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A phase 2b/3 registrational study of NRX-101 in patients with bipolar depression and acute suicidal ideation and behavior (ASIB) (requiring hospitalization)

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A phase 2b/3 registrational study of NRX-101 in patients with bipolar depression and acute suicidal ideation and behavior (ASIB) (requiring hospitalization)

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

Latest Information Update: 19 Mar 2025

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At a glance

  • Drugs Cycloserine/lurasidone (Primary) ; Ketamine
  • Indications Bipolar depression
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 17 Mar 2025 According to a NRx Pharmaceuticals media release, The Company announced its intention to file an NDA for Accelerated Approval under Breakthrough Designation and Priority Review of NRX-101 for the treatment of bipolar depression in people at risk of akathisia, based on the Phase 2b/3 and STABIL-B data. and company anticipated PDUFA date for this application 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.
    • 09 Feb 2024 Status changed from recruiting to active, no longer recruiting, according to a NRx Pharmaceuticals, Inc media release.

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