AOD-9604
Clinical reviewer: Jacob Moore, MD · Last checked September 22, 2026
Is AOD-9604 legal?
AOD-9604 is not FDA-approved, and its 503A compounding nomination was withdrawn after FDA raised safety concerns. It is a synthetic fragment of the C-terminal end of human growth hormone, described as hGH(177–191) with an added N-terminal tyrosine. It has been studied in obese mice, where it increased fat oxidation and lipolysis markers, and human evidence is limited.
What does research show about AOD-9604?
In mice, a 2001 study reported that both human growth hormone and AOD9604 "are capable of inducing weight loss and increasing lipolytic sensitivity following long-term treatment," reducing body weight and fat after 14 days of chronic injections in obese animals [1]. A 2026 narrative review places AOD-9604 in an evidence tier with "only limited or indirect human data," reporting minimal systemic growth-hormone activation in humans and transient, modest metabolic changes in some studies [2].
Is AOD-9604 legal or FDA-approved?
Neither. AOD-9604 is not an approved drug, and FDA's Category 2 list, current as of April 22, 2026, records its 503A nomination as withdrawn, citing potential immunogenicity risk, peptide-impurity complexities, and adverse events FDA says "may be associated with AOD-9604, though causality is not clear" [3]. A pharmacy may compound from a bulk substance under section 503A only if it has a USP or NF monograph, is a component of an FDA-approved drug, or is on the 503A bulks list [4]; AOD-9604 is none of these.
Related terms
Sources
- Heffernan M et al. The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice. Endocrinology, 2001.
- Dominikowski A et al. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis, bridging the gap between clinical evidence and patient self-administration. Front Endocrinol, 2026.
- FDA — Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2), current as of April 22, 2026
- FDA — Bulk Drug Substances Used in Compounding Under Section 503A
This entry is for education and is not medical advice. Talk with a licensed clinician about your own situation before starting, stopping, or changing any treatment.
