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Modified C-terminal fragment of human growth hormone (tyrosine-modified hGH 176-191); lipolytic peptide

AOD-9604

Prohibitedaka AOD9604, Anti-Obesity Drug 9604, Tyr-hGH(177-191), analog of HGH fragment 176-191

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 (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 (Stier H, et al. Journal of Endocrinology and Metabolism (summarizes human phase 1/2 safety/tolerability data))