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

What AOD-9604 is

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 sold as hGH fragment 176-191 [10]. Metabolic Pharmaceuticals, an Australian company, developed it as an anti-obesity candidate; phase IIa trials were underway by February 2002, it never reached approval, and the obesity program was later dropped [1][2].

The federal position

AOD-9604 has no approved new drug application, and a new drug needs one before US commercial marketing [11][1][2].

FDA's page on bulk substances that may present significant safety risks lists AOD-9604 in the table of substances nominated but withdrawn, which holds substances previously in category 2 whose nominators withdrew them. On the same page FDA states that compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration because of peptide impurities and characterization problems, that it has identified no, or only limited, safety information, and that 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 [3].

AOD-9604 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians [4], and it is not on FDA's list for outsourcing facilities [5]. FDA's category 1 approach, in which the agency generally does not intend to act against a compounder that meets the stated conditions, applies only to substances placed in category 1 [6]. AOD-9604 is not one of them [3][4][6]. It is also not among the six peptides named in HHS's draft enforcement-discretion policy for peptide compounding, filed October 28, 2026 [7][8].

Does Massachusetts add anything?

This page rests on federal documents. They do not place AOD-9604 in a category covered by FDA's non-enforcement policy, and they do not name it in HHS's draft peptide policy [3][4][6][7][8].

What the human data show

The main human test of AOD9604 for weight loss was a 24-week study, 534 enrolled and 502 randomized, of an oral drug candidate. It failed to show a significant benefit on the primary weight-loss endpoint. That conclusion rests on sponsor-reported phase 2 results rather than peer-reviewed randomized trials, and there are no robust human data for visceral-fat reduction or other metabolic benefit [2].

The animal results were more striking. In obese Zucker rats, oral AOD9604 at 500 microgram/kg a day for 19 days cut body-weight gain by more than half, 15.8 g versus 35.6 g in controls [12]. Rodent results are not human results. There is no approved dose, and no efficacy trials of injected gray-market products were located [2].

Sport and human safety evidence

WADA's Prohibited List names AOD-9604 and hGH 176-191 in S2.2.3 as growth hormone fragments, prohibited at all times, in and out of competition. It is on the 2026 List and stays on the 2027 List [9][13].

A 2026 review of performance-enhancing peptides describes human evidence on AOD-9604 as limited and largely short-term [2], and a 2026 Sports Medicine review of unapproved peptides notes that rigorous human safety data are scarce and that there is potential for serious harm [14].