Legal Status and Safety
AOD-9604 is sometimes described online as a safe fat burner or even as a food ingredient. Officially, it is an unapproved drug candidate whose development ended without a licence.
Sport
In April 2013 the World Anti-Doping Agency issued a statement on AOD-9604. Because no government health authority has approved it for human use, it falls under section S0 of the Prohibited List, which covers non-approved substances. S0 applies in and out of competition. The statement came during a period of media attention on peptide use in Australian football.
Medicines Regulators
- European Union: no medicine containing AOD-9604 is authorised. Selling it with health claims would bring it under medicines law.
- United Kingdom: the MHRA has not licensed any AOD-9604 product.
- Australia: despite its Australian origins, it was never registered as a medicine there.
- Elsewhere: rules on importing and possessing research peptides differ by country, so local law always needs checking.
The FDA Compounding Review
In the United States, AOD-9604 is not an approved drug. In September 2023 the FDA placed it in a category of bulk substances that may pose significant safety risks for pharmacy compounding, citing possible immune reactions, impurities and limited safety information. After the nomination was withdrawn it was removed from that category in September 2024, and an FDA advisory committee discussed it in December 2024. It is not on the lists of substances that U.S. compounding pharmacies may use.
Open Safety Questions
- Short trials only: human data cover at most 24 weeks of use.
- Different forms: the trials used tablets, while products sold today are often powders for injection, which were not tested in the same way.
- Immune reactions: no antibodies were found in the trials, but the FDA still listed immunogenicity as a concern for compounded versions.
- Product quality: research material is not made to pharmaceutical standards, and seized vials have been analysed by forensic laboratories.
A Laboratory Reagent
Research-grade AOD-9604 is supplied for experiments. It has no approved dose, no patient leaflet and no system for reporting side effects.
Bottom Line
AOD-9604 is of interest to researchers studying fat metabolism and doping detection. It is not a licensed medicine or a supplement. Athletes risk sanctions, and anyone considering it for health reasons should speak to a doctor first.
This page gives general information and is not legal advice.