AOD-9604
Also sold as: AOD9604, Anti-Obesity Drug 9604, hGH fragment 176-191, hGH 176-191, Tyr-hGH(177-191)
AOD-9604 is not an FDA-approved drug — FDA's approvals database returns no matches for it — and it is not on FDA's 503A bulk drug substances list, appearing instead in FDA's table of substances 'nominated but withdrawn', which records a withdrawal by the nominator rather than any clearance by FDA. Real human data does exist, unusually for a peptide sold this way: six double-blind, placebo-controlled trials run by sponsor Metabolic Pharmaceuticals between 2001 and 2006 dosed roughly 900 adult subjects, of which only the two long-term trials are described by the sponsor's own methods as randomised. But the programme was terminated in 2007 after its 24-week trial failed to induce significant weight loss, no primary report of the long-term efficacy results was ever published in the peer-reviewed literature, and FDA states it has identified serious adverse events that may be associated with AOD-9604, though causality is not clear.
Which molecule this is. Sold almost universally as 'hGH fragment 176-191', which is not what it is. AOD-9604 is a hexadecapeptide: the C-terminal fragment of human growth hormone spanning residues 177-191 plus an ADDITIONAL TYROSINE residue at the N-terminus that is not present in human GH. It is a synthetic analogue, not a native fragment. This has one consequence worth stating plainly: the endogenous-biomarker trap that inflates the apparent human evidence base for MOTS-c and TB-500 cannot operate here, because AOD-9604 does not occur in the body and cannot be measured as an endogenous analyte. Every human measurement of it is a measurement of an administered drug.
FDA status
FDA has not approved this and it is not in active development toward approval. That says nothing about whether it is being sold — most substances in this category are.
Not an FDA-approved drug for any indication, and not in active development toward approval. That says nothing about whether it is sold — it is.
“Bulk drug substances nominated but withdrawn”Checked against the source on .
503A compounding
The nominator withdrew the nomination. This is not a legalisation event — the substance is not on the 503A bulks list and remains non-compoundable.
Absent from Categories 1, 2 and 3 in the list updated 2026-05-14 — verified by fetching and text-extracting the document directly. Category 2 contains exactly six substances (Cesium Chloride, Domperidone, Germanium Sesquioxide, Ibutamoren Mesylate, Kisspeptin-10, Quinacrine HCl for intrauterine administration) and AOD-9604 is not among them. The absence is documented, not inferred: FDA's companion safety-risks page lists AOD-9604 under the table heading 'Bulk drug substances nominated but withdrawn', which is what rules out `never-nominated`. The nomination was withdrawn by the nominator. That is not a legalisation event — AOD-9604 did not enter Category 1, is not on the 503A bulks list, and remains non-compoundable. Status moved sideways, not forward. Separately: AOD-9604 is NOT one of the seven substances before the Pharmacy Compounding Advisory Committee on 23-24 July 2026 (those are BPC-157, emideltide/DSIP, epitalon, KPV, MOTS-c, semax and TB-500). No PCAC review of AOD-9604 is scheduled, so readers waiting on a July 2026 decision for this compound are waiting for a meeting that is not about it.
“Bulk drug substances nominated but withdrawn”Checked against the source on .
Evidence
There is human data, but efficacy is not established. This includes programmes that were tested and failed.
