Editorial review · United States
AOD-9604
Source review:
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.
This is the status described in the dated review. It is not a live FDA database check.
What was measured in people?
- Health outcomes · Limited
- Older obesity studies exposed hundreds of participants, but the evidence did not establish an approved weight-loss use.
- Body effects · 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.
Limits that matter
Not independently medically reviewed. This tool 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.
Exact product records in this review
These are selected records, not every product or form. A route means how a product enters the body.
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 claims and their limitsSources used in the full review
A source is not support for every claim. Use the claim links above or the full review to check what each source supports.
- 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