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Case Study · Research Summary
A Two-Participant Pilot Study of Intravenous BPC-157: Findings and Limitations
Research summary · Human pilot study · Published 2025
An independent educational summary of a 2025 single-center pilot safety study in which two adults received intravenous BPC-157 infusions. Reported here for what it did and did not measure — not as medical advice, dosing guidance, or an endorsement of human use.
Participants
Two adults
One 68-year-old woman and one 58-year-old man, both previously exposed to IV BPC-157.
Design
Pilot, uncontrolled
Prospective single-center study. No comparison group, randomization or blinding.
Follow-up
~24 hours
Observation ended roughly one day after the second infusion.
Efficacy measured
None
Safety observations only. No healing, pain or function outcomes assessed.
Neutral, research-use-only reference articles on peptide classification, structure, and analytical documentation. These articles summarize independently published third-party literature. The studies and their authors are not affiliated with, sponsored by, or endorsed by Ovrform, and nothing here describes or implies any use of Ovrform products.
Key Takeaway
Preliminary, and limited by design
A 2025 pilot study reported that two adults experienced no reported adverse effects during two intravenous BPC-157 infusions or during the study’s brief follow-up period. Laboratory measurements and vital signs did not show changes that the investigators considered clinically significant.
Because the study involved only two participants, both of whom had previously received intravenous BPC-157, its findings should be considered preliminary. The study does not establish the general safety, long-term safety or effectiveness of BPC-157.
01 · Study Identification
Study identification
Original study
Lee E, Burgess K. Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study. Alternative Therapies in Health and Medicine. 2025;31(5):20–24.
PMID
40131143
Study type
Prospective, single-center pilot safety study
Research setting
A private clinic in Orlando, Florida
Participants
Two adults
Published
Altern Ther Health Med, 2025;31(5):20–24
Objective
Short-term tolerability, selected labs and vital signs after IV administration
02 · At a Glance
Study at a glance
| Study characteristic | Description |
|---|---|
| Number of participants | Two |
| Participant demographics | One 68-year-old White woman and one 58-year-old Asian man |
| Previous exposure | Both participants had previously received intravenous BPC-157 |
| Intervention | One 10 mg infusion followed the next day by one 20 mg infusion |
| Infusion protocol | Each dose was diluted in 250 mL of normal saline and administered over one hour |
| Follow-up period | Through approximately 24 hours after the second infusion |
| Comparison group | None |
| Randomization or blinding | None described |
| Primary focus | Short-term adverse symptoms, vital signs and laboratory measurements |
| Efficacy assessed | No |
| Ethics | The authors reported IRB approval and written informed consent |
The protocol information above describes what the researchers did and is not dosing or administration guidance.
03 · Methods
What the researchers did
The investigators enrolled two adults considered relatively healthy under the study’s eligibility criteria. People with chronic kidney disease, diabetes, hypothyroidism, liver failure, pregnancy or a heart condition were excluded.
Both participants had previously received a 5 mg intravenous BPC-157 infusion without a reported adverse reaction. Neither participant had an active musculoskeletal injury or acute pain during the pilot study.
On the first study day, baseline fasting blood samples and vital signs were collected. Each participant then received 10 mg of BPC-157 in 250 mL of normal saline over one hour. Blood testing and vital-sign measurements were repeated the following day, after which each participant received a 20 mg infusion. Measurements were collected again on the third day.
The investigators asked the participants about symptoms including nausea, gastrointestinal symptoms, swelling, dry mouth or eyes, abdominal pain, fatigue, muscle or joint discomfort, headache, sweating, rash, hot flashes and shortness of breath.
04 · Measurements
What was measured
The investigators recorded blood pressure and pulse before and after the infusions. Laboratory testing included:
- Complete blood count
- Creatine kinase and creatine-kinase isoenzymes
- Cardiac C-reactive protein
- Red-blood-cell magnesium
- Comprehensive metabolic panel
- B-type natriuretic peptide
- Thyroid-stimulating hormone
These measurements provided information about selected cardiovascular, kidney, liver, metabolic, hematologic and thyroid markers over the study’s short observation period. They did not constitute a comprehensive evaluation of every possible adverse effect.
05 · Findings
What the study observed
Neither participant reported an adverse reaction during the infusions or through approximately 24 hours after the second infusion. Blood pressure and pulse did not show changes the investigators considered clinically significant.
Most measured laboratory values remained within or close to their respective reference ranges. The investigators did not identify clinically significant changes in the measured cardiac, liver, thyroid or blood-glucose markers.
One transient change
One participant experienced a temporary increase in serum creatinine from 0.6 to 0.9 and a corresponding decrease in estimated glomerular filtration rate from 106 to 66 after the first infusion. Both values returned to their baseline levels the following day. The authors suggested dehydration as a possible explanation and did not interpret the change as evidence of kidney injury.
Because there were only two participants and no untreated comparison group, the cause and significance of individual laboratory fluctuations cannot be determined from this study.
06 · Interpretation
How the findings should be interpreted
The most supportable interpretation is:
In this pilot study, two previously exposed adults had no reported adverse symptoms and no persistent clinically significant changes in the selected measurements during a short observation period following intravenous BPC-157 infusions.
