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Is AOD-9604 Legal in Tennessee?

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At a glance

  • FDA approval / None — AOD-9604 is not an approved drug [1][2]
  • Federal compounding lists / In no category on FDA's list for state-licensed pharmacies and physicians or its list for outsourcing facilities [3][4][5]
  • FDA safety view / Listed in the nominated-but-withdrawn table for bulk substances that may present significant safety risks when compounded [8]
  • Human weight-loss data / 24-week study, 502 randomized, failed its primary endpoint [2]
  • Approved dose / None [2]
  • Sport / Prohibited at all times by WADA [9]

Regulatory status of AOD-9604 by authority [3]

WhereStatus
United States (FDA approval)Not an FDA-approved drug
FDA list for state-licensed pharmacies and physiciansNot in any of the three categories on the list
FDA list for outsourcing facilitiesNot on the list
FDA bulk substances safety pageListed in the nominated-but-withdrawn table for significant safety risks when compounded
World Anti-Doping Agency (WADA)Prohibited at all times

Is AOD-9604 an approved drug?

No. It is a 16-amino-acid fragment of human growth hormone (hGH amino acids 177 to 191 plus a tyrosine at the N-terminus), not full-length growth hormone [10]. Metabolic Pharmaceuticals developed it for obesity. Phase IIa trials were underway by February 2002, it never reached approval, and the obesity program was later dropped [1][2]. FDA's GRAS Notice Inventory search returned no AOD-9604 record, so the inventory shows no GRAS notice and no FDA no-questions letter for it [11].

What do the FDA compounding materials say?

FDA's page on bulk substances that may present significant safety risks when compounded (content dated 22 April 2026) lists AOD-9604 in its nominated-but-withdrawn table. That table holds substances previously in category 2 whose nominators withdrew them [8]. FDA states that compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration (peptide impurities and characterization problems). It also says it has identified no, or only limited, safety information, and that it has identified serious adverse events that may be associated with AOD-9604, though causality is not clear [8].

AOD-9604 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians (updated 14 May 2026) or on FDA's list for outsourcing facilities (updated 21 March 2025). FDA's category 1 policy, which is generally no action against qualifying compounders, therefore does not cover it [3][4][5]. Compounded drugs are not FDA-approved, meaning FDA does not review their safety, effectiveness or quality before they reach patients.

What does the human evidence show?

A 2026 review reports that a 24-week study of an oral AOD9604 product (534 enrolled, 502 randomized) failed to show a significant benefit on the primary weight-loss endpoint. The review says this conclusion rests on sponsor-reported phase 2 results rather than peer-reviewed randomized trials [2]. There is no approved dose [2]. Cartilage-repair claims trace to a rabbit study of intra-articular AOD9604 in a collagenase-induced knee osteoarthritis model, and the same review found no convincing human osteoarthritis trial [12][2].

What should a patient watch for?

FDA says it has identified serious adverse events that may be associated with AOD-9604 and that causality is not clear [8]. A 2026 review of unapproved peptides used in sports medicine concluded that rigorous human safety data are scarce and that there is potential for serious harm [13]. AOD-9604 has been found in confiscated vials in the United States and in preparations seized by Belgian authorities [10][14]. WADA names AOD-9604 and hGH 176-191 in S2.2.3 and prohibits it at all times, on both the 2026 List and the tracked-changes 2027 List [9][15].

Frequently asked questions

Is AOD-9604 an approved drug?
No. It is a 16-amino-acid fragment of human growth hormone, not full-length growth hormone. Metabolic Pharmaceuticals developed it for obesity, phase IIa trials were underway by February 2002, and it never reached approval. [1][2][10]
Can a compounding pharmacy make AOD-9604?
AOD-9604 is in none of the three categories on FDA's list for state-licensed pharmacies and physicians, and it is absent from FDA's list for outsourcing facilities. FDA's category 1 policy therefore does not cover it. FDA lists it in its nominated-but-withdrawn table of bulk substances with stated safety concerns, and removal from category 2 was not a finding that it is safe. [8][3][4][5]
Did AOD-9604 work for weight loss?
A 24-week study of an oral product (534 enrolled, 502 randomized) failed to show a significant benefit on the primary weight-loss endpoint, based on sponsor-reported phase 2 results rather than peer-reviewed randomized trials. [2]
Is AOD-9604 the same as growth hormone?
No. It is a 16-amino-acid fragment of human growth hormone (amino acids 177 to 191 plus a tyrosine), not full-length hGH. Preclinical work found no growth-hormone-receptor binding. [2][10]
Is AOD-9604 banned for athletes?
Yes. WADA names AOD-9604 and hGH 176-191 in S2.2.3, growth hormone fragments, and prohibits them at all times in and out of competition. It is on the 2026 List in force since 1 January 2026 and remains on the tracked-changes 2027 List. [9][15]

References

  1. Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004;5(4):436-40. AOD-9604 Metabolic
  2. Dominikowski A, Rękoś Z, Olejarz M, Szczepanek-Parulska E, Domin R, RuchaŁa M. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration. Front Endocrinol (Lausanne). 2026;17:1822475. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration
  3. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  4. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  5. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA
  6. Official web page. Official web page
  7. Official web page. Official web page
  8. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
  9. World Anti-Doping Agency. World Anti-Doping Agency
  10. Cox HD, Smeal SJ, Hughes CM, Cox JE, Eichner D. Detection and in vitro metabolism of AOD9604. Drug Test Anal. 2015;7(1):31-8. Detection and in vitro metabolism of AOD9604
  11. GRAS Notices. GRAS Notices
  12. Kwon DR, Park GY. Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model. Ann Clin Lab Sci. 2015;45(4):426-32. Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model
  13. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026;56(8):1921-1935. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance
  14. Vanhee C, Moens G, Deconinck E, De Beer JO. Identification and characterization of peptide drugs in unknown pharmaceutical preparations seized by the Belgian authorities: case report on AOD9604. Drug Test Anal. 2014;6(9):964-8. Identification and characterization of peptide drugs in unknown pharmaceutical preparations seized by the Belgian authorities: case report on AOD9604
  15. World Anti-Doping Agency. World Anti-Doping Agency
Evidence overview for Is AOD-9604 Legal in Tennessee?