Is AOD-9604 FDA Approved?
DrugStatusIndex provides a clear, data-driven view of the regulatory status of medications, compounds, and related products. This page explains whether AOD-9604 is FDA approved and how it is commonly categorized.
Overview
AOD-9604 is a synthetic peptide derived from a fragment of human growth hormone. It has been marketed for fat loss and metabolic support but remains an investigational compound rather than an approved prescription medication.
FDA Status Details
AOD-9604 is classified as Not FDA Approved. It is not approved by the FDA for obesity treatment, weight loss, or general medical prescription use. FDA has also identified potential safety concerns with compounded AOD-9604 products. :contentReference[oaicite:0]{index=0}
Clinical & Research Status
AOD-9604 is commonly associated with peptide clinics and research use. Clinical development for obesity treatment did not lead to FDA approval, and it does not have an FDA-approved branded prescription equivalent.
Compounding & Safety Considerations
The FDA has stated that compounded drugs containing AOD-9604 may pose significant risks including immunogenicity concerns and peptide-related impurities. These products should not be treated as FDA-approved medications. :contentReference[oaicite:1]{index=1}
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