BPC Is in FDA Purgatory
BPC-157 sits in a dead zone.
It is too developed to dismiss as fringe science. Too underdeveloped to become an FDA-approved drug. Too economically risky to attract serious investment from pharmaceutical or biotech companies. Too in demand to disappear.
This piece explains how it got there and why it stays there.
The answer involves two connected failures. The first is a private-incentive failure: the structure of U.S. drug development gives companies no financial incentive to run trials on any compound that threatens their bottom line. The second is a public-system failure: the FDA's regulatory framework has left no workable path for anyone outside large pharmaceutical companies to advance a compound like this one through the approval process.
BPC-157 is not unique, but it is one of the clearest examples of how the public health system can fail consumers.
This piece will establish, in order: what the human and animal evidence actually shows; why the economics of drug development make BPC-157 unattractive to investors; how the structure of the compound's development network has compounded that problem; and how the FDA's regulatory handling has locked the compound in place without ever formally reviewing the evidence.
How the Media Gets Peptides Wrong
In 2026, peptides became a subject of mainstream media coverage.
The New York Times profiled Silicon Valley's gray-market peptide scene, quoting a tech investor who compared biohacker meetups to gatherings of heroin addicts. TechSpot described the trend as Silicon Valley's "next risky self-optimization craze." Dr. Aaron Kesselheim, a professor at Harvard Medical School and an expert on medical regulation, told reporters that users were "doing things that are bad for their health based on the evidence, which is that there is none." [45]
The framing in much of this coverage was alarmist and misleading. Unfortunately, it has become a documented pattern: A 2024 Nieman Lab investigation documented how pandemic-era institutional health information systems, including social media platforms acting on guidance from public health agencies, labeled legitimate scientific positions as misinformation and suppressed credentialed researchers whose views later proved defensible. [46]
The same conflation of "unapproved" with "dangerous" shapes how BPC-157 is covered today. The compound is not dangerous according to any published evidence. It is unapproved. Those are different things, and the coverage treats them as the same.
What that coverage missed is the more important question: why is the evidence thin? The absence of robust human trials is not a verdict on the science. It is a product of how the U.S. drug development system decides which compounds get tested.
Where BPC-157 Comes From
The modern BPC-157 story begins in Croatia with Predrag Sikiric, a pharmacology professor at the University of Zagreb. Sikiric's group filed the first BPC peptide patent in 1992 [4a], and the first published study followed in 1993. [22] His collaborators have remained central to the compound's academic literature ever since. Later reporting also linked Sikiric to direct ownership stakes in companies with commercial interests in BPC-157. [7] The nature of that involvement is relevant to understanding why the compound's development stalled, and is addressed in detail later in this piece.
What We Know from Human Trials
Since that early work, BPC-157 appears to have been tested in humans five times. Here is what each of those attempts produced.
The PLIVA Studies
The first two were sponsored by PLIVA, a Croatian pharmaceutical company that developed BPC-157 under the drug code PL 14736.
In 2002, PLIVA tested PL 14736 as a rectal enema in healthy men to assess its safety and its absorption and metabolism. Results were presented at a European gastroenterology conference and published as a brief abstract in Gut in 2003. [38] The abstract reported no significant adverse effects from single doses or seven consecutive days of treatment. A fuller accounting of the data was never published. It exists only in an internal PLIVA report that has never been made publicly available.
In 2005, PLIVA presented results from a more ambitious study: a multicenter, randomized, placebo-controlled trial testing PL 14736 enemas in patients with mild-to-moderate ulcerative colitis. That abstract was presented at Digestive Disease Week and published in Gastroenterology in 2005. [39] It was reported that the compound improved disease activity and was well tolerated, with no difference in side effects between the treatment and placebo groups. The number of patients enrolled cannot be independently verified from any publicly available record. Like the healthy-volunteer study, this trial never became a full peer-reviewed publication.
