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A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type

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Trial Profile

A Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Mar 2026

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At a glance

  • Drugs Bupropion/dextromethorphan (Primary)
  • Indications Agitation
  • Focus Registrational; Therapeutic Use
  • Acronyms ACCORD 1
  • Sponsors Axsome Therapeutics

Most Recent Events

  • 23 Feb 2026 According to Axsome Therapeutics media release, the company announced that sNDA for AXS-05 for the treatment of Alzheimer's disease agitation was accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026.
  • 03 Mar 2025 According to Axsome Therapeutics media release, the company announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) supporting a supplemental NDA (sNDA) submission for AXS-05 in Alzheimer's disease agitation. The purpose of the meeting was to reach agreement with the FDA on the proposed content and format of the Company's planned sNDA submission including the clinical and nonclinical requirements.
  • 03 Mar 2025 According to Axsome Therapeutics media release, based on the feedback from the FDA, the Company's regulatory data package would be sufficient for the submission of an sNDA for AXS-05 for the treatment of Alzheimer's disease agitation. Axsome anticipates submitting the planned sNDA in the third quarter of 2025. Acceptance of the final sNDA will be subject to the FDA's review of the complete filing.

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