The study should not be interpreted as proving that:
- Intravenous BPC-157 is safe for the general population.
- BPC-157 is safe when used repeatedly or over longer periods.
- Rare or delayed adverse effects do not occur.
- BPC-157 is safe for people with underlying medical conditions.
- Other doses, administration routes or product formulations have the same risk profile.
- BPC-157 treats pain, injuries or any medical condition.
- Products from other manufacturers or suppliers are equivalent to the material used in the study.
The study was not designed to measure healing, pain reduction, physical function or any other efficacy outcome.
07 · Strengths
Study strengths
This pilot study adds a small amount of directly observed human data to a research area in which published human evidence remains limited. Additional strengths include:
- Reported institutional review board approval
- Collection of objective laboratory and vital-sign measurements
- Individual participant results presented in the paper
- Reported informed consent
- Measurements collected before and after exposure
- Use of one laboratory for the reported blood testing
The authors reported that the study material came from an unnamed 503A compounding pharmacy and had a certificate of analysis and independent endotoxin testing. Because the supplier was not disclosed and complete analytical data were not published in the article, those product-quality statements cannot be independently evaluated from the paper alone.
08 · Limitations
Important limitations
Extremely small sample
Only two people participated. A study of this size cannot estimate the frequency of adverse events or reliably identify uncommon risks.
For illustration, even when an adverse event occurs in 10% of users, there is an 81% probability that a two-person study will observe zero such events. The absence of an event in two people therefore provides very limited reassurance about population-level risk.
Participants had already tolerated BPC-157
Both participants had previously received intravenous BPC-157 without a reported problem. This may have selected participants already known to tolerate an earlier exposure and limits the study’s relevance to people receiving BPC-157 for the first time.
Very short observation period
Follow-up extended only through approximately 24 hours after the second infusion. The study could not meaningfully evaluate delayed immune reactions, cumulative toxicity, effects of repeated administration or adverse outcomes that take longer to develop.
No control group
There was no saline-only or untreated comparison group. Ordinary biological variation, hydration, diet, activity and laboratory variability therefore cannot be separated from changes potentially associated with the intervention.
No randomization or blinding
The article does not describe random allocation or blinding. Participant-reported symptoms and investigator interpretation could consequently be influenced by expectations, although objective laboratory measurements are less susceptible to this type of bias.
Restricted population
The study excluded several medical conditions and included only two adults between 58 and 68 years old. Its findings cannot be generalized to younger people, pregnant people, people with significant medical conditions or more diverse populations.
Limited safety assessment
The study evaluated selected vital signs, symptoms and blood markers. It did not report formal testing for immune responses or anti-drug antibodies, pharmacokinetics, cardiac rhythm abnormalities, reproductive outcomes, cancer-related outcomes or long-term organ effects.
Product-specific uncertainty
The study involved one compounded BPC-157 preparation from an unnamed source. Peptide identity, purity, aggregation, sterility, endotoxin levels and peptide-related impurities can differ between products. The study cannot validate research-grade materials, products from online suppliers or any product sold by another company.
No efficacy conclusions
The participants did not have active injuries, and the study did not evaluate whether BPC-157 improves healing, pain, mobility or clinical outcomes. Safety observations cannot be used as evidence of effectiveness.
09 · Context
Funding and author context
The authors reported that the research received no external funding and declared no conflict of interest. The paper states that the participants paid the reported $1,000 cost of the BPC-157 and laboratory work.
The paper also states that the lead author had prescribed intravenous BPC-157 in clinical practice since 2018 and founded an organization advocating continued access to compounded peptides. These details provide relevant context when evaluating the study’s framing and interpretation, even though the authors formally declared no conflict of interest.
10 · Regulatory
Regulatory and safety context
BPC-157 is not a component of an FDA-approved drug. FDA has stated that it has no or only limited safety-related information for proposed routes of administration and lacks sufficient information to determine whether compounded BPC-157 would cause harm in humans.
FDA has also identified potential concerns involving immunogenicity, peptide aggregation, peptide-related impurities and characterization of the active pharmaceutical ingredient. These broader concerns were not resolved by the two-participant pilot study.
Conclusion
Overall conclusion
This study contributes a preliminary short-term observation: two previously exposed adults received two intravenous BPC-157 infusions without reporting adverse symptoms and without persistent clinically significant changes in the selected laboratory measurements or vital signs.
The study is too small, too short and too narrowly designed to establish the safety of intravenous BPC-157 in humans generally. It also provides no evidence that BPC-157 is effective for muscle injuries, tendon injuries, pain or any other condition.
Larger, independently conducted and appropriately controlled clinical studies with diverse participants, standardized product characterization, formal adverse-event monitoring and longer follow-up would be required to make reliable conclusions about human safety.
Editorial Disclaimer
This page is an independent educational summary of third-party research. It is not medical advice, a treatment recommendation or an endorsement of BPC-157 for human use.
Descriptions of amounts and administration methods are included only to accurately report the published study protocol. They should not be interpreted as instructions.
Reference
Lee E, Burgess K. Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study. Alternative Therapies in Health and Medicine. 2025;31(5):20–24. PMID: 40131143.