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

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17 linked public sourcesEditorial, sourcing, and corrections policy

At a glance

  • FDA approval / None, for any indication [5][6]
  • Compounding lists / In no category on FDA's list for state-licensed pharmacies and physicians or its list for outsourcing facilities [2][3][4]
  • FDA safety view / In FDA's nominated-but-withdrawn table, with stated immunogenicity and safety concerns [1]
  • HHS peptide policy / Not one of the six peptides in HHS's draft enforcement-discretion policy [7][8]
  • Human efficacy / 24-week oral obesity study (502 randomized) showed no significant benefit on its primary weight-loss endpoint; sponsor-reported [6]
  • Sport / Prohibited at all times by WADA as a growth hormone fragment [9][10]
  • Supply / Found in confiscated vials in the US and Belgium [11][12]

Is AOD-9604 FDA-approved?

No. AOD-9604 is a 16-amino-acid fragment of human growth hormone: hGH amino acids 177 to 191 with an extra tyrosine at the N-terminus, which is why it is also called hGH fragment 176-191 [11]. An Australian company, Metabolic Pharmaceuticals, developed it as an anti-obesity candidate; phase IIa trials were underway by February 2002 and it never reached approval [5][6]. FDA's GRAS Notice Inventory contains no AOD-9604 notice, so there is no FDA no-questions letter for it [13].

What FDA says about compounding it

AOD-9604 sits in FDA's table of bulk substances nominated but withdrawn, which holds substances previously in category 2 whose nominators withdrew them [1]. FDA's stated concerns are immunogenicity risk for certain routes of administration, no or only limited safety information, and 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].

It appears in no category on FDA's list for state-licensed pharmacies and physicians, or on FDA's list for outsourcing facilities, so the category 1 policy does not extend to it [2][3][4]. It is not one of the six peptides in HHS's draft enforcement-discretion policy filed October 28, 2026, and was not on the agenda of FDA's July 2026 advisory committee meeting [7][8][14]. Compounded drugs are not FDA-approved: FDA does not review their safety, effectiveness or quality before they reach patients [15].

Does Kentucky change this?

The federal status above applies in Kentucky. It leaves no FDA-recognized compounding route for AOD-9604 in the state.

What the animal and human data show

Animal studies have reported weight and fat changes, but these findings do not establish benefit in people. Oral AOD9604 at 500 micrograms per kilogram per day for 19 days cut body-weight gain in obese Zucker rats to 15.8 g versus 35.6 g in controls, without worsening insulin sensitivity [16]. In obese mice, 14 days of injected AOD9604 reduced body weight and body fat; in mice lacking the beta-3 adrenergic receptor the long-term effects were not seen [17].

In people, a 2026 review describes a 24-week study (534 enrolled, 502 randomized) of AOD9604 as an oral anti-obesity candidate that did not show a significant benefit on its primary weight-loss endpoint. The review notes that this rests on sponsor-reported results rather than a peer-reviewed randomized trial [6]. AOD-9604 has no approved dose, and that human study tested an oral candidate, not the injected products sold online [6].

Where the peptide comes from

AOD-9604 has been found in confiscated vials in the United States and Belgium, and a study reported that it was available on internet websites [11][12]. WADA's Prohibited List names AOD-9604 and hGH 176-191 in section S2.2.3 as growth hormone fragments, prohibited at all times, and it is on both the 2026 and 2027 Lists [9][10].

Frequently asked questions

Is AOD-9604 approved for weight loss?
No. A 24-week study with 534 enrolled and 502 randomized participants testing oral AOD9604 as an anti-obesity drug did not show a significant benefit on its primary weight-loss endpoint, and the sponsor's obesity program was dropped [6].
Can a Kentucky pharmacy compound AOD-9604?
FDA's category 1 policy of generally not acting against qualifying compounders does not extend to AOD-9604, which is in no category on the list for state-licensed pharmacies and physicians or the list for outsourcing facilities [2][3][4]. FDA has also listed immunogenicity risk and limited safety information among its concerns [1].
Is AOD-9604 banned in sport?
Yes. WADA names AOD-9604 and hGH 176-191 in section S2.2.3 as growth hormone fragments, prohibited at all times, and it is on both the 2026 and 2027 Prohibited Lists [9][10].
Does AOD-9604 have GRAS status?
No. FDA's GRAS Notice Inventory contains no AOD-9604 entry, so there is no FDA no-questions letter [13]. GRAS is a food-ingredient standard and would not make an injectable lawful as a drug [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. 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. 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
  13. GRAS Notices. GRAS Notices
  14. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  15. Human Drug Compounding Laws | FDA. Human Drug Compounding Laws | FDA
  16. 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
  17. 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
Evidence overview for Is AOD-9604 Legal in Kentucky? How to Access It Legally