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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

[13] References [edit] State Hydraulic Works Organization (in Turkish) "Yldz: 'DS olarak lkemizin 2023 hedefleri dorultusunda alyoruz'"

A potent human neutralizing antibody Fc-dependently reduces established HBV infections

Kiel J, Kaiser K

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