BPC-157 Clinical Trials: Complete Research Database
BPC-157 (Body Protection Compound-157) has generated enormous interest as a healing peptide — and enormous frustration among researchers waiting for proper human data.
BPC-157 (Body Protection Compound-157) has generated enormous interest as a healing peptide — and enormous frustration among researchers waiting for proper human data. Despite more than 100 published preclinical studies spanning three decades, the total number of human studies can be counted on one hand. This article catalogs every published clinical trial, every significant preclinical study category, and the regulatory actions that have shaped BPC-157's current status.
If you've been searching for a clear-eyed summary of what the BPC-157 research actually shows — and where the gaps are — this is it.
Table of Contents
- What Is BPC-157?
- Human Clinical Trials: The Complete Record
- Preclinical Research Database by Category
- Mechanisms of Action: What the Research Has Identified
- Safety and Toxicology Data
- Systematic Reviews (2025)
- Regulatory Timeline
- Frequently Asked Questions
- The Bottom Line
- References
What Is BPC-157?
BPC-157 is a synthetic pentadecapeptide (15-amino acid chain) with the sequence GEPPPGKPADDAGLV and a molecular weight of 1,419 daltons. It is derived from a larger protein called Body Protection Compound, found naturally in human gastric juice [1].
The peptide was first characterized in the early 1990s by Professor Predrag Sikiric and colleagues at the University of Zagreb, Croatia. Most of the published research on BPC-157 — well over 100 studies — has come from this group or their collaborators.
Key properties that set BPC-157 apart from most peptides:
- Gastric juice stability: Unlike most peptides, BPC-157 is not degraded in stomach acid, which means it can be taken orally [1]
- Short half-life: Metabolized in the liver with a half-life under 30 minutes, excreted through the kidneys, and detectable in urine for up to 4 days [2]
- No identified lethal dose: Preclinical toxicology studies could not establish an LD50 (the dose that kills 50% of test animals), even at very high doses [3]
Human Clinical Trials: The Complete Record
As of early 2026, the complete body of published human data on BPC-157 consists of three pilot studies, one set of Phase I/II trials published only as conference abstracts, and one cancelled Phase I trial. Here is every one of them.
Ulcerative Colitis Trials (PL14736) — Phase I and Phase II
Status: Phase II completed; results published as conference abstracts only
BPC-157 was developed for inflammatory bowel disease under the code names PL-10, PLD-116, and PL14736 by the Croatian pharmaceutical company Pliva.
Phase I (Safety/PK) — Healthy Volunteers
| Detail | Value |
|---|---|
| Publication | Veljaca M, et al. Gut. 2003;51(Suppl III):A309 (abstract) |
| Participants | Healthy male volunteers |
| Route | Rectal (enema) |
| Outcome | Safe and well tolerated; pharmacokinetic data collected |
Phase II — Mild-to-Moderate Ulcerative Colitis
| Detail | Value |
|---|---|
| Publication | Ruenzi M, et al. Gastroenterology. 2005;128:A584 (abstract) |
| Design | Multicenter, randomized, double-blind, placebo-controlled |
| Population | Patients with acute mild-to-moderate ulcerative colitis |
| Route | Enema (PL 14736) |
| Outcome | Reported as effective and safe |
Limitations: Neither trial was ever published as a full peer-reviewed paper. Only the abstracts — brief summaries presented at gastroenterology conferences — are available. The specific efficacy numbers, dropout rates, and detailed safety data have never been made public. No further clinical development followed [4, 5].
Despite these limits, many subsequent BPC-157 papers reference the IBD trials as evidence that the peptide "has been in clinical trials" and was found "efficacious and safe." This is technically true but somewhat misleading given the abstract-only publication status.
