Article
Are there BPC-157 human trials? Almost none controlled: here is the human evidence for BPC-157 and the other five PCAC peptides
As of October 19, 2026, none of the six peptides FDA's advisers recommended in July (BPC-157, TB-500, KPV, MOTS-c, Semax, Epitalon) has a completed, peer-reviewed controlled human trial of that compound with posted results. BPC-157 has uncontrolled pilots and one controlled colitis trial, known only from a 2005 abstract FDA called inadequate. A committee vote is not new evidence.
This is for MDs, DOs, NPs, and PAs in longevity, functional, regenerative, and cash-pay clinics who are being told that July's Pharmacy Compounding Advisory Committee vote means these peptides are ready for patients. FDA's own July 2026 briefing documents found that none of the six has a completed peer-reviewed controlled trial of the compound itself. This article goes to the original FDA briefing documents, PubMed records, and ClinicalTrials.gov, and builds a per-peptide human-evidence map you can use in the exam room.
What does this page cover, and what does it leave out?
This page is an evidence map. For each peptide it asks: what human studies exist, what design and sample size are reported, what outcomes and safety signals were described, what FDA's July 2026 briefing said, and what is still missing.
It is not a compounding-status update. As of October 19, 2026, none of the six is on the 503A bulks list at 21 CFR 216.23, and none sits in Category 1 of FDA's interim policy. For current compounding status, see Scriptura's federal peptide rules page. Use this page when a patient asks whether the science, not the headlines, supports use.
On July 23 and 24, 2026, PCAC reviewed seven peptides. It recommended six for the 503A bulks list and did not recommend emideltide, as NCPA summarized on July 31. FDA's own briefing introduction said FDA staff proposed that none of the forms be added, and that FDA does not intend to issue a final determination until it has considered the committee's input and finished its reviews. Advisory votes are non-binding.
How does the human evidence compare across all six peptides?
Uses in the table are the ones FDA evaluated at the meeting, from the meeting agenda page. "Best human evidence" means published or abstract human data on the compound itself, not animal work and not full-length proteins that share a fragment name.
| Peptide | Use FDA evaluated | Best human evidence for the compound itself | What FDA staff briefing said | What is still missing |
|---|---|---|---|---|
| BPC-157 | Ulcerative colitis | Uncontrolled pilots (knee IA, interstitial cystitis, 2-person IV); one controlled UC enema trial only as a 2005 meeting abstract | Proposed not to list; no human PK by oral, SC, nasal, or transdermal routes; UC abstract data inadequate | Peer-reviewed controlled trial with results; human PK by clinic routes |
| TB-500 | Wound healing | None for TB-500 (Ac-LKKTETQ) itself in the briefing record | No human data by any route; TB-500 is not the same as thymosin beta-4 | Any controlled human dosing study of the fragment |
| KPV | Wound healing and inflammatory conditions | None | No human data by any route; immunogenicity not assessed | Any human dosing or safety study |
| MOTS-c | Obesity and osteoporosis (agenda); briefing noted limited nomination detail | None for administered MOTS-c in the briefing; endogenous MOTS-c rises with exercise in separate research | No human data by any route; molecular targets unknown | Completed trial of administered MOTS-c with results |
| Semax | Cerebral ischemia, migraine, trigeminal neuralgia | Russian clinical reports; FDA reviewed limited English sources and found them insufficient for those uses | Proposed not to list; possible bleeding concern from antithrombotic signals | English controlled trials with clear randomization and endpoints |
| Epitalon | Insomnia | Small study of AEDG on melatonin metabolite and clock-gene markers; no sleep outcomes | Proposed not to list; telomerase activation raises a theoretical cancer concern; no human safety package for injection | Blinded sleep-outcome trials; injection-route safety data |
Vote tallies are left out on purpose. FDA's meeting page still lists briefing documents and questions but no minutes as of October 19, 2026, and published tallies differ by outlet.
What human evidence exists for BPC-157?
BPC-157 has more human reports than the other five, and still no completed peer-reviewed controlled trial of the compound with posted results.
FDA's BPC-157 briefing document (media 193343) located a multicenter, randomized, double-blind, placebo-controlled ulcerative colitis enema study (Ruenzi et al., 2005) only as a meeting abstract. Fifty-three subjects with mild to moderate UC were randomized 1:1 to BPC-157 (PL 14736) enema 80 mg or placebo once daily for two weeks. Forty-six completed. FDA wrote that several trial details are missing from the abstract, that the confidence interval for the between-group difference in the authors' Disease Activity Index crossed zero, and that "the data presented for this study are therefore inadequate to support the efficacy and safety of BPC-157 given as an enema for two weeks for the treatment of UC." FDA also noted the nominator had proposed a rectal suppository, not an enema.
