BPC-157: what has been measured about safety

BPC-157 has something almost nothing else in this catalog has: one formal preclinical safety package, published in 2020 and read by FDA for the July 2026 advisory committee [25] [33]. It is the substance of most of this page, and it is the reason this compound can be discussed in the specific terms the others cannot: an organ, a sex, an exposure level and a direction.

The design was twenty-eight days of intramuscular treatment in two species, rats and dogs, and FDA summarises its findings as statistically significant safety signals that are potentially clinically relevant. Both halves of that phrase are load bearing and this page keeps them together. The first half says a measurement moved and met the study's threshold for statistical significance; the second says nobody knows yet whether it matters in a person, and the studies that would have told anyone were never run.

FDA's own closing line is the one that belongs with all of it: longer repeat-dose toxicity studies were unavailable to demonstrate whether these safety signals persist, or whether additional signals emerge with chronic exposure. Nobody has looked past twenty-eight days.

What this page reports, and what it does not

We report what has been documented. We do not prescribe what should be done.

Every sentence below reports what a named source measured, in what species, at what exposure, and what it found. Where the answer is that nobody has looked, the page says which study would have looked and names the document recording that it was not done.

This page publishes no dose, no schedule, no route instruction and no list of people who should avoid anything. A list of who should not use a compound is a directions-for-use document, and it only makes sense if the reader is going to use the thing. What replaces it is a description of the compound and its record, written about the molecule rather than about the reader.

What has been measured

What the 28-day package measured, and in which species

One formal preclinical safety package exists, published in 2020 by a Chinese group, and FDA read it for the July 2026 advisory committee [25] [33]. Twenty-eight days of intramuscular treatment in rats and dogs produced the signals below, and they are worth reading by species because two of them ran in opposite directions between the two.

Activated partial thromboplastin time, a standard measure of how long blood takes to clot, fell in rats and rose in dogs. Serum triglycerides rose in female rats and in female dogs during treatment. Two weeks after treatment ended, female rats showed raised triglycerides, raised alanine aminotransferase, raised glucose and a raised relative liver weight. In female dogs at the highest level tested, serum creatinine fell.

One column is missing from every line above and it is the exposure. FDA's presentation reports which measurements moved, in which species and sex, and at which relative level, and it does not publish the milligrams per kilogram behind them; the underlying paper is not open access. So the amount that produced each of these findings cannot be stated here, and the site does not supply a number it has not read.

Two results in the package came back negative and both are real findings rather than absences. The genotoxicity assays, in the laboratory and in animals, found no effect on DNA. Rats dosed through the middle of gestation produced no fetal malformation and no change in fetal viability. What FDA records as missing is everything around that window: no study covered a complete reproductive cycle, and none covered development around birth or after it.

What the package does not cover is the part FDA states in its own words: longer repeat-dose studies were unavailable to demonstrate whether these signals persist or whether additional ones emerge with chronic exposure. Everything on this page stops at 28 days, in two species, by one route. [Animal] [25] [33]

What has been reported to regulators

Three FAERS reports were retrieved for the 2026 review, every one of them about compounded product [33]. In the first, a 55-year-old woman had redness and swelling around an injection site for nine days, while also taking an injectable compounded thymosin product. In the second, a 28-year-old man injecting the acetate salt under the skin for injury and inflammation developed shortness of breath and went to an emergency room. In the third, a 40-year-old woman taking BPC-157 alongside TB-500 developed diffuse hyperpigmentation and darkening of the gums, which came back when she took the products again.

The agency attaches three limits to those reports and they are not detachable from them. Whether BPC-157 caused any of the events is unclear. Missing information and other products taken at the same time bound what FAERS reports can be read to mean at all. And reporting is voluntary, so the agency does not see every event that occurs, least of all for compounded products.

Read in both directions, three reports is neither a safety signal nor a clean record. Two of the three involved a second product taken at the same time, which is the limitation FDA names. And a voluntary system that compounded products largely do not report into would return a small number whether the true number were small or large.

The clotting signal, which arrives from two directions

This is the one place where an efficacy finding and a safety signal point at the same organ system, and the two belong beside each other. Rat work reporting reduced bleeding time under heparin, warfarin and aspirin is a benefit claim made for this compound [21]. The 28-day toxicology found clotting-time changes in both species it tested, in opposite directions between them [25].

Two separate lines of work therefore point at the same system, one arriving as a claim about what the compound does and one as a signal a safety study picked up. What the pair means together has not been investigated in any species, and nothing has ever measured clotting in a person given this compound.

So what can be said is exactly this much: something in the clotting system moves in animals given BPC-157, it moved in both species tested and not in the same direction, and no measurement has been made in a person. [Animal] [21] [25]

Immunogenicity and characterization, both unassessed

FDA's position is that a peptide of this length given by a parenteral or nasal route may pose a significant risk for immunogenicity, potentially amplified by aggregation and by peptide-related impurities, and that peptides given rectally or through the skin may also carry that potential depending on the environment [32]. Nothing in the nomination, and nothing the agency turned up on its own, suggests the substance does not carry those risks.

