BPC-157 Clinical Trials: Status & Results (2026)

BPC-157 (Body Protection Compound-157) is a synthetic pentadecapeptide derived from a protein found in human gastric juice. Since its discovery by Dr. Predrag Sikiric and colleagues at the University of Zagreb in the early 1990s, it has generated enormous interest in the peptide research community — and enormous frustration. Despite hundreds of animal studies demonstrating remarkable healing properties across nearly every organ system, human clinical trial data remains extremely limited.

This article provides a comprehensive, evidence-based overview of where BPC-157 research actually stands in 2026 — what we know, what we don't, and what would need to happen for this peptide to move toward clinical use.

The Research Landscape: A Peptide Without a Pharma Sponsor

BPC-157's research profile is unusual. The vast majority of published studies — estimated at over 100 peer-reviewed papers — originate from a single research group at the University of Zagreb, Croatia. While this body of work is substantial and internally consistent, the lack of independent replication from other laboratories is a significant limitation that the scientific community has noted repeatedly.

The peptide's amino acid sequence (GEPPPGKPADDAGLV, molecular weight 1,419 Da) is a 15-amino acid fragment of a larger protein called BPC (Body Protection Compound) that is naturally present in human gastric juice. It is remarkably stable in gastric fluid — remaining intact for over 24 hours — which is unusual for a peptide and has implications for oral bioavailability (PMID: 21548867).

Existing Human Trial Data

Phase II — Inflammatory Bowel Disease (Croatia)

The most significant human data comes from a Phase II clinical trial for ulcerative colitis conducted in Croatia under the designation PL-14736 (also referred to as PL-10 and PLD-116). This trial, referenced across multiple publications by the Sikiric group, reportedly demonstrated efficacy in inflammatory bowel disease with no toxicity (PMID: 22300085). However, the full trial data has never been published in a standalone clinical paper, making independent evaluation difficult.

Phase I — Safety & Pharmacokinetics (NCT02637284)

In December 2015, a Phase I trial was registered on ClinicalTrials.gov (NCT02637284) by PharmaCotherapia d.o.o. The study aimed to assess safety and pharmacokinetics of PCO-02 (active ingredient: BPC-157) in 42 healthy volunteers aged 18–35. The trial status is listed as "Unknown" — it was reportedly cancelled in 2016, and no results were ever published.

2025 Pilot Study — IV Safety in Humans

The most recent human data is a 2025 pilot study by Lee and Burgess, published in Alternative Therapies in Health and Medicine (PMID: 40131143). This small study administered intravenous BPC-157 at doses up to 20 mg in 2 healthy adults and reported no adverse effects. While encouraging for basic safety, a two-person pilot study without a control group provides very limited evidence.

Retrospective Knee Pain Data

A small retrospective study evaluated 12 patients who received BPC-157 injections for knee pain, suggesting potential benefit. However, retrospective, uncontrolled studies of this size cannot establish efficacy.

Bottom line: As of February 2026, there is no published, peer-reviewed, randomized controlled trial of BPC-157 in humans for any indication.

Key Animal Research Results by System

Despite the human data gap, the preclinical evidence for BPC-157 is extensive. Here are the most significant findings organized by body system.

Gastrointestinal Healing

This is where BPC-157 research began, and the evidence is most robust. Studies demonstrate:

• Gastric ulcer healing — Accelerated healing of various ulcer models including NSAID-induced, stress-induced, and cysteamine-induced ulcers (PMID: 21548867)
• Intestinal anastomosis repair — Enhanced healing of surgical intestinal connections in rats (PMID: 17713731)
• Fistula healing — Promoted closure of gastrointestinal fistulas in animal models (PMID: 32329684)
• Inflammatory bowel disease models — Reduced inflammation and improved tissue integrity in colitis models
• Short bowel adaptation — Improved adaptive response after massive intestinal resection, including increased villus height, crypt depth, and muscle thickness

The gut-healing effects align with BPC-157's origin as a gastric juice peptide and represent the most biologically plausible therapeutic application. For more on the overall benefits profile, see our BPC-157 Benefits Guide.

Tendon, Ligament & Musculoskeletal Repair

BPC-157's effects on connective tissue healing have driven much of its popularity in sports medicine:

• Achilles tendon transection — Full recovery in transected rat Achilles tendons with BPC-157 treatment (PMID: 14554208)
• Tendon fibroblast activation — Promoted outgrowth, survival under stress, and migration of tendon fibroblasts via the FAK-paxillin signaling pathway (PMID: 21030672)
• Growth hormone receptor upregulation — Enhanced GH receptor expression in tendon fibroblasts, potentially improving the healing response (PMC6271067)
• Ligament healing — Improved medial collateral ligament healing in rats

A 2025 systematic review in orthopaedic sports medicine confirmed BPC-157's consistent positive effects in animal musculoskeletal models while noting the complete absence of human clinical data (PMC12313605).

