouse experiment is a reason to run a human trial, not proof of human benefit.
- A small uncontrolled human report cannot separate treatment effect from placebo response, natural recovery, selection, or measurement bias.
FDA also searched adverse-event databases. A search returning zero reports is weak reassurance here. FDA staff told the committee that 503A compounders are not required to report adverse events to the agency. An empty database can mean no harm occurred, no report was filed, or nobody was looking closely enough to know.
BPC-157 did not have a literally empty record. FDA found three reports in its adverse-event database through December 4, 2025, and three poison-center cases. The reports included redness and swelling, shortness of breath, and pigmentation changes, but they were sparse, involved other substances, or did not establish which product caused the event. These are observed reports, not proof of causation or a measurable adverse-event rate. They also mean the public record cannot support a claim of zero reported harm.
The yes and no voters applied different decision rules
The BPC-157 roll call made the split unusually clear. No voters emphasized the absence of controlled effectiveness data, missing long-term safety evidence, chemical-characterization problems, available approved treatments for ulcerative colitis, and the risk that patients would read a 503A listing as FDA endorsement.
Yes voters applied a different threshold. Bobby Harshbarger, PharmD, said the 503A question was not the same as new-drug approval. Other yes voters emphasized the limited human risk signal, clinician and patient choice, and the possibility that access through a prescriber and licensed pharmacy could be safer than products bought from unregulated sellers. Several referred to clinical experience or individual patient accounts. Those accounts can identify a question worth studying. They cannot establish how often a benefit or harm occurs or whether the peptide caused it.
During the BPC-157 vote, Melissa Loseke, DO, said her yes was conditional on tighter sourcing, patient registries, and mandatory adverse-event reporting. Other members argued that patients already buying from unregulated sellers would be safer under the care of a prescriber and licensed pharmacy.
The evidence packet did not test whether pharmacy access would reduce harm from unregulated sellers.
FDA staff returned the next morning to explain the regulatory problem. A 503A drug does not receive an FDA-approved label, the agency cannot require 503A compounders to report adverse events, and the route restrictions members mentioned were not enforceable simply because a voter attached them to a yes. A conditional yes was still recorded as yes.
The opposite assumption was also untested. During the Emideltide vote, Kevin Zacharoff, MD, said he was not convinced listing would reduce gray-market use because people might keep buying the cheaper product. The meeting produced two competing theories about behavior and no evidence measuring either one. FDA staff's safety concerns and the committee's safer-access theory both need evidence matched to the claim.
The BPC-157 vote split by institutional background
The BPC-157 roll call lets us match every vote to FDA's final roster.
- Yes: Gabriel Alizaidy of Maximus Health; Asare Christian of Aether Medicine; Bobby Harshbarger of Premier Pharmacy; Melissa Loseke of Re-new Institute; Haleem Mohammed of Gameday Health; David Pope of Xifin Pharmacy Solutions; Joshua Starbuck of Makena Health; and Kris Wusterhausen of The Resurge Clinic.
- No: Elizabeth Rebello of MD Anderson Cancer Center; Brian Serumaga of the United States Pharmacopeia; consumer representative Todd Durham of the Foundation Fighting Blindness; patient representative Josh Mailman of NorCal CarciNET Community and the Neuroendocrine Tumor Research Foundation; William Zamboni of the University of Pittsburgh; and BPC-157 specialist Brian P. Lee of the Keck School of Medicine of USC.
- Abstained: Timothy Fensky, the National Association of Boards of Pharmacy representative.
All eight yes voters were core committee members, not temporary members. FDA's current roster shows that their four-year terms began on April 19 or May 31, 2026, weeks before the July meeting. Four of the six no voters were temporary patient, consumer, pharmacology, or gastroenterology members assigned to the BPC-157 topic.