Intra-Articular Knee Pain Pilot Study (2021)
Status: Published retrospective study; no control group
| Detail | Value |
|---|---|
| Citation | Lee E, Padgett B. Intra-Articular Injection of BPC 157 for Multiple Types of Knee Pain. Altern Ther Health Med. 2021;27(4):8-13 |
| PubMed ID | 34324435 |
| Design | Retrospective chart review, single-center |
| Location | Institute for Hormonal Balance, Orlando, FL |
| Participants | 17 patients with chronic knee pain (16 contacted for follow-up) |
| Dose | 4 mg (2,000 mcg/mL) intra-articular injection |
| Follow-up | 6-12 months post-injection |
Results:
- 12 patients received BPC-157 alone; 11 of 12 (91.6%) reported significant improvement
- 4 patients received BPC-157 + TB-500 (Thymosin Beta-4); 3 of 4 (75%) reported significant improvement
- Overall: 14 of 16 patients (87.5%) reported meaningful pain relief
- 7 of 12 BPC-157-only patients reported relief lasting longer than 6 months
- 4 patients had follow-up MRI scans showing structural improvement
Limitations: This was a retrospective chart review with no placebo control, no randomization, and no standardized outcome measures. Pain assessment was based on patient phone calls, not validated tools. The same physician who injected the peptide also collected the outcome data. These are significant methodological weaknesses [6].
For more on how BPC-157 relates to joint recovery, see our guide on Best Peptides for Joint Health.
Interstitial Cystitis Pilot Study (2024)
Status: Published pilot study; no control group
| Detail | Value |
|---|---|
| Citation | 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;30(10):12-17 |
| PubMed ID | 39325560 |
| Design | Prospective pilot study, single-center, no control group |
| Participants | 12 women (ages 39-76, mean 58.3) with interstitial cystitis |
| Prior Treatment | All had failed pentosan polysulfate therapy |
| Dose | 10 mg total, injected around areas of bladder inflammation during cystoscopy |
| Follow-up | 6 weeks |
Results:
- 10 of 12 patients (83.3%) reported 100% symptom resolution
- Remaining 2 patients reported 80% symptom resolution
- All 12 patients scored 5/5 on the Global Response Assessment (corresponding to "significant improvement")
- No adverse events reported; patients were screened for fevers, skin rash, nausea, vomiting, worsening urinary symptoms, and dyspareunia
Limitations: No placebo group, no randomization. The cystoscopy procedure itself (without BPC-157) may have provided some relief. Published in an alternative medicine journal, not a mainstream urology publication. Conducted at a private practice by a physician who also published the knee pain study [7].
IV Safety Pilot Study (2025)
Status: Published pilot study; safety focus
| Detail | Value |
|---|---|
| Citation | Lee E, Burgess J. Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study. Altern Ther Health Med. 2025 |
| PubMed ID | 40131143 |
| Design | Safety pilot, no control group |
| Participants | 2 healthy adults |
| Dose | IV infusion up to 20 mg |
| Biomarkers Monitored | Heart, liver, kidney, thyroid, blood glucose |
Results:
- No measurable effects on any tested biomarker
- No side effects reported
- Infusion was well tolerated
Limitations: With only two participants and no control group, this study can do nothing more than suggest BPC-157 infusion may be tolerated. It cannot establish safety in any meaningful statistical sense. The authors' own framing as a "pilot" is accurate — this is preliminary data that supports the need for larger trials, not evidence that IV BPC-157 is safe [8].
The Cancelled Phase I Trial (NCT02637284)
Status: Cancelled; no results published
| Detail | Value |
|---|---|
| ClinicalTrials.gov ID | NCT02637284 |
| Sponsor | PharmaCotherapia d.o.o. |
| Design | Phase I, randomized, placebo-controlled |
| Population | 42 healthy volunteers, ages 18-35 |
| Location | Hospital Angeles, Tijuana, Mexico |
| Drug | Bepecin (oral BPC-157 tablets, 1 mg per tablet) |
| Planned Duration | January 2015 – June 2015 |
Study Design:
- Phase 1a: Single-dose escalation (1, 3, or 6 tablets vs. placebo)
- Phase 1b: Multiple-dose (3 tablets three times daily for 2 weeks vs. placebo)
What Happened: Results were reportedly submitted to ClinicalTrials.gov on May 23, 2016, but the submission was then cancelled before quality control review. No data was ever published. No public explanation was provided [9].
Why This Matters: This was supposed to be the first rigorous pharmacokinetic study of oral BPC-157 in humans. Without it, there is no formal data on:
- How much BPC-157 gets absorbed after oral dosing
- What blood levels are achieved at different doses
- How the peptide is distributed and metabolized in the human body
- Whether a dose-response relationship exists
The doses currently used by people self-administering BPC-157 are essentially extrapolated from rat studies — a poor substitute for human pharmacokinetic data.
