Review · United States
AOD-9604
Reviewed on
Approval and product status
No FDA-approved AOD-9604 drug product
A study product, an injection, and a skin product are not automatically the same. Oral clinical-study material, compounded injections, and transdermal products are not interchangeable. FDA found route-specific evidence gaps.
What was measured in people?
- Health results · Limited
- Older obesity studies exposed hundreds of participants, but the evidence did not establish an approved weight-loss use.
- Body changes · Limited
- FDA found insufficient pharmacokinetic and pharmacodynamic information for proposed uses and routes.
A change in a hormone or body signal does not by itself prove a health benefit.
Important limits
This tool is not an independent medical review. It does not recommend treatment.
An incomplete development program does not provide instructions for self-treatment. No sourcing, reconstitution, injection, or weight-loss regimen is provided.
Still unknown: The record does not establish meaningful weight loss, long-term benefit, or safety for injectable or transdermal products. FDA found no human information for some proposed routes of use.
This record cannot check a package, seller, batch, or personal treatment. It does not provide sport clearance.
Products in this review
These are selected records, not every product or form.
No product label record is included here. That is not a separate approval decision. Read the status and sources above.
What the research shows
FDA reviewed several obesity studies in people, including larger oral programs, and documented the available adverse-event reporting. This confirms that people received it in studies. It does not establish a benefit.
Read all AOD-9604 fact checksSources used in this review
A source may support some statements, not all of them. Use the links above or this review to see what each source supports.
Show 4 sources
- FDA briefing document for AOD-9604-related bulk drug substances
U.S. Food and Drug Administration · FDA review · 2024
Source accessed
- Bulk drug substances that may present significant safety risks
U.S. Food and Drug Administration · Regulatory · 2026
Source accessed
- Sterile compounded AOD-9604 recall for lack of sterility assurance
U.S. Food and Drug Administration · Regulatory · 2021
Source accessed
- 2026 Prohibited List
World Anti-Doping Agency · Anti-doping · 2026
Source accessed