AOD-9604
Synthetic 16-amino-acid peptide corresponding to the C-terminal lipolytic domain of human growth hormone (Tyr-hGH 177-191 with an added N-terminal tyrosine). Developed by Metabolic Pharmaceuticals for obesity. Failed to produce significant weight loss in human Phase 2b clinical trials. Placed in Category 2 bulk compounding restrictions by US FDA. Unapproved.
60-Second Scientific Briefing
AOD-9604 is a synthetic 16-amino acid peptide derived from the lipolytic C-terminus of human growth hormone (hGH 177-191) with an added tyrosine at the N-terminus. Investigated in early clinical trials for obesity, it failed to show statistically significant weight loss in a large Phase 2b trial and clinical development as an anti-obesity drug was discontinued.
What is AOD-9604?
Pharmacological Classification & Molecular IdentitySynthetic modified peptide corresponding to amino acids 177-191 of human growth hormone with an additional tyrosine residue at the amino terminus.
Verified Chemical & Regulatory Registry Identifiers
Mechanism of Action & Receptor Targets
Biological Pathway and Target BindingBiological pathway and target receptor binding mechanism.
Receptor Selectivity: Stimulates beta-3 adrenergic receptor pathways in adipose tissue to enhance lipolysis in preclinical models without binding growth hormone receptors or elevating IGF-1.
Regulatory & FDA Approval Status
Legal and Regulatory ClassificationsNot approved by the US FDA for obesity, fat loss, or any medical indication. Classified under FDA 503A Category 2 with safety concerns. Banned by WADA under Category S2.
AOD-9604 is not approved for commercial sale, prescription therapy, or compounded medication distribution. It exists strictly within authorized scientific and clinical research frameworks.
Human Evidence & Clinical Trials
Clinical Study Readouts and Evidence SynthesesEvaluated in human Phase 2 trials for obesity in Australia; failed to show statistically significant weight loss over placebo in a 300-patient Phase 2b trial (OPTIONS study), leading to discontinuation of systemic drug development.
Clinical Evidence
Evaluated in human Phase 2 trials for obesity in Australia; failed to show statistically significant weight loss over placebo in a 300-patient Phase 2b trial (OPTIONS study), leading to discontinuation of systemic drug development.
Safety Profile & Clinical Limitations
Documented Adverse Events and Known UncertaintiesReported adverse events in trials were generally mild (headache, fatigue, palpitations, injection site reactions). Absence of comprehensive safety surveillance data.
Lack of long-term human safety, immunogenicity data, and lack of reproducible efficacy in robust human studies.
Dose Approval Status
Commercial Dosing Status and Policy DirectivesNOT ESTABLISHED. No approved human dosage exists.
Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.
What is Known vs. What is Unknown
Evidence Comparison and Clinical Evidence Boundaries✓ Confirmed Scientific Evidence
- Synthetic modified peptide corresponding to amino acids 177-191 of human growth hormone with an additional tyrosine residue at the amino terminus.
- Targets & Selectivity: Stimulates beta-3 adrenergic receptor pathways in adipose tissue to enhance lipolysis in preclinical models without binding growth hormone receptors or elevating IGF-1.
- Evaluated in human Phase 2 trials for obesity in Australia; failed to show statistically significant weight loss over placebo in a 300-patient Phase 2b trial (OPTIONS study), leading to discontinuation of systemic drug development.
- Safety considerations: Reported adverse events in trials were generally mild (headache, fatigue, palpitations, injection site reactions). Absence of comprehensive safety surveillance data.
? Unknown / Under Ongoing Investigation
- Lack of long-term human safety, immunogenicity data, and lack of reproducible efficacy in robust human studies.
Verified Questions & Answers
10 Verified scientific answers with permanent anchor keysAOD-9604 is classified as a Growth Hormone Lipolytic Fragment Analogue. Molecular structure: Synthetic modified peptide corresponding to amino acids 177-191 of human growth hormone with an additional tyrosine residue at the amino terminus..
Pharmacological classification and molecular integrity are documented in verified regulatory and scientific literature.
AOD-9604 exerts biological activity via Stimulates beta-3 adrenergic receptor pathways in adipose tissue to enhance lipolysis in preclinical models without binding growth hormone receptors or elevating IGF-1..
Receptor binding affinity and selectivity dictate the physiological response observed in laboratory and clinical trials.
Regulatory status: Not approved by the US FDA for obesity, fat loss, or any medical indication. Classified under FDA 503A Category 2 with safety concerns. Banned by WADA under Category S2.
Investigational and research-only compounds cannot be legally distributed or marketed as prescription drugs.
- World Anti-Doping Agency (WADA) Prohibited List: Non-Approved Substances (S0) and Peptide Hormones (S2) (World Anti-Doping Agency, 2024-01-01)
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Clinical evaluation status: Evaluated in human Phase 2 trials for obesity in Australia; failed to show statistically significant weight loss over placebo in a 300-patient Phase 2b trial (OPTIONS study), leading to discontinuation of systemic drug development.
Clinical trial readouts and systematic analyses establish the boundary between demonstrated findings and experimental hypotheses.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Reported safety profile: Reported adverse events in trials were generally mild (headache, fatigue, palpitations, injection site reactions). Absence of comprehensive safety surveillance data.
Adverse reaction monitoring and contraindications are critical parameters in pharmacological risk-benefit evaluation.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Key scientific uncertainties: Lack of long-term human safety, immunogenicity data, and lack of reproducible efficacy in robust human studies.
Egypt Peptides enforces strict transparency regarding scientific limitations and gaps in longitudinal clinical data.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
NOT ESTABLISHED. No approved human dosage exists.
Under medical governance mandates, clinical study dosages represent strictly controlled experimental parameters and must never be interpreted as individual therapeutic advice.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Storage status: NOT ESTABLISHED. Unapproved for commercial human pharmacy distribution.
Peptide integrity degrades rapidly when exposed to elevated temperatures, repeated freeze-thaw cycles, or direct UV light exposure.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Yes. Unapproved pharmacological substances are strictly prohibited at all times in competitive sports under WADA Category S0 (Non-approved substances) or Category S2.
Athletes subject to drug testing face strict liability and multi-year competition bans upon detection of prohibited peptides or their metabolites.
- World Anti-Doping Agency (WADA) Prohibited List: Non-Approved Substances (S0) and Peptide Hormones (S2) (World Anti-Doping Agency, 2024-01-01)
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Egypt Peptides provides peer-reviewed scientific reference monographs for research documentation. We strictly prohibit individual medical consultations, reconstitution guides, stacking recipes, or off-label use instructions.
All scientific claims must link to verified authoritative sources (FDA, PubMed, ClinicalTrials.gov) with zero tolerance for ungrounded marketing claims.
Authoritative Sources & Literature Registry
Regulatory dossiers, clinical trial registries, and peer-reviewed studiesWorld Anti-Doping Agency (WADA) Prohibited List: Non-Approved Substances (S0) and Peptide Hormones (S2) ↗
https://www.wada-ama.org/en/prohibited-list
FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) ↗
https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta(3)-AR knock-out mice ↗
https://doi.org/10.1210/endo.142.12.8522