BPC-157
Properties
| Substance class | Synthetic pentadecapeptide. Its sequence is a 15-amino-acid fragment of BPC, a roughly 40 kDa protein isolated from human gastric juice and first described in 1993. BPC-157 as supplied is made by solid-phase synthesis, not isolated from gastric juice; sources that describe the pentadecapeptide itself as "isolated from human gastric juice" are conflating the fragment with the parent protein. | source |
|---|---|---|
| Sequence | H-Gly-Glu-Pro-Pro-Pro-Gly-Lys-Pro-Ala-Asp-Asp-Ala-Gly-Leu-Val-OH | source |
| Other names | Bepecin; PL-14736; PL-10; PLD-116; Body Protection Compound 157. FDA notes that BPC-157 is a common name and not a United States Adopted Name, and that multiple salts and derivatives, including different active moieties, are sold commercially under that same common name. | source |
| Cas number | 137525-51-0 | source |
| Unii | 8ED8NXK95P | source |
| Acetate salt identifiers | BPC-157 acetate is a separate substance from BPC-157 (free base), with UNII PAR2FC72XP and CAS 216441-37-1 against the free base's 8ED8NXK95P and 137525-51-0. FDA states the two are different active pharmaceutical ingredients and therefore different bulk drug substances, sharing the same active moiety. Both nomination packages FDA reviewed named one form and attached a certificate of analysis for the other. | source |
| Molecular formula | C62H98N16O22 | source |
| Molecular weight | 1419.5 g/mol | source |
| Appearance | White to off-white lyophilised powder, stated under FDA's physicochemical characterisation heading for BPC-157 (free base). FDA describes BPC-157 acetate separately as a white to off-white solid powder. | source |
| Melting point | Greater than 232 degrees C. PROVENANCE: this figure appears in FDA's characterisation section, but FDA's own footnote attributes it to a commercial chemical catalogue rather than to a peer-reviewed measurement. No primary determination was located. degrees C | source |
| Solubility | Soluble in water at 5 mg/mL. PROVENANCE: FDA states this in its characterisation section for both the free base and the acetate, but footnotes it to supplier product pages rather than to a published measurement. Because the substance is water-soluble and would be solubilised before administration, FDA does not consider particle size a critical quality attribute for the solution dosage forms it reviewed. | source |
| Storage | READ THE PROVENANCE BEFORE USING THIS. FDA's evaluation reports that lyophilised BPC-157 (free base) is stable at room temperature for three weeks, that it is recommended to be held desiccated below -18 degrees C because exposure to moisture greatly decreases the long-term stability of lyophilised peptides, and that once reconstituted it is stable for two to three weeks at 4 degrees C and for three to four months at -20 degrees C. FDA's own footnotes attribute every one of those figures to supplier product pages, not to a published stability study, and FDA states the conclusion as what is "reported in the literature" rather than as an agency determination. No peer-reviewed forced-degradation or shelf-life study for BPC-157 was located. FDA separately warns that peptides such as this one are extremely sensitive to formulation, process and environmental conditions including pH, temperature, concentration and excipients, which may lead to aggregation and degradation and to loss of biological activity, and that significant amounts of aggregates can form during storage. | source |
| Stability in biological matrices | Distinct from shelf stability, and frequently confused with it. In an anti-doping laboratory study of vials confiscated from athletes, in vitro plasma metabolism experiments showed BPC-157 forms a stable metabolite, and BPC-157 was stable in urine for at least 4 days. These are assay matrices at laboratory conditions; they say nothing about how a vial or a powder behaves in storage. | source |
| Elimination half life animal | Under 30 minutes for the parent peptide in Sprague Dawley rats and beagle dogs after a single intravenous dose and after intramuscular doses; pharmacokinetics were linear at all doses tested. This is an animal measurement. No equivalent human figure exists. | source |
| Bioavailability intramuscular animal | Mean absolute bioavailability after intramuscular administration was approximately 14 to 19 percent in rats and approximately 45 to 51 percent in beagle dogs. Radiolabel work in the same study identified urine and bile as the main excretory pathways, with the peptide rapidly broken down into small peptide fragments and then into single amino acids. | source |
| Human pharmacokinetics | None established. FDA found no human pharmacokinetic data for BPC-157 by the oral, subcutaneous, nasal or transdermal route. In the two published studies that gave BPC-157 as a rectal enema, the authors report that BPC-157 was not detected in plasma samples; in one abstract the authors state that most plasma concentrations were below the lower limit of quantification of the assay, with no further detail given. | source |
| Genotoxicity | Negative across a standard battery in one published preclinical package: bacterial reverse mutation (Ames) tests in five Salmonella typhimurium strains with and without metabolic activation, chromosome aberration tests in Chinese hamster lung cells with and without S9, and a bone marrow micronucleus assay in mice. FDA's reviewers summarise these findings as demonstrating that BPC-157 is not a mutagen. | source |
| Carcinogenicity data | None. FDA states that neither the nominators submitted, nor did the agency identify, any carcinogenicity study of BPC-157 (free base) or BPC-157 acetate. | source |
