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Bupropion/dextromethorphan - Axsome Therapeutics

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Drug Profile

Bupropion/dextromethorphan - Axsome Therapeutics

Alternative Names: AUVELITY; AXS-05; Dextromethorphan-HBr-bupropion-HCl; Dextromethorphan/bupropion; Dextromethorphan/bupropion modulated delivery tablet

Latest Information Update: 26 Feb 2026

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At a glance

  • Originator ANTECIP BIOVENTURES
  • Developer Axsome Therapeutics; Duke University
  • Class Anti-inflammatories; Antidementias; Antidepressants; Behavioural disorder therapies; Morphinans; Propiophenones; Small molecules; Smoking cessation therapies
  • Mechanism of Action Adrenergic receptor antagonists; Cytochrome P-450 CYP2D6 inhibitors; Dopamine uptake inhibitors; Nicotinic receptor antagonists; NMDA receptor antagonists; Norepinephrine plasma membrane transport protein inhibitors; Serotonin plasma membrane transport protein inhibitors; Sigma-1 receptor agonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Major depressive disorder
  • Preregistration Agitation
  • Phase II Smoking withdrawal

Most Recent Events

  • 23 Feb 2026 Axosome Therapeutics plans a pivotal phase II/III trial for Smoking withdrawal in the second quarter of 2026
  • 28 Jan 2026 Axsome Therapeutics terminates the phase II EVOLVE trial in Major depressive disorder (Treatment-resistant) in USA (PO) as overall program objectives were met before January 2026 (NCT04634669)
  • 31 Dec 2025 US FDA accepts sNDA for Bupropion/dextromethorphan for Agitation for priority review

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