Peptide dossier, updated Oct 31, 2026
BPC-157
Body protection compound 157. A synthetic peptide studied mainly in animals. It is not approved as a drug anywhere. Since Oct 30, HHS has said it will pause enforcement against some pharmacies that compound it. This page lays out what each source actually says.
Human studies
Four entries on ClinicalTrials.gov as of Oct 31, 2026, plus the small published reports. None of the four registry entries has posted results.
| Registry | Study | Sponsor | Status | What the record says |
|---|---|---|---|---|
| NCT07437547 | Phase 2, randomized, placebo-controlled: acute hamstring strain | Hudson Biotech | Recruiting | Planned 120 participants, daily injections for 14 days, one site in Shenzhen, China. Started Feb 2, 2026. Primary completion estimated Feb 2027. |
| NCT07803250 | Randomized, placebo-controlled pilot: recovery after rotator cuff repair | University of Arkansas | Not yet recruiting | Daily self-injection for 90 days. Estimated start Jan 2027. The summary says 20 patients and the enrollment field says 30. |
| NCT07752381 | Open-label, single group: a BPC-157 supplement gummy (500 µg per serving) | Parlay Wellness, a product seller | Completed | 40 participants, 8 weeks, ended Nov 2025. No control group. First registered Aug 2026, after it ended. Tests a dietary supplement, not a drug. |
| NCT02637284 | Phase 1, oral tablets in healthy volunteers: safety and pharmacokinetics | PharmaCotherapia | Status unknown | Planned 42 volunteers in Tijuana, Mexico. Last verified Oct 2015. No results posted. |
Registry entries are written by the sponsors and are not reviewed for scientific merit. A registered study is not a result.
Published human reports
- Interstitial cystitis, 2024. 12 women whose previous drug had failed got a single 10 mg injection around the bladder lesion during a cystoscopy. All reported symptom relief on a questionnaire, and no adverse events were reported. No control group. Altern Ther Health Med PubMed
- Intravenous safety, 2025. 2 adults got up to 20 mg by infusion. No change in the tested blood markers and no side effects reported. Both had received intravenous BPC-157 before. Altern Ther Health Med PubMed
- Knee pain, retrospective. The only human musculoskeletal study found by two separate reviews. Uncontrolled, with no validated outcome measures.
Read with care
- Both published pilots are by the same first author, Edwin Lee, in the same journal, at private clinics.
- Both used self-reported or small-sample measures, with no placebo group.
- The cystitis report used a compounding pharmacy's product, and the IV report's abstract does not say where its BPC-157 came from.
FDA enforcement
FDA's own page lists BPC-157 among bulk substances that may present significant safety risks, citing immunogenicity, peptide-related impurities and difficulty characterizing the ingredient. Five public warning letters since 2019 mention it.
| Date | Recipient | Type | What the letter says about BPC-157 |
|---|---|---|---|
| Jun 12, 2023 | Warrior Labz | Online seller | Its website took orders for BPC-157 (injectable and nasal spray) and TB-500, alongside SARMs and other products. Issued by FDA's drug center. |
| Nov 10, 2021 | Advanced Nutriceuticals (Guyer Institute) | Compounder | Lists BPC-157 among substances that were not nominated for the 503A bulks list. |
| Oct 23, 2020 | Predator Nutrition | Supplement seller | A product "labeled to contain BPC-157" was among those FDA said were marketed with claims to mitigate, prevent or treat disease. Issued by FDA's food center. |
| Apr 1, 2020 | Tailor Made Compounding | Compounding pharmacy | Investigators noted the pharmacy compounded products using BPC 157, among many other peptides. |
| July 30, 2019 | PD Labs | Compounding pharmacy | Cites compounding with BPC-157 acetate, notes it was not nominated for the 503A bulks list, and records the firm saying it would continue to compound it. |
These letters were found through a web search and each was opened and checked, but the list may not be complete. A letter states FDA's position at the time, not a court finding.
Patents
Google Patents lists about 53 results for "BPC 157". Counts include applications and family members, and I did not check legal status.
The original filings
- "New BPC peptide salts with organo-protective activity." Priority May 23, 1997, filed 1998. Inventors include Predrag Sikiric, who also authors many of the BPC-157 papers cited in PubMed. The family was filed in more than 20 jurisdictions, including the US, Europe, China and Japan.
