AOD-9604 is sold on trials that were run, finished, and quietly ended the program.

Key facts

• StatusResearch compound, not FDA-approved
• Animal half lifeAbout 3 minutes after IV injection in pigs, with almost all drug cleared from plasma by 12 minutes; about 4 minutes in rat plasma in vitro, with intact peptide undetectable at 56 minutes minsource
• Human cmax12.6, 10.2 and 13.8 ng/mL after single IV infusions of 0.8, 1.2 and 1.8 mg/kg respectively (means, healthy volunteers) ng/mLsource
• Human tmax0.08 hours (about 5 minutes) at every IV dose level hsource
• Igf1 responseNo significant IGF-1 elevation in any human trial, including at 12 and 24 weeks of daily oral dosing (p = 0.50844 and p = 0.75754 versus placebo). This is the compound's most reproducible human finding, and it is a negativesource
• MetabolismDegraded by sequential removal of amino acids from the N-terminus. Six metabolites identified in serum and urine; the fragment CRSVEGSCG is markedly more stable than the parent peptide and is used to extend the doping-control detection windowsource
• Oral bioavailabilityOrally bioavailable in pigs and rats: parent peptide and its degradants appear in plasma after oral dosing, with slower absorption than IV and the same degradation products. No human bioavailability figure has been publishedsource
• Subcutaneous kineticsUnstudied. Every human study of this molecule used the intravenous or oral route. No published human subcutaneous pharmacokinetic data exist, which is the route the injectable gray market usessource
• ClassSynthetic C-terminal fragment of human growth hormone (Tyr-hGH 177-191); a growth hormone fragment, not a growth hormone secretagogueChemical referencesource
• Human half-lifeNot determinable from posted human data; about 3 minutes IV in pigs minHuman PKsource
• MoleculeHexadecapeptide, sequence YLRIVQCRSVEGSCGF, disulfide-bridged, C78H123N23O23S2, molecular weight 1815.1Chemical referencesource
• DeveloperMetabolic Pharmaceuticals Ltd (Australia); phase 2a trials were underway by February 2002Review or guidelinesource
• Human trials9 with published or posted results: 6 in the obesity program (about 900 participants) and 3 later pain trials of the same peptideRegistry recordsource
• Obesity outcomeThe 24-week, 502-patient phase 2b trial failed its primary weight-loss endpoint and the program was terminatedReview or guidelinesource
• Anti-dopingProhibited at all times under WADA section S2.2.3, growth hormone fragments, named explicitly as AOD-9604 and hGH 176-191Regulatory recordsource
• IGF-1 effectNone detected in humans at any dose or duration studied, including 24 weeks of daily dosingHuman RCTsource