Administration check run and PASSED — the drug was genuinely given to humans. Six double-blind, placebo-controlled trials conducted 2001-2006 by sponsor Metabolic Pharmaceuticals dosed roughly 900 adult subjects: three Phase I/IIa single-dose studies and one Phase IIa multiple-dose study, plus two long-term Phase IIb studies of 12 and 24 weeks. Intravenous route in the two earliest studies, oral thereafter. This is administration of an exogenous synthetic analogue, not endogenous biomarker measurement. ON RANDOMISATION, because it is the key quality marker and the source is internally inconsistent about it: Stier's ABSTRACT says 'Six randomized, double-blind, placebo-controlled trials were performed with AOD9604', but Stier's own METHODS label only the two Phase IIb studies — METAOD005 and METAOD006 — as randomized. METAOD001 and METAOD004 are described as '(double-blind, placebo-controlled, dose escalation)' and METAOD002 and METAOD003 as '(double-blind, placebo-controlled 4 × 4 Latin Square design)', with no randomisation stated for any of the four. We therefore describe all six as double-blind and placebo-controlled, which the methods support, and only the two Phase IIb trials as randomised. Repeating the sponsor's strongest framing in our own voice would be the same deference this record criticises elsewhere. ON REGISTRATION: ClinicalTrials.gov returns ZERO registrations for AOD-9604/AOD9604 (API queried 2026-07-16), but that bare negative reads as concealment and the fuller fact is in our own load-bearing source — Stier states 'The two largest studies (METAOD005 and METAOD006) were registered at the Therapeutic Goods Administration's Clinical Trial Notification (CTN) Scheme in Australia.' The two pivotal trials WERE registered, on the Australian regulator's scheme rather than a US registry. This is the jurisdiction artefact stated positively: the usual 'no registrations therefore no human data' inference is simply wrong for this compound, and so is any vendor claim resting on registry counts in either direction. The tier is 'promising-but-unproven' strictly in this schema's sense — human data exists, efficacy is NOT established — and the word 'promising' should not be read as encouraging. The vocabulary is explicit that this tier includes programmes that were tested and failed, which is what happened here. There is no Phase 3, and AOD-9604 is not an FDA-approved drug (Drugs@FDA, fdaFindings below). We make no claim about approval in other jurisdictions: we hold no source for one, and the obviously relevant regulator for an Australian sponsor — the TGA — was not successfully checked on 2026-07-16. A blank is honest. The honest gap, now narrower than this record previously stated it: Stier 2013 reports SAFETY AND TOLERABILITY ONLY and does not report the efficacy results of the Phase IIb studies. No PRIMARY peer-reviewed trial report of those outcomes appears ever to have been published. The outcomes are nonetheless known — from the sponsor's ASX announcement of 21 February 2007 (not peer-reviewed; its URL is dead and the company is gone) and from peer-reviewed secondary reviews that report it, principally Valentino et al. 2010. The 12-week figures are not reproduced here because they carry dosing. What is verified: a real controlled programme in ~900 humans ran, its 24-week trial failed to induce significant weight loss, and it did not produce an approved drug.
“All studies were performed as double-blind placebo-controlled trials … Approximately 900 adult subjects participated in these 6 clinical trials.”Checked against the source on .
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
FDA identifies AOD-9604 as posing significant immunogenicity risk for certain routes of administration, with complexities regarding peptide-related impurities and API characterization.
Note the scope: this finding is about COMPOUNDED DRUGS containing AOD-9604 as a bulk substance — impurity profiles and characterization of the API as supplied — not about the sponsor's pharmaceutical-grade material used in the 2001-2006 trials. A safety record generated under GMP in a controlled trial does not transfer to a compounded or gray-market preparation of the same sequence. Of the substances FDA lists here, AOD-9604 is one of the few given 'significant' rather than plain 'risk' for immunogenicity — FDA's wording for BPC-157, CJC-1295 and epitalon omits that adjective.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026“Compounded drugs containing AOD-9604 may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization.”
Checked against the source on .FDA states it lacks sufficient information to know whether AOD-9604 would cause harm when administered to humans.
This sits in genuine, unresolved tension with the evidence record above, and we are recording the tension rather than smoothing it. FDA says it has 'no, or only limited' safety information; a sponsor-funded pooled analysis reports six placebo-controlled trials in ~900 subjects. Both statements are documented. READ THE SCOPING CLAUSE CAREFULLY, because it is not what it is for BPC-157. FDA's BPC-157 entry on this same page says it has identified no, or only limited, safety-related information 'for the proposed routes of administration'. The AOD-9604 sentence contains no such qualifier — FDA states flatly that it has identified no, or only limited, safety-related information. Re-verified against the page text on 2026-07-16. An earlier version of this note offered route-scoping as one candidate explanation for the tension; the document does not support that reading, and it is withdrawn. Only the immunogenicity sentence above is route-scoped. We still do NOT know which of the remaining explanations is correct — the nomination may never have put the trial data before the agency; unpublished sponsor data is not data FDA holds; the trials were never registered on a US registry and were published, in part, in a journal not indexed in PubMed; or FDA may weigh a sponsor's own unpublished-efficacy programme differently than the sponsor does. Anyone asserting a single explanation is guessing. What must not be done with this quote is either available distortion: it is not FDA conceding AOD-9604 is untested, and it is not FDA calling it dangerous.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026“FDA has identified no, or only limited, safety-related information. Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans.”
Checked against the source on .FDA states that the bulk drug substances it lists as 'nominated but withdrawn' — the table AOD-9604 appears in — were previously in category 2 and were withdrawn by the nominators, not by FDA.
The sentence the market gets backwards, quoted as printed (including FDA's own subject-verb disagreement). It establishes three things at once, and the third is the one that matters. First, AOD-9604 was nominated — this is the documentary basis for `withdrawn-from-nomination` rather than `never-nominated`. Second, it was in category 2, the significant-safety-risk category, before it left. Third, the actor was the NOMINATOR. FDA did not clear AOD-9604, did not reverse its safety assessment, and did not move it anywhere; a private party stopped asking. FDA's retention of the substance on this safety-risks page, with its risk text intact, after the withdrawal is the point: the assessment survived the nomination. Withdrawal removed the request, not the finding.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026“This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators.”