Later reviews, mostly from Sikiric's group, have repeatedly cited these results as evidence that BPC-157 is safe and effective. But the underlying data has never been released for outside scrutiny. As STAT and Undark confirmed in 2026, neither trial appears in any major research database as a complete published paper. [7]
PLIVA's research program did not survive its ownership changes. In early 2006, PLIVA sold its R&D division to GlaxoSmithKline. [43a] Later that year, Barr Pharmaceuticals acquired PLIVA for $2.5 billion. [43b] Barr was then acquired by Teva Pharmaceutical Industries in December 2008 for $8.9 billion. [43c] None of these companies had any evident interest in advancing a novel peptide therapeutic. After that transition, the public clinical trial record for BPC-157 goes dark.
The Lee Studies
Between 2021 and 2025, Edwin Lee, MD, founder of the Institute for Hormonal Balance in Orlando, published three small BPC-157 studies in Alternative Therapies in Health and Medicine, a peer-reviewed journal focused on complementary medicine research.
In "Intra-Articular Injection of BPC 157 for Multiple Types of Knee Pain," 12 of 17 patients reported improvement after intra-articular injections. [24] In "Effect of BPC-157 on Symptoms in Patients with Interstitial Cystitis," 12 of 12 women reported improvement at six weeks. [25] In "Safety of Intravenous Infusion of BPC157 in Humans," two healthy adults showed no measurable abnormalities in cardiac, liver, kidney, thyroid, or glucose markers, and the infusion was well tolerated with no adverse effects. [26]
Those are not trivial findings. They count as human safety data and signal-generating observations. But they are weak as scientific evidence. None of the three studies used a control group. None were prospectively registered before the study began, a standard practice that prevents researchers from adjusting their methods after seeing the data. Sample sizes were tiny.
NCT02637284
The only formal registry entry for BPC-157 on ClinicalTrials.gov is NCT02637284. It was registered in December 2015 by PharmaCotherapia d.o.o., a company in which Predrag Sikiric is listed as a member and owner in Croatian business records. [7] The trial was designed to enroll 42 healthy volunteers at Hospital Ángeles Tijuana to study safety and pharmacokinetics (how the drug moves through the body). [2]
The registry now lists the study status as "Unknown," meaning the sponsor stopped updating the record years ago, and the National Library of Medicine cannot confirm what happened. The ClinicalTrials.gov results history shows that data were submitted on May 23, 2016, then withdrawn by the sponsor before any outside review took place.
The study was reported to have never moved forward. Yet someone submitted results to a federal database, then pulled them back without explanation.
Later review articles, including a 2025 literature and patent review, note that researchers "cancelled submission of the results" and describe the study as showing oral BPC-157 to be safe and well tolerated. [27] No public dataset or peer-reviewed report has been released to allow independent verification. When Undark and STAT News requested the underlying data in early 2026, Sikiric did not respond. Neither did the trial's principal investigator or the hospital in Tijuana. [7]
That does not prove the findings were false. It does mean the public is being asked to accept a favorable safety narrative without access to the evidence behind it.
Summary
Taken together, the five human studies provide a limited record that is directionally positive on tolerability and sometimes suggestive of benefit. After more than two decades, BPC-157 still lacks a complete, transparent, publicly accessible human evidence base. The existing studies are either unpublished, unregistered, or unverified.
What We Know from Preclinical Trials
The overwhelming majority of BPC-157 studies have been conducted in animals or in isolated cells in a lab setting. The preclinical record is extensive, directionally consistent, and the primary reason BPC-157 has remained a focus since 1993.