Preclinical Research Database by Category
The preclinical literature on BPC-157 is extensive. A 2025 systematic review identified 544 articles published between 1993 and 2024, ultimately including 36 studies (35 preclinical, 1 clinical) in a focused musculoskeletal analysis alone [2]. Below is a categorized overview of the key research areas.
Gastrointestinal Studies
BPC-157's original research focus — and arguably its strongest preclinical evidence base.
| Study Area | Key Findings | Representative References |
|---|---|---|
| Gastric ulcers | Protected against multiple ulcer models (alcohol, NSAID, stress, cysteamine); outperformed standard treatments | Sikiric et al., various 1993-2020 |
| Inflammatory bowel disease | Improved functional and structural outcomes in colitis models; healed experimental fistulas | Sikiric et al., World J Gastroenterol. 2017 [10] |
| Intestinal anastomosis | Promoted healing of surgical connections between bowel segments | Sikiric et al., Surgery Today. 2007 [4] |
| Short bowel syndrome | Reversed weight loss and improved villus height, crypt depth, and muscle thickness in rat models | Sikiric et al., various |
| NSAID-induced GI injury | Prevented and reversed gastrointestinal damage from NSAIDs | Multiple preclinical studies |
| Esophageal lesions | Protected against esophageal injury in various experimental models | Sikiric et al., various |
The gastrointestinal research has been characterized as showing BPC-157 acts as "a novel cytoprotection mediator which is native and stable in human gastric juice," with effects on the NO-system, somatosensory neurons, endothelium protection, and angiogenesis [10].
For more on peptides with gut-healing research, see Best Peptides for Gut Health.
Musculoskeletal Studies
The 2025 systematic review in Sports Health identified 35 preclinical studies on BPC-157 for musculoskeletal injuries [2].
Tendon Healing (8+ studies)
- Accelerated outgrowth of tendon explants in vitro
- Increased survival of tendon fibroblasts under oxidative stress
- Dose-dependent increase in tendon fibroblast migration
- Improved biomechanical strength and collagen organization after transection
- Counteracted corticosteroid-induced impairment of tendon healing
- Mechanism: FAK-paxillin signaling, fibroblast proliferation, enhanced collagen synthesis [11]
Ligament Healing (8 studies)
- In eight tendon and ligament transection models, BPC-157 treatment reduced instability, reduced post-injury contracture, and restored biomechanical and motor function measures [2]
Muscle Healing (4 studies)
- In four muscle transection and crush models, BPC-157 improved load-to-failure metrics, motor function, and muscle fiber diameter
- Promoted myogenesis, muscle fiber regeneration, and functional recovery
- Facilitated re-establishment of myotendinous junctions and reduced fibrosis at injury sites [2, 12]
Bone Healing (1 study)
- In one fracture model, BPC-157 performed comparably to autologous bone marrow injection and bone grafting
- Promoted callus mineralization with predominantly lamellar bone formation versus fibrous scar tissue [12]
For a broader look at wound healing peptides, see Best Peptides for Wound Healing.
Liver and Organ Protection Studies
| Study Area | Key Findings | Reference |
|---|---|---|
| CCl4 liver injury | Prevented liver necrosis and fatty changes; reduced bilirubin and liver enzymes | Sikiric et al., Life Sciences. 1993 [13] |
| Bile duct ligation | Protected against liver damage from surgical bile duct + hepatic artery ligation | Sikiric et al., 1993 [13] |
| Restraint stress liver injury | Prevented stress-induced liver damage in rats | Sikiric et al., 1993 [13] |
| Ischemia-reperfusion (I/R) | Reduced sinusoidal dilation, necrotic cells, and inflammatory infiltration; increased antioxidant activity | PMC, 2025 [14] |
| Alcohol-related liver damage | Reduced hepatocyte fat accumulation and necrosis | Multiple studies |
BPC-157 outperformed reference drugs (bromocriptine, amantadine, somatostatin) across all tested liver injury models [13]. For more on peptide approaches to liver health, see our guide on Best Peptides for Liver Health.
