Is AOD-9604 Legal in Missouri? 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 also circulates as hGH fragment 176-191 [11]. It is not full-length growth hormone. An Australian company, Metabolic Pharmaceuticals, developed it as an obesity drug candidate, with phase IIa trials under way by February 2002 [1]. It was never approved, and the obesity program was later dropped [7].

The federal position

FDA's page on bulk substances used in compounding says state-licensed pharmacies and physicians may compound only with bulk substances that comply with an applicable USP or NF monograph, are components of FDA-approved drug products, or appear on FDA's list of bulk substances that can be used in compounding [5]. AOD-9604 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians or on its list for outsourcing facilities, and the category 1 policy does not cover it [3][4][5].

Instead it sits in FDA's nominated-but-withdrawn table, which holds substances previously in category 2 whose nominators withdrew them. FDA's stated concerns: compounded drugs containing AOD-9604 may pose a significant immunogenicity risk for certain routes of administration, due to peptide impurities and characterization problems; FDA has identified no, or only limited, safety information; and FDA 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 [2].

Two other federal actions also leave it out. HHS's draft enforcement-discretion policy for compounding, filed 28 October 2026, names six peptides (BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500), and AOD-9604 is not among them [8][9]. It was not on the agenda of FDA's July 2026 advisory committee meeting either [12]. Compounded drugs are not FDA-approved in any case: FDA does not review their safety, effectiveness or quality before they are marketed [13].

Missouri

Missouri regulates pharmacists and pharmacies under Chapter 338 of the Revised Statutes, whose section titles cover licensure, prescription labeling, recordkeeping and discipline [6]. Those section titles, through 338.270, do not name AOD-9604, peptides or growth hormone fragments [6]. The federal position above is the same in Missouri: the category 1 policy does not cover AOD-9604 [3][4][5].

What the evidence shows

Animal studies reported weight effects. In obese Zucker rats, oral AOD9604 at 500 micrograms/kg/day for 19 days cut weight gain to 15.8 g versus 35.6 g in controls [14]. Obese mice given injected AOD9604 for 14 days lost body weight and fat [15].

In people, a 24-week study (534 enrolled, 502 randomized) tested AOD9604 as an oral anti-obesity candidate and failed to show a significant benefit on its primary weight-loss endpoint. A 2026 review notes that this conclusion rests on sponsor-reported phase 2 results rather than peer-reviewed randomized trials [7]. There is no approved dose [7].

Athletes

WADA's Prohibited List names AOD-9604 and hGH 176-191 in section S2.2.3, growth hormone fragments, and prohibits them at all times, in and out of competition [10]. It is on the 2026 List and remains on the 2027 List [10][16].