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Is AOD-9604 Legal in New York? How to Access It Legally

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17 linked public sourcesEditorial, sourcing, and corrections policy

At a glance

  • FDA approval / None; AOD-9604 never reached approval [1][2]
  • FDA compounding lists / Not in any category for state-licensed pharmacies or outsourcing facilities [3][4][5]
  • FDA safety note / Serious adverse events may be associated; causality unclear [6]
  • HHS draft peptide policy / AOD-9604 is not one of the six peptides [7][8]
  • WADA status / Prohibited at all times as a growth hormone fragment [9][10]
  • Human evidence / Limited; main oral obesity study failed its weight-loss endpoint [2]

What is AOD-9604?

AOD-9604 is a 16-amino-acid fragment of human growth hormone: hGH amino acids 177 to 191 plus an extra tyrosine at the N-terminus, not full-length growth hormone [11][2]. Metabolic Pharmaceuticals developed it as an anti-obesity candidate; phase IIa trials were underway by February 2002, but it never reached approval and the obesity program was later dropped [1][2].

Is AOD-9604 FDA-approved?

No. AOD-9604 is not an FDA-approved drug for any indication [1][2]. A 2026 review reports that a 24-week oral obesity study (534 enrolled, 502 randomized) failed to show a significant benefit on its primary weight-loss endpoint [2]. That is sponsor-reported phase 2 data, and the review notes no peer-reviewed randomized efficacy paper was found [2]. FDA's GRAS notice inventory has no AOD-9604 entry [12]. A food-ingredient conclusion would not make an injectable drug lawful.

Can a New York pharmacy compound AOD-9604?

FDA's page for state-licensed pharmacies says a bulk substance may be used only if it complies with a USP or NF monograph, is a component of an FDA-approved drug, or appears on FDA's list [5]. AOD-9604 is not approved [1][2], and it appears in no category on FDA's list for state-licensed pharmacies and physicians or on FDA's list for outsourcing facilities [3][4][5]. FDA's category 1 policy, under which it generally does not act against compounders who meet conditions, does not cover it [3][5].

FDA's page on bulk substances that may present significant safety risks lists AOD-9604 in its 'nominated but withdrawn' table, which holds substances previously in category 2 whose nominators withdrew them [6]. FDA's stated concerns include immunogenicity risk for certain routes from peptide impurities and characterization problems, limited safety information, and serious adverse events that may be associated with AOD-9604 though causality is not clear [6]. Removal from category 2 was not a finding that it is safe [6].

Does a federal peptide policy cover AOD-9604?

No. HHS's draft enforcement-discretion policy for compounding, filed October 28, 2026, covers six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax, and TB-500 [7][8]. AOD-9604 is not one of them [7][8]. It was also not on the agenda of FDA's July 2026 advisory committee [13].

What evidence exists?

Most efficacy claims rest on animal work. In obese Zucker rats, oral AOD9604 at 500 micrograms/kg/day for 19 days produced body-weight gain of 15.8 g versus 35.6 g in controls, over 50% less, and increased fat-tissue lipolytic activity without worsening insulin sensitivity [14]. In obese mice, 14 days of intraperitoneal AOD9604 reduced body weight and fat; the long-term effect was absent in beta-3 receptor knockout mice [15]. Joint-repair claims rest on a rabbit study, and no convincing human osteoarthritis trial exists [16][2]. There is no approved dose [2]. The 24-week human obesity study tested an oral drug candidate, and a 2026 review concludes human evidence is limited and largely short-term [2].

Is AOD-9604 a gray-market or doping product?

Belgian authorities and US investigators have found AOD-9604 in seized or confiscated vials, which shows it circulates on the gray market [17][11]. WADA names AOD-9604 and hGH 176-191 in S2.2.3 and prohibits growth hormone fragments at all times, in and out of competition; it is on the 2026 List and stays on the 2027 List [9][10].

How can someone access AOD-9604 legally in New York?

There is no FDA-approved AOD-9604 product, and it is in no category on FDA's compounding lists [1][2][3][4][5]. Federal materials do not show a legal route to it, and they do not address New York state rules. The product that circulates is gray-market material [17][11]. FDA says serious adverse events may be associated with AOD-9604, though causality is not clear [6].

Frequently asked questions

Is AOD-9604 legal in New York?
AOD-9604 is not FDA-approved and is not in any category on FDA's compounding lists for state-licensed pharmacies or outsourcing facilities [1][2][3][4]. Those federal materials do not address New York state rules.
Can a New York doctor prescribe AOD-9604?
AOD-9604 has no FDA approval and is in no category on FDA's compounding lists [1][2][3][4]. FDA's page for state-licensed pharmacies limits compounding to bulk substances with a USP or NF monograph, those in an FDA-approved drug, or those on FDA's list, and AOD-9604 meets none of these [5].
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 with an extra tyrosine, not full-length growth hormone [11][2].
Is AOD-9604 approved for weight loss?
No. A 2026 review reports that an oral obesity study of AOD9604 failed to show a significant benefit on its primary weight-loss endpoint [2].
Is AOD-9604 banned in sports?
Yes. WADA names AOD-9604 and hGH 176-191 in S2.2.3 and prohibits growth hormone fragments at all times, in and out of competition [9][10].

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 Under Section 503A of the FD&C Act | FDA. Bulk Drug Substances Used in Compounding Under Section 503A 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. World Anti-Doping Agency. World Anti-Doping Agency
  10. World Anti-Doping Agency. World Anti-Doping Agency
  11. 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
  12. GRAS Notices. GRAS Notices
  13. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  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
Evidence overview for Is AOD-9604 Legal in New York? How to Access It Legally