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**BPC-157, a synthetic gastric pentadecapeptide studied primarily in animal models for tissue repair, gut healing, and anti-inflammatory effects, remains unapproved by the FDA as a finished drug with only limited small-scale human data available.** It was placed in Category 2 in 2023 due to concerns over immunogenicity, peptide impurities, and insufficient safety information for compounding under Section 503A

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Sun M, Wu W, Liu Z, Cong Y