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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

Latest Information Update: 29 May 2025

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At a glance

  • Originator Apnimed
  • Class Alkynes; Antispasmodics; Carbocyclic acids; Cyclohexanes; Diethylamines; Esters; Mandelic acids; Propylamines; Sleep disorder therapies; Small molecules
  • 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

  • Phase III Sleep apnoea syndrome

Most Recent Events

  • 19 May 2025 Apnimed announces intention to submit NDA to US FDA for Sleep apnoea syndrome by early 2026 for regulatory review
  • 19 May 2025 Efficacy and adverse events data from a phase III SynAIRgy Study in Sleep apnoea syndrome released by Apnimed
  • 14 Mar 2025 Apnimed completes the phase III (SynAIRgy) trial for Sleep apnoea syndrome in the US and Canada (PO) (NCT05813275)

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