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Is AOD-9604 Legal in Massachusetts?

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At a glance

  • FDA approval / None; AOD-9604 never became an FDA-approved drug [5][6]
  • FDA compounding lists / In no category on the state-licensed pharmacy list; absent from the outsourcing-facility list [2][3]
  • FDA safety flag / Sits in the 'nominated but withdrawn' table with immunogenicity and serious-adverse-event concerns [1]
  • HHS peptide policy / Not one of the six peptides in the October 2026 draft policy [7][8]
  • Sport / WADA S2.2.3, prohibited at all times [9]

What AOD-9604 is

AOD-9604 is a 16-amino-acid fragment of human growth hormone: amino acids 177 to 191 with an extra tyrosine at the front, which is why it is also called hGH fragment 176-191 [10]. It is not full-length growth hormone, and preclinical work found no binding to the growth-hormone receptor [6]. An Australian company, Metabolic Pharmaceuticals, developed it as an obesity candidate; phase IIa trials were under way by February 2002, it never reached approval, and the obesity program was later dropped [5][6].

What the federal compounding lists say

FDA publishes separate lists for state-licensed pharmacies and physicians and for outsourcing facilities [2][3][4]. AOD-9604 appears in none of the three categories on the state-licensed pharmacy and physician list (updated May 14, 2026) and is absent from the outsourcing-facility list (updated March 21, 2025) [2][3][4]. FDA's category 1 policy, under which it generally does not act against compounders that meet its conditions, does not cover AOD-9604 [2][3][4].

'Withdrawn' does not mean cleared

AOD-9604 sits in FDA's 'nominated but withdrawn' table, which holds substances previously in category 2 whose nominators withdrew them. FDA's stated concerns: compounded drugs containing it may pose significant immunogenicity risk for certain routes of administration, with peptide impurities and characterization problems; FDA has identified no, or only limited, safety information; and it 'has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear' [1]. Removal from category 2 was not a finding that it is safe [1].

What the studies show

In obese Zucker rats, oral AOD-9604 at 500 micrograms per kilogram per day for 19 days cut weight gain to 15.8 g against 35.6 g in controls, and unlike growth hormone it did not worsen insulin sensitivity [11]. A 2026 review reports that in a 24-week oral obesity study (502 randomized), AOD-9604 did not show a significant benefit on its primary weight-loss endpoint; that conclusion rests on sponsor-reported phase 2 results rather than peer-reviewed randomized trials [6]. There is no approved dose [6], and the joint-repair claims rest on a rabbit knee osteoarthritis study [12].

Frequently asked questions

Is AOD-9604 legal in Massachusetts?
Federally it is not an approved drug, it appears in no category on FDA's compounding lists, and it sits in FDA's withdrawn-nomination table with stated safety concerns [1][2][3]. This page does not address Massachusetts statutes or board rules.
Can a Massachusetts pharmacy compound AOD-9604?
AOD-9604 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians, and it is absent from the outsourcing-facility list. FDA's category 1 policy does not cover it [2][3][4].
Is AOD-9604 FDA-approved?
No. It was developed as an obesity candidate, phase IIa trials were under way by February 2002, and it never reached approval [5][6]. A review reports that a 24-week oral study failed its primary weight-loss endpoint, based on sponsor-reported results [6].
Is AOD-9604 banned in sport?
Yes. WADA names it and hGH 176-191 in S2.2.3, prohibited at all times in and out of competition, on the 2026 and 2027 Lists [9][13].

References

  1. 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
  2. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  3. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  4. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA
  5. Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004;5(4):436-40. AOD-9604 Metabolic
  6. 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
  7. Official web page. Official web page
  8. Official web page. Official web page
  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. 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
  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. World Anti-Doping Agency. World Anti-Doping Agency
Evidence overview for Is AOD-9604 Legal in Massachusetts?