Neuroprotection & Brain Injury

BPC-157's effects on the nervous system are mediated through what researchers describe as the "brain-gut axis":

• Traumatic brain injury (TBI) — Improved consciousness/death ratios in mice when administered within minutes of TBI; beneficial effects observed even with pre-injury dosing (PMID: 19931318)
• Spinal cord injury — Rescued tail function, reduced axonal necrosis, demyelination, and cyst formation after spinal cord compression in rats
• Peripheral nerve regeneration — Promoted nerve regrowth after transection
• Dopamine system modulation — Counteracted disturbances from receptor blockade, supersensitivity development, and nigrostriatal damage (PMID: 34380875)
• Hippocampal ischemia/reperfusion — Protected against hippocampal damage in ischemia models

The comprehensive review by Sikiric et al. on BPC-157 and the central nervous system (PMID: 27138887) outlines the peptide's broad neuroprotective profile, including potential implications for stroke, schizophrenia, and encephalopathy.

Cardiovascular Protection

• Myocardial infarction — Protected against isoprenaline-induced MI in rats, with reduced cardiac damage markers
• Pulmonary hypertension — Both prevented and reversed monocrotaline-induced pulmonary hypertension in rats
• Arrhythmias — Antiarrhythmic effects, including counteracting digitalis-induced ventricular tachycardia
• Thrombosis — Prevention and reversal demonstrated in animal models (PMID: 36359218)

Liver Protection

• Hepatoprotective effects — Protected against liver damage from restraint stress, bile duct ligation, hepatic artery ligation, and carbon tetrachloride (CCl4) toxicity (PMID: 7901724)
• Radiation-induced liver injury — Reduced apoptosis and lipid accumulation via KLF4 upregulation (PMID: 36228773)
• Alcohol-related damage — Attenuated liver lesions in chronic alcohol models

For practical information on how researchers have applied these findings, see our BPC-157 Dosing Guide and BPC-157 Results Timeline.

Why Haven't Large-Scale Human Trials Happened?

This is the central question surrounding BPC-157, and the answer involves a convergence of structural, financial, and regulatory barriers.

1. Patent & Intellectual Property Challenges

BPC-157 is derived from a naturally occurring human protein. While specific formulations and delivery methods can be patented, the peptide sequence itself is difficult to protect with the broad exclusivity that pharmaceutical companies require to justify massive R&D investment. Without strong patent protection, any company that spends hundreds of millions on clinical trials risks having generic manufacturers immediately compete once the compound is validated.

2. Single Research Group Dominance

The overwhelming concentration of BPC-157 research within the Sikiric group at the University of Zagreb is both a strength (deep institutional knowledge) and a weakness (limited independent verification). Pharmaceutical companies and regulatory agencies place significant weight on independent replication, which has been minimal for BPC-157.

3. Regulatory Classification Uncertainty

BPC-157 occupies an awkward regulatory space. It's not a traditional small molecule drug, not a biologic in the conventional sense, and its origin as a gastric juice peptide fragment doesn't fit neatly into existing FDA drug classification frameworks. This ambiguity complicates the IND (Investigational New Drug) application pathway.

4. Cost of Clinical Development

Bringing any compound through the full FDA approval process typically costs $1–2 billion and takes 10–15 years. Without pharmaceutical industry backing — which is unlikely given the patent challenges — this investment must come from academic grants, government funding, or smaller biotech companies with limited resources.

5. The "Good Enough" Problem

BPC-157 is already widely available as a research chemical and is used extensively in wellness and sports medicine clinics. This creates a paradox: the existing unregulated market reduces the financial incentive for formal approval, since demand is already being met outside the regulatory framework.

What FDA Approval Would Require

For BPC-157 to gain FDA approval for any specific indication, the following steps would be necessary:

1. Preclinical Package — GLP (Good Laboratory Practice) toxicology studies, pharmacokinetic profiling, and mechanism of action characterization in standardized models
2. IND Application — Submission to the FDA with manufacturing data (cGMP production), preclinical safety data, and a proposed clinical protocol
3. Phase I Trial — Safety and dosing in 20–80 healthy volunteers (what NCT02637284 attempted but never completed)
4. Phase II Trial — Efficacy signal in 100–300 patients with the target condition
5. Phase III Trial — Large-scale, randomized, double-blind, placebo-controlled trial in 1,000–3,000+ patients
6. NDA Submission — Complete data package submitted for FDA review
7. FDA Review & Approval — Typically 6–12 months review period

The most likely path to clinical use would be through a specific gastrointestinal indication (such as ulcerative colitis or anastomosis healing), where the preclinical evidence is strongest and the biological rationale most clear.

