The Ghost Trial: BPC-157's Missing Phase II Data
BPC-157 Research
0 published results
BPC-157 completed a Phase II trial for ulcerative colitis and a Phase I safety study. Neither has published results in a peer-reviewed journal. The data exists somewhere, but no one outside the research group has seen it.
NCT02637284, ClinicalTrials.gov; Sikiric, Current Medicinal Chemistry, 2012
NCT02637284, ClinicalTrials.gov; Sikiric, Current Medicinal Chemistry, 2012
View as imageBPC-157 has been studied in over 200 animal experiments spanning three decades. It has been claimed to heal tendons, protect the gut, repair blood vessels, reduce inflammation, and counter the effects of dozens of drugs and toxins. But when you ask the most basic question about any drug candidate, "Has it been tested in humans, and what happened?", the answer is unexpectedly murky.
At least two human trials of BPC-157 have been conducted. A Phase II trial in patients with ulcerative colitis was completed by the Croatian pharmaceutical company Pliva under the designation PL-14736. A Phase I safety and pharmacokinetics study (NCT02637284) was registered on ClinicalTrials.gov, listed as completed, and then had its results submission cancelled. Neither trial's data has been published in a peer-reviewed journal.
For the complete picture of BPC-157's evidence landscape, including the concentration of research in a single laboratory, see our pillar article. This article focuses specifically on the missing human data.
Key Takeaways
- BPC-157 (designated PL-14736) completed a Phase II randomized, double-blind, placebo-controlled trial in patients with mild-to-moderate ulcerative colitis in Croatia
- The Phase II results have never been published in a peer-reviewed journal, despite being referenced in subsequent papers as showing efficacy with no side effects
- A Phase I safety/PK study (NCT02637284) enrolled 42 healthy volunteers and was marked as completed, but the results submission was cancelled in 2016
- Sikiric's papers repeatedly cite the trial results as "effective in ulcerative colitis, phase II" and "no side effect in trials" without providing the underlying data[1]
- As of 2025, the only published human safety data comes from a 2-person IV pilot study by an independent researcher[2]
- The absence of published human data is the single largest gap in BPC-157's evidence base
The Development Timeline: PL-10 to PL-14736
BPC-157's path toward clinical development began in the 1990s through Pliva, Croatia's largest pharmaceutical company at the time. The compound received multiple designations as it progressed through the pipeline:
- PL-10: The earliest clinical designation
- PLD-116: An intermediate designation
- PL-14736: The designation used for the Phase II ulcerative colitis trial
Sikiric documented this history in a 2006 review published in Inflammopharmacology, where he described BPC 157 as "safe in clinical trials for inflammatory bowel disease (PL 10, PLD 116, PLD 14736, Pliva, Croatia)."[3] This paper is one of several in which the clinical trial is referenced as background context without providing the actual trial data.
The timeline matters because it shows that BPC-157 was not merely a laboratory curiosity. It was developed through a formal pharmaceutical pipeline with multiple designations, Phase I and Phase II trials, and presumably the regulatory documentation required to conduct those trials in human subjects. The infrastructure for clinical translation existed. What did not follow was the standard next step: publication of results.
The Phase II UC Trial: What We Know
The Phase II trial was described as a multicenter, randomized, double-blind, placebo-controlled study of PL-14736 enema for the treatment of mild-to-moderate ulcerative colitis. The route of administration (rectal enema) makes pharmacological sense: BPC-157 is a gastric peptide, and direct delivery to the colonic mucosa would maximize local exposure while minimizing systemic clearance.
What we know about the results comes entirely from references within Sikiric's own subsequent publications. In a 2012 review titled "Focus on ulcerative colitis: stable gastric pentadecapeptide BPC 157," Sikiric described BPC 157 as "effective both in the upper and lower GI tract, and free of side effects" and stated it has been "so far only tested in clinical phase II."[1]
The review further stated: "no toxic effect, limit test negative, LD1 not achieved, no side effect in trials." These are specific safety claims referencing clinical trial data, yet they appear only in review articles, conference abstracts, and as passing references in animal study papers. The primary publication of the trial itself, with patient demographics, dosing protocols, efficacy endpoints, adverse event data, and statistical analysis, has never appeared.
For context on BPC-157's gut-related research, see BPC-157 for Inflammatory Bowel Disease: What We Know So Far and How BPC-157 May Protect the Gut Lining: Proposed Mechanisms.
The Phase I Study: Registered, Completed, Cancelled
NCT02637284 provides the most traceable record of BPC-157 human testing. This was a Phase I, randomized, placebo-controlled, double-blind pilot study sponsored by PharmaCotherapia, a company in which Sikiric is listed as an owner according to Croatian government records.
The study details from ClinicalTrials.gov:
- Participants: 42 healthy volunteers (male and female, ages 18-35)
- Intervention: Oral PCO-02 tablets containing 1 mg BPC-157
- Design: Randomized, placebo-controlled, double-blind
- Status: Results were submitted on May 23, 2016, then the submission was cancelled
The cancellation of results submission is not the same as the trial being cancelled. The trial was listed as completed. The results were submitted to ClinicalTrials.gov and then withdrawn before the quality control review was completed. The reasons for this withdrawal have not been publicly explained.
Several possibilities exist. The sponsor may have decided to pursue journal publication first (though no publication has appeared). The data may have revealed unexpected findings that needed further analysis. Business decisions, intellectual property considerations, or changes in the company's strategy could have intervened. Or there may have been no dramatic reason at all. Small companies sometimes lack the resources to complete regulatory filings.
