AOD-9604

This compound reached genuine phase 2 human work under a named commercial sponsor. The programme comprised six randomised double-blind placebo-controlled studies, including a dose-escalation intravenous study in 23 adults with obesity, two oral studies in 16 and 36 men, a 12-week oral study in 300 participants aged 30 to 65, and a 24-week study which enrolled 536 and randomised 502 adults with a body mass index of 30 to 45 to oral doses or placebo alongside a supervised diet and exercise programme. On 21 February 2007 the sponsor announced publicly that the phase 2b results did not support commercial viability and that development for obesity was terminated; the FDA records that the primary weight endpoint showed no significant difference from placebo. Animal work includes obese mice, receptor knockout mice, obese rats by oral gavage, a pharmacokinetic study in pigs and a four-week intravenous toxicity study in rats.

What is not established

The FDA identified no human study assessing pharmacokinetics or pharmacodynamics by any route, and no human exposure data at all for the two routes that were nominated. Genotoxicity work was inconclusive, with equivocal signals in in-vitro and in-vivo assays, and the agency concluded the non-clinical package was too limited in scope to inform safety for those routes. A widely repeated claim that the substance holds a US food-additive status traces to a sponsor's own stock exchange filing rather than to any regulator-reviewed notice; a search of the FDA inventory found nothing supporting it.

What distinguishes AOD-9604

It is not a novel molecule but the carboxy-terminal fragment of an approved biologic: a 16-amino-acid peptide corresponding to growth hormone residues 177 to 191 with an extra tyrosine added, carrying an intramolecular disulfide bond between the cysteines at positions 7 and 14. That disulfide is the specific structural feature the FDA flags as a degradation and aggregation route, and nothing else in this group has one. It is also the only compound here with a completed large placebo-controlled phase 2b programme and a public sponsor termination notice.

Sources

1. US FDA. Briefing document, Pharmacy Compounding Advisory Committee, evaluation of AOD-9604-related bulk drug substances, 5 November 2024
2. US FDA. Pharmacy Compounding Advisory Committee meeting agenda, 4 December 2024
3. US FDA. Certain bulk drug substances for use in compounding that may present significant safety risks
4. World Anti-Doping Agency. 2026 Prohibited List, section S2.2.3
5. Wilding JPH. AOD-9604. Curr Opin Investig Drugs. 2004;5(4):436-40

This page describes a compound as a material and summarises published research about it. It is for general and procurement information only. It is not medical advice, not a treatment recommendation, and not guidance on use. Supplied for laboratory and research use, not for human consumption.