| Approval status | Not an approved drug anywhere. FDA states that neither BPC-157 (free base) nor its acetate form is a component of an FDA-approved drug, and that a search identified no approved product containing either substance in any country. | source |
| Pharmacopoeial status | No monograph anywhere. FDA states there is no applicable United States Pharmacopeia or National Formulary drug substance monograph for BPC-157 (free base) or its acetate form, no USP dietary supplement monograph for either, and no monograph in the European Pharmacopoeia (11th Edition, 11.8), the Japanese Pharmacopoeia (18th Edition) or the International Pharmacopoeia (12th Edition). | source |
| Fda 503a bulks list status | Not on the 503A Bulks List. In an evaluation dated 5/11/2026, FDA concluded that a balancing of the statutory criteria weighs against adding BPC-157 (free base) and BPC-157 acetate to that list, and wrote "Accordingly, we propose not adding BPC-157 (free base) or BPC-157 acetate to the 503A Bulks List." FDA's stated grounds were that both substances are not well characterised physicochemically, that there is a lack of information on their safety profile and immunogenicity risk, that the evidence is insufficient to reach a conclusion on effectiveness for the nominated use, and that approved drug products already exist for that condition. | source |
| Fda category 2 history | BPC-157 appears on FDA's page of bulk drug substances that may present significant safety risks, in the table headed "Bulk drug substances nominated but withdrawn". FDA describes that table as a "list of bulk drug substances previously in category 2 of the interim policies [that] were withdrawn by the nominators" — so BPC-157 was formerly in category 2 and sits in the withdrawn table today, not in the active category 2 table. Page content current as of 04/22/2026. | source |
| Fda identified safety risks | FDA's published entry reads in full "Compounded drugs containing BPC-157 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization. FDA has identified no, or only limited, safety-related information for the proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans." | source |
| Fda advisory committee review | FDA put BPC-157 (free base) and BPC-157 acetate to its Pharmacy Compounding Advisory Committee on July 23, 2026, with the published voting questions "Should BPC-157 (free base) be placed on the list?" and "Should BPC-157 acetate be placed on the list?". An advisory committee recommendation does not bind FDA, and as of the date of this entry FDA had not published minutes, a transcript or a vote record for that meeting. | source |
| Fda enforcement position | In a warning letter dated June 12, 2023 to a firm selling BPC-157 in injectable and nasal spray form, FDA stated that the firm's BPC-157 product, among others, was "not generally recognized as safe and effective for the above referenced uses and, therefore, [is a] 'new drug[]' under section 201(p) of the FD&C Act". The determination attaches to that firm's products as marketed with those claims; it is not a finding about the molecule in the abstract. | source |
| Compounding volume reported to fda | Zero. FDA reports that according to its outsourcing facility product reporting data from January 2017 to June 2025, there were no reported compounded drug products containing BPC-157 (free base) or BPC-157 acetate. FDA notes separately that compounders operating under section 503A generally do not report to that database, so this figure covers registered outsourcing facilities rather than all compounding. | source |
| Anti doping status | Prohibited. The United States Anti-Doping Agency states "Yes, BPC-157 is prohibited under the S0 Non-Approved Substances category of the List." FDA's evaluation states the same, citing the World Anti-Doping Agency prohibited list. | source |
| First description | 1993, by a group at the Department of Pharmacology, Medical Faculty, University of Zagreb. The originating paper describes BPC as a newly isolated gastric juice peptide of relative molecular mass 40,000 and BPC 157 as a 15-amino-acid fragment of it, characterised and investigated as "a possible endogenous free radical scavenger and organoprotection mediator". | source |
What the research does not show
- There is no published, adequately reported, randomised controlled trial of BPC-157 in people for any condition. The single randomised comparison that exists was published only as a conference abstract, and FDA states the data presented there are inadequate to support either efficacy or safety.
- FDA's regulatory evaluation found only five clinical studies of BPC-157 in the entire published medical literature. Two of them are meeting abstracts rather than full papers. FDA describes the set as short in duration, small in sample size, exploratory in the doses used, and limited in the safety information the authors provided, and notes that safety monitoring is unclear for most of them. source
- An independent systematic review of the orthopaedic literature screened 544 articles published between 1993 and 2024 and included 36 studies, of which 35 were preclinical and 1 was clinical. Its authors classify the body of work as level IV and level V evidence and state plainly that no clinical safety data were found. source
- Route of administration in the published human studies does not match how the substance is actually supplied and used. FDA states it identified no study that gave BPC-157 to humans by the oral, subcutaneous, nasal or transdermal route. The two human studies FDA identified in which the substance was given repeatedly both used a rectal enema, a route almost nobody buying this compound uses.
