By Nancy Lapid
Sept 15 (Reuters) - An experimental peptide backed by U.S. Health Secretary Robert F. Kennedy Jr. and marketed online for pain, healing and performance enhancement is being used for a wide range of ailments despite little safety and efficacy evidence from human studies, a new analysis found.
The peptide, BPC-157, has not been approved for use in the United States but has attracted consumers in a gray market, bolstered by social media posts that claim benefits for muscle growth and injury
recovery not backed by scientific testing. It is often taken together with a second peptide, TB-500, in a combination popularly known as the "Wolverine stack."
In July, a panel of U.S. Food and Drug Administration advisers voted to allow pharmacy compounding of BPC-157, encouraged by Kennedy. Previously, the FDA had restricted BPC-157 compounding due to what it said were significant safety risks and insufficient human data.
Analysts have estimated that BPC-157 and other peptides could quickly become a $2 billion to $3 billion market if legitimized.
Real-world use of BPC-157 is hard to track using electronic health records because it lacks a National Drug Code. Instead, data analytics firm nference reviewed more than 15 million medical records and identified 1,039 patients whose doctors had manually documented use of the peptide in written clinical notes.
The analysis sheds more light on the rise of BPC-157, but is still incomplete since the actual scale of its use is unknown, said study leader Venky Soundararajan.
“Most likely, very few doctors are even asking their patients, ‘Are you taking BPC-157?’” he said.
The number of new confirmed users increased 33-fold between 2020 and 2026, the researchers found.
Reasons for use were documented in 644 patients, who took the unapproved compound for conditions ranging from sports injuries and chronic pain to gastrointestinal disorders, the analysis found.
BPC-157 was most often initiated to help manage pain or gastrointestinal symptoms and most commonly obtained from a compounding pharmacy or gray-market peptide vendor.
The proportion of new users who were male increased from 57% in 2020 to 70% in 2026, while the average age decreased from 55 in 2020 to 49 in 2026. Among 972 BPC-157 users with recorded race, 96% were white.
Responses to treatment were only recorded for one-third of the patients in the study. While some doctors’ notes described symptom improvement, the limited data highlighted uncertainty about the peptide's effects and underscored a lack of data on its safety and effectiveness, according to a report published ahead of peer review.
When patients discontinued BPC-157, it was most often because their doctors advised them to stop. Others cited adverse effects, including neuropsychiatric, dermatologic, and gastrointestinal symptoms.
Dr. Flynn McGuire of the University of Utah, who has researched BPC-157 but was not involved in the study, noted that about half of patients with documented use by nference were taking other drugs as well, including testosterone, NSAIDs, TB-500, and corticosteroids, plus interventions such as physical therapy and surgery.
“There was no placebo or untreated comparator, and there was no standardized indication, formulation, dose, route, treatment duration, or outcome assessment,” he said.
Therefore, it's impossible to know how much of any improvement was attributable to BPC-157 versus natural recovery, other treatments, placebo effects, or selective documentation, McGuire and the paper’s authors emphasized.
The paper “tells us a lot about who is using BPC-157, how they are using it, and what is being reported in practice,” McGuire said. But randomized controlled trials are needed to answer whether BPC-157 actually causes clinically meaningful improvement, he said.
(Reporting by Nancy Lapid; editing by Michele Gershberg and Bill Berkrot)