Cardiovascular Studies
BPC-157's cardiovascular research is extensive in animal models, though entirely preclinical.
| Study Area | Key Findings | Reference |
|---|---|---|
| Myocardial infarction | Protected against isoprenaline-induced MI; improved cardiac function | Sikiric et al., Pharmaceuticals. 2022 [15] |
| Arrhythmias | Anti-arrhythmic properties in digitalis toxicity models; reduced premature ventricular beats | Sikiric et al., 2022 [15] |
| Pulmonary hypertension | Counteracted monocrotaline-induced pulmonary arterial hypertension in rats | Sikiric et al., 2022 [15] |
| Thrombosis | Prevented and reversed thrombus formation; maintained platelet function | Sikiric et al., various [16] |
| Vascular tone | Modulated vasomotor tone through Src-Caveolin-1-eNOS pathway | Hsieh et al., Sci Rep. 2020 [17] |
| Collateral vessel recruitment | Rapidly recruited collateral vessels to bypass occluded arteries/veins | Sikiric et al., various [15] |
The collateral vessel finding is particularly notable. In animal models with occluded major vessels, BPC-157 activated alternative blood flow routes, restoring circulation and reducing organ damage across multiple systems simultaneously [15].
Neurological Studies
| Study Area | Key Findings | Reference |
|---|---|---|
| Traumatic brain injury | Preserved consciousness, lowered brain edema, decreased hemorrhagic lesions and mortality | Sikiric et al., Regulatory Peptides. 2010 [18] |
| Spinal cord injury | Recovered tail function after compression injury; reduced axonal necrosis and demyelination | Perovic et al., J Orthop Surg Res. 2019 [19] |
| Stroke (bilateral carotid occlusion) | Resolved neuronal damage; restored memory, locomotion, and coordination | Sikiric et al., various [20] |
| Peripheral nerve transection | Promoted peripheral nerve regeneration | Sikiric et al., various [20] |
| Dopaminergic system | Modulated dopamine-related behaviors; counteracted effects of dopaminergic drugs | Sikiric et al., various [20] |
| Serotonergic system | Modulated serotonin-related disturbances | Sikiric et al., Pharmaceuticals. 2024 [20] |
In the spinal cord study, a single injection of BPC-157 given 10 minutes after compression injury produced rapid and sustained recovery of tail function, with effects documented up to one year after injury. Histology showed reduced grey matter edema, less cyst formation, and an increased number of preserved axons [19].
Mechanisms of Action: What the Research Has Identified
The breadth of BPC-157's reported effects raises an obvious question: how can one peptide do so many things? The research points to several interconnected pathways.
Nitric Oxide (NO) System
Most studies identify the NO system as BPC-157's primary molecular target, particularly eNOS-derived nitric oxide. A 2020 study in Scientific Reports demonstrated for the first time that BPC-157 activates eNOS through Src-Caveolin-1 phosphorylation — the peptide stimulates Cav-1 phosphorylation, which reduces the binding of eNOS to Cav-1, freeing eNOS to produce NO [17].
This matters because NO controls blood flow, inflammation, and tissue repair. BPC-157 appears to stabilize NO production during injury — not simply increasing or decreasing it, but restoring balance [1, 17].
Angiogenesis (VEGFR2)
BPC-157 upregulates VEGFR2 expression at both mRNA and protein levels, promoting new blood vessel formation. Notably, it increases the receptor without increasing its ligand (VEGF-A). This receptor-level activation drives downstream signaling cascades that promote vessel growth and tissue repair [1, 12].
Growth Factor and Signaling Pathways
- ERK1/2 phosphorylation: In endothelial cells, BPC-157 activates ERK1/2 in a dose-dependent manner, driving proliferation and migration [12]
- FAK-paxillin signaling: Central to BPC-157's tendon and ligament healing effects [11]
- Growth hormone receptor upregulation: Identified in the 2025 systematic review as a pathway relevant to musculoskeletal healing [2]
- EGR-1 gene expression: Stimulates early growth response gene responsible for cytokine and growth factor generation [1]
Antioxidant and Anti-Inflammatory Effects
BPC-157 upregulates heme oxygenase-1 (HO-1), heat shock proteins (HSP 70 and 90), glutathione reductase, glutathione peroxidase 2, and GST-pi. It also reduces pro-inflammatory cytokines including IL-6 and TNF-alpha [1, 14].
Cytoprotection
The peptide shows direct protective effects on both epithelial and endothelial cells — what researchers call "Robert's cytoprotection," a concept that extends beyond simple anti-inflammatory action to include direct cellular defense against toxic insults [15].
