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Is AOD-9604 Legal in Virginia?

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At a glance

  • FDA approval / None. Never approved as a drug [1][2]
  • FDA safety view / Possible immunogenicity risk, limited safety data, serious adverse events of unclear cause [6]
  • FDA compounding categories / Not in any category for pharmacies, physicians, or outsourcing facilities [3][4][5]
  • Approved dose / None [2]
  • Sport / Banned at all times by WADA [7]
  • What it is / A 16-amino-acid fragment of growth hormone [8]

What FDA's lists say about AOD-9604

AOD-9604 was developed by an Australian company, Metabolic Pharmaceuticals, as an obesity drug candidate; phase IIa trials were under way by February 2002, it never reached approval, and the obesity program was later dropped [1][2]. Chemically it is growth hormone amino acids 177 to 191 with an extra tyrosine at the front — 16 amino acids, not full-length growth hormone [8]. A 2026 review reports that the main human obesity study, which tested an oral drug candidate, did not show a significant benefit on its primary weight-loss endpoint [2].

FDA's page on bulk substances that may present significant safety risks lists AOD-9604 in the table of nominations withdrawn by the nominator, which is where substances previously placed in category 2 ended up [6]. FDA's stated concerns: compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration related to peptide impurities and characterization problems; FDA has identified no, or only limited, safety information; and 'FDA has also identified 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].

FDA does not list AOD-9604 in any category for state-licensed pharmacies and physicians, and it does not appear on FDA's outsourcing-facility list [3][4][5]. Compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they reach patients [9].

Is AOD-9604 in the new federal peptide policy?

No. HHS filed a draft enforcement-discretion policy for compounded peptides on October 28, 2026 covering six peptides — BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 — and AOD-9604 is not one of them [10][11]. It was also not on the agenda of FDA's July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting, which took up BPC-157, KPV, TB-500, MOTS-c, emideltide, Semax and epitalon [12].

Is AOD-9604 'GRAS'?

FDA's GRAS Notice Inventory has no AOD-9604 entry; searches of the inventory for 'AOD9604', 'AOD', 'growth hormone' and 'peptide' on October 29, 2026 returned nothing [13]. GRAS concerns intended uses of substances added to food and is not an FDA drug approval [14].

Is it banned in sport?

WADA's Prohibited List names AOD-9604 and hGH 176-191 in S2.2.3 (growth hormone fragments), prohibited at all times, in and out of competition; S2 substances are non-Specified Substances [7]. It is on the 2026 List, in force since January 1, 2026, and stays on the 2027 List [15]. Anti-doping scientists have published a urine detection method for AOD-9604 and a stable metabolite [8].

Frequently asked questions

Is AOD-9604 legal in Virginia?
The available federal information does not establish that AOD-9604 may be dispensed as a medicine in Virginia. It is not FDA-approved [1][2], and it is absent from FDA's listed compounding categories [3][4][5].
Does removal from FDA's category 2 list mean AOD-9604 is now allowed?
No. FDA lists AOD-9604 in the table of nominations withdrawn by the nominator, and removal from category 2 was not a finding that it is safe [6].
Is AOD-9604 the same as human growth hormone?
No. It is growth hormone amino acids 177 to 191 with an added tyrosine at the N-terminus, 16 amino acids rather than full-length growth hormone [8]. Preclinical work found no growth-hormone-receptor binding, and human data on IGF-1 and body composition are too limited to say more [2].
Is AOD-9604 banned in sport?
Yes. WADA's Prohibited List names AOD-9604 and hGH 176-191 in S2.2.3, prohibited at all times in and out of competition [7]. It is on the 2026 List and stays on the 2027 List [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. 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. World Anti-Doping Agency. World Anti-Doping Agency
  8. 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
  9. Human Drug Compounding Laws | FDA. Human Drug Compounding Laws | FDA
  10. Official web page. Official web page
  11. Official web page. Official web page
  12. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  13. GRAS Notices. GRAS Notices
  14. Generally Recognized as Safe (GRAS) | FDA. Generally Recognized as Safe (GRAS) | FDA
  15. World Anti-Doping Agency. World Anti-Doping Agency
Evidence overview for Is AOD-9604 Legal in Virginia?