Peptide dossier, updated Nov 1, 2026
AOD-9604
A modified fragment of human growth hormone, developed as an obesity drug candidate. Papers describe it as a lipolytic fragment of growth hormone. It has no approved use. We found no registered trial and no published human trial; what we found of the sponsor’s phase 2 trials comes from a 2004 news report and a 2006 company release. FDA says it may be associated with serious adverse events, though causality is not clear. This page lays out what each source actually says.
See all 10 verified records for AOD-9604 on the Records page
In plain terms
Approved for: Nothing. FDA has not approved AOD-9604 for any use.
What it is: A modified piece of human growth hormone. Papers describe it as a lipolytic fragment, meaning a piece that breaks down fat in lab and animal tests, without the rest of the hormone.
What it is said to do, and by whom:
- The sponsor, Metabolic Pharmaceuticals: developed it as a candidate obesity drug. A 2004 news report says its phase 2 trial found a mean weight change of 2.8 kg at 1 mg, with a p-value of 0.1 against placebo in the primary analysis. Analysts quoted in the report questioned the significance.
- Researchers: 2001 studies in obese mice reported increased fat oxidation and weight loss.
- We did not collect sellers’ claims for this compound.
How strong the evidence is: Very thin. The only human efficacy result we found is a company-reported figure in a news article, and a larger 536-person phase 2b whose own results we could not find. The sponsor’s 2013 ASX announcement says its six trials overall showed no clinically meaningful weight loss. A 2015 rabbit study looked at joint injection for osteoarthritis. FDA says serious adverse events may be associated with it, though causality is not clear.
FDA review
FDA’s safety-risk page (content current Apr 22, 2026) is the one FDA document on AOD-9604 that we read.
What the page says
- It lists AOD-9604 in the table of bulk drug substances nominated but withdrawn, previously in category 2 under the interim policies.
- It says compounded drugs containing it may pose significant risk for immunogenicity for certain routes and may have complexities with peptide-related impurities and API characterization.
- It says FDA has identified no, or only limited, safety information, so it lacks sufficient information to know whether the drug would cause harm in humans. It adds that FDA has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear.
What we did not find
- The page does not describe the adverse events or cite their source.
- We found no FDA briefing document, advisory committee review or press release specific to AOD-9604.
Published research and the sponsor’s trial
PubMed returns 11 results for “AOD-9604” and 22 for “AOD9604” as of Nov 1, 2026, with overlap. We found no published human trial among them. ClinicalTrials.gov has no record.
What the sources show
- Sponsor profile, 2004. A drug-pipeline note says Metabolic was developing AOD-9604 for obesity and that phase IIa trials were underway by February 2002. Curr Opin Investig Drugs PubMed
- News report, Dec 17, 2004. Reports the phase 2 results for 1 mg and 30 mg doses: a mean weight change of 2.8 kg at 1 mg, a primary-analysis p-value of 0.1 against placebo, and analysts questioning the dose-response pattern. The article gives no group sizes or duration. LabOnline News
- Company announcement, Oct 5, 2006. Says a placebo-controlled phase 2b trial of oral AOD9604 at 0.25, 0.5 and 1 mg had enrolled 536 people in Australia, with a 12-week weight-loss primary endpoint and 24 weeks of treatment. It reports no results and says results were expected in March 2007. BioSpace Company release
- Obese mice, 2001. Papers on chronic treatment with human growth hormone and its fragment; one reports increased fat oxidation and weight loss. Int J Obes Relat Metab Disord PubMed
- Rabbits, 2015. Intra-articular injection, with or without hyaluronic acid, in an osteoarthritis model. Ann Clin Lab Sci PubMed
Read with care
- The phase 2 figures come from a news report that relays the company’s statements. We did not find the trial report.
- The larger phase 2b was announced as fully enrolled in 2006, with results due in March 2007. We searched and found no results announcement or publication.
- We read titles and one news article, not full papers.