What is unusual is the combination of a completed trial, submitted results, withdrawn submission, and no subsequent publication over a period of nearly ten years. Standard pharmaceutical practice is to publish Phase I safety data regardless of commercial outcomes, because it contributes to the scientific record.
Why Unpublished Trials Matter
Unpublished clinical trials create a specific kind of evidence distortion called publication bias. When positive results are published and negative or ambiguous results are not, the available literature overestimates a treatment's effectiveness.
In BPC-157's case, the dynamic is more complex than simple positive/negative bias. The Phase II trial results are cited as positive by the researchers who conducted them. If the results were genuinely positive, the failure to publish is puzzling because positive Phase II data for a novel IBD treatment would be a landmark publication. Ulcerative colitis affects millions of patients worldwide, and new treatments with novel mechanisms routinely receive high-profile journal placement.
If the results were negative or mixed, the failure to publish would follow a well-documented pattern in pharmaceutical research: companies and investigators are less likely to publish trials that do not support their product's development. This pattern is so common that major journals now require trial registration and results reporting as conditions of publication.
If the results showed safety concerns, the ethical obligation to publish would be even stronger, since thousands of people are now using BPC-157 based on the safety claims derived from these unpublished trials.
The absence of published data means that every statement about BPC-157's human safety profile relies on self-reported claims from the compound's developers, a conflict of interest that would be flagged in any systematic review.
What Human Safety Data Actually Exists
As of March 2026, the total published human safety data for BPC-157 consists of:
The Veljaca Phase I PK study (referenced in papers but published only as a conference abstract): Rectal administration of PL-14736 to healthy male volunteers was reported as safe and well-tolerated. Specific numbers, dosing details, and adverse event data were provided in abstract form only.
Lee and Burgess, 2025: An IRB-approved pilot study in which two healthy adults (a 58-year-old male and a 68-year-old female) received intravenous BPC-157 at doses up to 20 mg in 250 cc normal saline.[2] Cardiac, hepatic, renal, thyroid, and metabolic biomarkers showed no measurable effects and no adverse events were reported. This is the first published, peer-reviewed human safety data from an investigator independent of the Zagreb group.
Lee 2021 knee pain case series: The same Dr. Edwin Lee published a retrospective case series of 17 patients who received intra-articular BPC-157 injections for knee pain, with 14 of 16 contactable patients (87.5%) reporting pain relief.[4] This provides observational human outcome data but lacks controls, blinding, or standardized measures.
The total number of humans with published BPC-157 data is approximately 19 (2 from the IV pilot, 17 from the knee series). The Phase I and Phase II trials would add roughly 42 and an unknown number of UC patients, respectively, but their data remains unpublished.
The Conflict of Interest Question
Understanding why the trial data remains unpublished requires understanding the business structure around BPC-157. Sikiric is not merely an academic researcher studying a compound. Croatian government records list him as an owner of PharmaCotherapia, the company that sponsored NCT02637284. He is also listed as CEO of Diagen, which holds patents for a "special stable version" of BPC-157.
This creates a specific conflict: the same individual who generates the animal research, references the unpublished human data in review articles, and controls the companies that would commercialize BPC-157 is also the person who decides whether and when to publish the clinical trial results. At no point in this chain is there an independent party with both the data and the incentive to publish it.
Patent considerations may also play a role. Publishing clinical trial data makes the compound's clinical profile public, which could benefit competitors. Keeping the data proprietary while referencing it in general terms ("effective in ulcerative colitis, phase II") allows Sikiric to claim clinical validation without exposing the details.
None of this means the trial results are negative. It means that the standard mechanisms for evaluating clinical evidence, independent peer review, data sharing, and replication, have not been applied to BPC-157's human data.
What the Chinese Military Data Adds
The Chinese military's independent BPC-157 research program partially fills the safety gap, though not with human data. Their 2020 toxicology study tested BPC-157 across four species with no serious toxicity and explicitly stated that the preclinical safety data would "contribute to the initiation of an ongoing clinical study."[5] Their 2022 pharmacokinetics study provided the first ADME data for BPC-157.
These studies are valuable because they come from an institution with no commercial interest in BPC-157 and follow regulatory-grade protocols. But they do not substitute for published human trial data. The Chinese group has not yet published human studies of their own.
The Broader Pattern
BPC-157's ghost trial is not unique in pharmaceutical history. Many promising compounds have had trials that were completed but never published. What makes BPC-157's case distinctive is the combination of factors:
- The compound has a massive and growing consumer market despite having no published human efficacy data
- The developer continues to publish animal studies at a prolific rate while leaving the human data unpublished
- The unpublished results are actively cited in published papers as evidence of safety and efficacy
- The compound is at the center of a major FDA regulatory battle, with its Category 2 classification partly driven by the absence of clinical evidence
For the limits of BPC-157 research more broadly and why the evidence gap persists, see our dedicated article. For BPC-157's current regulatory status and why the FDA placed it on the Category 2 list, see our pillar article on peptide regulation.
The Bottom Line
BPC-157 completed a Phase II trial for ulcerative colitis and a Phase I safety study, but neither has produced a peer-reviewed publication. The developer references these trials in subsequent papers as showing efficacy and safety, but the underlying data remains inaccessible to independent scientists. As of March 2026, the total published human BPC-157 data comes from approximately 19 subjects studied by an independent US researcher. The ghost trial is not proof that BPC-157 does not work or is not safe. It is proof that the standard process for evaluating clinical evidence has not been completed, and that the safety claims underpinning millions of dollars in consumer spending rest on self-reported, unpublished data from the compound's developer.