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Sequential Therapy (NRX-100 Followed by NRX-101) for the Treatment of Acute Suicidal Ideation and Behavior in Bipolar Depression: the STABIL-B Study

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Trial Profile

Sequential Therapy (NRX-100 Followed by NRX-101) for the Treatment of Acute Suicidal Ideation and Behavior in Bipolar Depression: the STABIL-B Study

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 24 Dec 2025

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At a glance

  • Drugs Cycloserine/lurasidone (Primary) ; Ketamine; Lurasidone
  • Indications Bipolar depression; Suicidal ideation
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Acronyms STABIL-B
  • Sponsors NeuroRX

Most Recent Events

  • 17 Nov 2025 According to a NRx Pharmaceuticals media release, the company has submitted the Module 3 manufacturing file to publishing and is requesting rolling review of the NDA, under its Breakthrough Therapy designation for NRX-101.
  • 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.

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