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

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Published Updated Last reviewed
11 linked public sourcesEditorial, sourcing, and corrections policy

At a glance

  • FDA approval / None, for any indication [1]
  • FDA bulk-substance lists / In no category; in the nominated-but-withdrawn table with stated safety concerns [5][4]
  • HHS draft peptide policy / Names six other peptides, not AOD-9604 [6][7]
  • Human weight-loss data / 24-week oral study, 502 randomized, failed its primary endpoint [1]
  • Sport / Prohibited at all times under WADA S2.2.3 [8]

Is AOD-9604 legal in the United States?

AOD-9604 is a 16-amino-acid fragment of human growth hormone: hGH residues 177 to 191 with an extra tyrosine at the N-terminus, hence the alternative name hGH fragment 176-191 [9]. Metabolic Pharmaceuticals developed it as an anti-obesity candidate, with phase IIa trials underway by February 2002; it never reached approval [10][1].

There is no approved version to prescribe. AOD-9604 sits in the nominated-but-withdrawn table on FDA's page on bulk substances that may present significant safety risks (content dated 04/22/2026). The stated concerns are that compounded drugs containing it may pose significant immunogenicity risk for certain routes of administration, and that FDA has no or only limited safety information. FDA also says it has identified serious adverse events that may be associated with AOD-9604, though causality is not clear. Removal from category 2 was not a finding that it is safe [5].

AOD-9604 appears in none of the three categories on FDA's bulk-substance list for state-licensed pharmacies and physicians (updated May 14, 2026) or on FDA's list for outsourcing facilities (updated March 21, 2025). The category 1 policy, under which FDA generally does not intend to act against compliant compounders, therefore does not cover it [2][3][4].

HHS's draft enforcement-discretion policy for compounded peptides, filed October 28, 2026, names six peptides and not AOD-9604 [6][7]. Compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness or quality before marketing [6][7].

For athletes, WADA's Prohibited List names AOD-9604 and hGH 176-191 under S2.2.3, prohibited at all times [8].

What the human evidence shows

The main human test was a 24-week study of an oral drug candidate: 534 people enrolled and 502 were randomized. A 2026 review reports that it failed to show a significant benefit on the primary weight-loss endpoint. The review also says this 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 [1]. There is no FDA-approved dose for AOD-9604 [1]. The fat-loss reputation comes from rodent work: in obese Zucker rats, oral AOD9604 at 500 micrograms/kg per day for 19 days cut body-weight gain to 15.8 g versus 35.6 g in controls [11].

Frequently asked questions

Is AOD-9604 legal in Maryland?
Not as an approved drug. AOD-9604 is not FDA-approved, so there is no approved version to prescribe in any state [1].
Can a compounding pharmacy make it?
AOD-9604 appears in none of the three categories on FDA's bulk-substance list for state-licensed pharmacies and physicians, or on FDA's list for outsourcing facilities. FDA places it in the nominated-but-withdrawn table with stated safety concerns [5][2][3][4].
Did AOD-9604 work for weight loss?
In a 24-week study of an oral formulation, 534 people enrolled and 502 were randomized, and it failed to show a significant benefit on the primary weight-loss endpoint. The obesity program was later dropped [1].
What does FDA say about AOD-9604 safety?
FDA says it has identified serious adverse events that may be associated with AOD-9604, though causality is not clear, and it gives no details. It also says it has no or only limited safety information [5].

References

  1. 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
  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. 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
  6. Official web page. Official web page
  7. Official web page. Official web page
  8. World Anti-Doping Agency. World Anti-Doping Agency
  9. 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
  10. Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004;5(4):436-40. AOD-9604 Metabolic
  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
Evidence overview for Is AOD-9604 Legal in Maryland? How to Access It Legally