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AXS-05 FDA Approval Status

Last updated by Judith Stewart, BPharm on April 29, 2021.

FDA Approved: No
Brand name: AXS-05
Generic name: dextromethorphan and bupropion
Company: Axsome Therapeutics
Treatment for: Major Depressive Disorder

AXS-05 (dextromethorphan and bupropion) is an investigational NMDA receptor antagonist with multimodal activity in development for the treatment of major depressive disorder and other central nervous system (CNS) disorders.

  • The dextromethorphan component of AXS-05 is an uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist (also known as a glutamate receptor modulator) and a sigma-1 receptor agonist.
  • The bupropion component of AXS-05 is a norepinephrine and dopamine reuptake inhibitor and serves to increase the bioavailability of dextromethorphan.

Development timeline for AXS-05

DateArticle
May 18, 2022Axsome Therapeutics Announces Publication of Pivotal Ascend Phase 2 Trial of AXS-05 in Major Depressive Disorder in the American Journal of Psychiatry
Aug 23, 2021Axsome Therapeutics Provides Update on the New Drug Application for AXS-05 for the Treatment of Major Depressive Disorder
Apr 26, 2021Axsome Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for AXS-05 for Treatment of Major Depressive Disorder
Jun 26, 2020Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Alzheimer’s Disease Agitation
Mar 27, 2019Axsome Therapeutics Receives FDA Breakthrough Therapy Designation For AXS-05 For The Treatment Of Major Depressive Disorder

Further information

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