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doi: 40

Regulatory pathways specifically designed for aging interventions could accelerate clinical development

10.1016/0300-483x(82)90003-8 53 DehayB.BoveJ.Rodriguez-MuelaN.PerierC.RecasensA.BoyaP.et al

**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