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

Print or save as PDF

Is AOD-9604 FDA-approved?

No. It is a 16-amino-acid piece of human growth hormone: amino acids 177 to 191 with an extra tyrosine at the N-terminus, which is why it also circulates as hGH fragment 176-191 [13]. It is not growth hormone, and preclinical work found no binding to the growth hormone receptor [2].

An Australian company, Metabolic Pharmaceuticals, developed it as an anti-obesity candidate, and phase IIa trials were underway by February 2002 [1]. It never reached approval, and the obesity program was later dropped [1][2]. A 2026 review reports that a 24-week study of AOD-9604 as an oral obesity drug candidate showed no significant benefit on its primary weight-loss endpoint. The review notes that this conclusion rests on sponsor-reported phase 2 results rather than a peer-reviewed trial report, and that there are no robust human data on visceral fat or other metabolic benefit [2]. There is no approved dose [2].

Can a licensed pharmacy prepare it?

State-licensed pharmacies and physicians may compound with a bulk substance only if it complies with an applicable USP or NF monograph, is a component of an FDA-approved drug, or appears on FDA's bulks list [5]. AOD-9604 is not FDA-approved, and it appears in none of the three categories on FDA's list for those pharmacies and physicians (updated May 14, 2026) or on FDA's list for outsourcing facilities (updated March 21, 2025) [3][4][5].

FDA's page on bulk substances that may present significant safety risks lists AOD-9604 in the table of nominations that were withdrawn by the nominator. FDA's stated concerns are that compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration (peptide impurities and characterization problems), that FDA has identified no, or only limited, safety information, and that FDA has identified serious adverse events that may be associated with AOD-9604, though causality is not clear [6]. Withdrawal was the nominator's decision and was not a finding that the substance is safe [6]. Compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness or quality before they are marketed [8].

Does GRAS status make it legal to inject?

No. FDA's GRAS Notice Inventory contains no AOD-9604 entry, so there is no FDA "no questions" letter for it [10]. Claims that it is "GRAS" trace back to the developer, which announced in 2012 a "conditional GRAS" conclusion from a panel it commissioned, for use as a food or drink ingredient at up to 1 mg per day. That was not an FDA review. GRAS is also a food-ingredient concept and would not make an injectable lawful as a drug [10].

Did the 2026 federal peptide actions change anything?

No. HHS's draft enforcement-discretion policy for compounded peptides, filed October 28, 2026, covers six peptides and AOD-9604 is not one of them [7][8]. It was also absent from the agenda of FDA's July 23-24, 2026 advisory committee meeting [9].

What the evidence shows

The efficacy data are from animals. In obese Zucker rats, oral AOD9604 at 500 microgram/kg a day for 19 days cut body-weight gain to 15.8 g versus 35.6 g in controls [14]. In obese mice, 14 days of injected AOD9604 reduced body weight and fat, and the long-term effect was not seen in mice lacking the beta-3 adrenergic receptor [15]. The cartilage-repair claim rests on a rabbit knee study, and no convincing human osteoarthritis trial exists [16][2]. A 2026 review of unapproved peptides finds favorable animal results alongside scarce rigorous human safety data and potential for serious harm [17].

WADA names AOD-9604 and hGH 176-191 in section S2.2.3 and prohibits them at all times, in and out of competition, on both the 2026 and 2027 Lists [11][12]. Anti-doping scientists have published urine detection methods for the peptide and a stable metabolite [13].