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Administration of Intravenous NRX100 (Ketamine) vs Placebo Infusion for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Patients With Bipolar Depression

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Trial Profile

Administration of Intravenous NRX100 (Ketamine) vs Placebo Infusion for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Patients With Bipolar Depression

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 22 May 2025

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At a glance

  • Drugs Ketamine (Primary) ; Cycloserine/lurasidone
  • Indications Bipolar depression; Suicidal ideation
  • Focus Registrational; Therapeutic Use
  • Acronyms SevereBD
  • Sponsors NeuroRX; NRx Pharmaceuticals

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 obtained $10.8 million in convertible-debt funding from an institutional investor Anson Funds of Toronto, to be used as funds targeted to support FDA New Drug Applications for NRX-100 (ketamine) and NRX-101 and to support FDA New Drug filings of NRX-100 and NRX-101.

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