AOD9604

Summary

AOD9604 is a modified fragment of human growth hormone developed primarily as an anti-obesity agent. It promotes fat breakdown and inhibits fat synthesis without the growth-promoting or diabetogenic effects of full-length GH. Originally developed by Metabolic Pharmaceuticals (Australia), it received GRAS (Generally Recognized As Safe) status from the US FDA as a food additive ingredient but failed to meet primary endpoints in phase 3 obesity trials. It is widely used in research and by fitness communities despite limited clinical approval.

Mechanism of Action

AOD9604 is a synthetic analogue of the C-terminal fragment (residues 176–191) of human growth hormone. It stimulates lipolysis and inhibits lipogenesis by mimicking the lipolytic actions of GH without binding to the GH receptor or affecting IGF-1 levels, possibly via interaction with beta-adrenergic receptors or direct fat cell signaling.

Routes of Administration

Goals & Uses

• Fat loss / lipolysisBody CompositionModerate
• Anti-lipogenic effectMetabolicModerate
• Cartilage and bone repairRegenerativeLow
• Metabolic syndrome improvementMetabolicLow

Contraindications

• Active malignancyOncologyHighUse caution or avoid depending on agent and context
• PregnancyPopulationHighPotential fetal risk or insufficient safety data
• Hypersensitivity to hGH fragmentsImmunologicalHigh

Adverse Effects

• Injection site reactionsLocalCommon
• HeadacheNeurologicUncommonPain in the head or upper neck
• FlushingVascularUncommonWarmth and redness of the skin
• NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit

Drug Interactions

• Insulin / antidiabetic agentsLow
• Full-length recombinant human growth hormone (rhGH)Low

Population Constraints

• Elderly (>65 years)AgeRelative
• Pediatric populationAgeAbsolute
• Lactating womenReproductiveAbsolute

Regulatory Status

• European UnionUnapprovedNo EMA approval; classified as a research peptide. Phase 3 trial results were insufficient for approval.
• United StatesUnapprovedReceived GRAS status as food ingredient (GRN 000423) but not approved as a drug. Widely available through compounding pharmacies and research chemical suppliers.
• United KingdomUnapprovedNot approved by MHRA. Regulated as an unlicensed medicine if sold for human use.

Received US FDA GRAS status (GRN 000423) as a food ingredient. Never received full drug approval for obesity or any other indication by FDA, EMA, or TGA. Phase 3 clinical trials did not demonstrate statistically significant weight loss vs. placebo. Used in compounded preparations in various jurisdictions; classified as a research compound in most countries.

Evidence & Sources

No sources recorded yet.