Read that as written: it records what has not been excluded, not a problem anybody has found. Both readings of it belong on this page and only one of them is the sentence.

The characterization finding is the other half of the same gap. FDA concluded that neither the free base nor the acetate salt is well characterized physically or chemically, and listed why: names that follow no chemical nomenclature standard, no data on impurities, aggregates, bioburden or endotoxin, and nothing at all on the critical attributes of the transdermal cream, oral capsule and rectal suppository forms put to it [32]. Risks are described against a composition, so a composition nobody has described sets the ceiling on how far any risk statement about this material can go.

What the human studies measured, and what they were too small to see

Human exposure to this compound under a written protocol runs to roughly 80 people, across five studies and four different routes [28] [38]. Two of those looked at tolerability directly. One is a randomized, placebo-controlled phase 1 in 32 healthy volunteers across four ascending levels of a rectal course, 24 of whom received the compound. The other gave an intravenous infusion to two patients on two consecutive days. Both are published as abstracts rather than as full papers, and the phase 1 is read here through FDA's review of it.

What a reader may take from studies of that size is narrower than it looks, and it is worth stating precisely. Neither abstract publishes an adverse-event count, so there is no number here to report in either direction, and a sample size on its own establishes nothing about how often anything happened. Neither of those is a criticism of the studies, which were sized to do a different job. It is a statement about what is readable.

The most interesting result in the human record is a null. The only two attempts to measure this compound in human plasma did not find it, which means the exposure side of every human safety question is unmeasured as well [38]. [Human RCT] [28] [38]

Two corrections in the published record

A search of the full PubMed corpus for this compound by publication type returns one withdrawn paper and one corrigendum, both from the same research group [30]. The withdrawn article covered severe electrolyte disturbances in rats and carries a publisher's notice stating that it has been withdrawn at the author's request; PubMed indexes it as a retracted publication. The corrigendum belongs to a 2021 rat study of abdominal compartment syndrome; wherever either document is cited here, both are named.

Nothing else of that kind is in the corpus: no expression of concern and no retraction-of-publication notice was found. One item is often miscounted as a third. A 2025 comment and reply between two research groups about angiogenesis and the nitric oxide system is a disagreement published the ordinary way, and it corrects nothing.

Two of 225 records is an unremarkable rate and this page says so. It appears at all for two reasons: a site that reports how concentrated a literature's authorship is, and then leaves out that literature's corrections, is choosing what to show, and neither paper carries a claim made anywhere here.

Liver, kidney, blood and the organs the package actually touched

This is the one compound in the batch where an organ question has a measured answer rather than an absence, so each section below names what moved, in which species, in which sex, and when it was measured. Two limits apply to all of them and are not repeated in each: every figure comes from 28 days of intramuscular treatment in animals, and no equivalent measurement exists in a person.

Liver

The liver is where this package produced its most specific finding, and it appeared after treatment stopped rather than during it. Two weeks after the 28-day course ended, female rats showed raised alanine aminotransferase and a raised relative liver weight, alongside raised triglycerides and raised glucose [25] [33]. Alanine aminotransferase is an enzyme that leaks from liver cells into the blood, so a rise in it is the standard first indication that something has happened to the liver.

Four things bound what that means. It was measured in one sex of one species; it appeared in the recovery period rather than during treatment; the study ran 28 days, so nothing establishes whether it persists, resolves or grows; and FDA called the package's findings signals that are potentially clinically relevant rather than demonstrated harm.

In humans there is nothing. No human study of this compound has reported a liver enzyme, and the two attempts to measure the compound in human plasma did not detect it [38], so neither the effect nor the exposure has a human measurement behind it. [Animal] [25] [33]

Kidney

One renal measurement moved and it moved downward. Serum creatinine fell in female dogs at the highest level tested, in the same 28-day package [25] [33]. Creatinine is a waste product the kidneys clear, and it is read as a rough index of how well they are clearing.

FDA reports that change among the statistically significant findings and does not interpret it, in either direction, and neither does this page. What is on the record is a measured decrease in one sex of one species over 28 days, with no statement anywhere about what it means.

No other renal endpoint moved in either species, and no human study of this compound has reported a kidney marker of any kind. [Animal] [25] [33]

Blood and clotting

Activated partial thromboplastin time fell in rats and rose in dogs, in the same package [25]. That measure records how long blood takes to clot through one of the two clotting pathways, so a fall and a rise are movements in opposite directions in two species tested side by side.

This is the finding that connects to a claim made for the compound rather than sitting on its own, and the connection is set out above: rat work reports reduced bleeding time under three different blood-thinning drugs [21], while the toxicology reports clotting-time movement in both species. Nobody has followed up on what the two together mean.

