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Due to the compounds plasma half-life of approximately 3.86.9 hours [4] , twice-daily (BID) dosing may provide more sustained NNMT inhibition

AOD-9604 FDA Approval History At a glance FDA approval status / Never approved for any indication in the United States NDA filing history / No New Drug Application has ever been submitted to FDA Chemical identity / Synthetic peptide corresponding to amino acids 176-191 of human growth hormone, with a tyrosine residue added at the C-terminus Developer / Metabolic Pharmaceuticals Ltd (Melbourne, Australia), now defunct Clinical trial outcome / Phase IIb trial (2007) failed to meet primary efficacy endpoint for obesity FDA compounding status / Placed on Category 2 list

Strongest human evidence The METAOD006 (OPTIONS) Phase 2b trial randomized 502 adults with obesity (BMI 30-45 kg/m^2) to oral AOD-9604 (0.25, 0.5, or 1 mg/day) or placebo for 24 weeks alongside a supervised diet and exercise program

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