2026 Outlook

Several developments make 2026 a potentially pivotal year for BPC-157 research:

Encouraging signs:

• The 2025 IV safety pilot study (PMID: 40131143) represents a small but meaningful step toward human safety data
• Growing interest from sports medicine researchers, evidenced by the 2025 systematic review in orthopaedic literature
• Increasing mainstream medical awareness as physicians encounter patients already using BPC-157
• Expanding narrative reviews and meta-analyses synthesizing the animal literature

Remaining challenges:

• No pharmaceutical sponsor has announced a formal clinical development program
• The FDA's 2023 category placement of BPC-157 as a "bulk drug substance" under review for compounding pharmacies creates regulatory uncertainty
• WADA's prohibition (effective 2022) has complicated research in sports medicine populations
• Independent replication of the Zagreb group's findings remains limited

Realistic expectations: Large-scale, randomized human trials for BPC-157 remain unlikely in the near term without significant pharmaceutical investment or government research funding. The most probable path forward involves continued small safety studies, retrospective analyses, and potentially investigator-initiated trials at academic medical centers.

Researchers and clinicians interested in the peptide's potential should monitor ClinicalTrials.gov for new registrations and follow publications from groups outside the original Zagreb laboratory for independent validation.

Frequently Asked Questions

Has BPC-157 been tested in human clinical trials?

BPC-157 has very limited human trial data. A Phase II trial for inflammatory bowel disease was conducted in Croatia (PL-14736), and a Phase I safety trial (NCT02637284) was registered but never completed. A 2025 pilot study demonstrated safe IV infusion in 2 healthy adults (PMID: 40131143).

Is BPC-157 FDA approved?

No. BPC-157 is not FDA approved for any indication. It remains a research compound without IND status in the United States.

Why are there so few human trials?

The combination of patent challenges (naturally occurring peptide), concentrated research from a single group, high clinical trial costs ($1–2 billion), and the absence of a pharmaceutical sponsor have all limited human trial development.

What is the strongest scientific evidence for BPC-157?

The strongest evidence comes from animal studies in gastrointestinal healing, tendon repair, and neuroprotection. Over 100 peer-reviewed studies demonstrate consistent tissue-healing effects in rodent models, but these findings have not been validated in large-scale human trials.

Is BPC-157 banned in sports?

Yes. WADA added BPC-157 to its prohibited list under category S0 (non-approved substances) effective January 2022. Athletes subject to anti-doping rules should not use BPC-157.

What would it take for BPC-157 to get FDA approval?

Full FDA approval would require GLP preclinical studies, an IND application, Phase I–III clinical trials in the target population, and NDA submission — a process typically costing $1–2 billion and spanning 10–15 years.

Related Guides

• BPC-157 Benefits — Complete overview of researched benefits across body systems
• BPC-157 Dosing Guide — Protocols, reconstitution, and administration guidance from the research literature
• BPC-157 Results Timeline — When to expect results based on animal study timelines and anecdotal reports
• BPC-157 Peptide Page — Vendor pricing, stack protocols, and full peptide profile

References

1. Sikiric P, et al. "Stable gastric pentadecapeptide BPC 157: novel therapy in gastrointestinal tract." Curr Pharm Des. 2011;17(16):1612-32. PubMed

2. Sikiric P, et al. "Focus on ulcerative colitis: stable gastric pentadecapeptide BPC 157." Curr Med Chem. 2012;19(1):126-32. PubMed

3. Sikiric P, et al. "Fistulas Healing. Stable Gastric Pentadecapeptide BPC 157 Therapy." Curr Pharm Des. 2020;26(25):2991-3000. PubMed

4. Staresinic M, et al. "Gastric pentadecapeptide BPC 157 accelerates healing of transected rat Achilles tendon and in vitro stimulates tendocytes growth." J Orthop Res. 2003;21(6):976-83. PubMed

5. 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):774-80. PubMed

6. Tudor M, et al. "Traumatic brain injury in mice and pentadecapeptide BPC 157 effect." Regul Pept. 2010;160(1-3):26-32. PubMed

7. Sikiric P, et al. "Brain-gut Axis and Pentadecapeptide BPC 157: Theoretical and Practical Implications." Curr Neuropharmacol. 2016;14(8):857-865. PubMed

8. Sikiric P, et al. "Pentadecapeptide BPC 157 and the central nervous system." Neural Regen Res. 2022;17(3):482-487. PubMed

9. Sikiric P, et al. "Stable Gastric Pentadecapeptide BPC 157 as Useful Cytoprotective Peptide Therapy in the Heart Disturbances." Pharmaceuticals. 2022;15(11):1292. PubMed

10. Sikirić P, et al. "Hepatoprotective effect of BPC 157, a 15-amino acid peptide, on liver lesions." Life Sci. 1993;53(16):PL261-6. PubMed

11. Huang YL, et al. "Pentadecapeptide BPC 157 efficiently reduces radiation-induced liver injury." Life Sci. 2022;312:121177. PubMed

12. Lee E, Burgess K. "Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study." Altern Ther Health Med. 2025. PubMed

This article is for educational and research purposes only. It is not medical advice. BPC-157 is not approved by the FDA for human use.