Tendons. Staresinic et al., Sikiric lab, University of Zagreb. Researchers completely severed the Achilles tendons of rats, an injury that does not heal without intervention. Rats given BPC-157 regrew the connection, produced collagen faster, had stronger and more elastic repairs, and walked better than untreated animals. A follow-up from the same lab found that BPC-157 also reversed the healing suppression caused by steroid injections. This is significant because steroids are among the most common treatments for tendon injuries despite being known to slow tissue repair. [14, 15, 16]
Tendon cells. Chang et al., Chang Gung University, Taiwan. Working with tendon cells in a lab dish, this independent Taiwanese group found that BPC-157 caused repair cells to migrate faster toward a wound site, helped those cells survive the chemical stress of the kind that occurs at injury sites, and increased the number of growth hormone receptors on the cells, making them more responsive to one of the body's natural healing signals. They also confirmed a specific signaling pathway, FAK-paxillin, through which BPC-157 appears to act. This is one of the strongest pieces of independent mechanistic evidence in the literature. [17, 18]
Blood vessel growth. Hsieh et al., Chang Gung University, Taiwan. Zagreb had already claimed BPC-157 promotes new blood vessel growth, and a separate Taiwanese group ran their own experiment and confirmed it in isolated blood vessel tissue, providing independent replication of a core claim by a group with no connection to the original researchers. [34]
Muscle. Staresinic et al., Sikiric lab, University of Zagreb. After surgically cutting the quadriceps muscle in rats, BPC-157-treated animals showed stronger repairs, better movement, larger muscle fibers, and less wasting than untreated controls. [19]
Muscle wasting in cancer. Kang et al., Pusan National University, South Korea (in collaboration with the Zagreb group). A South Korean group found that BPC-157 reduced severe muscle loss associated with cancer in a rat model, extending the research into disease territory that the original researchers had not studied. Note: Sikiric is listed as a co-author, so this is a collaboration rather than a fully independent replication. [36]
Bone. Sebecic et al., Sikiric lab, University of Zagreb. In rabbits, BPC-157 promoted new bone growth at a rate comparable to bone marrow injections and bone grafting in gaps too large to heal naturally. [20]
Ligaments. Cerovecki et al., Sikiric lab, University of Zagreb. After cutting the inner knee ligament in rats, BPC-157 reduced joint instability and stiffness and restored normal movement. [21]
Gut. Sikiric et al., University of Zagreb. The earliest BPC-157 work focused on the stomach and intestines, which makes sense given that the peptide was originally isolated from gastric juice. Studies showed it protected against stomach damage caused by NSAIDs like ibuprofen, alcohol, and inflammatory bowel disease models. [22]
Cornea. Lazic et al., Sikiric lab, University of Zagreb. BPC-157 accelerated healing of corneal surface damage in rats, suggesting that the compound's effects extend beyond muscles and tendons. [23]
The Two Open Safety Questions
The safety record for BPC-157 in animals is, by the standards of preclinical drug development, unusually clean. Researchers could not establish a lethal dose across a wide dose range. One independent evaluation found no signs of DNA damage and no harm to developing fetuses. [40] No published animal study at any tested dose has flagged a serious harm signal. That is not a common profile for a bioactive compound tested this extensively.
Two scientific questions remain genuinely open.
Blood vessel growth and cancer risk. One of BPC-157's confirmed effects is that it stimulates the growth of new blood vessels, a process called angiogenesis. In a wound or injury, new blood vessel growth is part of how the body heals. The concern is that tumors use the same process to expand and sustain themselves. As of 2025, no study has tested whether BPC-157 accelerates or slows cancer growth in a living animal. A 2025 Polish research team flagged this as an unresolved question. [27] This is not evidence that BPC-157 causes cancer. It is an unanswered question that anyone using the compound should be aware of.
How long does it stay in the body? The Zagreb research group has long claimed, based on an unpublished 1996 internal report, that BPC-157 remains active in the body for 66 to 69 hours after a dose. That figure has never been independently verified. An independent Chinese research group directly contradicts it: their measurements found BPC-157 was completely cleared from the bloodstream within 15 minutes in rats and 5 minutes in dogs. [37] That is not a minor discrepancy. The Zagreb claim is 264 to 276 times longer than what the Chinese group found in rats, and 792 to 828 times longer than what they found in dogs. How long a compound stays in the body determines how much you take and how often you take it. If the Chinese measurements are accurate, every dosing protocol currently in common use is very wrong.
These are the two scientific concerns the literature raises. Everything else is a gap in evidence, not a finding of harm, but it does not inspire confidence either.
"Not FDA-Approved" Is Often a Business Outcome, Not a Scientific One
Getting a drug through the FDA approval process costs, on average, between $1 billion and $2.6 billion, according to the Tufts Center for the Study of Drug Development. [41] That money does not come from the government. It comes from private companies. And private companies do not spend at that scale out of scientific curiosity. They spend it because they expect to recover their investment and earn a large return on top of it.
The mechanism that makes that possible is exclusivity. A company develops a new drug, secures patent protection, receives FDA approval, and then has a window (typically ranging from several years to over a decade, depending on how much patent life remains) in which it is the only authorized seller. During that window, it sets the price, controls supply, and recoups development costs. That is how the entire system is financed. Without exclusivity, there is no investment case.
