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Also: AOD 9604 · hGH fragment 176-191 · HGH Frag 176-191 · Frag 176-191 · hGH 177-191 · advanced obesity drug 9604 · lipotropin fragment · AOD · AOD-9640 · AOD-9064 · AOD-6904 · AOD9600
Four separate measurements, never averaged. Independent evidence counts only studies with no sponsor attached. Methodology version v2.0-2026-10 · how we grade evidence
Not approved by any regulator, anywhere, for any indication. The obesity development programme was terminated in February 2007 for lack of efficacy.
The honest finding here is specific and unusual: AOD-9604 has by far the largest human trial programme of any compound in this cluster — roughly 893 to 925 participants across six company-funded, double-blind, placebo-controlled trials run between 2001 and 2007 — and it did not work. The pivotal Phase 2b randomised 502 adults with obesity and missed its primary 12-week weight-loss endpoint. Every other trial was null on weight as well: no significant loss against placebo on single intravenous doses over three weeks, none over four weeks of oral dosing, a 0.4 kg difference over one week, and differences in the 300-subject 12-week trial so small that FDA questioned whether they were meaningful. The sponsor’s own parent company stated the trials showed the compound "was safe but did not produce a clinically meaningful weight loss outcome across the total trial population." Marketing that cites "clinical trials in hundreds of patients" is factually accurate and materially misleading.
Claims — stated as claims — include fat loss and "fat-burning" without the side effects of growth hormone, targeted reduction of adipose tissue, no effect on blood glucose or IGF-1, and cartilage, joint and osteoarthritis benefit. FDA states the osteoarthritis and cartilage indication "has so far only been tested in preclinical studies." Its review concluded there is a "lack of evidence to support the effectiveness of AOD-9604" and that "the evaluation criteria weigh against placing" either form on the 503A compounding list.
This is also the one compound here with meaningful human safety data, which should be neither inflated nor dismissed. Across the six trials no anti-AOD9604 antibodies were detected in any tested sample — the only direct human immunogenicity data for any compound in this cluster — with no treatment-related withdrawals and no significant IGF-1 or glucose-tolerance changes against placebo. But all six trials were funded by the developer, all three authors of the pooled safety analysis have financial or consulting ties to it, the publication contains an internal inconsistency about serious adverse events, and the published trials used intravenous and oral routes only. There is no human safety data for subcutaneous injection, the route in which it is marketed, and none beyond 24 weeks. FDA found no acute toxicity, reproductive, developmental or carcinogenicity studies; six-month rat and nine-month monkey studies showed changes in osteocalcin levels and liver vacuolation that FDA considered possible safety signals; and genotoxicity results were equivocal and could not be dismissed.
On the "GRAS" claim, which sellers cite often, be precise. The developer announced in June 2012 a self-affirmed GRAS conclusion for use as a food ingredient, verified by a company-commissioned panel of US experts. That is not an FDA determination. The company’s own April 2013 announcement is internally inconsistent about whether the status was conditional, and does not mention any interaction with FDA. FDA searched the GRAS Notice Inventory and the NIH dietary supplement database and states no GRAS determination, and no FDA "no questions" letter was found. It should not be described as FDA-recognised GRAS.
One naming point: AOD-9604 and "hGH fragment 176-191" are sold as though interchangeable and WADA lists them together, but AOD-9604 is the modified 16-residue construct with an added tyrosine and a Cys7-Cys14 disulfide, not the bare 176-191 fragment.
At a glance
Proposed to reproduce the lipolytic and anti-lipogenic activity of the growth hormone C-terminus while lacking the growth-promoting and insulin-antagonising activity of the full-length hormone. Rodent studies reported reduced weight gain and increased lipolysis with no effect on glucose or insulin, and early mouse work implicated beta3-adrenergic receptor pathways. **FDA states the mechanism is unknown.** It identified no human pharmacokinetic studies for any route. The human trials consistently showed no significant change in IGF-1 and no significant change in glucose tolerance against placebo, which is consistent with the claimed selectivity but equally consistent with no pharmacological effect at all — and the clinical endpoint was null. A pig study found an intravenous half-life of about three minutes and a calculated oral bioavailability of 170%, which FDA judged unrealistic.
Dated determinations, each flagged for whether it is final and whether it covers safety only. A safety review is not an efficacy finding, and most reporting in this category conflates the two.
FDA states the mechanism is unknown and identified no human pharmacokinetic studies for any route. Nonclinical gaps are substantial: no acute toxicity, reproductive, developmental or carcinogenicity studies, and no subcutaneous or transdermal toxicity data — and subcutaneous injection is how the compound is sold. Six-month rat and nine-month monkey studies showed changes in osteocalcin levels and liver vacuolation, which FDA considered possible safety signals, and genotoxicity results (Ames, micronucleus, chromosome aberration) were equivocal and could not be dismissed. FDA concluded neither form is "physically and chemically well characterized" and that nonclinical studies were "too limited in scope" to inform safety for the nominated routes. FAERS and CAERS searches returned no reports and FDA states this does not establish safety. It found no AOD-9604 products in outsourcing facility reports from 2017 to 2023, though online sources show clinics and a compounding pharmacy marketing injectable and oral products. On the nominated osteoarthritis and cartilage indication, FDA states it "has so far only been tested in preclinical studies."
The developer announced in June 2012 a "GRAS status recognition" for use as a food ingredient at up to 1 mg per day, verified by an independent panel of US experts — i.e. self-affirmed GRAS. The company’s own April 2013 announcement is internally inconsistent, describing the status as "conditional only on publication of existing safety data in peer-reviewed journals" in one place and "unconditional" in another, and it does not mention any interaction with FDA. FDA’s briefing states it searched the GRAS Notice Inventory and the NIH dietary supplement database and does not state a GRAS determination, and no FDA "no questions" letter was found. It should not be described as FDA-recognised GRAS.
Recorded as stated in the research package. No instrument or date was retrievable, so the source key and date are null rather than invented.
WADA classifies AOD-9604 as a growth hormone fragment rather than a secretagogue, and lists it together with hGH 176-191 — although the two are not structurally identical.
A single group vote on 4 December 2024 covering both the free base and the acetate. It is not on the 503A Bulks List. The vote question was "Should [X] be placed on the list?", so yes means add.
One of the 19 substances added on 29 September 2023; it now appears only in the "nominated but withdrawn" table on FDA’s page, content current as of 22 April 2026, and it is not on the 503A Bulks List.
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The proposed mechanism for this ingredient has not been confirmed in humans. Marketing copy frequently states it as settled. It is not.
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