U.S. Food and Drug Administration (FDA)
Is AOD-9604 legal in United States?
Not approvedNo FDA approval; FDA lists AOD-9604 among withdrawn nominations after noting possible serious adverse events
Not approved as a medicine here.
AOD-9604 is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations and states that FDA found little safety information, a risk of immunogenicity for some routes, and serious adverse events that may be associated with the drug, though causality is unclear. It was not on the July 2026 advisory committee agenda and is not on the 503A bulks list, so it is an unapproved drug with no FDA compounding policy behind it.
Last verified 2026-09-29 · how we verify
AOD-9604 elsewhere
Sources (3)
- 01Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)U.S. Food and Drug Administration · 2026-04-22 · accessed 2026-09-29
- 02July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory CommitteeU.S. Food and Drug Administration · 2026-08-06 · accessed 2026-09-29
- 03Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. Food and Drug Administration · 2026-05-14 · accessed 2026-09-29