FDA has raised regulatory and safety concerns regarding certain BPC-157-related bulk substances used in compounding contexts, and the dietary supplement classification of BPC-157 products has been a topic of industry discussion through 2025 and into 2026
Some research suggests that BPC-157 Capsules protects the gut lining and may reduce symptoms linked to inflammatory bowel disease (IBD), ulcers, and other digestive disorders
It has an hepatic metabolism, mainly because of the glucuro-conjugation of the molecule, with the formation of inactive metabolites

Important Safety Information Do not use AOD-9604 if you: Have a known hypersensitivity to growth hormone fragments or any component of the formulation Have active malignancy (cancer that is currently being treated or monitored) Are pregnant or breastfeeding (insufficient safety data) Have a history of severe allergic reactions to peptide therapies Common side effects (typically mild and transient): Headache, mild gastrointestinal disturbances (flatulence, mild diarrhea at higher doses), upper respiratory tract symptoms, injection site reactions (redness, mild discomfort) Seek medical attention if you experience: Signs of allergic reaction (hives, difficulty breathing, swelling of face or throat), persistent gastrointestinal symptoms, unexplained significant changes in energy, mood, or physical symptoms Clinical Safety Data Safety studies involving approximately 900 participants across six randomized controlled trials documented that AOD-9604 displayed a very good safety and tolerability profile indistinguishable from placebo across most parameters

PMID: 18681440 Schwartz SR, Park J