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What it is
A synthetic peptide corresponding to the C-terminal fragment of human growth hormone: residues 177 to 191 with an extra tyrosine at the N-terminus, sixteen residues in all, which is why it is often labelled hGH 176-191. Developed in Australia specifically to separate growth hormone's lipolytic effect from its growth and IGF-1 effects.
How it is proposed to work
The fragment was proposed to reproduce growth hormone's effect on fat metabolism without receptor-mediated growth signalling — an elegant idea, and the reason the programme attracted investment. The clinical results did not support it.
Approved medical uses
None. AOD-9604 has no approved human medical indication in the jurisdictions we track. Any use is outside an approved label.
Human research
Each entry states what the study found and, separately, what it cannot show.
- Narrative review2013
Developer's pooled safety summary of six human trials, 2001-2006
Finding. A sponsor-funded safety summary of six randomised, double-blind, placebo-controlled trials run between 2001 and 2006, in which 893 adults took part, most of them clinically obese. The peptide was given either as a single intravenous dose, in the first two trials (a phase I and a phase IIa), or by mouth, as capsules in three trials and tablets in one — the oral four include both phase IIb trials, of 12 and 24 weeks. The paper reports no weight-loss result for either phase IIb trial. Its abstract states that no serious adverse event related to the peptide occurred in any study; its body lists five serious adverse events in the 12-week trial, all in groups receiving the peptide and none on placebo: basal cell carcinoma, squamous cell carcinoma, breast cancer, malignant melanoma and a lipoma. The investigators judged none of them related to treatment, because IGF-1 showed no clinically significant difference between groups and none of the cancers occurred in the highest-dose group.
Limitation. This is the developer's own account, not independent work. Two of the three authors are affiliated with the developer, one declares a financial interest in the company that owns it, and the acknowledgments thank the developer for funding all six trials. The article is not indexed in PubMed or Europe PMC. It pools safety data and reports no efficacy outcome, so it cannot confirm or quantify the phase IIb failure the dossier describes. Four cancers among five serious adverse events, all in treated groups, is reported here alongside the investigators' reasons for judging them unrelated; whether that judgement holds could only be tested with the trial data, which have not been published. None of the six trials used subcutaneous injection.
Preclinical research
Animal and laboratory work. Useful for generating hypotheses; it cannot establish that something works in people.
No preclinical studies catalogued.
Potential safety concerns
- CautionInsufficient
No human safety data for subcutaneous injection was found in any source searched, despite that being the only way it is used. Human safety data exist only for oral dosing and for single intravenous doses, and neither tells you what repeated subcutaneous injection does.
- SeriousEstablished
Fabricated regulatory claims circulate for this compound, including a specific but non-existent FDA GRAS notice number. A vendor repeating it is either not checking or not honest, and either should change how you weigh everything else they say.
- CautionEstablished
Prohibited in sport.
- CautionInsufficient
Five serious adverse events occurred in the developer's 12-week trial, all in groups receiving the peptide and none on placebo, and four were cancers: basal cell carcinoma, squamous cell carcinoma, breast cancer and malignant melanoma. The investigators judged none related to treatment, on the grounds that IGF-1 did not differ meaningfully between groups and that no cancer occurred in the highest-dose group. That is the investigators' judgement in a sponsor-funded paper, and the trial data needed to test it have never been published. The paper's abstract summarises the same events as no serious adverse event related to the peptide.
Known interactions and contraindication considerations
- Not characterised in humans for the route in actual use.
This list is not exhaustive and is not a substitute for a clinician reviewing your full medication history.
Regulatory status
Status is shown per jurisdiction and is accurate only as of the date stated. Where a compound is approved, the approval is bound to a specific formulation, manufacturer and indication — shown in the detail column.
| Jurisdiction | Standing | Detail |
|---|---|---|
United States FDA | Not approved as of 6 Aug 2026 | Not approved. Development for obesity was discontinued after the phase 2b failure. Widely repeated claims of FDA GRAS status are false — no GRAS notice for this substance was found, and FDA does not 'grant' GRAS in any case. The claim appears to trace to the developer's own 2013 paper, which reports that an expert panel it convened judged the peptide Generally Recognized As Safe for its intended use. That is a self-affirmed determination by the company, not a notice to FDA and not FDA's opinion. |
European Union EMA | Unapproved / investigational as of 6 Aug 2026 | No marketing authorisation. |
India CDSCO | Unapproved / investigational as of 6 Aug 2026 | Not approved for human use. |
How it is being used
What the grey community actually runs, the reasoning they give, and our read on whether it follows from known biology. This is observation, not evidence, and not a recommendation.
No community use documented for this compound yet. Absence here means our editorial team has not reviewed and verified a pattern — not that none exists.
Active clinical trials
No registered trials currently tracked for AOD-9604.
What remains unknown
The questions that would change our assessment if they were answered.
- Does subcutaneous administration behave differently from the oral and intravenous routes that were tested? No trial of it was found.
- Do the cartilage and osteoarthritis signals amount to anything in adequately powered work?
- Would the phase IIb trial data, if published, bear out the developer's announcement — and the investigators' judgement that the cancers in its 12-week trial were unrelated?
References
Editorial change history
When we change a grade or a regulatory note, we log it here rather than editing quietly.
Dossier created. Fact-check rejected the widely circulated 'FDA GRAS, GRN 000546' claim as fabricated — that notice number belongs to an unrelated substance. Also surfaced that no human efficacy trial used the injected route, which the claim set had missed entirely.
Grade of tested-negative kept, and its basis stated honestly. The summary called the compound 'properly tested', but the phase IIb weight-loss failure has never been published with data: it is known only from the developer's 2007 stock-exchange announcement. The trials themselves demonstrably ran — the developer's own 2013 safety paper describes them — and that paper now fills the human research section. The placeholder slot for the phase IIb result was removed rather than kept, because no source reporting its data exists to cite. That paper also lists five serious adverse events in the 12-week trial, four of them cancers and all in treated groups, which its abstract summarises as no serious adverse event related to the peptide; that is now a safety signal, with the investigators' reasons for judging them unrelated reported alongside. Three factual corrections: the structure is residues 177-191 plus an N-terminal tyrosine, sixteen residues, not 176-191 with a tyrosine added; 'every human efficacy trial used oral administration' was true only of the obesity programme, since a later analgesia trial as LAT8881 used a single intravenous infusion; and the GRAS myth now has its origin recorded — a self-affirmed expert-panel determination the developer reported, not an FDA notice.
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