Checked against the source on .Drugs@FDA, FDA's database of approved drug products, returns no matches for AOD-9604. There is no approved application for AOD-9604 for any indication or route.
The quote is the API's verbatim response body, not prose about it — the only honest way to cite an absence. Queried on generic name, active-ingredient name and brand name; all three return the same. The claim is deliberately narrow: it establishes that no approval EXISTS, not that FDA reviewed and refused one. Those are different facts and only the first is in evidence — we found no record that AOD-9604 was ever the subject of an NDA. This finding is load-bearing on THIS record in a way it is not on the others here. Everywhere else in this set, 'no approval' is unsurprising because there is no clinical programme. AOD-9604 has one — six controlled trials, ~900 subjects — which makes the inference 'a real trial programme, therefore it must be approved somewhere' available and wrong. A programme that ran and stopped leaves exactly this trace: trials in the literature, nothing in the approvals database.
Drugs@FDA — approved drug products database, queried for AOD-9604 (openFDA) — FDA, 16 July 2026“No matches found!”
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Documented safety signals
FDA has identified serious adverse events that may be associated with AOD-9604, with causality not established.
The most important sentence on this record and the least usable, in both directions. FDA does not say what the events were, how many, by what route, or from what source. We attempted corroboration and failed: the openFDA FAERS API returns NO matching records for medicinalproduct 'AOD-9604' or 'AOD9604' (queried 2026-07-16), so unlike BPC-157 — where the PCAC briefing document itemises two FAERS reports — we cannot characterise these events at all. The 'serious adverse events' language does imply some human exposure occurred, which the trial programme independently establishes; it does NOT follow that the events came from those trials. 'Causality is not clear' is FDA's own qualifier and must travel with the claim. Treated correctly, this is an unresolved signal: not evidence of harm, and not evidence of safety.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026“FDA has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear.”
Checked against the source on .The sponsor's pooled analysis of all six trials reports no treatment-related serious adverse events, directly contradicting FDA's serious-adverse-event statement.
Recorded as a CONTRADICTION, not as reassurance. Read the byline: Vos and Kenley were employed by Metabolic Pharmaceuticals, which funded all six trials, and the paper thanks the sponsor for that funding. A manufacturer-authored pooled safety analysis of its own unregistered trials, published in a journal not indexed in PubMed, is the weakest possible evidence against a regulator's adverse-event finding — and it is routinely the single citation vendor pages use to call AOD-9604 'clinically proven safe'. Note also what the sentence actually says: no serious events RELATED TO INTAKE, a causality judgement made by the sponsor. It does not say no serious events occurred. The two findings are not reconcilable from public documents, and we are not reconciling them.
Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans — Journal of Endocrinology and Metabolism 3(1-2):7-15, 1 April 2013“In none of the studies did a withdrawal or serious adverse event occur related to intake of AOD9604.”
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Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is AOD-9604 legal in 2026?
AOD-9604 is not on FDA's 503A bulk drug substances list — the list of substances that may lawfully be used in pharmacy compounding — as of the list updated 14 May 2026, and it appears in none of that list's three categories. It is not an FDA-approved drug and is not a component of one. Absence from the list is not a permission: it means AOD-9604 has not been found appropriate for compounding, not that it has been cleared for it.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .- Did AOD-9604 become legal when FDA removed it from Category 2?
No. FDA did not remove AOD-9604 from Category 2 — the nominator withdrew the nomination. FDA's own page states of the substances in that table: 'This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators.' A withdrawal moves a substance sideways rather than toward legality: AOD-9604 did not enter Category 1, did not join FDA's 503A bulk drug substances list, and remains outside the set of substances that may lawfully be used in compounding. FDA's safety assessment of AOD-9604 also survived the withdrawal — the agency still publishes it, and still states that compounded drugs containing AOD-9604 may pose significant risk for immunogenicity for certain routes of administration.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026“This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators.”
Checked against the source on .- Did FDA approve AOD-9604?
No. Drugs@FDA, FDA's database of approved drug products, returns 'No matches found!' for AOD-9604 when queried by generic name, active-ingredient name and brand name (checked 16 July 2026). There is no approved application for AOD-9604 for any indication or by any route. Drugs@FDA is a United States database, so this establishes non-approval in the US and nothing about other jurisdictions — we hold no source on those and are not going to guess. This is worth stating plainly because AOD-9604 does have a genuine clinical history — six controlled trials in roughly 900 adults, conducted 2001-2006 — which makes it tempting to assume an approval followed. None did in the US; the development programme was terminated in 2007 after its 24-week trial failed to induce significant weight loss.
