Is AOD-9604 Legal in Illinois? What Federal Rules Say

What is AOD-9604?

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, which is why it is also called hGH fragment 176-191 [9]. It is not full-length growth hormone [6][9]. An Australian company, Metabolic Pharmaceuticals, developed it as an anti-obesity drug candidate; phase IIa trials were under way by February 2002 [1]. It never reached approval [6].

Where AOD-9604 sits on FDA's lists

FDA's page on bulk substances that may present significant safety risks lists AOD-9604 in the nominated-but-withdrawn table [2]. FDA's stated concerns: compounded drugs containing AOD-9604 may pose a significant immunogenicity risk for certain routes because of 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 [2]. Removal from category 2 was not a finding that it is safe [2].

AOD-9604 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians, updated May 14, 2026 [3], and it does not appear on FDA's list for outsourcing facilities, updated March 21, 2025 [4]. FDA's category 1 policy does not cover it [5]. Compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness or quality before they reach patients [10].

The October 2026 HHS draft that would exercise enforcement discretion for certain compounded peptides names six (BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500), and AOD-9604 is not among them [7][11]. FDA's GRAS Notice Inventory contains no AOD-9604 notice, so there is no FDA no-questions letter for it [12].

What the human and animal data show

A 2026 review describes a 24-week oral AOD9604 study with 534 people enrolled and 502 randomized; it did not show a significant benefit on its primary weight-loss endpoint [6]. The review notes the conclusion 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 [6]. There is no approved dose [6].

In obese Zucker rats, oral AOD9604 at 500 microgram/kg daily for 19 days cut weight gain to 15.8 g versus 35.6 g in controls [13]. In obese mice, 14 days of intraperitoneal AOD9604 reduced body weight and fat, and the long-term effect did not appear in mice lacking the beta-3 adrenergic receptor [14].

What about Illinois?

FDA's compounding lists and the HHS draft policy are federal documents, and none of them addresses Illinois law. Federally, AOD-9604 has no approval and no place on FDA's compounding lists. It has been identified in confiscated vials in the US and in preparations seized by Belgian authorities, which shows it circulates on the gray market [9][15].

Is AOD-9604 banned in sport?

Yes. WADA's Prohibited List names AOD-9604 and hGH 176-191 in section S2.2.3 on growth hormone fragments, prohibited at all times in and out of competition, and it stays on the 2027 List [8][16].