Safety and Toxicology Data
Preclinical Safety
The preclinical safety record is remarkably clean:
- No lethal dose identified: Across multiple animal species (mice, rats, rabbits, dogs), researchers could not find a lethal dose or minimum toxic dose across a wide range (6 mcg/kg to 20 mg/kg) [3]
- No organ toxicity: No acute histologic or gross toxicity observed in liver, spleen, lung, kidney, brain, thymus, prostate, or ovaries [2, 3]
- No teratogenic effects: No evidence of birth defects in animal studies [3]
- No genotoxic effects: No DNA damage observed [3]
- No anaphylactic reactions: No immune hypersensitivity responses in animal studies [3]
Human Safety Data
Human safety data is extremely limited:
- IBD trials: No toxicity reported, but data published only as conference abstracts [4, 5]
- Knee pain study: No adverse events reported, though adverse event screening was not described in detail [6]
- Interstitial cystitis study: No adverse events after intravesicular injection; patients screened for fevers, rash, nausea, vomiting, and worsening symptoms [7]
- IV safety pilot: Two subjects received up to 20 mg IV with no measurable biomarker changes and no side effects [8]
Theoretical Safety Concerns
Despite the clean preclinical record, several concerns exist:
- Immunogenicity risk: As a synthetic peptide, BPC-157 could theoretically trigger immune responses. The FDA specifically cited "risk for immunogenicity" as a concern [21]
- Manufacturing impurities: Unregulated production could introduce contaminants with unknown safety profiles [21]
- Unknown drug interactions: No formal studies have examined how BPC-157 interacts with other medications
- Cancer concerns: Some researchers have raised theoretical questions about whether BPC-157's pro-angiogenic properties could promote tumor growth, though no evidence of this has been observed in any study [2]
Systematic Reviews (2025)
Three major reviews published in 2025 attempted to synthesize the BPC-157 evidence base.
Orthopaedic Sports Medicine Review (Sports Health, 2025)
Authors: Vasireddi N, Hahamyan H, Salata MJ, Karns M, Calcei JG, Voos JE, Apostolakos JM
- Searched PubMed, Cochrane, and Embase from inception to June 2024
- Identified 544 articles; included 36 studies (35 preclinical, 1 clinical)
- Conclusion: "BPC-157 shows promise for promoting recovery from musculoskeletal injuries. Adverse effects are possible due to unregulated manufacturing, contamination, or unknown clinical safety" [2]
Narrative Review — Regeneration or Risk? (PMC, 2025)
- Covered BPC-157's regenerative potential across musculoskeletal systems
- Identified multiple mechanism pathways (VEGFR2, Akt-eNOS, ERK1/2)
- Conclusion: Promising preclinical data, but "robust clinical trials are lacking" and human safety "remains unknown" [12]
Gastroenterology Review (ACG 2025 Abstract)
- Reviewed BPC-157 as an emerging adjunct for gastrointestinal conditions
- Summarized preclinical benefits in IBD, ulcer, NSAID injury, fistula, and anastomosis models
- Conclusion: No clinical safety data available to date [22]
All three reviews reached the same conclusion: extensive preclinical promise paired with a near-total absence of rigorous human evidence.
Regulatory Timeline
| Date | Event |
|---|---|
| Early 1990s | BPC-157 first characterized by Sikiric group at University of Zagreb |
| 1993-2000s | Extensive preclinical research published; compound developed as PL14736 by Pliva (Croatia) |
| 2003 | Phase I safety/PK data presented at European gastroenterology congress (abstract only) |
| 2005 | Phase II UC trial results presented at Digestive Disease Week (abstract only) |
| 2015 | Phase I trial (NCT02637284) initiated by PharmaCotherapia in Tijuana |
| 2016 | Phase I trial results submission cancelled; no data published |
| 2022 | WADA temporarily bans BPC-157 (later removed from banned list) |
| October 2023 | FDA classifies BPC-157 as Category 2 bulk drug substance |
| February 2024 | FDA finalizes restrictions; compounding pharmacies can no longer legally produce BPC-157 for human use |
| 2024-2025 | State medical boards begin auditing clinics using BPC-157; license suspensions reported |
| 2025 | Three pilot studies (knee pain, interstitial cystitis, IV safety) represent the total published human data |
FDA Category 2: What It Means
In late 2023, the FDA placed BPC-157 on its Category 2 list for Section 503A compounding — the classification for substances with "significant safety concerns." This prohibits all compounding pharmacies (both 503A and 503B) from producing BPC-157 for human use [21].