Drugs@FDA — approved drug products database, queried for AOD-9604 (openFDA) — FDA, 16 July 2026“No matches found!”
Checked against the source on .- Is there any human evidence that AOD-9604 works?
Human data exists, but it does not establish that AOD-9604 works. Six double-blind, placebo-controlled trials were conducted between 2001 and 2006 by the Australian sponsor Metabolic Pharmaceuticals, and a pooled analysis authored in part by that sponsor's own employees reports that 'All studies were performed as double-blind placebo-controlled trials' and that 'Approximately 900 adult subjects participated in these 6 clinical trials.' That same paper's methods describe only the two long-term Phase IIb studies as randomised, so the sponsor abstract's 'six randomized' framing overstates its own methods section. The paper reports safety and tolerability only. No primary report of the efficacy results of the two long-term trials, of 12 and 24 weeks, appears ever to have been published in the peer-reviewed literature — those outcomes are known only from the sponsor's 2007 announcement to the Australian Securities Exchange and from peer-reviewed reviews citing it. No trial in the programme was registered on ClinicalTrials.gov, though the same paper states the two largest studies were registered on the Australian Therapeutic Goods Administration's Clinical Trial Notification scheme — the absence is from the US registry, not from all registries. No Phase 3 trial was ever conducted. What is established is that a real controlled programme in roughly 900 humans ran and did not produce an approved drug.
Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans — Journal of Endocrinology and Metabolism 3(1-2):7-15, 1 April 2013“Approximately 900 adult subjects participated in these 6 clinical trials.”
Checked against the source on .- Why was AOD-9604 discontinued?
Because it did not work well enough in its largest trial. A 2010 peer-reviewed review in Clinical Pharmacology & Therapeutics reports that 'Development of this drug was terminated in 2007 because the drug failed to induce significant weight loss in a 24-week trial of 536 subjects.' That review is not itself a trial report: it attributes the termination to the sponsor Metabolic Pharmaceuticals' own announcement to the Australian Securities Exchange of 21 February 2007, which stated that the Phase 2B results did not support the drug's commercial viability as a treatment for obesity and that development for that condition was terminated. The sponsor's pooled safety paper describes that 24-week trial as enrolling 502 rather than 536 subjects; we cannot reconcile the two figures and assert neither as our own. The direction of the result is not in dispute. This is the fact most often missing from pages selling AOD-9604: it is not an untested compound awaiting its trial, it is a compound that had its trial.
Central and Peripheral Molecular Targets for Anti-Obesity Pharmacotherapy — Clinical Pharmacology & Therapeutics 87(6):652-662, 5 May 2010“Development of this drug was terminated in 2007 because the drug failed to induce significant weight loss in a 24-week trial of 536 subjects.”
Checked against the source on .- Is AOD-9604 safe?
Unknown, and the two available documents disagree. FDA states that it 'has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear', that it lacks sufficient information to know whether the drug would cause harm when administered to humans, and that compounded drugs containing AOD-9604 may pose significant risk for immunogenicity for certain routes of administration. FDA does not say what those adverse events were, and openFDA's adverse event database returns no matching reports for AOD-9604, so they cannot be characterised further from public records. Against this, a pooled analysis of the 2001-2006 trials — authored in part by employees of the company that funded them — reports that no serious adverse event related to intake occurred in any of the six studies. Neither document resolves the other, and a safety record generated with pharmaceutical-grade material under a sponsor's control does not transfer to a compounded or grey-market preparation of the same sequence.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026“FDA has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear.”
Checked against the source on .- Is AOD-9604 banned in sport?
Yes. AOD-9604 is named in the World Anti-Doping Agency's 2026 Prohibited List, which came into effect on 1 January 2026, at section S2.2.3: 'Growth hormone (GH), its analogues and fragments including, but not limited to: … growth hormone fragments, e.g. AOD-9604 and hGH 176-191.' Section S2 substances are prohibited at all times, both in- and out-of-competition, and the list states that all prohibited substances in that class are non-Specified Substances. Being prohibited in sport is a sport-eligibility fact only: it is not a finding that AOD-9604 is effective, and WADA prohibits substances regardless of whether their claimed effects have been demonstrated.
World Anti-Doping Code International Standard — Prohibited List 2026 — World Anti-Doping Agency, 1 January 2026“Growth hormone (GH), its analogues and fragments including, but not limited to: … growth hormone fragments, e.g. AOD-9604 and hGH 176-191”
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