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- BPC-157 lacks reliable clinical evidence for tendon, ligament, or joint repair in humans, with only one small human study identified across orthopedic literature.
- The FDA reviewed BPC-157 primarily for ulcerative colitis, the only use with human trial data, and declined to evaluate other proposed uses due to insufficient information.
- Only about 80 people have received BPC-157 across five published studies, with no studies using common consumer routes like subcutaneous, oral, nasal, or transdermal administration.
- BPC-157 is not FDA-approved in any country, not on the 503A bulks list, and prohibited by the World Anti-Doping Agency, making compounded versions currently illegal.
- An FDA advisory committee vote on July 23-24, 2026, will recommend whether to add BPC-157 to the 503A bulk list, but actual rulemaking will take months to complete.