Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
Trial Profile

A Randomized, Double-blind, Placebo-controlled 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 II/III

Latest Information Update: 05 Mar 2025

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

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

Most Recent Events

  • 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.
  • 18 Feb 2025 According to Axsome Therapeutics media release, the company planned to submit a New Drug Application (NDA) for AXS-05 for the treatment of Alzheimer's disease agitation to the FDA in the second half of 2025. The application is based on results from ADVANCE-1, ADVANCE-2, ACCORD-1, and ACCORD-2 trials.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top