BPC-157 IV Pilot Study 2025: The First Published Human Safety Data

In March 2025, Erica Lee and Kenneth Burgess published the first indexed human safety report on intravenous BPC-157 in Alternative Therapies in Health and Medicine. The paper is small, explicitly marked as pilot work, and appeared in a journal with limited reach. It still marks a turning point, because after three decades of preclinical literature, human IV data are now available in the peer-reviewed record.

TL;DR: Lee and Burgess 2025

Publication: Alternative Therapies in Health and Medicine 31(5):20-24, PMID 40131143 Date: March 2025 Study design: IRB-approved pilot trial, n=2 Dose: Up to 20 mg BPC-157 in 250 mL saline over two days intravenously Primary finding: Zero adverse effects on cardiac, hepatic, renal, thyroid or glucose biomarkers Significance: First published human IV BPC-157 safety paper

BPC-157regeneration

Gastric pentadecapeptide (15 amino acids) known for exceptional tissue repair properties. Promotes wound healing, angiogenesis, and cytoprotection across tendons, muscles, gut, and nerves. Over 30 years of preclinical research.

The context: 30 years of preclinical data, scarce human data

BPC-157 is a synthetic pentadecapeptide derived from a sequence found in human gastric juice. Since the early 1990s, the Predrag Sikiric group in Zagreb has published hundreds of preclinical reports on wound healing, angiogenesis and cytoprotection. A 2025 systematic review in the HSS Journal by Vasireddi and colleagues counted 36 studies in orthopedic research, 35 of them preclinical and only one clinical (Vasireddi et al., 2025).

Before Lee and Burgess 2025, the published human evidence was narrow:

Pliva PL14736 Phase II in ulcerative colitis: An enteral BPC-157 formulation developed by the original Croatian pharmaceutical firm. Results were reported but the molecule never reached approval.
Interstitial cystitis pilot: Lee and colleagues published a 2024 pilot in the same journal with twelve patients receiving intra-articular BPC-157, reporting 80 to 100 percent symptom reduction at six weeks.
Knee injection pilot: Another small Lee pilot with twelve patients and intra-articular application for knee complaints.

The intravenous route, across which much of the preclinical pharmacokinetic work was performed, had until now remained entirely undocumented in human subjects.

What Lee and Burgess 2025 showed

Study design

Lee and Burgess 2025 design

Setting: IRB-approved pilot trial at a private US clinic Subjects: n=2 adult volunteers Administration: Intravenous infusion, BPC-157 in 250 mL 0.9 percent saline Dose: Escalating up to 20 mg total peptide, distributed across two days Monitoring: Comprehensive blood panel before, during and after infusion, including cardiac, hepatic, renal, thyroid and glycemic markers

The authors explicitly call this a "first-in-human IV pilot." It is not randomized or placebo-controlled, and the sample size does not allow statistical effect sizes or confidence intervals for safety. The purpose is descriptive: to document whether an intravenous dose in this range produces measurable biomarker changes that would justify or preclude further development.

Results

Cardiac markers: No significant changes in troponin, BNP or ECG parameters Liver: No elevation in ALT, AST, alkaline phosphatase or bilirubin Kidney: Creatinine, eGFR and urea within normal range across time points Thyroid: TSH, fT3, fT4 unchanged Glucose metabolism: Fasting glucose and HbA1c stable Subjective: No reported adverse effects during or after infusion

The authors phrase the conclusion cautiously. Under the conditions of this pilot, intravenous doses up to 20 mg over two days in two subjects were associated with no measurable negative biomarker signals. They claim no efficacy and draw no conclusions about long-term safety, repeat dosing or higher doses.

An honest reading: why n=2 still matters

Study limitations

Sample size: n=2 provides no statistical power for rare event incidence Duration: Two days of exposure says nothing about chronic or repeat use Control: No placebo group, no blinding, no randomization Journal: Alternative Therapies in Health and Medicine has an impact factor below one and is rarely cited in mainstream biomedical literature Generalizability: No claims possible for pregnant women, children, multimorbid patients or combination therapy

The critical point is that these limitations do not negate the scientific value of the paper. They define it. Lee and Burgess do not claim to have established BPC-157 as an IV drug. They document the first step any new molecule traverses in a regulatory development path: a small observational exposure in healthy subjects to generate initial safety signals. Without this step, larger Phase 1 trials do not begin.

