MetabolicNot approvedEvidence tier: Human Observational

AOD-9604

Last updated October 21, 2026. Approval line checked October 21, 2026. Compounding sources checked October 10, 2026.

FDA status

Not approved

Not approved. This record is not an FDA-approved drug product. Approval, where it exists, is specific to a drug product, indication, and route.

FDA primary source on file

Evidence tier

Human Observational. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 2/5. 75 PubMed citations indexed.

Products sold as "research use only" are not approved for human use. FDA warning.

AOD-9604 in the literature

C-terminal fragment of human GH (hGH176-191) that mimics lipolytic effects of GH without IGF-1-mediated growth promotion by activating beta-3 adrenergic receptors.

What the literature studies

Metabolic & Fat Loss

Evidence tier

Human Observational

Compounding record

Nomination withdrawn

Confidence
2/5

Regulatory record

Nomination withdrawn. FDA substance context: AOD-9604. Previously in Category 2; FDA still identifies potential significant safety risks. Withdrawal is not FDA approval or a determination of safety or compounding eligibility. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.

Regulatory source checked October 10, 2026. This compounding label is separate from the approval line above.

FDA primary source 1

Regulatory context and verification limits are documented below.

Questions

Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.

Short answer

AOD-9604 is a modified C-terminal fragment of human growth hormone (Tyr-hGH 177-191) developed for obesity; early trials looked tolerable, a pivotal 24-week Phase 2b study in 536 people failed to beat placebo on weight loss, development stopped, and FDA has weighed against putting it on the 503A bulks list.

What it is

Hexadecapeptide Tyr-hGH(177-191), sometimes called a "lipolytic fragment" of hGH, advanced by Metabolic Pharmaceuticals for oral obesity treatment [R1][FDA-AOD].

Legal / FDA status (as of Oct 27 2026)

Not FDA-approved. Nominations for AOD-9604-related bulk substances for 503A compounding were withdrawn; FDA evaluated free base and acetate on its own initiative for obesity and concluded the evaluation criteria weigh against placing either on the 503A Bulks List [FDA-AOD]. FDA's safety-risk page lists AOD-9604 under nominated-but-withdrawn with immunogenicity/impurity concerns and limited safety information [FDA-RISK].

Human evidence

  • Six randomized, double-blind, placebo-controlled trials (n=893 adults) summarized for safety: no IGF-1 rise, no adverse carbohydrate-metabolism signal vs hGH, no anti-AOD antibodies in assayed patients; withdrawals/SAEs related to AOD9604 not reported in that safety summary [R2].
  • Pivotal Phase 2b oral trial (536 subjects): primary weight-loss endpoints did not show a significant difference vs placebo across dose arms; development was terminated in 2007 [R1][R3].
  • An earlier shorter RCT reported modest mean weight loss (about 2.6 kg at 1 mg/day vs about 0.8 kg placebo over 12 weeks) that did not hold up in the larger, longer trial [R1].

Animal / lab evidence

Rodent work reported lipolytic effects without classic GH growth effects [FDA-AOD nomination materials]. Animal results are not evidence of effect in people.

Risks and unknowns

Failed efficacy on the pivotal obesity endpoint; FDA immunogenicity and characterization concerns for compounded forms [FDA-RISK][FDA-AOD]. Gray-market vials unverified.

What's coming

No active FDA approval path identified for obesity. PCAC materials from Dec 2024 document FDA's negative weighing for 503A listing [FDA-AOD].

Sources

  1. [R1] Valentino MA et al. Central and peripheral molecular targets for anti-obesity pharmacotherapy. Clin Pharmacol Ther 2010;87:652-662. (summarizes AOD9604 trial program and 2007 termination)
  2. [R2] Stier H, Vos E, Kenley D. Safety and tolerability of the hexadecapeptide AOD9604 in humans. J Endocrinol Metab 2013;3:7-15. doi:10.4021/jem157w
  3. [R3] Metabolic Pharmaceuticals. Phase 2B clinical trial results (SEC archive summary of 536-subject oral study). Mar 2007. https://www.sec.gov/Archives/edgar/vprr/0702/07021963.pdf
  4. [FDA-AOD] FDA. PCAC Dec 4 2024 Briefing: Evaluation of AOD-9604-related Bulk Drug Substances. https://www.fda.gov/media/183584/download
  5. [FDA-RISK] FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

Last checked 2026-10-27

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