The Ghost Trial: What Happened to BPC-157's Phase II for UC?
BPC-157 GI and Gut Health
0 Published Results
A Phase II clinical trial of BPC-157 for ulcerative colitis was initiated by Croatian pharmaceutical company Pliva in the early 2000s. Phase I showed safety in 32 volunteers. Phase II results were never published.
Sikiric et al., Inflammopharmacology, 2006
Sikiric et al., Inflammopharmacology, 2006
View as imageIf you have read anything about BPC-157, you have probably encountered the phrase "in clinical trials." It appears in dozens of published papers, across more than a decade of research. It is technically true. BPC-157 was in clinical trials. A Phase II trial for ulcerative colitis was initiated by a real pharmaceutical company, with real patients, under real regulatory oversight. Then the BPC-157 clinical trial results disappeared.
No journal article. No conference abstract. No press release. No public explanation. The closest BPC-157 ever came to standard drug development ended in silence, and that silence is one of the most important data points in the real BPC-157 story.
Key Takeaways
- Croatian pharmaceutical company Pliva sponsored BPC-157 trials for inflammatory bowel disease under 3 drug designations: PL-10, PLD-116, and PL14736
- Phase I tested rectal BPC-157 in 32 healthy male volunteers and found it safe with no significant adverse effects over 7 days of dosing (Veljaca et al.)
- Phase II for mild-to-moderate ulcerative colitis was initiated but results were never published in any peer-reviewed journal
- Pliva was acquired by Barr Pharmaceuticals for $2.5 billion in 2006, then Barr was acquired by Teva Pharmaceutical Industries for $7.5 billion in 2008
- A separate Phase I trial (NCT02637284) in Tijuana tested oral BPC-157 in 42 volunteers but has been listed as unknown status since 2016
- Sikiric's published papers from 2006 through 2018 continued describing BPC-157 as "in clinical trials," years after the program stopped producing public data
What "In Clinical Trials" Actually Meant
BPC-157 is frequently described as being "in clinical trials for inflammatory bowel disease." That phrase appears in paper titles, abstracts, and review articles spanning from 2006 to at least 2018. But what it actually refers to is a single development program run by one Croatian pharmaceutical company more than two decades ago.
The company was Pliva, Croatia's largest drugmaker at the time. The peptide was assigned three sequential drug designations as it moved through development: PL-10, PLD-116, and PL14736. Sikiric described PL-10 as the earliest designation in a 1999 review of BPC-157's pharmacological properties in Inflammopharmacology.[5] By the time the clinical program was described in detail in 2006, the working designation had become PL14736.[1]
The three names likely represent different formulation stages. PL-10 was the initial compound. PLD-116 appears in Sikiric's references as an intermediate step. PL14736 was the version that entered human trials. All three are BPC-157. The naming reflects a pharmaceutical pipeline that was moving forward, through formulation development, preclinical testing, and into humans.
The Phase I Results
The Phase I trial was the high point of the BPC-157 clinical story. Veljaca and colleagues conducted a placebo-controlled study in 32 healthy male volunteers. The peptide was administered rectally, which matches the intended route for treating ulcerative colitis (a disease of the colon and rectum).
Sikiric's 2006 review in Inflammopharmacology provides the most detailed published account of these results.[1] According to that review, seven days of PL14736 enemas produced no significant adverse effects. Physical examination, clinical observation, and laboratory testing all came back clean. The peptide was well-tolerated at the doses tested.
This is meaningful data. Phase I trials are designed to answer one question: is this substance safe enough to test in sick patients? For BPC-157, the answer was yes. The Veljaca study was never published as a standalone journal article. It exists as a conference presentation, cited in subsequent Sikiric papers. But its findings were clear enough to justify the next step.
There is an important detail about the route of administration. The Phase I trial used enemas, delivering BPC-157 directly to the colon and rectum. This is standard for ulcerative colitis drug development. Mesalamine, the most common first-line UC treatment, is also available as an enema for distal disease. The choice of rectal delivery was pharmacologically rational: put the peptide where the disease is.
