NRx PharmaceuticalsNASDAQ: NRXP
NRx Pharmaceuticals is a US-based NASDAQ-listed biopharmaceutical company developing NRX-100, a proprietary preservative-free formulation of intravenous ketamine, for the acute treatment of suicidal ideation in patients with depression including bipolar depression. Unlike most commercially available ketamine products, NRX-100 omits the benzethonium chloride preservative, whose safety profile in repeated dosing has not been established. Rather than running a traditional Phase 3 trial, NRx is pursuing NDA approval based on already-completed government-funded controlled trials (demonstrating 55–63% response/remission vs 30–31% for comparators), expanded access data, and — in a regulatory first — de-identified real-world evidence from over 70,000 US patients treated with IV or intranasal ketamine, licensed and submitted to the FDA in January 2026. The FDA granted Fast Track Designation to NRX-100 for suicidal ideation in depression in August 2025, and the company has applied for a Commissioner’s National Priority Voucher (CNPV) review, which could reduce review time to 1–2 months. The NDA filing is underway, with PDUFA date expected 2025–2026. A parallel generic pathway (KETAFREE™ ANDA) targets the broader ketamine market, with a Q2 2026 GDUFA date anticipated.
Development Programmes
2NRX-100
KetamineNRX-100 is a preservative-free intravenous ketamine formulation for acute treatment of suicidal depression in hospital emergency/inpatient settings. Used as induction therapy before oral maintenance with NRX-101. FDA Fast Track Designation (August 2025) for suicidal ideation in MDD and bipolar depression. Rolling NDA filing initiated December 2024; full NDA targeted June 2026.
Programme Tracker
Suicidality
Forecast
nda-submitted - Approval eventual: 35%
Rolling NDA filing in progress. Module 3 (manufacturing, 1,800 pages) filed December 2024. Full NDA with real-world evidence (70,000+ patients) targeted June 2026. PDUFA date TBD.
Milestones
Regulatory filing submitted
PlannedLikely: 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
Regulatory filing submitted
CompletedActual: 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)
Regulatory review accepted
CompletedActual: 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)
Recorded Events
Aug 11, 2025: Regulatory review accepted
Dec 30, 2024: Regulatory filing submitted
Evidence Links
company-website - NRx Pharmaceuticals - Verified
NRX-101
KetamineNRX-101 is a fixed-dose combination of D-cycloserine (partial NMDA agonist) and lurasidone (atypical antipsychotic) for oral maintenance treatment of severe bipolar depression with acute suicidal ideation or behavior (ASIB). Follows initial IV ketamine stabilization with NRX-100. FDA Breakthrough Therapy Designation (November 2018). Phase 2b/3 (NCT03396068): 58% relative reduction in time to sustained remission from suicidality vs. lurasidone alone (p=0.05).
Programme Tracker
Suicidality
Forecast
nda-submission - Approval eventual: 35%
Pursuing Accelerated Approval NDA on suicidality surrogate endpoint. Phase 2b/3 data (NCT03396068) published and presented. NDA submission in preparation.
Milestones
Phase III topline
CompletedActual: 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
Regulatory review accepted
CompletedActual: 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
Recorded Events
Mar 1, 2024: Phase III topline
Nov 13, 2018: Regulatory review accepted
Evidence Links
trial-registry - ClinicalTrials.gov - Verified
Quick Facts
- Type
- Public Biotech
- Founded
- 2017
- Ticker
- NASDAQ: NRXP
- Lead Stage
- FDA Review / NDA Filed
- HQ
- Wilmington, DE, United States
- Website
- Visit