What is it?
Synthetic fragment related to human growth hormone
Peptide Library · checked July 17, 2026
AOD-9604
AOD-9604 is sold as the fat-burning piece of growth hormone. FDA's evidence review found the opposite of a clean win: the largest study included 536 people and did not show significant weight loss versus placebo.
TL;DR
The lowdown
Four answers first. The source record follows.
What do humans show?
Limited obesity studies; largest identified study missed its primary endpoint
Where does FDA stand?
Not FDA-approved; advisory committee voted against 503A Bulks List inclusion in 2024
What is known—and not?
FDA reported limited clinical safety information, no human information for proposed subcutaneous and transdermal use, potential immunogenicity, and unresolved findings from nonclinical studies. The agency concluded that use of AOD-9604-related bulk drug substances in compounding may raise safety concerns.
U.S. status · July 17, 2026
Approval, compounding, product, sport.
- FDA approval
- Not FDA-approved; PCAC voted against 503A Bulks List inclusion in 2024; final list status should be checked before publication
- U.S. federal record
- Not FDA-approved; PCAC voted against 503A Bulks List inclusion in 2024; final list status should be checked before publication
- Product identity
- Reviewed named-product record: None in the United States.
- Sport
- No WADA status recorded in the reviewed source.
This reports the dated federal and sport record. It does not determine whether a particular product or transaction complies with state or federal law, and it is not legal advice.
01
What it is
AOD-9604 is a 16-amino-acid peptide fragment developed in the late 1990s and studied for obesity. Online descriptions often begin with a biological theory about fat metabolism, then jump directly to a clinical promise.
The missing step is outcome evidence: whether people actually lost more weight than a comparison group in a well-described trial.
02
What humans actually show
- Largest study identified by FDA: A company-sponsored Australian study enrolled 536 people with obesity and found no significant difference in weight loss after 12 weeks between oral AOD-9604 and placebo.
- Development stopped: FDA's briefing says the company terminated development for obesity after that study failed.
- Evidence quality problem: FDA found only short summaries for several human studies, with insufficient methodological and results detail. Most identified studies did not show benefit over placebo.
- Route mismatch: FDA found no human information for the subcutaneous or transdermal routes proposed in compounding nominations. Evidence from an oral study cannot simply be reassigned to an injected or topical product.
03
FDA and U.S. status
AOD-9604 is not an FDA-approved drug. In December 2024, the Pharmacy Compounding Advisory Committee voted 12 to 0 against placing AOD-9604 free base and acetate on the 503A Bulks List. An advisory vote is not itself the same as a final FDA rule or drug-approval decision, so the current list status must be checked before publication.
FDA's review concluded that the effectiveness, characterization, and safety information weighed against inclusion.
04
Risks and warning limits
FDA reported limited clinical safety information, no human information for proposed subcutaneous and transdermal use, potential immunogenicity, and unresolved findings from nonclinical studies. The agency concluded that use of AOD-9604-related bulk drug substances in compounding may raise safety concerns.
That does not prove that every adverse event is caused by AOD-9604. It means the available record is too incomplete to support broad safety assurances.
05
What would change this answer
- Any final FDA action following the 2024 advisory vote
- Publication of full results from the historical obesity program
- Human data that clearly identifies chemical form, route, product, and comparator
- Marketing that substitutes “designed to” for a measured clinical outcome
06
Sources and records
- FDA briefing document for AOD-9604-related substances, 2024
- FDA Pharmacy Compounding Advisory Committee final minutes, 2024
- FDA compounding safety-risk table
Educational journalism only; not medical advice. We do not evaluate individual products or link vendors.
What changed
Added the source-verified Claim Check to the structured claim/source/change registry.
What would change our answer
A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.
Version history · 1 entry
- v1 · 2026-07-17Initial structured record created from the reviewed Claim Check.Source ↗
Boundary: PepCurrent explains public evidence and regulatory records. We do not evaluate individual products, recommend use, name vendors, or provide protocols.