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?

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

Next Previous
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: 28 Oct 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 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 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.
  • 14 May 2024 According to a NRx Pharmaceuticals media release, based on results from this trial the company plans to submit NDA for Accelerated Approval under Breakthrough Therapy and Priority Review of NRX-101 in treatment of bipolar depression in people at risk of akathisia to FDA in July 2024.

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