Lead program: NDA Filed

NRx PharmaceuticalsNASDAQ: NRXP

Data updated June 27, 2026

Wilmington, DE, United States

2 Drug Candidates

NRx Pharmaceuticals is a US-based NASDAQ-listed biopharmaceutical company developing ketamine- and NMDA-targeted treatments for acute suicidal depression and related mood-disorder pathways. Its lead asset, NRX-100, is a preservative-free intravenous ketamine formulation for acute suicidal ideation in depression, including bipolar depression. The company is pursuing an NDA package based on completed controlled trials, expanded-access experience, and a large real-world evidence dataset. NRx reported in May 2026 that full NRX-100 NDA submission was expected in Q2 2026, supported by more than 1,000 clinical-trial participants and more than 65,000 real-world ketamine-treated patients.

NRx also develops NRX-101, a fixed-dose D-cycloserine/lurasidone combination. The original programme targets oral maintenance treatment after ketamine stabilization in severe bipolar depression with acute suicidal ideation or behavior. In 2026, NRx also advanced a distinct NRX-101/TMS track as augmentation of accelerated transcranial magnetic stimulation, with FDA expanded-access clearance and the pivotal SPARC-TMS study initiated.

Pipeline Intelligence

Developer Momentum

Programme tracker

Active candidates: 2
Active programmes: 2
Lead stage: NDA Filed
Forecast coverage: 2 of 2

Latest sourced update

NRx — Confirms NDA Path After Type C FDA Meeting

Mar 16, 2026 - Press release - NRx Pharmaceuticals - NRX-100 / NRX-100 — IV Ketamine NDA Filing

Next known catalyst

nda-submitted

Q2 2026 - NRX-100 / NRX-100 — IV Ketamine NDA Filing - Confidence: 60%

7 sources0 pipeline-linked trials0 pipeline-linked papers1 NDA Filed1 Phase III

Development Programmes

NRX-100

Ketamine

NDA Filed

Suicidality

NRX-100 is a preservative-free intravenous ketamine formulation for acute treatment of suicidal depression in hospital emergency/inpatient settings. NRx reported in May 2026 that the full NDA was expected in Q2 2026 and would include data from more than 1,000 clinical-trial participants plus more than 65,000 real-world ketamine-treated patients.

Programme Tracker

Suicidality

Primary: US (FDA)

FDA Review / NDA FiledActive

Forecast

nda-submitted - Likely: Q2 2026 - Approval eventual: 35%

NRx reported on 2026-05-18 that full NRX-100 NDA submission was expected in Q2 2026, with Module 3 already filed and a request for rolling review. PDUFA timing remains TBD until FDA acceptance/review status is announced.

Milestones

Regulatory filing submitted

Planned

Likely: Q2 2026

Full NDA completion targeted June 2026, incorporating 70,000+ patient real-world evidence dataset confirmed in Type C FDA meeting (March 16, 2026)

Why it matters: Full NDA acceptance would trigger 12-month standard review or 6-month priority review; potential PDUFA date late 2026 or early 2027

Watch next: NDA acceptance letter from FDA and PDUFA action date assignment

NRx — Confirms NDA Path After Type C FDA Meeting(Press release)[Verified]

Regulatory filing submitted

Completed

Actual: Dec 30, 2024

Initial NDA section (Module 3, manufacturing) filed with FDA via rolling review; first section of planned full NDA for IV ketamine in suicidal depression

Why it matters: Rolling review allows FDA to assess completed sections as they are filed, potentially shortening total review time

Watch next: Full NDA submission including clinical data (June 2026)

NRx — Files Initial NDA Section for NRX-100 (IV Ketamine, Suicidal Depression)(Press release)[Verified]

Regulatory review accepted

Completed

Actual: Aug 11, 2025

FDA granted Fast Track Designation to NRX-100 for suicidal ideation in patients with depression including bipolar depression

Why it matters: Fast Track enables rolling NDA review, more frequent FDA meetings, and priority review eligibility

Watch next: Full NDA submission (June 2026 target)

NRx Pharmaceuticals — FDA Grants Fast Track to NRX-100 for Suicidal Depression(Press release)[Verified]

Recorded Events

Aug 11, 2025: Regulatory review accepted

Dec 30, 2024: Regulatory filing submitted

Evidence Links

NRx Pharmaceuticals — Company Website

company-website - NRx Pharmaceuticals - May 27, 2021 - Verified

NRX-101

Ketamine

Phase III

Suicidality Bipolar Disorder

NRX-101 is a fixed-dose D-cycloserine/lurasidone combination. The original pathway is oral maintenance treatment after ketamine stabilization in severe bipolar depression with acute suicidal ideation or behavior. NRx is also advancing a newer NRX-101/TMS track, using the D-cycloserine/lurasidone combination as augmentation of accelerated transcranial magnetic stimulation.

Programme Tracker

Suicidality

Primary: US (FDA)

Phase IIIActive

Forecast

nda-submission - Likely: Q3 2026 - Approval eventual: 35%

The original suicidal bipolar depression accelerated-approval path remains in preparation, while NRx separately reported FDA expanded-access clearance for NRX-101/TMS and initiation of the pivotal SPARC-TMS study in June 2026.

Milestones

Phase III topline

Completed

Actual: Mar 1, 2024

Phase 2b/3 (NCT03396068) results: 58% relative reduction in time to sustained remission from suicidality vs. lurasidone alone (p=0.05); 76% reduction in akathisia (p=0.03). Primary antidepressant endpoint not differentiated.

Why it matters: Suicidality endpoint met — clinically meaningful. Akathisia reduction is notable as akathisia independently increases suicide risk. Data supports Accelerated Approval NDA.

Watch next: NDA submission for Accelerated Approval

NRx — Phase 2b/3 Promising Findings for NRX-101 (Suicidal Bipolar Depression)(Press release)[Verified]

Regulatory review accepted

Completed

Actual: Nov 13, 2018

FDA granted Breakthrough Therapy Designation to NRX-101 for suicidal bipolar depression — first BTD for a drug specifically targeting suicidality

Why it matters: BTD provides intensive FDA guidance; validates suicidality as a registrational endpoint, enabling Accelerated Approval pathway

Watch next: Phase 3 SPA trial completion and NDA filing

NeuroRx — FDA Breakthrough Therapy Designation for NRX-101(Regulatory filing)[Verified]

Recorded Events

Mar 1, 2024: Phase III topline

Nov 13, 2018: Regulatory review accepted