Phase I safety data is the minimum threshold for any drug development program. Passing Phase I does not mean a drug works. It means it did not cause obvious harm in a small number of healthy people over a short period. Drugs with clean Phase I data fail in Phase II and Phase III at high rates. But without passing Phase I, there is no path forward. That is where BPC-157 stood when the Phase II trial began.
The Phase II That Disappeared
Based on the Phase I safety data, Pliva initiated a placebo-controlled Phase II trial. The target population was patients with mild-to-moderate ulcerative colitis. The goal was to test whether BPC-157, administered rectally, could safely and effectively treat active disease.
Sikiric confirmed the trial's existence in his 2006 review.[1] Vuksic and colleagues referenced it in a 2007 paper in Surgery Today.[2] Klicek and colleagues included "in clinical trials as a therapy for inflammatory bowel disease (PL14736)" in the title of a 2008 paper in the Journal of Pharmacological Sciences.[3]
After that, nothing.
No Phase II results were ever published. No journal article, no conference poster, no press release from Pliva. The 2012 review by Sikiric titled "Focus on ulcerative colitis: stable gastric pentadecapeptide BPC 157" discussed the animal evidence for BPC-157 in colitis models at length but contained no new human data.[4] It referenced the same Phase I safety data from years earlier.
In clinical research, a trial that is conducted but whose results are never made public is called a ghost trial. Ghost trials are a recognized problem. A Cochrane review found that trials with positive findings were roughly 3.9 times more likely to be published than trials with negative or null results. When trials go unpublished, the evidence base becomes distorted. Positive results appear while negative results stay invisible, creating a false picture of how well a treatment works.
Whether the BPC-157 Phase II results were positive, negative, or inconclusive is not publicly known. What is known is that they were never published. In a field where BPC-157 supporters frequently cite "clinical trials" as evidence of the peptide's legitimacy, the absence of those trial results is the single most important gap in the evidence.
The Corporate Chain That Swallowed the Data
The timing of the Pliva acquisitions overlaps directly with the period when Phase II results should have emerged.
In October 2006, Barr Pharmaceuticals acquired Pliva for approximately $2.5 billion after a bidding war with Icelandic company Actavis. As part of the acquisition, Pliva exited its proprietary drug development business and became Barr's European generics operation. Proprietary pipeline assets, including any ongoing clinical programs, became Barr's property.
In December 2008, Teva Pharmaceutical Industries acquired Barr Pharmaceuticals for $7.5 billion. Pliva became a subsidiary of Teva, the world's largest generic drug manufacturer. Teva's business model is generics, not novel drug development. Early-stage pipeline assets from acquired companies are routinely deprioritized or shelved entirely when they do not fit the acquirer's strategic focus.
The BPC-157 Phase II data, if it exists, is most likely sitting in Teva's archives. Teva has made no public statement about the Pliva IBD program, BPC-157, or PL14736. There is no indication that Teva has any interest in developing BPC-157 as a therapeutic product.
This is not unusual in pharmaceutical history. Corporate acquisitions kill early-stage programs routinely. A compound that was promising enough for one company to take into Phase II can become irrelevant overnight when that company is absorbed by a larger one with different priorities. Pfizer's acquisition of Warner-Lambert, AstraZeneca's merger with MedImmune, Roche's absorption of Genentech's pipeline: in each case, some programs survived and others were quietly shelved. The more niche the indication and the earlier the stage, the more likely the program dies.
BPC-157 was an early-stage peptide for a gastrointestinal indication at a Croatian company that was being absorbed into a global generics operation. It fit the profile of a program that would not survive the transition. And by all available evidence, it did not.
The Other BPC-157 Clinical Trial
There is one BPC-157 clinical trial registered on ClinicalTrials.gov: NCT02637284. It is important to understand that this is not the Pliva UC trial.
NCT02637284 was a Phase I safety and pharmacokinetics study conducted at Hospital Angeles in Tijuana, Mexico. It ran from January to June 2015. Forty-two healthy volunteers were randomized into three cohorts of 14, each receiving different oral doses of BPC-157 (designated PCO-02) or placebo. The study tested oral administration, not rectal. Its purpose was safety and pharmacokinetics, not efficacy in any disease.