- A follow-on family, "New peptide salts..." Priority Jan 2, 2001.
- A patent filed in 1998 would normally run out about 20 years after filing, but I did not check each member's status.
Recent filings (applications, not grants)
- A US application for a sublingual semaglutide and BPC-157 combination for weight loss (priority May 2023, published July 2, 2026).
- Four Chinese applications published May to August 2026: an oral dissolving film of BPC-157 sodium salt, a polypeptide variant, a use of the gastric pentadecapeptide, and a beverage.
- A 2011 Chinese application on a preparation method for BPC 157.
A patent shows what an owner claims, not that a product works or is safe. A 2025 literature and patent review (Józwiak et al., Pharmaceuticals) exists and has not been read for this page.
SEC filings
EDGAR full-text search for "BPC-157" returns 9 filings from 6 filers. "Body protection compound" returns none. No large drugmaker appears.
| Filer | Filing | What it says |
|---|---|---|
| BioScience Health Innovations | 10-K10-Q Mar 30 & May 11, 2026 | Says its oral delivery system could unlock commercial pathways for formulations containing BPC-157 if FDA formally enacts a reclassification of peptides that the company describes as announced Feb 27, 2026. Lists BPC-157 among peptides it aims to deliver orally. |
| Regenerative Medical Technology Group | 10-Q10-Q Aug 19 & Nov 19, 2025 | Describes a preloaded BPC-157 and TB-500 injectable pen as its current best seller. |
| A Paradise Acquisition Corp. (blank-check company) | Rule 425 Mar 16, 2026 | A shareholder email from its merger partner, Enhanced Ltd., lists BPC-157 among peptides it intends to provide if the regulatory change occurs. A second filing on Apr 30 also matched and was not read. |
| Fifty 1 Labs | Reg A offering Aug 10, 2026 | Describes itself as a biotechnology company focused on peptide products, naming BPC-157 and TB-500. |
| Spinnaker ETF Series | 485APOS July 1, 2026 | Risk language noting the July 23–24 FDA committee meeting would evaluate BPC-157 among other peptides. |
| Carnyx Therapeutics | Form C Dec 3, 2025 | A crowdfunding offering document. Matched the search and was not read. |
What a company says in a filing is its own claim about its business. It is not a finding about BPC-157.
Timeline
Newest first. Every entry links to the document it comes from.
- Government or registry record
- Journal
- Advocacy or opinion
- Oct 30, 2026RegulatoryHHS publishes draft policy pausing enforcement on six compounded peptides, BPC-157 among them
State-licensed pharmacies, federal facilities and licensed physicians would not face enforcement for compounding it, under conditions including a patient-specific prescription and quality testing. Not FDA approval. HHS says it may revisit the policy if a safety or quality problem arises.
- Oct 27, 2026LiteratureOrthopaedic surgeons' review: routine clinical use cannot currently be recommended
Tham, Hodgkins and Kennedy, J Am Acad Orthop Surg, online ahead of print. A narrative review searching through June 2026. Finds human musculoskeletal evidence limited to one small retrospective uncontrolled case series, no validated dosing, pharmacokinetic or long-term safety data, and concerns about the identity, purity and sterility of commercial products.
- Oct 1, 2026LiteratureNarrative review of BPC-157 for liver protection, written by the Zagreb group
Sever et al., Pharmaceuticals. Summarizes animal-model findings, including on portal hypertension. The authors state that experimental evidence, however extensive, does not establish clinical efficacy. The author list includes Predrag Sikiric and Sven Seiwerth, who also wrote several other recent BPC-157 papers cited in PubMed.
- Sept–Aug 2026TrialsTwo more studies appear on the registry
A University of Arkansas pilot in rotator cuff repair was posted Sept 3. A supplement company's completed gummy study was posted Aug 7. Details in the table above.
- July 23–24, 2026RegulatoryFDA advisory committee recommends BPC-157 for the compounding list
The committee recommended it, with the one exception among the peptides reviewed being emideltide. The vote is nonbinding: compounding stays unlawful until FDA finishes rulemaking or Congress changes the law. Vote tallies were not available in the sources I could read.
