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Is AOD-9604 Legal in New York? Federal Rules, State Law, and How to Get It

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18 linked public sourcesEditorial, sourcing, and corrections policy

At a glance

  • Federal approval / Not FDA-approved for any use [1][2]
  • FDA compounding page / Listed among bulk substances whose nominations were withdrawn; safety concerns stated [6]
  • State-licensed pharmacies / In none of the three categories on FDA's list for these compounders [3][5]
  • Outsourcing facilities / Not on FDA's list for outsourcing facilities [4]
  • HHS draft peptide policy / Not one of the six named peptides [7][8]
  • Advisory committee / Not on FDA's July 2026 agenda [9]
  • Sport / WADA prohibits AOD-9604 at all times [10][11]

Is AOD-9604 an approved drug?

No. It was developed by an Australian company, Metabolic Pharmaceuticals, as an anti-obesity candidate, and phase IIa trials were underway by February 2002 [1]. It never reached approval, and the obesity program was later dropped [2]. AOD-9604 is a 16-amino-acid fragment of human growth hormone: hGH amino acids 177 to 191 with an extra tyrosine added at the N-terminus [12]. It is not full-length growth hormone [2][12].

FDA's GRAS Notice Inventory has no AOD-9604 entry [13], and a GRAS claim is not FDA approval of AOD-9604. GRAS is a food-ingredient concept.

What does FDA say about compounding?

FDA lists AOD-9604 in its nominated-but-withdrawn table, which holds bulk substances previously placed in its safety-risk category whose nominators withdrew them. FDA's stated concerns are immunogenicity risk for certain routes of administration from peptide impurities and characterization problems, no or only limited safety information, and serious adverse events that may be associated with AOD-9604 though causality is not clear [6]. Removal from the safety-risk category was not a finding that AOD-9604 is safe [6].

AOD-9604 is in none of the three categories on FDA's list for state-licensed pharmacies and physicians [3][5], and it is not on FDA's list for outsourcing facilities [4]. FDA's policy of generally not acting against compounders that use certain nominated substances does not cover AOD-9604 [3][4][5]. HHS's draft enforcement-discretion policy names six peptides, and AOD-9604 is not one of them [7][8]. FDA's July 2026 advisory committee agenda did not include it [9].

Does a prescription change the federal status?

No. A prescription does not make an unapproved drug approved. FDA describes three potential pathways for a bulk drug substance used by a state-licensed pharmacy: an applicable USP or NF monograph, use as a component of an FDA-approved drug, or inclusion on FDA's list of bulk drug substances that can be used in compounding [5]. AOD-9604 is not FDA-approved [1][2] and is in none of the three categories on FDA's list [3].

What did the human studies show?

A 2026 peer-reviewed review states that a 24-week study of AOD9604 as an oral anti-obesity drug candidate, with 534 enrolled and 502 randomized, failed to show a significant benefit on the primary weight-loss endpoint. The review notes that this conclusion rests on sponsor-reported phase 2 results rather than peer-reviewed randomized trials, and that there are no robust human data for visceral-fat reduction or other metabolic benefit [2].

The animal findings looked different. In obese Zucker rats, oral AOD9604 at 500 micrograms/kg daily for 19 days cut body-weight gain to 15.8 g versus 35.6 g in controls, increased fat-tissue lipolytic activity and did not worsen insulin sensitivity [14]. In obese mice, 14 days of injected AOD9604 reduced body weight and fat, and the long-term effect was not seen in mice lacking the beta-3 adrenergic receptor [15]. The cartilage-repair claim rests on a rabbit knee osteoarthritis model [16].

What about online sellers and research-use labels?

AOD-9604 is sold online and has been found in confiscated vials in the US and Belgium [12][17]. Those reports do not establish an approved medical use. A 2026 review groups it with unapproved gray-market peptides: many show favorable results in animal models, but rigorous human safety data are scarce and there is potential for serious harm [18].

Frequently asked questions

Is AOD-9604 FDA-approved?
No. It was developed as an anti-obesity candidate, and phase IIa trials were underway by February 2002, but it never reached approval and the program was dropped [1][2]. A 24-week oral trial with 502 randomized participants failed its primary weight-loss endpoint [2].
Can a state-licensed pharmacy compound AOD-9604?
FDA describes three pathways: a USP or NF monograph, use as a component of an FDA-approved drug, or inclusion on FDA's bulk-substance list [5]. AOD-9604 is not approved and is in none of the three categories on FDA's list [1][3]. It also sits in FDA's nominated-but-withdrawn safety table [6].
Can an outsourcing facility compound AOD-9604?
AOD-9604 is not on FDA's list for outsourcing facilities [4], and it is not one of the six peptides in HHS's draft enforcement-discretion policy [7][8].
Is AOD-9604 banned in sport?
Yes. WADA names AOD-9604 and hGH 176-191 in S2.2.3 and prohibits it at all times, in and out of competition [10]. It is on the 2026 List and remains on the 2027 List [10][11].
Does a prescription make AOD-9604 an approved drug?
No. A prescription does not change approval status [1][2]. AOD-9604 is in none of the three categories on FDA's list for state-licensed pharmacies and physicians [3][5].

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. 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
  7. Official web page. Official web page
  8. Official web page. Official web page
  9. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  10. World Anti-Doping Agency. World Anti-Doping Agency
  11. World Anti-Doping Agency. World Anti-Doping Agency
  12. 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
  13. GRAS Notices. GRAS Notices
  14. Ng FM, Sun J, Sharma L, Libinaka R, Jiang WJ, Gianello R. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Horm Res. 2000;53(6):274-8. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone
  15. Heffernan M, Summers RJ, Thorburn A, Ogru E, Gianello R, Jiang WJ, et al. 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. Endocrinology. 2001;142(12):5182-9. 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
  16. 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
  17. 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
  18. 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
Evidence overview for Is AOD-9604 Legal in New York? Federal Rules, State Law, and How to Get It