AOD-9604 (Anti-Obesity Drug 9604) is a synthetic 16-amino acid peptide derived from the C-terminal region of human growth hormone (hGH), corresponding to amino acids 176–191. It was developed by researchers at Monash University in Australia with the goal of preserving the fat-metabolizing (lipolytic) effects of growth hormone while eliminating its growth-promoting and diabetogenic properties.
Unlike recombinant human growth hormone, AOD-9604 does not appear to significantly stimulate growth hormone secretion, increase IGF-1 levels, or promote tissue growth in published human studies. Instead, it was designed to selectively promote fat metabolism without many of the hormonal effects associated with growth hormone therapy.
Although AOD-9604 advanced through multiple human clinical trials for obesity, development as a prescription weight-loss medication was discontinued after larger Phase II studies failed to meet their primary efficacy endpoints. It is not FDA-approved for any medical indication in the United States.
The precise mechanism of AOD-9604 has not been completely established. Current research suggests it acts primarily on adipose (fat) tissue rather than through the classical growth hormone receptor pathway.
Proposed mechanisms include:
Unlike full-length growth hormone, AOD-9604 was specifically designed to avoid many of the endocrine effects of GH while preserving potential fat-metabolizing activity. Most mechanistic evidence comes from laboratory and animal studies.
Published research has investigated AOD-9604 primarily for obesity and metabolic health.
Potential benefits reported in research include:
While some early clinical studies demonstrated modest reductions in body fat, larger placebo-controlled trials did not demonstrate sufficient efficacy to support FDA approval as an obesity treatment. More recent laboratory research has also investigated possible applications in cartilage repair, although these findings remain preclinical.
Human clinical trials generally reported that AOD-9604 was well tolerated, with adverse event rates similar to placebo. However, because development was discontinued and the peptide remains unapproved, long-term safety has not been established.
Potential side effects include:
The FDA has specifically noted that compounded AOD-9604 products may present concerns related to peptide impurities, immunogenicity, and limited human safety information. The agency has also noted reports of serious adverse events associated with AOD-9604, although a direct causal relationship has not been established.
Formal contraindications have not been established because AOD-9604 is not an FDA-approved medication.
Based on current knowledge, AOD-9604 should generally be avoided or used only with specialist supervision in individuals with:
Because comprehensive long-term safety studies have not been completed, caution is warranted in patients with significant chronic medical conditions.
AOD-9604 is NOT FDA-approved for any medical indication in the United States.
It is not FDA-approved for:
AOD-9604 completed multiple human clinical trials but ultimately failed to demonstrate sufficient efficacy to obtain FDA approval as an anti-obesity medication. The FDA has also identified safety concerns regarding compounded AOD-9604 products because of limited human safety data and potential risks related to peptide impurities and immunogenicity.
Human Studies
AOD-9604 has been evaluated in six published human clinical trials involving approximately 900 participants.
Human studies have investigated AOD-9604 for:
Clinical studies demonstrated:
Investigators concluded that although AOD-9604 appeared safe and well tolerated, the clinical benefit for weight reduction was insufficient to support regulatory approval.
Animal & Preclinical Studies
Animal and laboratory studies have demonstrated that AOD-9604 may:
These findings support biologic activity but do not establish clinical efficacy for obesity or musculoskeletal disorders in humans.
Human Studies
Animal & Preclinical Studies
Review Articles
The information provided on this page is intended for educational and informational purposes only. It is not intended to diagnose, treat, cure, or prevent any disease and should not be considered medical advice.
This content was generated with the assistance of artificial intelligence (AI) and should be reviewed by a qualified medical professional before publication or clinical use. AI-generated medical content may contain errors, omissions, outdated information, or incomplete interpretations of the available scientific literature.
AOD-9604 is not FDA-approved for any medical indication in the United States. While early clinical trials suggested a favorable safety profile, larger studies did not demonstrate sufficient efficacy for approval as an anti-obesity medication. Individual results vary, and no specific outcome or benefit can be guaranteed. Patients should consult a qualified healthcare provider before beginning or changing any medical treatment.
R2 Medical Clinic uses medications sourced from compounding pharmacies. Compounded medications are not approved by the U.S. Food and Drug Administration (FDA). Unlike FDA-approved medications, compounded drugs have not undergone FDA review for safety, effectiveness, or efficacy through the FDA drug approval process. While 503B outsourcing facilities are registered with and inspected by the FDA and must comply with Current Good Manufacturing Practice (CGMP) requirements, the compounded medications they produce are not individually approved by the FDA. Similarly, compounded medications prepared by 503A pharmacies are not FDA-approved and are primarily regulated by state boards of pharmacy, with FDA oversight under applicable federal law.
# PT-141 (Bremelanotide)