FDA warning letters
We found one FDA warning letter that names AOD-9604. It is addressed to a compounding pharmacy and is not a finding about AOD-9604’s safety. This rests on web searches.
| Recipient | Date | Letter | What it says |
|---|---|---|---|
| Tailor Made Compounding LLC, a compounding pharmacy | Apr 1, 2020 | Warning letter 594743 | FDA says an inspection found the firm compounding with a list of 22 bulk substances that includes AOD 9604, and that drugs made from them were not eligible for the section 503A exemptions because none is covered by a USP or NF monograph, is a component of an FDA-approved drug, or appears on the 503A bulks list. The letter also says AOD 9604 and other listed substances had not been nominated for FDA to evaluate. We read the letter text. FDA’s page now lists AOD-9604 as nominated and withdrawn. |
A warning letter is FDA’s statement about one firm’s conduct on one date. It is not a finding about the substance. FDA’s list of letters cannot be searched by peptide, so other letters could exist that we did not find.
Timeline
Newest first. Every entry links to the document it comes from.
- Government or registry record
- Journal
- Oct 30, 2026RegulatoryHHS publishes draft policy pausing enforcement on six peptides; AOD-9604 is not one of them
The draft policy’s appendix names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. The policy is a draft and not FDA approval. We read the appendix through a text extraction.
- July 23–24, 2026RegulatoryFDA advisory committee meets on seven peptides; AOD-9604 is not among them
The committee recommended six of the seven, all nonbinding. FDA’s notice of the meeting does not list AOD-9604.
- Apr 22, 2026RegulatoryFDA’s safety-risk page lists AOD-9604
FDA lists AOD-9604 as nominated-but-withdrawn and says serious adverse events may be associated with it, though causality is not clear.
- Jan 1, 2026Anti-dopingWADA’s 2026 Prohibited List names AOD-9604 in S2.2.3
The list names it among growth hormone fragments. We read a copy hosted by an athletics federation, not WADA’s own file.
- Apr 1, 2020EnforcementFDA warning letter to a compounding pharmacy names AOD-9604 among 22 substances
The letter says drugs the firm compounded from these bulk substances were not eligible for the 503A exemptions.
- Apr 26, 2013Company filingSponsor tells the ASX its six obesity trials showed no clinically meaningful weight loss
Calzada’s announcement says six trials in 925 patients between 2001 and 2007 did not show a clinically meaningful weight loss outcome across the total trial population, and that the obesity program ended in February 2007. It gives no per-trial results. It also describes a 2012 GRAS recognition for use as a food ingredient, which we did not verify.
- Oct 5, 2006Company releaseSponsor says its 536-person phase 2b obesity trial has finished recruiting
The release reports no results and gives March 2007 as the expected date. We found no results announcement.
- Dec 17, 2004News reportNews report on the sponsor’s phase 2 obesity trial
Reports a mean 2.8 kg weight change at 1 mg and a primary-analysis p-value of 0.1, with analysts questioning the results.
Still not covered
Left off rather than guessed:
- HHS policy: we read the draft policy appendix through a text extraction, not as the original PDF layout. It names six covered peptides and not AOD-9604.
- FDA review: we found no FDA briefing document or advisory committee evaluation for AOD-9604. FDA’s notice for the July meeting does not name it, so the safety-risk page entry is the only FDA statement on it that we read.
- The phase 2 trials: we found no trial report for the 2004 phase 2, and no results specific to the 536-person phase 2b announced in 2006. The sponsor’s later ASX announcement (Apr 26, 2013) says six trials in 925 patients between 2001 and 2007 “did not show a clinically meaningful weight loss outcome across the total trial population” and that the obesity program ended in February 2007. It gives no per-trial results, so the 536-person trial’s own numbers are still unpublished as far as we found.
- The adverse events FDA cites: not described on the page.
- Drugs@FDA: we searched openFDA’s copy of the Drugs@FDA data by active ingredient and found no application. FDA’s own Drugs@FDA site could not be searched from our tools.
- Patents and SEC filings: not researched for this dossier.
- Seller claims and independent lab reports: how gray-market product is marketed versus what testing finds. We have not collected testing data.
- Unread items: full text of most papers; EU and other non-US regulators and registries; WADA lists for years other than 2026; FDA warning letters beyond those listed, which rest on web searches.