From a research perspective, the paper shifts the evidence base in two ways. First, the claim that there are "no human data" on IV BPC-157 is no longer correct. Second, it provides a reference point against which subsequent, larger studies will measure their results.

The other human BPC-157 pilot studies

Together with the 2025 IV paper, the current human BPC-157 evidence package consists of four data points:

Pliva PL14736 Phase II in ulcerative colitis: Enteral formulation, completed more than 15 years ago, only fragmentarily documented in the peer-reviewed literature.
Lee 2024 interstitial cystitis: Intravesical/intra-articular administration, n=12, 80 to 100 percent symptom reduction at six weeks, published in Alternative Therapies in Health and Medicine.
Knee pilot Lee: Intra-articular, n=12, similar journal, preliminary positive signals.
Lee and Burgess 2025 IV safety: n=2, up to 20 mg IV, no AE.

The total number of human subjects in published controlled or quasi-controlled BPC-157 studies is below 30. For comparison, semaglutide was studied in 17,604 adults in the SELECT trial alone. This ratio is not meant as disqualification. It is the frame within which BPC-157 still operates.

Safety profile: what Vasireddi 2025 and McGuire 2025 summarize

Alongside the Lee and Burgess pilot, two systematic reviews appeared in 2025 that summarize the current state:

Vasireddi et al. 2025 (HSS Journal): Systematic review of orthopedic applications. 36 studies, 35 of them preclinical. The authors frame BPC-157 as an experimental substance with robust preclinical signals but applied without clinical evidence base. They cite GHR binding and VEGFR2/NO signaling as potential mechanisms (Vasireddi et al., 2025).
McGuire et al. 2025 (Current Reviews in Musculoskeletal Medicine): Narrative review focused on theoretical risks. Discusses possible negative effects through angiogenesis stimulation, NO pathway activation and neurodegeneration. The authors explicitly note that these risks are theoretical and not supported by clinical data, but also not refuted (McGuire et al., 2025).

Together the two papers sketch a picture consistent with Lee and Burgess 2025. BPC-157 shows no severe acute toxicity signals in preclinical models, and the first human IV data confirm the pattern in a very small sample. The open questions remain chronic exposure, pharmacokinetic characterization and interactions with concomitant medication.

What comes next

The obvious next step would be a formal Phase 1 trial with larger subject numbers, dose-finding, pharmacokinetic monitoring and defined exclusion criteria. Whether Lee and Burgess will continue on this path themselves or whether academic or commercial sponsors will take over has not been publicly communicated at the time of this publication.

Regulatorily, BPC-157 remains non-FDA-approved in the United States. WADA lists the substance as prohibited in sport. No central European approval exists, and application occurs exclusively in research contexts or in jurisdictions without explicit regulation. peptidesdirect.io distributes BPC-157 strictly for research purposes.

For peptide research, Lee and Burgess 2025 is less a destination than a starting point. The paper demonstrates that human IV data are technically and ethically feasible, and it delivers a first baseline dataset against which future studies can be measured.

Further BPC-157 analyses on peptidesdirect.io:

References

Lee E, Burgess K. "Safety of Intravenous BPC-157: A Pilot Trial." Alternative Therapies in Health and Medicine. 2025;31(5):20-24. PMID: 40131143. PubMed
Vasireddi N, et al. "Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review." HSS J. 2025. DOI: 10.1177/15563316251355551. PMC
McGuire FP, et al. "Regeneration or Risk? A Narrative Review of BPC-157." Curr Rev Musculoskelet Med. 2025. PMC
Lee E, et al. "A Pilot Study of Intravesical BPC-157 in Interstitial Cystitis." Alt Ther Health Med. 2024;30(10):12-17.

This article is for informational and educational purposes only. All mentioned peptides are intended exclusively for laboratory research and not for human consumption. For Research Purposes Only.