Molecule profile · Module 3
AOD-9604 — evidence and research limits
This label describes the research context of this profile, not a product-by-product approval determination. It does not mean every use of the molecule lacks approval. Read the existing evidence details and regulatory context for the specific preparation, indication and jurisdiction; no new approval is inferred.
MOLECULE PROFILE
- Evidence summary
- Investigational — profile context
- The 2013 report by Stier and colleagues summarizes safety data from six human trials using intravenous or oral administration. It is not a trial of the subcutaneous regimens promoted elsewhere and does not establish their efficacy or long-term safety. Author links to the developer are relevant when appraising the report. The interpretation is specific to the studied molecule, formulation, route, population, and endpoint. Reported commercial regimens are not validated by a study of a different product or outcome.
- Regulatory status varies by jurisdiction
- The academic source does not establish a current authorization for every preparation sold under this name. Product identity, formulation, indication, jurisdiction, and current official labeling must be checked separately. A discussion of compounding or an advisory meeting is not a product approval.
Educational information for healthcare professionals and the general public. Not individual medical advice, diagnosis, treatment, or a recommendation to use a compound.
Identity and mechanism
AOD-9604 is a modified fragment related to the C-terminal region of growth hormone. The rationale discussed in the course concerns metabolic effects attributed to the fragment, rather than assuming that it reproduces every action of full-length growth hormone. Identity, formulation, and route must be specified when comparing reports.
Identity: FDA describes AOD-9604 as a 16-amino-acid synthetic fragment of human growth hormone (hGH) residues 177–191 with an added N-terminal tyrosine, often written Tyr-hGH(177–191); the free base and the acetate are different substances. It is not human chorionic gonadotropin (hCG), a different hormone, and it should not be assumed to be the same material as products labelled “hGH fragment 176–191”. A label that treats “HCG Frag 176–191”, hGH 176–191 and AOD-9604 as interchangeable is an inconsistency that calls for analytical verification, not a sign of transparency.
What the evidence supports
The 2013 report by Stier and colleagues summarizes safety data from six human trials using intravenous or oral administration. It is not a trial of the subcutaneous regimens promoted elsewhere and does not establish their efficacy or long-term safety. Author links to the developer are relevant when appraising the report.
The interpretation is specific to the studied molecule, formulation, route, population, and endpoint. Reported commercial regimens are not validated by a study of a different product or outcome.
The obesity development program is a negative-evidence case: FDA’s 2024 briefing document quotes a 2015 publication by Cox and colleagues stating that AOD-9604 “did not show a clinically meaningful weight loss outcome across the trial population.” Those trials do not support claims of reliable fat loss or of safe continuous use.
Regulatory context
The academic source does not establish a current authorization for every preparation sold under this name. Product identity, formulation, indication, jurisdiction, and current official labeling must be checked separately. A discussion of compounding or an advisory meeting is not a product approval.
Safety and uncertainty
Do not infer long-term subcutaneous safety from studies with other routes. Human safety cannot be inferred from a cell result, a product name, or lack of events in a small report. These educational adaptations do not provide an administration protocol.
Sport and anti-doping status
The WADA 2026 Prohibited List names AOD-9604 and hGH 176-191 as growth hormone fragments in section S2.2.3, prohibited at all times (in and out of competition). This is an anti-doping classification, separate from clinical evidence, product quality and regulatory approval. Medical supervision, a prescription or an approved indication does not by itself permit use in sport; any exemption for a documented medical condition is a separate decision by the competent anti-doping organization. The List is revised each year, so check the List in force on the relevant date.
Continue learning
Explore Module 3 in PEPTIDE Academy for the full evidence discussion.
References
Bibliographic sources shown for transparency. Citation verification pending; no citation is marked verified.
- Stier H, Vos E, Kenley D. 2013. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans. J Endocrinol Metab 3:7–15. DOI 10.4021/jem157w. Synthesis of developmental studies; conflicts of interest related to the program.DOI 10.4021/jem157w
- U.S. Food and Drug Administration. Briefing document, Pharmacy Compounding Advisory Committee meeting of 4 December 2024: AOD-9604 bulk drug substances. Checked 19 October 2026.
- World Anti-Doping Agency. International Standard: Prohibited List 2026 (in effect from 1 January 2026). Checked 19 October 2026.
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