Is AOD-9604 Legal in Georgia? How to Access It Legally in 2025

What Is AOD-9604?

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, also called hGH fragment 176-191 [9][2]. It is not full-length growth hormone [9]. It was developed by Metabolic Pharmaceuticals as an anti-obesity drug candidate, with phase IIa trials underway by February 2002; it never reached approval [1][2].

Is It FDA-Approved or GRAS?

No. It is not FDA-approved for any indication [1][2]. FDA's GRAS Notice Inventory returned no AOD-9604 notice, so there is no FDA no-questions letter for it [10]. GRAS is a food-ingredient concept and would not make an injectable lawful as a drug [10].

What Does FDA Say About Compounding?

FDA's page dated 04/22/2026 lists AOD-9604 in its "nominated but withdrawn" table of substances that may present significant safety risks when compounded [3]. FDA's stated concerns include immunogenicity risk for certain routes of administration from peptide impurities and characterization problems, no or limited safety information, and serious adverse events that may be associated with AOD-9604, though causality is not clear [3]. Removal from category 2 was not a finding that it is safe [3].

AOD-9604 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians (updated May 14, 2026) or on FDA's list for outsourcing facilities (updated March 21, 2025) [4][5][6]. FDA's category 1 policy, under which FDA generally does not act against compounders if conditions are met, does not cover it [4][5][6].

It is also not one of the six peptides (BPC-157, epitalon, KPV, MOTS-c, Semax, TB-500) in HHS's draft enforcement-discretion policy for compounding, and it was not on the agenda of FDA's July 2026 advisory committee [11][12][15]. Compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before marketing [11][12].

Is It Banned in Sport?

Yes. 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 [7]. It is on the 2026 List, in force since January 1, 2026, and stays on the 2027 List [7][8].

What Does the Human Evidence Show?

A 2026 review describes a 24-week study (534 enrolled, 502 randomized) of AOD9604 as an oral anti-obesity drug candidate that failed to show a significant benefit on the primary weight-loss endpoint [2]. The review notes that this conclusion rests on sponsor-reported phase 2 results rather than peer-reviewed randomized trials [2]. That human study tested an oral candidate, not an injectable [2].

The positive findings are from animals. In obese rats, oral AOD9604 at 500 microgram/kg per day for 19 days cut body-weight gain to 15.8 g versus 35.6 g in controls [13]. In obese mice, 14 days of injected AOD9604 reduced body weight and fat [14].