The roster establishes that alignment. It does not prove that a member sold BPC-157, held a financial interest in it, or voted to benefit an employer. FDA's public membership pages say the Commissioner or a designee selects committee members from nominations, but they do not identify who nominated each person or why each new member was selected. The public record therefore cannot answer who put each name forward or why this group was chosen.
At the start of the meeting, FDA said its Office of Ethics and Integrity had reviewed the members' financial interests, including interests attributed through employers and immediate family. FDA said all members complied with federal conflict-of-interest rules and that no waivers under 18 U.S.C. 208 had been issued. The roster's designated industry representative, Donnette D. Staas, PhD, of Jazz Pharmaceuticals, was non-voting.
The ethics review and the panel's composition answer different questions. One addresses statutory financial conflicts. The other shows which kinds of professional experience were represented in the vote. The public record does not show whether professional setting affected any member's judgment.
Why is the research so thin?
The public record only partly answers why the research is so thin.
Ordinary research attrition belongs at the front of this explanation. A 2024 umbrella review covered 122 systematic reviews, 54 diseases, and 367 interventions tested in animals. About half progressed to any human study, about 40% reached a randomized trial, and about 5% reached regulatory approval. Animal promise commonly fails, weakens, or stalls before a usable treatment emerges.
Money also changes which ideas get the chance to fail in people. A study that followed 101 basic-science papers published from 1979 through 1983 found that 27 later reached a randomized trial and five became licensed treatments by 2002. Industry involvement was the strongest predictor that a claim would reach clinical testing. That older cohort cannot explain any one peptide, but it shows why "most promising ideas fail" and "funding incentives shape the evidence" can both be true.
The nominations for all seven substances were withdrawn. FDA continued the reviews on its own initiative. The briefing packets do not explain why the nominators withdrew, why development stopped for some peptides, or who would fund the next trial.
BPC-157 gives us one useful paper trail. ClinicalTrials.gov record NCT02637284 names PharmaCotherapia d.o.o. as the industry sponsor of an early oral safety trial planned for 42 healthy volunteers. The protocol assigned BPC-157 or placebo by chance and concealed the assignment from participants, care providers, investigators, and outcome assessors. Its last known status was active, not recruiting. The record has not been updated since 2015, lists no results, and shows a 2016 results-release event followed by an undated unrelease event. It does not say why.
There was also intellectual property. A US patent covering BPC peptide salts and therapeutic use was granted in 2001. That does not tell us how commercially valuable the protection was, whether later formulations could be protected, or why no approval program followed. It does mean the simple claim that BPC-157 was never studied because it could not be patented is not established by the record.
Research incentives can fail. A compound can look promising and still be unattractive to fund if exclusivity is weak, manufacturing is difficult, the market is small, or somebody else can sell the result. We have examined that conflict in Why BPC-157 Falls Through the Drug Approval System.
But a plausible explanation is not a finding. For these seven peptides, the primary record does not yet show which commercial, patent, regulatory, or institutional barrier caused each evidence gap. The answer is not automatically that the compound failed. It is not automatically that the compound worked and was suppressed. It is unresolved.
What happens next
FDA now has the committee's advice and the rest of the meeting record. To change the 503A list, the agency would still need to use notice-and-comment rulemaking. That means publishing a proposed rule, accepting public comments, considering the record, and issuing a final rule.
FDA has announced no date for that decision. Its 503A process page says substances are addressed on a rolling basis through rulemaking.
Until the regulation changes, the legal status has not changed. Six peptides received favorable advisory recommendations. Emideltide did not. FDA staff opposed all seven. None was approved, and the evidence gaps remain exactly where they were before the vote.
Frequently asked questions
Is BPC-157 FDA approved now?
No. An outside advisory committee recommended that two forms of BPC-157 be placed on the 503A compounding list. FDA has not added either form, and a place on that list would not be drug approval.
Did FDA vote for BPC-157 and TB-500?
No. FDA staff recommended against both forms of every peptide. Voting members of the Pharmacy Compounding Advisory Committee made the contrary recommendations. FDA employees at the meeting were non-voting.