No human coagulation measurement of any kind exists for this compound. [Animal] [25]

Pregnancy and development

The package includes a developmental study and it is partial. Rats dosed through the middle of gestation showed no fetal malformation and no effect on fetal viability [25]. That is a real negative result, taken in the window it covers.

What it does not cover is what FDA names: no study covering a complete reproductive cycle, and no peri- or postnatal development study, was submitted or found. So fertility before conception, the last third of gestation, delivery and offspring development after birth are all unmeasured, in every species. [Animal] [25]

What has not been characterised

Set out plainly, so the shape of the gap is visible rather than implied. Nothing establishes what happens after 28 days in any species, which is FDA's own stated limit on the one package that exists. Nothing establishes what the substance's impurity profile contains, whether it aggregates, or whether it produces an immune response [32].

No human safety measurement of any kind exists for the route the compound is mostly sold by, because no human study has used it. The human studies that exist ran to roughly 80 people across four other routes, two of them reported only as abstracts, and the two attempts to measure the compound in human plasma did not detect it [28] [38].

One sentence in FDA's presentation covers the whole of it and is worth quoting whole: there is insufficient clinical safety information to characterize the safety profile of BPC-157 free base and BPC-157 acetate [33]. Nothing on this site says how well the compound is tolerated, in either direction, because the record holds nothing that could settle it.

Our takeThis compound gets discussed as though the 2020 package settled something, by people on both sides of the argument. Read at source it settles one thing: several measurements moved, in two species, over 28 days, and the study that would say whether any of it persists was never run. FDA wrote both halves of that in the same document, and quoting either half alone produces a different compound than the one on the record.

Talk to a licensed clinician about anything concerning your health.