The FDA's stated rationale: concerns about "risk for immunogenicity, peptide-related impurities, and limited safety-related information."
BPC-157 is not a controlled substance under the DEA's scheduling system. Simple possession is not a federal crime. But selling it for human use now constitutes distributing an unapproved, adulterated drug [21].
Frequently Asked Questions
How many human clinical trials has BPC-157 had?
Depending on how you count: between three and six. The ulcerative colitis program included a Phase I and Phase II trial (published only as abstracts). Three pilot studies have been published as full papers (knee pain, interstitial cystitis, IV safety). One formal Phase I trial (NCT02637284) was cancelled without publishing results. No randomized, placebo-controlled trial with published full results exists.
Is BPC-157 legal?
It depends on context. BPC-157 is not a controlled substance, so personal possession is not federally illegal. However, the FDA's Category 2 classification makes it illegal for compounding pharmacies to produce it for human use. Selling it labeled for human consumption is prohibited. It is widely available online as a "research chemical," but this does not make its use for self-treatment legal or safe.
Why hasn't there been a proper clinical trial?
Several factors. The compound was developed by a small Croatian company (Pliva) without the resources for global clinical trials. The only attempted formal Phase I trial (NCT02637284) was cancelled for unknown reasons. BPC-157 cannot be patented as a naturally occurring peptide fragment, which limits the financial incentive for pharmaceutical companies to invest in expensive clinical development.
What are the most common doses people use?
Most self-experimenters use 250-500 mcg per day, typically via subcutaneous injection. These doses are extrapolated from rat studies, adjusted for body weight. Without human pharmacokinetic data, there is no way to know if these doses achieve therapeutic tissue concentrations in humans.
Is BPC-157 the same as TB-500?
No. BPC-157 and TB-500 are different peptides with different structures and mechanisms. BPC-157 is a 15-amino acid fragment from gastric juice. TB-500 (Thymosin Beta-4 fragment) is involved in actin regulation and cell migration. They are sometimes combined in the biohacker community. Both have been subject to FDA compounding restrictions.
Can BPC-157 cause cancer?
No study has found BPC-157 promotes tumor growth. However, its pro-angiogenic properties (stimulating new blood vessel formation) have raised theoretical questions about whether it could support tumor blood supply. This concern remains theoretical — it has not been observed in any preclinical or clinical study to date.
What happened to the cancelled Phase I trial?
PharmaCotherapia's trial (NCT02637284) in Tijuana, Mexico enrolled 42 healthy volunteers to test oral BPC-157 tablets. Results were reportedly submitted to ClinicalTrials.gov in May 2016 but the submission was cancelled before review. No explanation was published. Theories range from funding issues to poor oral absorption to undisclosed safety signals. The truth is unknown.
Are the pilot studies reliable?
They offer signals, not proof. All three published pilot studies (knee pain, interstitial cystitis, IV safety) lack control groups, use very small sample sizes (2-17 participants), and were conducted by the same primary investigator. They were published in an alternative medicine journal rather than a mainstream medical journal. These are legitimate criticisms that don't invalidate the results but do mean the findings require confirmation through rigorous, controlled trials.
The Bottom Line
BPC-157's research profile is a study in contradiction. On one hand, over 100 preclinical studies — spanning gastrointestinal healing, musculoskeletal repair, liver protection, cardiovascular protection, and neuroprotection — paint a consistent picture of a remarkably versatile healing peptide. The preclinical safety record is clean, with no organ toxicity or lethal dose identified across multiple animal species.
On the other hand, the human data could fit on a notecard. Three small pilot studies without control groups. Phase I/II ulcerative colitis data that was never published beyond conference abstracts. A cancelled Phase I trial with no explanation. We do not have basic pharmacokinetic data — how much is absorbed, what blood levels are achieved, how it distributes in the human body.
Three decades of research have produced one of the most heavily studied peptides in preclinical science and one of the least studied in clinical medicine. The 2025 systematic reviews all reached the same conclusion: BPC-157 looks promising, but without proper human trials, it remains investigational and should not be considered a standard therapy.
