Failed Trials Not a Protocol
FDA · TGA · WADA · peer-reviewed literature Updated May 2026 Reviewed by Allmeds AI Pharmacist

AOD-9604 Dosage: After Failed Phase II Trials, No Regulator-Validated Dose Exists

AOD-9604 is a fragment of the growth hormone molecule developed by Metabolic Pharmaceuticals as a weight-loss therapy. It failed phase II weight-loss trials and was not approved. It is now sold as a compounded peptide. The FDA has identified AOD-9604 among compounded substances that may present significant safety risks. No regulator-validated human dose exists for the marketed uses.

AOD-9604 failed phase II weight-loss trials and is not FDA-approved. The FDA has flagged it among compounded substances that may present significant safety risks. No regulator-validated human dose exists for the currently marketed uses. Allmeds does not publish a protocol.

Key Takeaways

  • AOD-9604 was developed by Metabolic Pharmaceuticals as a weight-loss therapy and failed phase II trials.
  • Not FDA-approved.
  • FDA-flagged compounded substance.
  • No regulator-validated human dose for the marketed uses.
  • WADA prohibits AOD-9604 in competitive sport.

AOD-9604 trial history

AOD-9604 is a 16-amino-acid fragment of the C-terminal of the growth hormone molecule. Metabolic Pharmaceuticals investigated it as an oral and injectable weight-loss therapy. Phase II trials did not demonstrate the efficacy required for FDA approval. AOD-9604 did not proceed to phase III for the weight-loss indication.

Regulator position

AOD-9604 is not approved by the FDA, EMA, or TGA. The FDA has identified AOD-9604 among compounded substances that may present significant safety risks. WADA prohibits AOD-9604 in competitive sport.

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Common Questions

Did AOD-9604 actually work for weight loss?

Phase II trials did not demonstrate the weight-loss efficacy required for FDA approval, and the development programme for the weight-loss indication was discontinued.

Why is AOD-9604 still sold?

AOD-9604 is now marketed as a compounded peptide outside the original drug-approval pathway. The FDA has flagged it among compounded substances that may present significant safety risks.

Is there a regulator-validated dose?

No. No regulator has validated a safe and effective dose for the currently marketed uses.

Is AOD-9604 banned in sport?

Yes. WADA prohibits AOD-9604.

References

  1. Heffernan M et al. The effects of growth hormone fragment AOD9604 on body composition. Diabetes Obes Metab. 2001. Source.
  2. U.S. Food & Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks. Source.
  3. World Anti-Doping Agency. WADA Prohibited List. Source.
Not medical advice. This page summarises regulator statements and peer-reviewed literature for general information. It is not a substitute for professional medical advice. Speak to your doctor or pharmacist before starting, stopping, or changing any medicine.