Frequently asked questions

References

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15. Chang CH, Tsai WC, Lin MS, Hsu YH, Pang JH. The promoting effect of pentadecapeptide BPC 157 on tendon healing involves tendon outgrowth, cell survival, and cell migration. J Appl Physiol (1985). 2011. PMID 21030672 DOI 10.1152/japplphysiol.00945.2010
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21. Stupnisek M, Franjic S, Drmic D, Hrelec M, Kolenc D, Radic B, Bojic D, Vcev A, Seiwerth S, Sikiric P. Pentadecapeptide BPC 157 reduces bleeding time and thrombocytopenia after amputation in rats treated with heparin, warfarin or aspirin. Thromb Res. 2012. PMID 21840572 DOI 10.1016/j.thromres.2011.07.035
22. Tudor M, Jandric I, Marovic A, Gjurasin M, Perovic D, Radic B, Blagaic AB, Kolenc D, Brcic L, Zarkovic K, Seiwerth S, Sikiric P. Traumatic brain injury in mice and pentadecapeptide BPC 157 effect. Regul Pept. 2010. PMID 19931318 DOI 10.1016/j.regpep.2009.11.012
23. Perovic D, Kolenc D, Bilic V, Somun N, Drmic D, Elabjer E, Buljat G, Seiwerth S, Sikiric P. Stable gastric pentadecapeptide BPC 157 can improve the healing course of spinal cord injury and lead to functional recovery in rats. J Orthop Surg Res. 2019. PMID 31266512 DOI 10.1186/s13018-019-1242-6
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26. Lee E, Padgett B. Intra-Articular Injection of BPC 157 for Multiple Types of Knee Pain. Altern Ther Health Med. 2021. PMID 34324435
27. Lee E, Walker C, Ayadi B. Effect of BPC-157 on Symptoms in Patients with Interstitial Cystitis: A Pilot Study. Altern Ther Health Med. 2024. PMID 39325560
28. Lee E, Burgess K. Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study. Altern Ther Health Med. 2025. PMID 40131143
29. Vasireddi N, Hahamyan H, Salata MJ, Karns M, Calcei JG, Voos JE, Apostolakos JM. Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review. HSS J. 2025. PMID 40756949 DOI 10.1177/15563316251355551
30. Grubisic MM, Strbe S, Barisic I, Balenovic D, Stambolija V, Lozic M, Ostojic SB, Oreskovic I, Zizek H, Brcic K, Coric L, Staresinic M, Blagaic V, Oreskovic LB, Halle ZB, Matek D, Soldo D, Grizelj B, Blagaic AB, Skrtic A, Sikiric P, Seiwerth S. Withdrawn: Stable Gastric Pentadecapeptide BPC 157 as a Therapy of Severe Electrolyte Disturbances in Rats. Curr Neuropharmacol. 2025. PMID 39865815 DOI 10.2174/011570159X349612241205065330 Flagged by PubMed as a Retracted Publication. The publisher's own notice says the article has been withdrawn at the author's request, which is the wording the title carries.
31. Mateescu DM, Gavrilescu DM, Constantinescu FE, Oancea C, Ilie AC, Folescu R, Popa MD, Iurciuc S, Muresan CO, Enache A. BPC-157 as an Investigational Peptide Therapeutic: Biopharmaceutical Challenges, Formulation Strategies, and Translational Development Barriers. Pharmaceutics. 2026. PMID 42198317 DOI 10.3390/pharmaceutics18050625
32. US Food and Drug Administration. FDA briefing document for BPC-157-related bulk drug substances, Pharmacy Compounding Advisory Committee, 23 and 24 July 2026. 68 pages. Carries FDA's reprinting of the Ruenzi 2005 and Veljaca 2002 and 2003 meeting abstracts, the characterization findings, and the recommendation against listing. FDA advisory committee materials. 2026. Source document
33. US Food and Drug Administration. July 23, 2026 Meeting of the Pharmacy Compounding Advisory Committee: FDA presentations. 149 pages. Carries the pharmacology limitations, the animal pharmacokinetics, the 28-day toxicology signals, the three FAERS reports and the clinical safety conclusion. FDA advisory committee materials. 2026. Source document
34. US Food and Drug Administration. Questions for PCAC regarding whether FDA should include certain bulk drug substances on the 503A Bulks List, 23 and 24 July 2026. BPC-157 free base and BPC-157 acetate are the first two votes of the 23 July morning session. FDA advisory committee materials. 2026. Source document
35. US Food and Drug Administration. Pharmacy Compounding Advisory Committee; notice of meeting; establishment of a public docket; request for comments. Docket No. FDA-2025-N-6895. The chart of uses records the use evaluated for BPC-157 free base and BPC-157 acetate as ulcerative colitis. Federal Register, document 2026-07361, 91 FR 20465. 2026. Source document
36. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Page content current as of 22 April 2026. BPC-157 appears in the second table, bulk drug substances nominated but withdrawn, and not in the active category 2 table. FDA human drug compounding. 2026. Source document
37. US Food and Drug Administration. July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee, meeting page and materials index. Page content current as of 6 August 2026 and read on 8 August 2026: briefing documents, agenda, roster, questions, webcast information and two presentation decks are posted, and no minutes, transcript or vote record is. FDA advisory committee calendar. 2026. Source document
38. PharmaCotherapia d.o.o. Phase I, pilot study in healthy volunteers to assess the safety and pharmacokinetics of PCO-02, whose active ingredient is BPC-157, a pentadecapeptide from a gastric source (NCT02637284). Randomized, quadruple-masked, placebo-controlled, 42 estimated, single site in Tijuana. Status unknown; first posted and last updated 22 December 2015; no results posted. ClinicalTrials.gov. 2015. Source document
39. Hudson Biotech. A randomized, double-blind, placebo-controlled phase 2 trial of pentadecapeptide BPC 157 for accelerated repair of acute grade II hamstring strain confirmed by MRI (NCT07437547). Registered as recruiting, 120 estimated, single site at Peking University Shenzhen Hospital, actual start 2 February 2026, primary completion estimated 14 February 2027; no results posted. Read in full 8 August 2026, together with the sponsor account below. ClinicalTrials.gov. 2026. Source document
40. Parlay Wellness, with Citruslabs. A clinical trial to evaluate the effects of peptide gummies on markers of inflammation, physical performance, and recovery (NCT07752381). Single-arm, open-label, no randomization or masking, 40 actual participants, site in Las Vegas. Completed 1 November 2025 and first posted 7 August 2026; no results posted. ClinicalTrials.gov. 2026. Source document
41. US National Library of Medicine. ClinicalTrials.gov registry, API v2, read in full on 8 August 2026. An intervention and free-text search for BPC-157 and its variants returns three records: NCT02637284, NCT07437547 and NCT07752381. A sponsor search for Hudson Biotech returns eight records: NCT07437547, NCT07437560, NCT07437586, NCT07467447, NCT07481734, NCT07481747, NCT07487363 and NCT07505745. Three of the eight describe themselves in their own registered text as an example, a mock study or a fictional study, and two carry Eli Lilly protocol identifiers for Lilly molecules. ClinicalTrials.gov. 2026. Source document
42. World Anti-Doping Agency. The 2026 Prohibited List, international standard, effective 1 January 2026. 26 pages. BPC-157 is named on the face of class S0 at page 4 and carries its own index entry. WADA. 2026. Source document
43. US Department of Defense, Operation Supplement Safety. Ingredient and substance index, and the article BPC-157: a prohibited peptide and an unapproved drug found in health and wellness products, posted 29 April 2025. Index checked 8 August 2026: the BPC-157 entry reads that BPC-157 is on the DoD Prohibited Dietary Supplement Ingredients list, with a status label of Prohibited. OPSS, Uniformed Services University. 2026. Source document