AOD-9604 Not available

Metabolic

AOD-9604

An unapproved fragment of human growth hormone

Not FDA-approved · not available for sale or prescription
Stylised model of the real sequence

Overview.

AOD-9604 is not approved as a drug, and oral AOD-9604 failed its phase 2b obesity trial (OPTIONS); development stopped in 2007. It is a 16-amino-acid synthetic peptide (tyrosine plus human growth hormone residues 177-191) designed to reproduce growth hormone's fat-breakdown activity without its growth-promoting, IGF-1-raising effects. It is still sold as an unregulated research chemical. It has no lawful US compounding pathway: its bulks nominations were withdrawn in 2024, and FDA's compounding advisory committee voted 12-0 in Dec 2024 against adding it to the 503A bulks list.

Also known as Anti-Obesity Drug-9604 · AOD9604

The molecule, decoded.

Sequence

Y-LRIVQCRSVEGSCGF (disulfide bridge between the two Cys residues)

Length
16 residues
Molecular weight
1,815.1 g/mol
Formula
C78H123N23O23S2
CAS number
221231-10-3
Half-life
Not established in humans (about 3 minutes after IV dosing in pigs)
Routes studied
oral (phase 2b trials), intravenous (early single-dose and 4-week studies)
Modifications
N-terminal Tyr addition to native hGH(177-191); intramolecular disulfide bond stabilizing the fragment

How it works.

AOD-9604 reproduces the C-terminal lipolytic domain of hGH (residues 177-191, with an added N-terminal tyrosine). It is proposed to activate beta-3 adrenergic receptors on adipocytes, upregulating hormone-sensitive lipase to break down stored triglycerides and inhibiting new lipogenesis, without engaging the GH receptor pathway that raises IGF-1.

Evidence · Early or small human studies

What the research shows

phase 2b RCT2007

The OPTIONS phase 2b trial (about 500 adults with obesity; FDA cites 502) of oral AOD-9604 for 24 weeks with diet and exercise found no significant difference in weight loss vs placebo, and Metabolic Pharmaceuticals ended obesity development in 2007.

about 500 adults with obesity (FDA: 502), phase 2b, 24 weeks

pooled safety data, sponsor-funded2013

In sponsor-funded safety data from six placebo-controlled IV and oral studies (Stier et al. 2013, summarized by FDA), AOD-9604 did not change serum IGF-1 vs placebo, and no anti-AOD-9604 antibodies were detected with up to 24 weeks of oral use.

participants in six placebo-controlled IV/oral studies

phase 2b RCT, abstract only2004

In a 12-week phase 2b trial, 300 adults with obesity took oral AOD-9604 (five dose arms) or placebo; the sponsor announced that the best-performing arm lost 2.8 kg vs 0.8 kg on placebo. FDA later noted the result rests on small between-group differences reported only in an abstract.

300 adults with obesity, phase 2b

regulatory2024

FDA removed AOD-9604 from Category 2 of its interim 503A policy in September 2024 after the nominators withdrew, then evaluated it on its own initiative; on Dec 4, 2024 the Pharmacy Compounding Advisory Committee voted 12-0 against placing AOD-9604 (free base and acetate) on the 503A Bulks List.

n/a - regulatory

anti-doping rule2026

AOD-9604 is explicitly named as an example substance under WADA's S2 category (Growth Hormone fragments), making it prohibited in and out of competition.

n/a - regulatory/anti-doping

What to know first.

Based on: published clinical trials.

Reported side effects

  • FDA notes serious adverse events that may be associated with AOD-9604 (causality unclear) and limited reporting detail; sponsor-funded studies reported adverse-event rates comparable to placebo

Cautions

  • development was discontinued for lack of efficacy; long-term human safety data are very limited
  • FDA cites potential immunogenicity with injectable use and peptide-impurity/characterization concerns
  • current market supply is unregulated research-grade/gray-market material with no quality assurance
  • no FDA-approved label exists; safe human dosing has not been established

Checked 2026-09

Where it stands.

Not FDA-approved · not available for sale or prescription. AOD-9604 is not FDA-approved and is not available for sale or prescription. We profile it because people ask about it.
FDA
not approved; phase 2b/3 obesity program discontinued in 2007 after failing to show significant efficacy
Compounding
Previously in 503A Category 2 (significant safety risks); removed in Sep 2024 after the nominations were withdrawn and now on FDA's 'nominated but withdrawn' list. FDA evaluated it anyway and on Dec 4, 2024 the PCAC voted 12-0 against placing it on the 503A Bulks List. Because it is not on the 503A Bulks List, has no USP monograph and is not a component of an approved drug, it has no lawful 503A (or 503B) compounding pathway; product in circulation is research-chemical/gray-market material.
Sport (WADA)
Prohibited at all times - explicitly named as an example under WADA Prohibited List section S2 (Peptide Hormones, Growth Factors and Related Substances / GH fragments)
Enforcement
  • FDA removal from 503A Category 2 after nominators withdrew (Sep 2024); listed as 'nominated but withdrawn'
  • FDA Pharmacy Compounding Advisory Committee voted 12-0 against placing AOD-9604 on the 503A Bulks List (Dec 4, 2024)
References (2)
  1. U.S. FDA · download
  2. U.S. FDA · download

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