Without an investment case, trials do not get funded. Without trials, there is no approval.
The IP Problem
BPC-157 is derived from a protein that occurs naturally in human gastric juice. Naturally occurring substances cannot be broadly patented. The Supreme Court reinforced this principle in its 2013 Myriad Genetics ruling, which held that naturally occurring DNA sequences cannot be patented, a principle courts and the USPTO have applied more broadly to natural compounds. [11] What can be patented are specific formulations, delivery methods, and synthetic analogs.
A useful analogy: you cannot patent a river. You cannot patent water. But you can patent a specific method of filtering, bottling, and delivering it. Patent protection is real, but it covers only your version of the product, not the underlying thing.
In BPC-157's case, U.S. Patent US9850282B2 covers a specific salt form of the compound. It is assigned to Diagen d.o.o., a Croatian company whose website identifies Prof. Predrag Sikiric as its CEO. [5, 44] The patent expires in 2033.
U.S. Patent US9850282B2 protection is narrow. A patent on a specific salt form or delivery method can be worked around. Competitors can develop their own formulations. For a pharmaceutical company evaluating whether to spend $1 billion or more on clinical trials, a narrow patent does not provide the market certainty that justifies that investment. The rational economic response is not to fund trials on BPC-157 as it exists. It is to develop a proprietary analog (a modified version the company can cleanly own) and run trials on it instead.
The system does not reward demonstrating that an existing, weakly patentable compound works. It rewards the creation of new compounds that can be owned exclusively.
The Sponsor-Inventor Network
The IP problem explains why outside pharmaceutical companies have little financial incentive to develop BPC-157. The structure of the compound's existing development network offers a second explanation.
Predrag Sikiric is at the center of nearly every major node in the BPC-157 story. [7] He leads the Croatian research group responsible for the vast majority of published BPC-157 studies. Croatian government records list him as an owner of PharmaCotherapia d.o.o., the company that registered and sponsored the only formal human trial. He has been identified as CEO of Diagen d.o.o., the company that holds the key BPC-157 patent and has offered those patent rights for licensing on its website. [7]
Lead researcher. Trial sponsor. Patent holder. Commercial operator.
That does not prove wrongdoing. Plenty of drugs begin with a single inventor-champion who wears multiple hats. But when a pharmaceutical company evaluates whether to license or acquire a drug candidate, it is not just assessing the patent. It is evaluating the entire risk profile: How independent is the evidence base? How many external groups have replicated the core findings? How clean is the ownership structure?
On each of those questions, BPC-157 presents a difficult answer. The majority of published studies come from one lab. The only formal trial was registered by a company connected to the same researcher. The data from that trial was submitted to a federal database and then withdrawn without explanation.
This does not prove misconduct, but it does not inspire confidence either. And for a pharmaceutical company running due diligence, lack of confidence is reason enough to move on.
The Gray Market as a Business Barrier
As long as there is demand, there will be a supplier. Compounding pharmacies, clinics, and "research use only" vendors have sold BPC-157 for years without the evidence base required for FDA approval. That gray market creates a direct business problem for any regulated entrant.
A pharmaceutical company evaluating BPC-157 would need to fund clinical trials, navigate a multi-year approval process, and then compete with products already in the market, products sold at lower cost, with no development overhead. The regulated company would pay to generate the evidence, while the unregulated market continues to operate in parallel.
FDA approval does not automatically clear that market. It gives the approved company a stronger legal standing to pursue sellers of unauthorized versions through litigation, injunctions, and enforcement referrals. That effort is expensive, slow, and uncertain.
This dynamic is not hypothetical. Novo Nordisk, the maker of the GLP-1 drug semaglutide, has filed more than 130 lawsuits across 40 states against entities selling compounded versions of its drug, resulting in 44 permanent injunctions as of August 2025. [42] Eli Lilly has described the same problem around its GLP-1 drug tirzepatide. [42]
Any company evaluating whether to sponsor BPC-157 trials would enter that calculation knowing they would face the same fight, on top of funding the clinical research itself.
