The short answer. AOD-9604 is not FDA-approved and, as of September 26, 2026, has no compounding pathway. FDA’s advisory committee voted 0 to 12 against listing it on December 4, 2024. The “GRAS” claim on vendor pages is not an FDA determination: FDA said on the record that AOD-9604 is not on its GRAS list.
| FDA approved | No. Its developer ended obesity development in 2007 after a Phase 2b trial. |
|---|---|
| 503A pharmacy | No pathway. Not on 21 CFR 216.23 and in no category since Sep 27, 2024. |
| 503B outsourcing facility | No pathway. |
| Latest FDA action | Advisory committee, Dec 4, 2024: 0-12 against listing. |
| Sport and military | WADA prohibited (S2.2.3, growth hormone fragments). DoD prohibited dietary supplement ingredient. |
| MDside position | Our providers do not prescribe it. |
| Last verified | 2026-09-26 |
The GRAS claim does not hold
Vendors often describe AOD-9604 as “GRAS,” generally recognized as safe. At the December 2024 committee meeting, FDA staff stated on the record that AOD-9604 is not on FDA’s GRAS list and has not been through FDA’s GRAS process, and that the company’s claim was its own self-determination. A GRAS position, even a valid one, covers use in food. It says nothing about an injection.
The drug program ended in 2007
AOD-9604 is a synthetic fragment of human growth hormone. FDA’s briefing records that its developer, Metabolic Pharmaceuticals, announced on February 21, 2007 that Phase 2b results did not support it as a treatment for obesity and ended development for that use. No approved drug followed.
The compounding record
Both nominators withdrew in September 2024, which took AOD-9604 out of Category 2. FDA reviewed it at the December 4, 2024 committee meeting regardless, and the committee voted 0 to 12 against listing it, matching FDA’s recommendation. FDA’s safety-risk page cites a possible immunogenicity risk and serious adverse events of unclear cause. FDA’s 2022 warning letter to Innoveix cited a recall of compounded AOD-9604 for lack of sterility assurance.
What this means for you
Take AOD-9604 off your menu, in injectable and oral forms. Remove any page that calls it GRAS or FDA-cleared. If a patient wants a weight program, the conversation belongs with the approved options: see our weight management program and the semaglutide page.
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Frequently asked questions
Is AOD-9604 legal to compound?
No. As of September 26, 2026 AOD-9604 is not on the 503A bulks list, sits in no FDA category, has no monograph and is not part of an approved drug. FDA’s advisory committee voted 0 to 12 against listing it in December 2024, and no rule has followed.
Is AOD-9604 GRAS?
Not by any FDA determination. At the December 2024 committee meeting FDA staff stated that AOD-9604 is not on FDA’s GRAS list and has not been through FDA’s GRAS process, and described the company’s claim as a self-determination. A GRAS position also covers food use only and never an injection.
Is AOD-9604 banned in sports?
Yes. The 2026 WADA Prohibited List names AOD-9604 under S2.2.3 as a growth hormone fragment, prohibited at all times. The Department of Defense also lists it as a prohibited dietary supplement ingredient. Clinics serving athletes or service members carry that exposure on top of the compounding problem.
Primary sources. Last verified September 26, 2026. Corrections are welcome: contact us.
- FDA, 503A bulk drug substance categories (updated May 14, 2026)
- FDA, Certain bulk drug substances that may present significant safety risks (updated Apr 22, 2026)
- FDA, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A (Jan 2025)
- 21 CFR 216.23, the 503A bulks list
- FDA briefing document, AOD-9604 (Dec 2024 PCAC)
- FDA, PCAC minutes, Dec 4, 2024
- FDA, PCAC transcript, Dec 4, 2024 (morning)
- Regulations.gov, withdrawal of AOD-9604 nomination, FDA-2015-N-3534-0471 (Sep 2024)
- FDA warning letter, Innoveix Pharmaceuticals (Jan 26, 2022)
- WADA 2026 Prohibited List
- DoD Operation Supplement Safety, DoD Prohibited Dietary Supplement Ingredients list
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.