The 2025 systematic review by Vasireddi and colleagues noted that this was the only registered BPC-157 clinical trial, and that its status has been listed as unknown since 2016.[7] No results from this trial have been published either.
The Tijuana trial and the Pliva trial are entirely separate programs with different sponsors, different routes of administration, different geographic locations, and different time periods. They are sometimes conflated in online discussions, which muddies the already unclear clinical picture.
This means there are two BPC-157 clinical programs with missing data: the Pliva IBD program (Phase I completed, Phase II results unpublished) and the Tijuana oral dosing study (completed, results unpublished). Neither has contributed published human efficacy data to the scientific record. The pattern is consistent: BPC-157 enters clinical testing, produces some data, and then the data never reaches a peer-reviewed journal.
The Present-Tense Problem
There is a pattern in the BPC-157 literature that compounds the confusion around the clinical trial program. Sikiric and colleagues continued to describe BPC-157 as "in clinical trials" using present tense for over a decade after the program stopped producing public data.
The 2006 review in Inflammopharmacology described the IBD program as active.[1] The 2007 paper by Vuksic included "in trials for inflammatory bowel disease" in its title.[2] The 2008 Klicek paper did the same.[3] Sikiric's 2011 review in Current Pharmaceutical Design referenced the clinical trial safety profile.[6] The 2012 "Focus on ulcerative colitis" review discussed BPC-157's clinical potential without noting that no new trial data had appeared in a decade.[4] The 2018 vascular recruitment review continued to reference the clinical program.[8]
This is not fabrication. The clinical trials did happen. The Phase I data is real. But describing a compound as "in clinical trials" when the last public data point is more than a decade old creates a misleading impression. A reader encountering these papers would reasonably assume that clinical development is ongoing, that human data is accumulating, and that regulatory approval might be on the horizon. None of those things is true.
For a broader look at how the concentration of BPC-157 research in one lab affects the evidence base, see the Sikiric problem.
What the Silence Tells Us
The Pliva IBD program is the closest BPC-157 has ever come to standard pharmaceutical development. It followed the normal path: preclinical testing, Phase I safety in healthy volunteers, Phase II efficacy in patients. Then it stopped.
There are three possible explanations for the unpublished Phase II results:
The results were negative. BPC-157 did not outperform placebo for ulcerative colitis. If so, the trial joins the roughly half of all clinical trials whose results go unpublished, disproportionately those with negative findings. This would not mean BPC-157 is useless for everything. But it would mean the compound failed in the one controlled human disease trial that was actually conducted.
The results were positive but the corporate acquisitions killed the program. Pliva's exit from proprietary drug development in 2006, followed by the Barr and Teva acquisitions, may have shelved a promising program for business reasons unrelated to the science. This happens routinely in pharmaceutical mergers.
The trial was never completed. It is possible that the Phase II was initiated but enrollment was halted before enough data was collected to analyze. Incomplete trials produce no publishable results.
Each of these scenarios produces the same outcome: zero published Phase II data. And each carries a different implication for BPC-157's potential as a treatment for IBD. Without access to the data, there is no way to distinguish between them.
What can be said is this: if the results were clearly positive, there was every incentive to publish them. Positive Phase II data for a novel IBD treatment would have been valuable to Pliva, to Barr, and to Teva. Ulcerative colitis is a large market. Drugs that show efficacy in Phase II attract licensing deals, further investment, and publication in high-impact journals. The fact that nobody published suggests the results were either negative, inconclusive, or lost in the transition between corporate owners.
The ghost trial does not prove BPC-157 failed. It does not prove it succeeded. It proves that the one time BPC-157 entered the system designed to separate drugs that work from drugs that do not, the system produced no public answer. For the broader context of BPC-157 and inflammatory bowel disease, the animal evidence is covered separately.
The Bottom Line
The Pliva IBD program represents the only time BPC-157 entered a standard pharmaceutical pipeline. Phase I showed safety in 32 volunteers. Phase II for ulcerative colitis was initiated. Then the company was acquired twice and the results were never published. That silence, not the animal data, not the internet hype, is the most important data point in the BPC-157 clinical story.