AOD-9604 Compounding Legal Status: What Patients and Prescribers Need to Know

See the public record for AOD-9604

What AOD-9604 is

AOD-9604 is a 16-amino-acid peptide: hGH amino acids 177 to 191 with an extra tyrosine added at the N-terminus, which is why it is also written hGH fragment 176-191 [12]. It is a fragment, not full-length growth hormone [2][12]. The name stands for 'anti-obesity drug 9604' [13].

Metabolic Pharmaceuticals, an Australian company, developed it as an obesity drug candidate, and phase IIa trials were underway by February 2002 [1]. It never reached approval, and the obesity program was later dropped [1][2].

Is AOD-9604 FDA-approved?

No. AOD-9604 has never been an FDA-approved drug [1][2]. There is no FDA-approved prescribing information for it and no approved dose [2].

Where AOD-9604 sits in FDA's compounding framework

Under the federal rules for state-licensed pharmacies and physicians, a bulk drug substance may be compounded only if it complies with an applicable USP or NF monograph, is a component of an FDA-approved drug product, or appears on FDA's list of bulk drug substances that can be used in compounding [5].

AOD-9604 does not appear in any category on FDA's lists for state-licensed pharmacies or outsourcing facilities. FDA's category 1 policy, under which the agency generally does not intend to act against compounders that meet the conditions in its guidance, therefore does not cover it [3][4][5].

The 'nominated but withdrawn' table

FDA's page on bulk substances that may present significant safety risks when compounded (content dated April 22, 2026) lists AOD-9604 in the 'nominated but withdrawn' table, which holds substances previously in category 2 whose nominators withdrew them [6]. FDA's stated concerns on that page are specific:

• compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration, related to peptide impurities and characterization problems;
• FDA has identified no, or only limited, safety information;
• 'FDA has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear' [6].

Removal from category 2 was not a finding that the substance is safe [6].

HHS's October 2026 peptide policy does not include AOD-9604

HHS filed a draft enforcement-discretion policy for compounding on October 28, 2026 (Federal Register document 2026-22192, publication scheduled for October 30, 2026) [7]. It names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 [7][8]. AOD-9604 is not among them [7][8].

Nor was AOD-9604 on the agenda of FDA's July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting, which discussed BPC-157, KPV, TB-500, MOTS-c, emideltide (DSIP), Semax and epitalon [14]. Compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness or quality before marketing [7][8].

The GRAS claim

AOD-9604 is sometimes described as GRAS. FDA's GRAS Notice Inventory contains no AOD-9604 notice; searches of the inventory for 'AOD9604', 'AOD', 'growth hormone' and 'peptide' returned no entry, so there is no FDA 'no questions' letter for it [9]. The claim traces to the developer, which announced in 2012 a 'conditional GRAS' conclusion by 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 [9].

GRAS is a food-ingredient concept, and it would not make an injectable lawful as a drug [9].

What is known about safety and about weight loss

FDA has identified serious adverse events that may be associated with AOD-9604, gives no details, and states that causality is not clear [6]. A 2026 review of gray-market peptides notes that many unapproved peptides look promising in animals while rigorous human safety data are scarce and there is potential for serious harm [13].

The main human weight-loss study is summarized in another 2026 review: a 24-week trial of AOD9604 as an oral anti-obesity drug candidate (534 enrolled, 502 randomized) failed to show a significant benefit on the primary weight-loss endpoint [2]. That 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 [2].

Animal results were different. In obese Zucker rats, oral AOD9604 at 500 micrograms/kg per day for 19 days cut body-weight gain to 15.8 g versus 35.6 g in controls, raised fat-tissue lipolytic activity, and, unlike chronic growth hormone, did not worsen insulin sensitivity on euglycemic clamp [15]. In obese mice, 14 days of intraperitoneal hGH or AOD9604 reduced body weight and fat and increased beta-3 adrenergic receptor RNA; in mice lacking that receptor, the long-term effects were not seen [16]. That study concluded the lipolytic action is not mediated directly through the beta-3 receptor, even though both compounds raise receptor expression [16]. Preclinical work reviewed in 2026 found no growth-hormone-receptor binding [2].

Claims that AOD-9604 repairs cartilage rest on one rabbit study of intra-articular injection in a collagenase-induced knee osteoarthritis model, and no convincing human osteoarthritis trial exists [17][2].

Sport and the gray market

WADA names AOD-9604 and hGH 176-191 in section S2.2.3 of its Prohibited List, covering growth hormone fragments [10]. It is prohibited at all times, in and out of competition, and S2 substances are non-Specified Substances; it is on the 2026 List in force since January 1, 2026 and remains on the 2027 List [10][11]. Anti-doping scientists have published urine detection methods for AOD-9604 and a stable metabolite [12].

AOD-9604 has also been identified in confiscated vials in the USA and in preparations seized by the Belgian authorities [12][18].