- July 23, 2026AdvocacyPublic Citizen urges the committee not to add it
Argues the benefit evidence is mostly anecdotal, no trials support the proposed routes, the mechanism is unclear, and impurities could raise immune risks. This is an advocacy group's testimony, not a finding.
- May 11, 2026RegulatoryFDA staff brief the committee: the criteria weigh against listing
FDA evaluated only the ulcerative colitis use. The only study it found was a small meeting abstract of a two-week rectal enema, too sparse to show efficacy or safety. Repeat-dose animal studies showed clotting- and liver-related signals; no carcinogenicity studies exist; three adverse event reports were confounded or lacked detail. FDA also called the substance poorly characterized, with inconsistent naming and certificates of analysis missing impurity, endotoxin and aggregate testing.
- Apr 22, 2026RegulatoryFDA's safety-risk page lists BPC-157
FDA's page on bulk substances that may present significant safety risks says compounded drugs containing BPC-157 may pose immunogenicity risk for certain routes and have peptide-impurity and ingredient-characterization problems, and that FDA has found no or only limited safety information for the proposed routes. The page showed content current as of Apr 22, 2026.
- Feb 2, 2026TrialsPhase 2 hamstring-strain trial starts enrolling in China
A randomized, placebo-controlled study of 120 planned participants, run by Hudson Biotech. Primary completion is estimated for Feb 2027.
- Sept 2025LiteratureTwo-person intravenous safety pilot published
Lee and Burgess, up to 20 mg by infusion in 2 adults, no side effects reported. Authors call for further studies.
- July 31, 2025LiteratureSystematic review of BPC-157 in orthopaedic sports medicine
Vasireddi et al., HSS Journal. Of 36 articles, 35 were preclinical and 1 was clinical. Authors conclude it shows promise in animal models, that human safety is unknown, and urge caution. Animal safety data covered six weeks or less.
- Oct 2024LiteratureInterstitial cystitis pilot study published
Lee, Walker and Ayadi, 12 women, uncontrolled. Details in the human studies section above.
- 2019–2023RegulatoryFive FDA warning letters mention BPC-157
Recipients were two compounding pharmacies, one compounder, a supplement seller and an online seller. Details in the FDA enforcement section above.
- Jan 1, 2022Anti-dopingWADA's Prohibited List names BPC-157 in section S0
The 2022 list says the non-approved substances class "covers many different substances including but not limited to BPC-157." The 2021 list does not name it. S0 already covered any substance without government approval for human therapeutic use, so the 2022 text names it as an example.
- Dec 2015TrialsPhase 1 oral safety study registered; its status was never updated
PharmaCotherapia registered a 42-volunteer study of oral tablets in Tijuana. The record was last verified in Oct 2015 and shows no results.
What the evidence does and doesn’t show
Drawn from the FDA briefing, the registry records and the reviews above.
Shown
- Protective effects in animal models. 35 of the 36 studies in the 2025 systematic review were preclinical.
- Small, uncontrolled human reports (knee, bladder, IV) with favorable self-reported results and no adverse events reported.
- Active interest from researchers: a placebo-controlled Phase 2 trial is now enrolling.
Not shown
- Efficacy in humans for any condition in a completed controlled trial.
- Human safety over time. Animal safety data covered six weeks or less.
- Dose-response, pharmacokinetics or a known mechanism of action.
- Safety of the oral, injected, nasal or skin routes in patients, per FDA.
- Carcinogenicity. FDA found no studies.
- Human safety reporting. FDA's three adverse event reports were confounded by other products or lacked detail.
- Product quality. Reviews and FDA flag identity, purity and sterility concerns in what is sold.
Still not covered
Added since the last draft: SEC filings, patents, FDA warning letters and the WADA listing date. Still missing, and left off rather than guessed:
- Seller claims and independent lab reports: how it is marketed versus what testing finds. Reviews and FDA flag quality concerns, but I have not collected testing data.
- Patent status: whether each patent was granted, is in force, or has expired.
- Unread items: the 2025 patent review, one more SPAC filing, the Carnyx offering, and the full text of the 2024 and 2025 pilot studies.
- Warning letter completeness: the five letters came from a search, not a full pull of FDA's database.
- Panel vote counts: not in the sources I could read.