This Is Not Just a BPC-157 Problem
BPC-157 is one example of a structural failure that applies to any compound whose public health value may be real but whose private capture is weak. Natural compounds, repurposed molecules, and generic reformulations all run into the same wall.
The U.S. drug development system is not designed to answer the question "Does this work?" It is designed to answer "Is there enough money to be made here to justify the risk?" When the answer is no, the evidence never gets generated. Not because the science is bad, but because the economics are.
When a compound reaches patients without FDA approval, the instinct is to treat that as a scientific verdict. It is not. It is a verdict on whether anyone could make the investment case work.
"Not FDA-approved" is not always a scientific conclusion. In many cases, it is a business outcome.
FDA's Category 2 Ruling: Challenged, Then Frozen
To understand why that ruling matters, some regulatory context is necessary.
Section 503A of the Food, Drug, and Cosmetic Act governs which raw drug substances compounding pharmacies are allowed to use. [1] After the Drug Quality and Security Act updated the framework in 2013, the FDA worked to build a formal list of permitted bulk substances through rulemaking and interim guidance. [1]
In 2017, while the permanent list was still being developed, the FDA created an interim system that sorted nominated substances into three categories. [1, 28] Category 1 covered substances with enough support for review and no apparent disqualifier. Category 2 covered substances for which the FDA had identified potential significant safety risks pending further evaluation. Category 3 covered substances nominated with insufficient supporting information. [1, 28] The agency's later guidance makes clear that this system was supposed to be temporary. [28]
On September 29, 2023, the FDA placed BPC-157 into Category 2 alongside 18 other peptides. [3] Its public explanation was brief.
First, immunogenicity: the possibility that the body's immune system could treat the compound as foreign and mount a response against it, potentially causing allergic reactions, inflammation, or reduced drug effectiveness over time.
Second, peptide-related impurities and API characterization issues. API stands for active pharmaceutical ingredient (the actual drug substance in a compounded product). Characterization means confirming that the substance is what it claims to be, in the right structure, at the right purity, with known and controlled impurities. The FDA was flagging that BPC-157, as a synthetic peptide, may be difficult to manufacture consistently, and that compounded versions could contain unwanted byproducts that vary from batch to batch.
Third, data gaps: the FDA stated it had identified "no, or only limited, safety-related information" for the proposed routes of administration. [3]
The notice does not point to a published human toxicity signal, a clinical trial demonstrating injury, or a specific adverse-event pattern associated with BPC-157. [3]
That approach was challenged in court. In March 2024, Evexias Medical Centers and Farmakeio Pharmacy Network filed suit against the FDA, challenging the Category 2 process. [32] A settlement was reached by September 2024. Five peptides had their nominations voluntarily withdrawn and were scheduled for formal review by the PCAC advisory committee. [4] BPC-157 was not among them. Its nomination was never withdrawn, never resubmitted, and never scheduled for PCAC review at the later October or December 2024 meetings. It simply stayed in Category 2, restricted from compounding, with no public advisory committee review of the evidence for or against it. [3]
Then, on January 7, 2025, the agency published its final interim guidance, formally ending the Category system for newly nominated substances. [28] Ending the system did not free the substances already trapped inside it. Category 1 substances kept their enforcement discretion, meaning the FDA would not take action against compounders using them. But Category 2 substances, including BPC-157, received no such discretion. The January 2025 guidance closed the door on any future interim reclassification while leaving existing Category 2 restrictions locked in place. [28]
Since September 2023, BPC-157 has sat in regulatory limbo. No PCAC hearing. No formal review of the evidence. No pathway to reclassification. HHS Secretary Robert F. Kennedy Jr. stated publicly in February 2026 that approximately 14 of the 19 Category 2 peptides are expected to be moved back to Category 1 [30], but that was during a podcast. No formal regulatory action has followed.
Where This Leaves Us
BPC-157 has a substantial preclinical record: extensive, directionally consistent animal and cell-based research spanning tendons, muscle, bone, ligaments, gut, and cornea. Independent research groups in Taiwan and South Korea have replicated key findings from the Zagreb lab. The compound has genuine scientific credibility at the preclinical level.
