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1 CT-388 is currently being evaluated in an additional Phase II study, CT388-104, designed to assess its efficacy, safety, and tolerability in participants living with obesity or overweight who also have type 2 diabetes
The FDAs position is unambiguous: BPC-157 "lacks sufficient safety data and has not been shown to be safe or effective in humans." Key implications: Compounding pharmacies cannot legally compound medications containing BPC-157 under Section 503A or 503B Marketing with therapeutic claims violates federal law regardless of disclaimers Warning letters have been issued to companies marketing BPC-157 as a therapeutic agent WADA Prohibition The World Anti-Doping Agency classifies BPC-157 as a prohibited substance under class S0: Non-Approved Substances , effective January 2023
Bayne et al., 2008
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FDA has warned about quality, dosing, storage, and fraud risks with unapproved GLP-1 products
