Research information only, not medical advice. AOD-9604 is a synthetic 16-amino-acid peptide corresponding to the C-terminal fragment (residues 177-191) of human growth hormone with an added N-terminal tyrosine. It is not approved by the US FDA as a drug for any indication, has no FDA-approved label, and no established human dosing. In December 2024 the FDA reviewed AOD-9604 for the Section 503A compounding bulk drug substances list and proposed that it NOT be included, citing insufficient evidence of safety and effectiveness. Marketed "research peptide" supply is unapproved and outside FDA-evaluated channels.
AOD-9604 at a glance
The evidence base is weak. In obese mice, AOD-9604 reduced body-weight gain, increased fat oxidation and stimulated lipolysis without binding the hGH receptor or affecting IGF-1, supporting a metabolic (non-growth) mechanism (Heffernan et al., Int J Obes 2001, PMID 11673763). In humans, a 24-week Phase IIb dose-finding trial of 536 adults with obesity did not produce statistically significant weight loss versus placebo, and clinical development was discontinued in 2007. AOD-9604 is not FDA-approved and has no proven human efficacy for fat loss.
See how we grade evidence for the methodology behind this page.
Evidence profile
48 studies- Human RCT 3 · 6%
- Human trial 4 · 8%
- Review 22 · 46%
- Animal 11 · 23%
- In-vitro 6 · 13%
- Unknown 2 · 4%
The longer the green, the stronger the human evidence. For most research peptides the bar is dominated by animal and in-vitro work, which is a signal to read every claim carefully.
Regulatory status
Indexed research
Sorted by evidence level, strongest first.
- Human RCT 2013Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans
This study summarizes safety and tolerability data from six randomized, double-blind, placebo-controlled trials of AOD9604 in humans, finding no significant adverse effects or immunogenicity.
- Human RCT 2013Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans
This study reports that the peptide AOD9604 demonstrated a safety and tolerability profile indistinguishable from placebo in six randomized, double-blind, placebo-controlled trials.
- Human RCT 2005The effect of AOD9604 on weight loss in obese adults: Results of a randomized, double-blind, placebo-controlled, multicenter study
This randomized, double-blind, placebo-controlled multicenter study evaluated the effect of AOD9604 on weight loss in obese adults.
- Human trial 2016Simplifying and expanding the screening for peptides <2 kDa by direct urine injection, liquid chromatography, and ion mobility mass spectrometry
This study presents a liquid chromatography and ion mobility mass spectrometry method for direct urine injection to detect low-molecular-mass peptides for doping control, demonstrating sensitivity, precision, and stability with proof-of-concept from elimination studies in humans.
- Human trial 2004AOD-9604 Metabolic.
This study describes the development of AOD-9604 for obesity treatment, with phase IIa trials underway by February 2002.
- Human trial 2003The anti-obesity drug AOD-9604* has demonstrated favourable safety and tolerability in a phase II clinical trial.
This article reports that the anti-obesity drug AOD-9604 showed favorable safety and tolerability in a phase II clinical trial.
- Human trial 2005AOD9604, an orally active peptide for the treatment of obesity: Results of a phase 2b study
This phase 2b study evaluates AOD9604, an orally active peptide, for the treatment of obesity.
- Review 2026Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance
- Review 2026Therapeutic Peptides in Orthopaedics: Applications, Challenges, and Future Directions
- Review 2014Detecting peptidic drugs, drug candidates and analogs in sports doping: current status and future directions
This review discusses the current status and future directions of analytical methods for detecting peptidic drugs and analogs in sports doping.
+ 38 more studies indexed for AOD-9604.
Frequently asked questions
- Is AOD-9604 approved for human use?
- AOD-9604 is a synthetic 16-amino-acid peptide corresponding to the C-terminal fragment (residues 177-191) of human growth hormone with an added N-terminal tyrosine. It is not approved by the US FDA as a drug for any indication, has no FDA-approved label, and no established human dosing. In December 2024 the FDA reviewed AOD-9604 for the Section 503A compounding bulk drug substances list and proposed that it NOT be included, citing insufficient evidence of safety and effectiveness. Marketed "research peptide" supply is unapproved and outside FDA-evaluated channels.
- What does the research on AOD-9604 show?
- The evidence base is weak. In obese mice, AOD-9604 reduced body-weight gain, increased fat oxidation and stimulated lipolysis without binding the hGH receptor or affecting IGF-1, supporting a metabolic (non-growth) mechanism (Heffernan et al., Int J Obes 2001, PMID 11673763). In humans, a 24-week Phase IIb dose-finding trial of 536 adults with obesity did not produce statistically significant weight loss versus placebo, and clinical development was discontinued in 2007. AOD-9604 is not FDA-approved and has no proven human efficacy for fat loss.