The human evidence is a different story. After more than two decades, the record consists of two unpublished PLIVA abstracts, three small unregistered studies from a single clinic, and one formal trial whose results were submitted to a federal database and then withdrawn without explanation. That is not a scientific verdict against BPC-157. It is the result of structural conditions that have prevented rigorous human trials.
Three barriers account for that failure.
First, the economics of drug development do not favor BPC-157. The compound cannot be broadly patented because it occurs in nature. The narrower protections that are available (specific salt forms, delivery methods) do not provide the market exclusivity that justifies spending $1 billion or more on clinical trials. Rational investors put their money elsewhere.
Second, the compound's development has remained concentrated in a single research network centered on Predrag Sikiric, who is simultaneously its lead researcher, trial sponsor, and patent holder. That concentration has not produced independent replication at the scale needed to build confidence. It has also created a due diligence risk that deters outside investment.
Third, a functioning gray market already meets consumer demand. Any regulated entrant would have to fund trials, navigate approval processes, and then fight a legal battle against established unregulated suppliers.
On the regulatory side, the FDA's Category 2 designation placed BPC-157 in a restricted category in September 2023 without conducting a formal review of the evidence for or against it. The designation cited safety concerns (immunogenicity, manufacturing inconsistency, data gaps) but found no published signal of human harm. The current administration has signaled that the designation may be reversed, but there have been no formal updates.
The absence of robust human evidence for BPC-157 is not primarily a scientific finding. It is the output of a development system that generates evidence only when someone can capture sufficient financial upside, combined with a regulatory framework that restricts compounds without reviewing the available evidence or providing suitable alternative paths to approval. That combination has produced a dead zone, and BPC-157 is sitting in it.
Final Thoughts
This discussion of BPC-157 ultimately reveals deeper issues in the broader system.
Regulatory gatekeepers, bureaucratic inertia, and profit motives often align to favor treatments with little downside, and that can be easily monopolized. Cheap or naturally derived compounds like BPC-157 face structural disadvantages, even when preclinical evidence is consistent and compelling.
The result? Genuine progress stalls. Patients either lack reliable access to promising options or turn to gray-market sources, while their health outcomes suffer. Solutions that could meaningfully improve lives remain sidelined in favor of those that best protect entrenched commercial interests.
Big Pharma exerts significant influence over healthcare priorities and development pipelines. Government agencies and lawmakers, intended to serve the public, frequently appear constrained by those same economic and political pressures. Mainstream media coverage of emerging therapies often lacks depth or balance, further shaping public perception in ways that align with institutional narratives rather than raw evidence.
Peptide efficacy is not an ideological battle. It is a scientific one. It deserves honest scrutiny, rigorous testing, and a genuine commitment to solutions that could actually improve lives, not just those that maximize returns for established players.
We will continue to deliver evidence-based analysis that cuts through exaggeration and institutional talking points.
A final note to readers: Question everything. That includes what you read here. Do not take any authority at face value, whether it carries an impressive title, government backing, or corporate funding. Fact-check claims, verify primary data, and take control of your own health decisions. In a system shaped by competing incentives, being your own advocate is the only reliable path forward.
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[43a] Pliva seals R&D sell-off to GSK. PharmaTimes, April 2006. pharmatimes.com. Transaction closed April 2006 for $35 million upfront, up to $50 million total with milestones.
[43b] Barr Pharmaceuticals Inc. Form 8-K. U.S. Securities and Exchange Commission, October 24, 2006. sec.gov. Barr finalizes acquisition of PLIVA d.d. for $2.5 billion.
[43c] U.S. Federal Trade Commission. FTC Intervenes in Teva Pharmaceutical Industries' Proposed $8.9 Billion Acquisition of Barr Pharmaceuticals. Press Release, December 2008. ftc.gov.
[44] Diagen d.o.o. "About Us." bpc157.si/about-us/. Identifies Prof. Predrag Sikiric as CEO.
[45] New York Times. "'Chinese Peptides' Are the Latest Biohacking Trend in the Tech World." January 3, 2026. nytimes.com. Dr. Aaron Kesselheim, professor at Harvard Medical School and expert on medical regulation, quoted.
[46] Talpos, Sara. "Did the battle against 'misinformation' go too far?" Nieman Journalism Lab. January 18, 2024. niemanlab.org. Originally published by Undark.
