AOD-9604

Not FDA-approved Evidence grade B — human randomised trials, not approved for that use Updated 2026-10-20

This page describes published research and public regulatory records. It is not medical advice. SoluneFit does not sell, supply, or recommend any compound. The SoluneFit app includes a private, on-device tracker for people who want a record of what they and their clinician have already decided — the app neither suggests compounds nor doses.

Also known as: AOD9604, Tyr-hGH(177-191), hGH fragment 177-191 (tyrosine-extended), anti-obesity drug 9604.

Regulatory status

Not approved. At the 4 Dec 2024 PCAC meeting FDA proposed excluding AOD-9604 from the 503A bulks list and the committee voted 0-12 against including it [1][2]; earlier it had been in category 2 (immunogenicity and impurity risk; serious adverse events of unclear causality) until the nomination was withdrawn [3]. GRAS: the sponsor announced in 2012 a conditional GRAS determination by its own expert panel for food use up to 1 mg/day [6]; FDA's GRAS Notice Inventory has no AOD-9604 entry (searched 2026-10-20) [7], so this is a self-determination, not an FDA 'no questions' letter, and it does not cover injection. WADA-prohibited (S2.2.3 GH fragments) [8].

What it is

Synthetic 16-amino-acid fragment of the C-terminus of human growth hormone (residues 177-191 plus an N-terminal tyrosine; one disulfide bond).

A modified piece of the growth hormone molecule designed to keep GH's fat-burning effect without its effects on growth or blood sugar. Metabolic Pharmaceuticals tested it by mouth and IV in about 900 people with obesity; it did not produce meaningful weight loss and the sponsor stopped developing it for obesity.

What the published research shows

Six randomised, double-blind, placebo-controlled sponsor trials (IV and oral; about 900 participants, the largest 502 randomised for 24 weeks) showed good tolerability but no clinically meaningful weight loss. No human data for subcutaneous or transdermal use.

Published human studies and reports (these describe trial populations, not SoluneFit claims):

Obesity, oral, 12 weeks (METAOD005; Stier 2013 and FDA review): 300 adults with obesity: 1, 5, 10, 20 or 30 mg by mouth daily or placebo (n = 50 per group) for 12 weeks. Mean weight loss was 0.22 kg/week at 1 mg, 0.13 at 20 mg and 0.15 at 30 mg vs 0.07 kg/week on placebo (non-linear dose response; FDA judged the differences of unclear clinical meaning).
Obesity, oral, 24 weeks (METAOD006; Stier 2013 and FDA review): 536 enrolled, 502 randomised: 0.25, 0.5 or 1 mg by mouth daily or placebo with a dietitian programme for 24 weeks. No significant difference in weight loss from placebo at the 12-week primary endpoint; the sponsor ended the obesity programme.
Obesity, IV single doses (FDA review of sponsor reports): 23 adults with obesity (mean BMI 42.3) received IV AOD-9604 25, 50 or 100 µg/kg or placebo once weekly for 4 weeks: a fat-metabolism marker (NEFA) rose at 2 hours, but average weight loss of 0.58 kg over 3 weeks was not different from placebo.
Obese mice (Heffernan 2001): 14 days of intraperitoneal dosing reduced body weight and body fat in obese mice, but not in beta-3 receptor knock-out mice.

Mechanism, as reported

In obese mice it increased fat breakdown and fat oxidation and restored beta-3 adrenergic receptor expression in fat, though its effect did not depend on that receptor. In human trials it did not raise IGF-1 or impair glucose tolerance.

Practical record

Elimination half-life: 0.5 h (confidence: low). No human half-life is published and FDA found no human PK study by any route. Animal data: about 3 min after an IV bolus (400 µg/kg) in pigs, and 4 min in rat blood in vitro (Moré and Kenley 2014, as reviewed by FDA). The app's 30 min is a placeholder: after a subcutaneous dose the real curve is set by absorption, which is unmeasured. Treat the curve as a guess.
Studied routes: oral, intravenous, subcutaneous.
Typical supply: No licensed product. Sold as lyophilised vials (marketed for SC injection) and creams on the research and compounding market; trials used oral capsules/tablets and IV solution.
Storage: API (acetate), per FDA review: -20 °C for storage over 6 months, 2-8 °C for shorter periods.

Safety signals on record

Reported adverse events: In the six trials adverse events were similar to placebo and none was judged definitely related to the drug; no anti-AOD-9604 antibodies were detected and IGF-1 and glucose tolerance were unchanged. FDA found no FAERS or CAERS reports, but notes these databases undercount compounded products.
Contraindications: None established (no label).
Interactions: None documented.
Notes: Human safety data exist only for oral and IV use in the sponsor's trials; the subcutaneous route that the research market sells has no human data. Banned in sport; Australia lists it as a performance- and image-enhancing drug (possession without authority illegal).

Sources

General wellness education, not medical advice. Unapproved compounds have no established dosing, purity standard, or safety profile.

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