Is AOD-9604 Legal in Missouri?

What AOD-9604 is

AOD-9604 is a 16-amino-acid fragment of growth hormone: hGH residues 177 to 191 with an extra tyrosine at the N-terminus. It was developed by Metabolic Pharmaceuticals as an anti-obesity candidate [6][2]. It never reached approval; phase IIa trials were under way by February 2002, and the obesity program was later dropped [1][2].

FDA's GRAS notice inventory has no AOD-9604 entry. A developer-commissioned panel's conditional GRAS conclusion for food or drink use was not an FDA review and says nothing about injected drug use [7].

What FDA's compounding lists show

FDA's table of bulk substances previously in category 2 whose nominators withdrew them includes AOD-9604, and it still carries the agency's stated concerns. Compounded drugs containing it may pose significant immunogenicity risk for certain routes of administration (peptide impurities and characterization problems). FDA has identified 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 [5]. Removal from category 2 was not a finding that it is safe [5].

FDA's page says state-licensed pharmacies and physicians may compound only with bulk drug substances that comply with an applicable USP or NF monograph, that are components of FDA-approved drug products where no monograph exists, or that appear on FDA's bulks list where neither applies [4]. Under FDA's category 1 policy, FDA says it does not intend to take action against compounders that meet certain conditions. AOD-9604 is in none of the three categories on FDA's list for state-licensed pharmacies and physicians, so that policy does not cover it [3][4].

It is also not among the six peptides named in HHS's draft enforcement-discretion policy filed October 28, 2026 [8][9], and it was not on the agenda of FDA's July 2026 advisory committee [10]. Compounded drugs are not FDA-approved: FDA does not review their safety, effectiveness or quality before patients receive them [11].

What this means in Missouri

These federal facts apply in every state. No federal policy gives AOD-9604 a compounding pathway, and FDA's own table lists safety concerns about it [3][5].

What the human evidence shows

A 24-week oral obesity study enrolled 534 people and randomized 502. A 2026 review reports that it failed to show a significant benefit on the primary weight-loss endpoint, a conclusion that rests on sponsor-reported phase 2 results [2].