Published human reports that are not controlled trials include:
- Lee and Padgett, 2021 (PMID 34324435): retrospective chart review of intra-articular BPC-157 for knee pain. Of 16 reachable patients, 12 received BPC-157 alone (11 of 12 reported improvement) and 4 received BPC-157 plus thymosin beta-4 (3 of 4 improved). No standardized function scores; some patients also received thymosin beta-4, which limits attribution.
- Lee, Walker, and Ayadi, 2024 (PMID 39325560): uncontrolled pilot in 12 women with interstitial cystitis who had not responded to pentosan polysulfate. A single intravesical procedure delivered 10 mg total BPC-157 around inflamed bladder areas. Authors reported complete symptom resolution in 10 of 12 and no adverse events. Product was described as manufactured by a 503A pharmacy.
- Lee and Burgess, 2025 (PMID 40131143): IV safety pilot in 2 adults (ages 58 and 68), both previously exposed to IV BPC-157. Infusions of 10 mg then 20 mg over one hour on consecutive days; authors reported no biomarker changes on the labs they ran and no reported side effects. Sample size is two.
A 2025 systematic review (Vasireddi et al., PMID 40756949) searched through June 3, 2024, included 36 studies (35 preclinical, 1 clinical), and stated that no clinical safety data were found. Formal animal PK work (He et al., 2022, PMID 36588717) reported half-life under 30 minutes in rats and dogs. FDA wrote it found no human pharmacokinetic data after oral, subcutaneous, nasal, or transdermal administration.
Registered trials without completed peer-reviewed results as of this writing include NCT02637284 (Phase 1 safety/PK, planned n=42, status unknown, no results posted), NCT07437547 (Phase 2 hamstring RCT, recruiting, n=120 planned), NCT07803250 (rotator cuff, not yet recruiting), and NCT07752381 (oral peptide gummies including 500 µg BPC-157, completed, no results posted). Registration is not evidence of efficacy.
FDA's FAERS search through December 4, 2025, retrieved three injectable BPC-157 reports (injection-site reaction with concomitant thymosin; shortness of breath; skin darkening). FDA said it cannot make definitive safety conclusions from FAERS alone. Staff proposed that BPC-157 free base and acetate not be placed on the 503A bulks list.
What human evidence exists for TB-500?
TB-500, as sold and as reviewed by FDA, is the acetylated heptapeptide Ac-LKKTETQ (residues 17 to 23 of thymosin beta-4), identified in a doping-control analysis of a product labeled TB-500 (PMID 22962027). Full-length thymosin beta-4 is a 43-amino-acid protein. They are not the same substance.
FDA's TB-500 briefing states that after a literature search, "no articles were found in which TB-500 was administered to humans," and that FDA "did not identify data, such as clinical studies, on the use of TB-500 in humans." Nomination references were studies of thymosin beta-4, not the fragment. FDA also cited an in vitro fibroblast scratch study in which TB-500 did not close wounds.
Phase 2 work on full-length thymosin beta-4 does not transfer to the fragment. Examples include a topical gel venous-ulcer study (PMID 20536470) and an ophthalmic dry-eye Phase 2 trial (PMID 26056426). Those used the full protein.
One registered trial of the fragment itself, NCT07487363 (TB-500 for cardiovascular biomarkers in stable ASCVD), shows as recruiting and has no results posted. It does not change FDA's July finding that published human dosing data for TB-500 were absent from the briefing record.
What about KPV and MOTS-c?
For KPV (lysine-proline-valine), FDA's briefing says the nomination did not include, and FDA did not find, any information on KPV free base or acetate administered in humans. Supporting citations were cell and animal work, including oral KPV in mouse colitis models (PMID 18061177). Staff flagged unknown immunogenicity risk for injectable use and proposed not to list either form.
For MOTS-c, FDA's briefing found no human data for drug products containing the substance by any route, and noted that molecular targets remain unknown. The discovery paper showed metabolic effects in mice (PMID 25738459). A separate human study reported that exercise raises the body's own MOTS-c levels (PMID 33473109). Endogenous peptide levels after exercise are a different question from injecting a compounded product.