The FDA's Category 2 classification reflects this gap. Whether you view that decision as appropriate caution or regulatory overreach depends on how you weigh the preclinical promise against the clinical uncertainty. What's not debatable is that BPC-157 needs — and has always needed — the kind of rigorous human trials that would either confirm its remarkable preclinical track record or reveal limits that animal studies cannot detect.
References
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Sikiric P, et al. The Stable Gastric Pentadecapeptide BPC 157 Pleiotropic Beneficial Activity and Its Possible Relations with Neurotransmitter Activity. Pharmaceuticals. 2024;17(4):461. PMC
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Vasireddi N, et al. Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review. Sports Health. 2025. PMC
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Chang CH, et al. Preclinical safety evaluation of body protective compound-157, a potential drug for treating various wounds. Regul Toxicol Pharmacol. 2020;114:104657. ScienceDirect
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Sikiric P, et al. Stable gastric pentadecapeptide BPC 157 in trials for inflammatory bowel disease (PL-10, PLD-116, PL14736, Pliva, Croatia) heals ileoileal anastomosis in the rat. Surgery Today. 2007;37(9):768-777. PubMed
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Veljaca M, et al. Safety, tolerability and pharmacokinetics of PL 14736, a novel agent for treatment of ulcerative colitis, in healthy male volunteers. Gut. 2003;51(Suppl III):A309. Semantic Scholar
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Lee E, Padgett B. Intra-Articular Injection of BPC 157 for Multiple Types of Knee Pain. Altern Ther Health Med. 2021;27(4):8-13. PubMed
-
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;30(10):12-17. PubMed
-
Lee E, Burgess J. Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study. Altern Ther Health Med. 2025. PubMed
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PharmaCotherapia. PCO-02 — Safety and Pharmacokinetics Trial. ClinicalTrials.gov Identifier: NCT02637284. ClinicalTrials.gov
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Sikiric P, et al. Stable gastric pentadecapeptide BPC 157 in the treatment of colitis and ischemia and reperfusion in rats: New insights. World J Gastroenterol. 2017;24(1):76-85. PMC
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Chang CH, et al. The promoting effect of pentadecapeptide BPC 157 on tendon healing involves tendon outgrowth, cell survival, and cell migration. J Appl Physiol. 2011;110(3):774-780. American Physiological Society
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Regeneration or Risk? A Narrative Review of BPC-157 for Musculoskeletal Healing. PMC. 2025. PMC
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Sikiric P, et al. Hepatoprotective effect of BPC 157, a 15-amino acid peptide, on liver lesions induced by either restraint stress or bile duct and hepatic artery ligation or CCl4 administration. Life Sciences. 1993;53(18):PL291-296. PubMed
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Protective Effects of BPC 157 on Liver, Kidney, and Lung Distant Organ Damage in Rats with Experimental Lower-Extremity Ischemia-Reperfusion Injury. PMC. 2025. PMC
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Sikiric P, et al. Stable Gastric Pentadecapeptide BPC 157 as Useful Cytoprotective Peptide Therapy in the Heart Disturbances, Myocardial Infarction, Heart Failure, Pulmonary Hypertension, Arrhythmias, and Thrombosis Presentation. Pharmaceuticals. 2022;15(12):1465. PMC
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Sikiric P, et al. BPC 157 and blood vessels. Curr Pharm Des. 2014;20(7):1041-1047. PubMed
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Hsieh MJ, et al. Modulatory effects of BPC 157 on vasomotor tone and the activation of Src-Caveolin-1-endothelial nitric oxide synthase pathway. Scientific Reports. 2020;10:17078. Nature
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Sikiric P, et al. Traumatic brain injury in mice and pentadecapeptide BPC 157 effect. Regulatory Peptides. 2010. ResearchGate
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Perovic D, et al. 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;14:199. PMC
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Sikiric P, et al. Pentadecapeptide BPC 157 and the central nervous system. Curr Neuropharmacol. 2021;19(8):1213-1220. PMC
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FDA Category 2 Classification of BPC-157. Regulatory Alert. Holt Law
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Oral Peptide BPC-157 — An Emerging Adjunct. Official Journal of the American College of Gastroenterology. 2025. ACG
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Jozwiak M, et al. Multifunctionality and Possible Medical Application of the BPC 157 Peptide — Literature and Patent Review. Pharmaceuticals. 2025;18(2):185. MDPI