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Aroxybutynin/atomoxetine - Apnimed

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Drug Profile

Aroxybutynin/atomoxetine - Apnimed

Alternative Names: AD 109 - Apnimed; AD-109; Atomoxetine/Aroxybutynin - Apnimed; Atomoxetine/R-oxybutynin - Apnimed; Atomoxetine/R-oxybutynin - combination therapy - Apnimed; Oxnimbi™; Oxnimbi™-Apnimed

Latest Information Update: 10 Aug 2026

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At a glance

  • Originator Apnimed
  • Class Acetates; Alcohols; Alkynes; Amines; Antispasmodics; Benzene derivatives; Carbocyclic acids; Cyclohexanes; Diethylamines; Esters; Mandelic acids; Methylamines; Phenyl ethers; Propylamines; Sleep disorder therapies; Small molecules; Toluenes
  • Mechanism of Action Adrenergic uptake inhibitors; Cholinergic receptor antagonists; Muscarinic receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Sleep apnoea syndrome

Most Recent Events

  • 14 Jul 2026 FDA assigns PDUFA action date of 28/02/2027 for Aroxybutynin/atomoxetine for Sleep apnoea syndrome
  • 14 Jul 2026 US FDA accepts NDA for Aroxybutynin/atomoxetine for Sleep apnoea syndrome for review
  • 20 May 2026 Efficacy data from a phase III SynAIRgy and LunAIRo trials in Sleep apnoea syndrome presented at the 122nd International Conference of the American Thoracic Society, 2026 (ATS-2026)

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