A registered trial of administered MOTS-c, NCT07505745 (MOTS-c for insulin sensitivity in adults with prediabetes and overweight or obesity), shows as recruiting with a subcutaneous once-daily regimen for 12 weeks and no results posted. Until results are published, it is a protocol, not evidence.
What about Semax and Epitalon?
Semax is a synthetic ACTH(4-10) analog used in Russia as nasal drops. FDA's Semax briefing evaluated cerebral ischemia, migraine, and trigeminal neuralgia. It set aside Russian-language references without certified translations and reviewed the limited English sources it could use. For migraine and trigeminal neuralgia, FDA concluded the available English references were insufficient. A Russian-language study of 110 ischemic stroke patients reported higher plasma BDNF and better Barthel index recovery in semax subgroups (PMID 29798983); the PubMed abstract does not describe randomization. FDA also flagged possible antithrombotic properties and a bleeding concern, and proposed not to list Semax free base or acetate.
Epitalon (Ala-Glu-Asp-Gly, also called epithalon) was evaluated for insomnia. FDA's Epitalon briefing discusses a human study of AEDG peptide on urinary 6-sulfatoxymelatonin and circadian gene expression in middle-aged night-shift workers (PMID 33280326). The abstract reports a 1.7-fold increase in 6-SOMT excretion and changes in clock-gene expression. FDA noted the study did not evaluate sleep outcomes and did not discuss clinical applicability for insomnia. FDA also wrote that epitalon activates telomerase and lengthens telomeres, raising a theoretical carcinogenic concern that available mouse tumor studies were too limited to settle, and proposed not to list either form.
What should a clinician tell patients?
Keep the script short and dated. As John Murray, Co-Founder and Chief Executive Officer of Scriptura Health (LinkedIn), said on the Rook podcast This Feature Will Save Us: "Things become less hype when they show actual results."
- Name the peptide and the claim. "You are asking about BPC-157 for tendon pain," not "peptides in general."
- State the evidence level in one sentence. For BPC-157: small uncontrolled human reports exist; no completed peer-reviewed controlled trial of the compound itself has posted results, and FDA called the only controlled UC abstract inadequate. For TB-500, KPV, and MOTS-c: FDA found no published human dosing data for the compound as used in compounding nominations.
- Separate the July vote from science. The committee recommended listing for compounding eligibility. It did not generate new trials.
- State current U.S. compounding status in one sentence: as of October 19, 2026, none of the six is on the 503A bulks list or in Category 1.
- Document the conversation, the source of any product the patient is already using, and that the patient was told the evidence and regulatory limits.
What should you do in clinic this week?
- Pull marketing that implies human RCTs or FDA approval for any of the six.
- If a pharmacy offers one of them, ask in writing which 503A route it relies on and request the certificate of analysis. Keep the answer in the chart.
- Do not treat research-use-only vials as a clinical bridge.
- If a patient is already self-sourcing, record product, source, dose, and the counseling you gave.
- Use primary sources in teaching materials: the FDA meeting page, each peptide's briefing PDF, PubMed PMIDs, and ClinicalTrials.gov records linked above.
- Recheck ClinicalTrials.gov for NCT07437547, NCT07487363, and NCT07505745 before any journal club that claims "no human trials exist at all." Registration without results is still not efficacy evidence.
Where does Scriptura fit?
When a patient asks whether "the FDA vote" means a peptide is ready, the clinician needs the evidence map and the regulatory status in the same workflow. Scriptura is clinical decision-support software for licensed practitioners. It is built to bring source-linked evidence and regulatory records into a clinician-reviewable plan. You review, edit, and sign every plan. Scriptura does not diagnose or prescribe, and it cannot turn an unlisted peptide into a lawful compounded drug. If you want to see how a dated evidence check lands in a chart, book a Scriptura demo. If your practice is ready to work this way, you can apply for clinical access. If you have a de-identified peptide case that shows careful evidence checks in practice, share it on Scriptura Live.
Key takeaways
- As of October 19, 2026, none of the six PCAC-recommended peptides has a completed peer-reviewed controlled human trial of the compound itself with posted results.
- BPC-157 has the most human reports: uncontrolled pilots plus one UC enema trial known only as a 2005 meeting abstract that FDA called inadequate.
- FDA briefings found no published human dosing data for TB-500, KPV, or administered MOTS-c.
- Semax and Epitalon rest on limited English-language clinical reports; FDA proposed not to list either.
- An advisory vote measures committee opinion on incomplete evidence. It does not add trials.
Frequently asked questions
Is there a completed controlled human trial of BPC-157?
