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Drug Pathway: No FDA New Drug Approval The FDA drug approval system is based on the NDA (New Drug Application) process

Both peptides have been well-tolerated in preclinical studies, with no significant adverse effects reported at therapeutic doses

This mechanism differs significantly from minoxidil, which simply dilates existing blood vessels

The FDA classifies BPC-157 as a Category 2 bulk drug substance meaning its not FDA-approved for human use and has been flagged as potentially presenting safety risks in unregulated compounding

Most research on the peptide has been conducted in animal models rather than human clinical trials