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Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial

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Trial Profile

Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 May 2025

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At a glance

  • Drugs Ketamine (Primary)
  • Indications Suicidal ideation
  • Focus Registrational; Therapeutic Use
  • Acronyms KETIS trial

Most Recent Events

  • 15 May 2025 According to a NRx Pharmaceuticals media release, NRX-100 (preservative-free IV ketamine) planned to complete New Drug Application (NDA) filing in Q2 2025, with expected 2025 PDUFA date; $4.3 million NDA submission fee waived by FDA. The Company also plans to file an Abbreviated New Drug Application (aNDA) for existing ketamine indications in Q2 2025
  • 17 Mar 2025 According to a NRx Pharmaceuticals media release, The anticipated PDUFA date for this NDA is prior to December 31, 2025.
  • 14 Nov 2024 According to a NRx Pharmaceuticals media release, the company has formed data-sharing partnerships to license clinical trial data from a French Government-funded trial together with multiple NIH-funded trials all of which demonstrate efficacy of racemic Intravenous ketamine against suicidal ideation in depression, including bipolar depression. The company will reformat these data into the presentation for review by the FDA.

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