FDA identified one randomized, placebo-controlled ulcerative colitis enema study, published only as a 2005 meeting abstract. FDA found the data inadequate. Other human reports are small and uncontrolled.
Is TB-500 the same as thymosin beta-4?
No. TB-500 is the seven-amino-acid acetylated fragment Ac-LKKTETQ. Thymosin beta-4 is the 43-amino-acid protein. FDA's briefing treats them as different substances, and Phase 2 trials of the full protein do not answer questions about the fragment.
Has MOTS-c been given to humans in a published trial?
FDA's briefing found no human data for administered MOTS-c. Exercise can raise endogenous MOTS-c. A registered trial of subcutaneous MOTS-c (NCT07505745) is recruiting and has no results posted as of October 19, 2026.
Did the July PCAC vote prove these peptides work?
No. The committee made non-binding recommendations on 503A listing. FDA staff had proposed against all six. Listing, if it ever happens, would address compounding eligibility, not efficacy or safety approval.
What should I say about Semax or Epitalon?
Say that English-language controlled evidence for the uses FDA reviewed is limited, that FDA proposed not to list them, and that Semax has a bleeding concern in FDA's review while Epitalon's melatonin-marker study did not measure sleep outcomes.
Where do I check compounding status?
Check 21 CFR 216.23, FDA's category list, and FDA press or Federal Register notices.
About the author
Sources
FDA primary materials
- FDA, July 23-24, 2026 PCAC meeting page: fda.gov
- FDA, PCAC briefing document introduction: fda.gov/media/193342
- FDA, BPC-157 briefing: fda.gov/media/193343
- FDA, KPV briefing: fda.gov/media/193346
- FDA, TB-500 briefing: fda.gov/media/193349
- FDA, MOTS-c briefing: fda.gov/media/193347
- FDA, Semax briefing: fda.gov/media/193348
- FDA, Epitalon briefing: fda.gov/media/193345
- FDA, PCAC voting questions: fda.gov/media/193711
- FDA PCAC materials hub: fda.gov
- 21 CFR 216.23 (503A bulks list): ecfr.gov
- FDA, bulk drug substances under 503A: fda.gov
- FDA, safety risks for certain nominated bulk substances: fda.gov
Peer-reviewed and registry records
- Lee E, Padgett B. Intra-articular injection of BPC 157 for multiple types of knee pain. PMID 34324435
- Lee E, Walker C, Ayadi B. Effect of BPC-157 on symptoms in patients with interstitial cystitis: a pilot study. PMID 39325560
- Lee E, Burgess K. Safety of intravenous infusion of BPC157 in humans: a pilot study. PMID 40131143
- Vasireddi et al. Emerging use of BPC-157 in orthopaedic sports medicine: a systematic review. PMID 40756949
- He et al. Pharmacokinetics of BPC-157 in rats and dogs. PMID 36588717
- Esposito et al. Identification of Ac-LKKTETQ in TB-500. PMID 22962027
- Guarnera et al. Thymosin beta-4 topical gel in venous ulcers. PMID 20536470
- Sosne et al. Thymosin beta-4 ophthalmic Phase II dry-eye trial. PMID 26056426
- Dalmasso et al. Oral KPV in mouse colitis models. PMID 18061177
- Lee C et al. MOTS-c discovery / mouse metabolism. PMID 25738459
- Reynolds et al. Exercise-induced MOTS-c in humans. PMID 33473109
- Gusev et al. Semax in ischemic stroke (Russian; English abstract). PMID 29798983
- Ivko et al. AEDG peptide, melatonin metabolite, and circadian genes. PMID 33280326
- ClinicalTrials.gov NCT02637284: clinicaltrials.gov
- ClinicalTrials.gov NCT07437547: clinicaltrials.gov
- ClinicalTrials.gov NCT07803250: clinicaltrials.gov
- ClinicalTrials.gov NCT07752381: clinicaltrials.gov
- ClinicalTrials.gov NCT07487363: clinicaltrials.gov
- ClinicalTrials.gov NCT07505745: clinicaltrials.gov
Trade and competitor context (not primary evidence)
- NCPA, FDA advisory committee nominates six peptides (July 31, 2026): ncpa.org
Educational and regulatory information only
This article is for educational and regulatory information only. It is not legal or medical advice and does not create an attorney-client or clinician-patient relationship. Evidence and regulatory status are as of October 19, 2026. Rules change. Confirm current requirements with your state boards, your malpractice carrier, and a healthcare attorney licensed in your state before acting.
