AOD-9604

Graded B: a randomized phase 2b trial in about 500 adults (oral form) exists; it missed its weight-loss goals, and injectable forms have no human studies.

Strengths: 5, 10 mg
Also known as: AOD9604, Anti-Obesity Drug 9604, Tyr-hGH(177–191), hGH fragment 176–191 analog
Molecule: 16-amino-acid modified growth hormone fragment
Formula: C78H123N23O23S2
Mol. weight: 1815.08 g/mol
CAS: 221231-10-3
Sequence: YLRIVQCRSVEGSCGF (Cys7–Cys14 disulfide)

Origin

Developed in Australia (Metabolic Pharmaceuticals) as an oral anti-obesity drug. It is growth hormone residues 177–191 with a tyrosine added at the start, differing from HGH Fragment 176–191 only in that first residue.

How it works

In obese mice it increased fat breakdown and fat oxidation without binding the growth hormone receptor, causing cell growth or raising blood sugar. Its weight effect depended on beta-3 adrenergic receptors in fat. The developer reports it does not raise IGF-1 in humans.

What the research shows

About 925 people took part in six developer-run trials using oral or IV forms. The largest, a 24-week trial of about 500 adults (OPTIONS), did not produce meaningful weight loss and was never published, and obesity development ended in 2007. Rodent studies reported reduced weight gain, and a rabbit study reported cartilage repair after joint injection. No human osteoarthritis trial exists, and injectable forms have no human data.

Key studies

Heffernan et al., Endocrinology 2001 Obese mice: increased fat oxidation; effect lost in beta-3 receptor knockout mice.
Ng et al., Hormone Research 2000 Obese Zucker rats: given by mouth, it cut weight gain by more than half.
Stier et al., J Endocrinol Metab 2013 Pooled six developer RCTs: tolerability similar to placebo, no IGF-1 change.
OPTIONS phase 2b, 2007 (unpublished) 502 adults over 24 weeks; weight-loss endpoint not met.

Safety findings

Oral and IV trials reported adverse events at placebo-like rates, with one possibly related chest-tightness event. FDA's 2024 review flagged poor characterization of bulk material, immunogenicity of injectables, possible liver and bone signals in animals, and equivocal genotoxicity.

Regulatory status

Not FDA-approved. FDA's compounding advisory committee voted 12–0 against adding it to the 503A bulks list in December 2024, so it is not lawfully compoundable. A 2012 "GRAS" status was self-affirmed by a company-hired panel for food use only, not reviewed by FDA. Prohibited at all times by WADA (S2).

Catalog notes

Available in 5 and 10 mg; the 5 mg strength has a certificate (lot AOD5-0803, 99.78% purity), and none is published for 10 mg. Follow the storage stated on the label and certificate.

In kits: Metabolix Bundle