Developer · NRXP · United States

NRx Pharmaceuticals, Inc.

Clinical-stage biopharmaceutical company based in Wilmington, Delaware (Nasdaq: NRXP) developing NMDA-targeted therapeutics for central nervous system disorders, specifically suicidal depression, chronic pain and PTSD. Its pipeline includes NRX-100 (preservative-free intravenous ketamine) and NRX-101 (oral D-cycloserine/lurasidone). Drug development runs through its wholly owned subsidiary NeuroRx, Inc., the registered sponsor of the NRX-101 trials; it also owns HOPE Therapeutics, an interventional-psychiatry clinic network.

nrxpharma.com ↗

1compound
2programs
2indications
Phase 3lead asset

Phase distribution

  • Phase 31
  • Phase 2/31

Modality

  • Small molecule 1

Mechanism focus

Pipeline (1)

Deals & partnerships

  • Sep 30, 2026FinancingNRx awarded $11 million DARPA prime contract for the SPARC-TMS trial of NRX-101 with robotic TMSNRx Defense Systems, an NRx subsidiary, announced an $11 million DARPA prime contract to evaluate single-day robotic neuronavigated TMS augmented by NRX-101 for treatment-resistant depression. The trial is to run at McLean Hospital, Arizona State University and HOPE Therapeutics, with military hospitals affiliated. DARPA had selected the proposal for negotiation on 2026-07-21.NRX-101 (D-cycloserine/lurasidone)source ↗
  • Jun 2026PartnershipNRx partners with Mass General-led Bipolar Action Network on an NRX-101 trial in treatment-resistant bipolar depressionIn June 2026 NRx agreed to partner with the Harvard Mass General-led Bipolar Action Network to support an open-label clinical trial of NRX-101 in treatment-resistant patients with bipolar depression.NRX-101 (D-cycloserine/lurasidone)source ↗

Catalysts · 1 upcoming · 2 reported

Recently reported

  • 2024-04-30mixed

    NRX-101 (D-cycloserine/lurasidone)forBipolar depressionTopline data

    Phase 2b/3 NRX-101 vs lurasidone in bipolar depression with subacute suicidal ideation (no ketamine lead-in): similar antidepressant effect (each about 50% MADRS reduction), a 33% advantage in sustained remission from suicidality that was not statistically significant, and about 70-75% less akathisia (P=0.076).

    source ↗

  • 2023-08-13met

    NRX-101 (D-cycloserine/lurasidone)forBipolar depressionFull results

    STABIL-B (Phase 2) published: after ketamine stabilization, NRX-101 beat lurasidone alone at maintaining improvement in depression (MADRS difference -7.7, p=0.03) and at reducing suicidal ideation (C-SSRS difference -1.5, p=0.02; CGI-SS p=0.03) in 22 patients with severe bipolar depression and acute suicidality.

    source ↗

Recent activity

  • Nov 12, 2025Phase changeNRX-101 (D-cycloserine/lurasidone)·Treatment-resistant depressionPhase 2/3SPARC-TMS (NCT07227103, NRX101-011) first posted on ClinicalTrials.gov as a Phase 2/3 study of NRX-101 vs placebo with robotic TMS for treatment-resistant depression. Registry estimated start 2026-12-01, so this date marks program entry by registration, not first patient dosed.source ↗
  • Jul 31, 2025Phase changeNRX-101 (D-cycloserine/lurasidone)·Bipolar depressionPhase 3NRx submitted more than 80,000 pages of manufacturing, nonclinical and clinical material (the Module 3 file) to the FDA to begin a rolling NDA for NRX-101 in suicidal bipolar depression, and requested rolling review under its Breakthrough designation. The NDA is not complete, so phase stays phase_3 and not 'filed'. The 10-K gives the month only (July 2025); the date is the month-end anchor.source ↗
  • Apr 30, 2024ReadoutNRX-101 (D-cycloserine/lurasidone)·Bipolar depressionmixedPhase 2b/3 NRX-101 vs lurasidone in bipolar depression with subacute suicidal ideation (no ketamine lead-in): similar antidepressant effect (each about 50% MADRS reduction), a 33% advantage in sustained remission from suicidality that was not statistically significant, and about 70-75% less akathisia (P=0.076).source ↗
  • Aug 13, 2023ReadoutNRX-101 (D-cycloserine/lurasidone)·Bipolar depressionmetSTABIL-B (Phase 2) published: after ketamine stabilization, NRX-101 beat lurasidone alone at maintaining improvement in depression (MADRS difference -7.7, p=0.03) and at reducing suicidal ideation (C-SSRS difference -1.5, p=0.02; CGI-SS p=0.03) in 22 patients with severe bipolar depression and acute suicidality.source ↗
  • Dec 1, 2019Phase changeNRX-101 (D-cycloserine/lurasidone)·Bipolar depressionPhase 3The Phase 3 SBD-ASIB maintenance trial (NCT03396068), run under the FDA Special Protocol Agreement, started (actual start date per ClinicalTrials.gov). Registry status is now UNKNOWN (last updated 2024-01-19, estimated primary completion 2024-12-31, 72 estimated), and no results are posted.source ↗
  • Jan 15, 2018Phase changeNRX-101 (D-cycloserine/lurasidone)·Bipolar depressionPhase 2STABIL-B (NCT02974010), a two-stage Phase 2 trial in severe bipolar depression with acute suicidal ideation, started (actual start date per ClinicalTrials.gov). Patients received a single ketamine or saline infusion, then NRX-101 or lurasidone. Primary completion 2018-08-31; 22 enrolled.source ↗

Trials recruiting · 1 recruiting of 5 sponsored

  • Phase 2/3NRX-101 (D-cycloserine/lurasidone)n=2403 sites · United States

    A Randomized, Double-Blind Controlled Comparison of NRX-101 vs. Placebo for Adults Being Treated With Transcranial Magnetic Stimulation for Treatment Resistant Depression: The SPARC-TMS Trial

    Treatment Resistant DepressionTreatment Resistant Depression (TRD)NCT07227103 ↗

Competitive landscape

Other companies developing against NRx Pharmaceuticals, Inc.'s targets or indications.