Can a 503A pharmacy compound these peptides now because of the vote?
The vote changed no regulation. The current 503A Bulks List still contains none of the seven peptides. A licensed pharmacist or physician must still follow the law that applied before the meeting.
Why did Emideltide fail when peptides with less human evidence passed?
There was no single reason. In the official roll call, members who voted no cited poor chemical characterization, weak efficacy evidence, safety concerns, approved alternatives, and the mismatch between a complex IV study regimen and the proposed subcutaneous use. Yes voters emphasized clinical option value and the amount of prior human exposure. The 6 to 7 result reflects that disagreement.
Were the yes voters tied to the peptide industry?
The eight BPC-157 yes voters all had FDA-listed roles at clinics, pharmacies, or healthcare companies, while the no voters came from university, standards, consumer, and patient organizations. That is a real institutional asymmetry. The roster does not establish that any member sold the peptide or held a financial interest in it. FDA said it screened the members' financial interests and issued no conflict waivers. The named industry representative was non-voting.
Did FDA find that these peptides are dangerous?
Not as a group. The packets contain a mixture of observed adverse events, inconclusive or weak efficacy results, manufacturing concerns, theoretical risks, and unanswered questions. Treating all five as the same thing would overstate the negative evidence.
References
- US Food and Drug Administration. July 23-24 Pharmacy Compounding Advisory Committee meeting record.
- US Food and Drug Administration. Official July 23 PCAC meeting recording.
- US Food and Drug Administration. Official July 24 PCAC meeting recording.
- US Food and Drug Administration. Final voting questions.
- US Food and Drug Administration. Briefing document introduction.
- US Food and Drug Administration. BPC-157 briefing document.
- US Food and Drug Administration. KPV briefing document.
- US Food and Drug Administration. TB-500 briefing document.
- US Food and Drug Administration. MOTS-c briefing document.
- US Food and Drug Administration. Emideltide briefing document.
- US Food and Drug Administration. Epitalon briefing document.
- US Food and Drug Administration. Semax briefing document.
- US Food and Drug Administration. Final meeting roster.
- US Food and Drug Administration. Current Pharmacy Compounding Advisory Committee roster.
- US Food and Drug Administration. Pharmacy Compounding Advisory Committee membership and selection.
- Electronic Code of Federal Regulations. 21 CFR 216.23, current 503A Bulks List.
- US Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A.
- US Food and Drug Administration. Human Drug Compounding Laws.
- ClinicalTrials.gov. NCT02637284, PCO-02 safety and pharmacokinetics trial.
- United States Patent 6,288,028. BPC peptide salts with organo-protective activity, preparation, and therapeutic use.
- Sosne G, Ousler GW. Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment model. Clinical Ophthalmology. 2015.
- Sosne G, et al. 0.1% RGN-259 ophthalmic solution promotes healing and improves comfort in neurotrophic keratopathy patients in a randomized, placebo-controlled, double-masked Phase III clinical trial. International Journal of Molecular Sciences. 2022.
- ClinicalTrials.gov. NCT01387347, Phase II thymosin beta-4 ophthalmic trial.
- ClinicalTrials.gov. NCT02600429, Phase III thymosin beta-4 ophthalmic trial.
- Vasireddi N, et al. Emerging use of BPC-157 in orthopaedic sports medicine: a systematic review. HSS Journal. 2025.
- Ineichen BV, et al. Analysis of animal-to-human translation shows that only 5% of animal-tested therapeutic interventions obtain regulatory approval for human applications. PLOS Biology. 2024.
- Contopoulos-Ioannidis DG, et al. Translation of highly promising basic science research into clinical applications. The American Journal of Medicine. 2003.
Disclosure: Evan Hafers is a co-founder of PeptideWiki. PeptideWiki may earn commissions from links to peptide vendors. Affiliate partners had no input into this article. Read our affiliate disclosure.
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