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AOD-9604

Grade D: Preclinical or anecdotal only

TL;DR: AOD-9604 is a synthetic human growth hormone fragment that was developed as an obesity treatment. The independently citable evidence is preclinical: lipolytic effects in obese mice (PMID 11713213) and an intra-articular study in rabbits (PMID 26275694), alongside anti-doping detection assays and narrative reviews. Weight-loss trials were registered, including a 24-week phase IIb (ANZCTR ACTRN12605000067673), but the results were never published in indexed peer-reviewed literature; the widely repeated figures, the participant counts, the kilograms lost, and a failed phase IIb, appear only in company press releases and secondary reviews, so they cannot be independently verified. Development was discontinued around 2007. There is no published human efficacy trial.

Key Takeaways

  • Grade D: Preclinical or anecdotal only
  • Not FDA approved: Not FDA-approved for any indication. In December 2024 the FDA Pharmacy Compounding Advisory Committee voted against adding AOD-9604 to the 503A bulk drug substances list.
  • Compounding: Not FDA-approved. In December 2024 the FDA Pharmacy Compounding Advisory Committee voted against including AOD-9604 (free base and acetate) on the 503A bulk drug substances list, so compounding it is not supported by current FDA policy.
AOD-9604 chemical structure
Structure via PubChem CID 71300630

Mechanism

AOD-9604 is a synthetic fragment of the C-terminus of human growth hormone (residues 176-191). In animal models it showed lipolytic activity; the proposed beta-3 adrenergic involvement is not straightforward, since lipolysis persisted in beta-3 receptor knockout mice. The mechanism in humans is not established.

Evidence

AOD-9604 is a synthetic human growth hormone fragment that was developed as an obesity treatment. The independently citable evidence is preclinical: lipolytic effects in obese mice (PMID 11713213) and an intra-articular study in rabbits (PMID 26275694), alongside anti-doping detection assays and narrative reviews. Weight-loss trials were registered, including a 24-week phase IIb (ANZCTR ACTRN12605000067673), but the results were never published in indexed peer-reviewed literature; the widely repeated figures, the participant counts, the kilograms lost, and a failed phase IIb, appear only in company press releases and secondary reviews, so they cannot be independently verified. Development was discontinued around 2007. There is no published human efficacy trial.

Safety and risks

No published controlled human safety data exist. As an exogenous peptide, immunogenicity (an immune reaction to the injected peptide) is a recognized theoretical concern, and synthesis impurities can carry unknown activity; the FDA's 2024 compounding review cited limited long-term safety data among its reasons for not recommending it. Effects on the growth-hormone and IGF-1 axis and on glucose and lipid metabolism over long-term use have not been adequately studied in humans. Use outside a supervised trial carries uncharacterized risk.

Interactions

No controlled human interaction data exist.

Federal compounding status

Nomination withdrawn (was Category 2) as of 2026-06-02.

This substance was nominated for the FDA 503A or 503B bulk-substances list and previously sat in the Category 2 (significant safety risk) group; the nomination was later withdrawn, so it is not on an active FDA bulks list and is not eligible for routine pharmacy compounding. FDA source

Federal status only, from public FDA records. State pharmacy-board rules vary and are not covered here. This is regulatory reporting, not legal advice. All compounds.

Compounding legality

Not FDA-approved. In December 2024 the FDA Pharmacy Compounding Advisory Committee voted against including AOD-9604 (free base and acetate) on the 503A bulk drug substances list, so compounding it is not supported by current FDA policy.

Sources

  1. AOD-9604 Metabolic. (2004) review
  2. Therapeutic Peptides in Orthopaedics: Applications, Challenges, and Future Directions. (2026) review
  3. AOD-9604 does not influence the WADA hGH isoform immunoassay. (2013) other
  4. Gateways to clinical trials. (2005) other
  5. Obesity drugs in clinical development. (2006) review
  6. Analytical approaches for the detection of emerging therapeutics and non-approved drugs in human doping controls. (2014) review
  7. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. (2026) review
  8. Gateways to clinical trials. (2003) other
  9. Gateways to clinical trials. (2003) other
  10. Detection and in vitro metabolism of AOD9604. (2015) other
  11. Detecting peptidic drugs, drug candidates and analogs in sports doping: current status and future directions. (2014) other
  12. Simplifying and expanding the screening for peptides <2 kDa by direct urine injection, liquid chromatography, and ion mobility mass spectrometry. (2016) other
  13. Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model. (2015) other
  14. Identification and characterization of peptide drugs in unknown pharmaceutical preparations seized by the Belgian authorities: case report on AOD9604. (2014) other
  15. The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta(3)-AR knock-out mice. (2001) other

AOD-9604 is Not FDA approved. PeptideGrids presents evidence and regulatory status for informational purposes only. We do not sell, supply, source, or help anyone obtain this compound, and we provide no dosing or administration guidance. This is not medical advice; consult a licensed clinician. Full disclaimer.

Last reviewed June 2, 2026 by PeptideGrids editorial team (independently audited).