- The same gap exists in the animal safety work. FDA states that neither the nominators submitted, nor did FDA identify, nonclinical pharmacokinetic, acute toxicity, repeat-dose toxicity or developmental toxicity studies by any of the oral, rectal, transdermal, subcutaneous or nasal routes. The available animal toxicology used the intramuscular route, and because the absolute bioavailability of the other routes in rats and dogs is unknown, FDA states the intramuscular no-observed- adverse-effect levels cannot be used to estimate levels for those routes. source
- The animal pharmacology does not establish a dose-response relationship. Across the rodent studies FDA reviewed, doses separated by three orders of magnitude (nanograms per kilogram versus micrograms per kilogram) produced effects of the same magnitude, so no dose-response could be established. FDA states the molecular targets of BPC-157 have not been identified and its mechanism of action remains poorly understood, which makes the biological plausibility of the reported effects difficult to assess. source
- The 28-day animal toxicology carries unresolved signals rather than a clean result. FDA summarises the repeat-dose intramuscular studies in rats and dogs as showing clinically relevant safety signals including shortened and prolonged activated partial thromboplastin time, suggestive of altered clotting properties, and liver-associated signals comprising raised serum ALT, glucose and triglyceride levels. FDA states longer repeat-dose studies were unavailable to show whether those findings reproduce or whether further signals emerge, and that no carcinogenicity study exists. source
- The published human studies that report favourable outcomes are uncontrolled and rely on self-report. The interstitial cystitis study cited here enrolled 12 women at a single private clinic, had one arm and no control group or blinding, and measured outcome with a self-rated Global Response Assessment questionnaire. The knee-pain report is a retrospective chart review in which some participants received BPC-157 combined with a second peptide, so nothing in it can be attributed to BPC-157 alone. source
- A registered phase 1 study in healthy volunteers (NCT02637284) was started in 2015 and its results were never posted; FDA searched and was unable to find an associated published study. An independent review records that the researchers cancelled submission of the results in 2016. The trials that would characterise this substance in people were begun and then not reported. source
- The evidence base is concentrated in a very small number of authors. A news investigation quotes a review team's count that the vast majority of the roughly 200 BPC-157 studies listed on PubMed include either Predrag Sikiric or Sven Seiwerth, both of the University of Zagreb, as a main author. That is a reported count from journalism rather than a published bibliometric analysis, and is recorded here as such. What can be checked directly is that the originating 1993 paper came from that same department, and that the reference list of FDA's own evaluation is dominated by papers from it. source
- Nobody has measured what BPC-157 does in a person's bloodstream. FDA states there is no information with which to assess its human pharmacokinetics. The half-life, bioavailability and excretion figures on this page are from rats and dogs, and the route that produced them is not a route anyone has studied in people.
- FDA considers the substance itself poorly characterised. Its evaluation concludes that both BPC-157 (free base) and BPC-157 acetate are "not well-characterized from the physical and chemical characterization perspective", citing naming conventions that do not follow USAN, INN or IUPAC standards, and missing or inadequate data on peptide-related impurities and aggregates, microbial quality, bacterial endotoxins and particle size. FDA notes that inconsistent naming is itself a safety risk because a patient may receive a different substance from the one intended. source
- Commercial certificates of analysis for this substance generally report purity and nothing else. FDA reviewed the certificates supplied with both nominations and searched the literature for others, and found that most contain only purity testing results, with no impurity limits or results that would demonstrate control of the impurity profile, and no bioburden or bacterial endotoxin testing. FDA states that because of this it cannot rule out the potential for immunogenicity from those impurities and from peptide-related aggregates. source
- The storage and solubility figures published on this site, and on every other site that carries them, trace back through FDA's evaluation to supplier product pages rather than to a published stability study. They are recorded here because FDA recorded them, with that provenance stated. No peer-reviewed shelf-life determination for this compound was located.
- Much of the literature does not say which substance it studied. FDA notes repeatedly that published articles do not clearly identify whether the BPC-157 used was the free base or the acetate salt, and that it is often unclear whether a product described in a source was compounded at all. Findings reported for "BPC-157" therefore cannot always be assigned to a specific substance.
- Adverse events reported to FDA exist but cannot be attributed. Every case FDA retrieved was confounded — by a second peptide given at the same time, by missing information about duration and concomitant medicines, or by use within a multi-ingredient product. Absence of a clean signal in a database this sparse is not evidence of safety.
- The published research does not establish a dose, a route, a schedule, a duration, or a formulation for any use in a person, and it does not establish what happens with long-term use, because no long-term human study has been published.
Storage and handling
READ THE PROVENANCE BEFORE USING THIS. FDA's evaluation reports that lyophilised BPC-157 (free base) is stable at room temperature for three weeks, that it is recommended to be held desiccated below -18 degrees C because exposure to moisture greatly decreases the long-term stability of lyophilised peptides, and that once reconstituted it is stable for two to three weeks at 4 degrees C and for three to four months at -20 degrees C. FDA's own footnotes attribute every one of those figures to supplier product pages, not to a published stability study, and FDA states the conclusion as what is "reported in the literature" rather than as an agency determination. No peer-reviewed forced-degradation or shelf-life study for BPC-157 was located. FDA separately warns that peptides such as this one are extremely sensitive to formulation, process and environmental conditions including pH, temperature, concentration and excipients, which may lead to aggregation and degradation and to loss of biological activity, and that significant amounts of aggregates can form during storage. source
Concentration calculator · Research index · Reading a certificate of analysis