AOD-9604
Developed by Metabolic Pharmaceuticals (Australia) with Monash University, AOD-9604 was designed to stimulate lipolysis and inhibit fat formation without the IGF-1, blood-glucose or growth effects of full-length human growth hormone. It was later promoted in some markets as a food/nutraceutical ingredient on the basis of self-affirmed GRAS safety data, but it has never been approved as a drug for obesity or any indication.
Mechanism
In plain terms it was engineered to keep only the fat-burning action of growth hormone. In animal studies it stimulates lipolysis and inhibits lipogenesis in adipose tissue without binding the growth hormone receptor or raising IGF-1; its lipolytic effect appears to depend on beta-3 adrenergic receptor signalling (it is markedly attenuated in beta-3-AR knockout mice) and it can restore repressed beta-3-AR expression in obese mice (Heffernan et al., 2001). Its precise receptor/mechanism in humans is not firmly established, and human trials have not confirmed a meaningful weight-loss effect.
Regulatory Status by Region
- United States (FDA)Not approved as a drug; no New Drug Application and no approval for any indication. It holds self-affirmed GRAS (Generally Recognized As Safe) status as a food/dietary-supplement ingredient (a safety designation only, not an efficacy or drug approval). In 2024-2026 FDA compounding actions it was treated as a Category 2 substance, i.e. not eligible for 503A pharmacy compounding.
- Australia (TGA)Not approved for therapeutic use; the obesity indication was not approved. When supplied for therapeutic use it is a prescription-only (Schedule 4) substance; it is not an approved medicine on the ARTG.
- European Union (EMA)No EMA marketing authorization; not an approved medicine in the EU.
- WADAProhibited at all times under Section S2; explicitly listed as a growth hormone fragment (alongside hGH 176-191).
Key Studies
- The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta3-AR knock-out mice (opens in a new tab) (Heffernan MA, Thorburn AW, Fam B, et al. Endocrinology. 2001;142(12):5182-5189 (mechanism; beta-3 adrenergic receptor dependence))
- Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans (opens in a new tab) (Stier H, et al. Journal of Endocrinology and Metabolism (summarizes human phase 1/2 safety/tolerability data))
Related News & Research
Common Questions
- What is AOD-9604?
- AOD-9604 is a synthetic analog of the fat-metabolising C-terminal fragment of human growth hormone (a tyrosine-modified hGH 176-191), originally developed as an anti-obesity drug. Despite a favourable safety record across six phase 1/2 trials, its pivotal phase IIb obesity trial did not beat placebo and drug development was halted in 2007; it is not an approved medicine. It is prohibited in sport by WADA, which lists it as a growth hormone fragment.
- Is AOD-9604 approved for medical use?
- AOD-9604 is not approved for medical use and is prohibited in one or more regulatory or anti-doping frameworks. United States (FDA): Not approved as a drug; no New Drug Application and no approval for any indication. It holds self-affirmed GRAS (Generally Recognized As Safe) status as a food/dietary-supplement ingredient (a safety designation only, not an efficacy or drug approval). In 2024-2026 FDA compounding actions it was treated as a Category 2 substance, i.e. not eligible for 503A pharmacy compounding. European Union (EMA): No EMA marketing authorization; not an approved medicine in the EU. Australia (TGA): Not approved for therapeutic use; the obesity indication was not approved. When supplied for therapeutic use it is a prescription-only (Schedule 4) substance; it is not an approved medicine on the ARTG.
- How does AOD-9604 work?
- In plain terms it was engineered to keep only the fat-burning action of growth hormone. In animal studies it stimulates lipolysis and inhibits lipogenesis in adipose tissue without binding the growth hormone receptor or raising IGF-1; its lipolytic effect appears to depend on beta-3 adrenergic receptor signalling (it is markedly attenuated in beta-3-AR knockout mice) and it can restore repressed beta-3-AR expression in obese mice (Heffernan et al., 2001).
- Is AOD-9604 legal in Australia?
- AOD-9604 in Australia (TGA): Not approved for therapeutic use; the obesity indication was not approved. When supplied for therapeutic use it is a prescription-only (Schedule 4) substance; it is not an approved medicine on the ARTG.
- Is AOD-9604 banned in sport?
- AOD-9604 under the World Anti-Doping Agency (WADA) code: Prohibited at all times under Section S2; explicitly listed as a growth hormone fragment (alongside hGH 176-191).