NRx Pharmaceuticals

What NRx Pharmaceuticals does

NRx Pharmaceuticals (NASDAQ: NRXP) is a clinical-stage biopharmaceutical company developing NMDA and 5-HT2A receptor-targeting therapeutics for central nervous system disorders, with a primary focus on treatment-resistant depression, bipolar depression with suicidality, PTSD, and chronic pain. The company's core pipeline comprises NRX-100 (preservative-free intravenous ketamine targeting acute suicidal ideation), NRX-101 (a fixed-dose combination of D-cycloserine and lurasidone positioned as the first oral medication in FDA trials for suicidal bipolar depression), and KETAFREE (preservative-free IV ketamine pending ANDA approval with a July 29, 2026 GDUFA goal date). The company has accumulated four FDA regulatory designations (Fast Track for NRX-100, Breakthrough Therapy, Special Protocol Agreement, and a Biomarker Letter of Support for NRX-101) and a granted Expanded Access Protocol for NRX-101 as TMS augmentation therapy. NRx differentiates through the absence of Benzethonium Chloride preservative, non-controlled-substance scheduling of NRX-101, and a non-hallucinogenic mechanism that avoids addiction and neurotoxicity risks of traditional NMDA inhibitors.

The company's go-to-market combines pharmaceutical commercialization with direct clinical operations via its wholly-owned HOPE Therapeutics subsidiary, which operates a network of interventional psychiatry clinics in Florida offering TMS, ketamine therapies, and one-day depression protocols. Revenue generation began in Q3 2025 at approximately $240,000 from the clinic network and is scaling toward a multi-million dollar run-rate as the network expands from 5 to 8+ Florida locations through acquisitions (Dura Medical, Neurospa TMS, Cohen & Associates). The company has integrated third-party AI capabilities, including Zeta Surgical's FDA-cleared AI-guided TMS Navigation System and Emobot's EMOCARE Depression Thermometer, into the clinical workflow, and incorporated a separate NRx Defense Systems subsidiary in 2026 to pursue military, veteran, and first responder applications. NRx operates as a public company formed through a December 2020 SPAC merger with Big Rock Partners Acquisition Corp., with headquarters in Wilmington, Delaware, 11-50 employees, and a management team and board featuring former executives from Allergan, J&J, Lilly, Novartis, Pfizer, FDA, Teva, and DARPA.

Name

NRx Pharmaceuticals

Legal name

NRx Pharmaceuticals, Inc.

Website

https://nrxpharma.com

Company type

Public

Founded year

2020

Operating status

Operating

Headcount range

11–50 employees

Short description

NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing NMDA-targeting therapeutics (NRX-100, NRX-101, KETAFREE) for suicidal bipolar depression and treatment-resistant depression, supplemented by a wholly-owned Florida clinic network (HOPE Therapeutics) offering TMS and ketamine therapies.

Ownership category

akta.pro rank

Product category

CNS Pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (32541), Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF)

akta.pro secondary industries

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC), Connected Therapeutics & Smart Drug Delivery Monitoring (HLACAFAL), Companion Diagnostics (CDx) & Therapy Selection Assays (HLAAALAF)

Keywords

• CNS therapeutics
• Preservative-free ketamine
• Bipolar depression treatment
• Interventional psychiatry services
• Suicidal ideation drugs

Headquarters

HQ city

Wilmington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain, Others

Revenue model

1. Pharmaceutical Product Sales: Revenue from sales of FDA-approved pharmaceutical products including preservative-free ketamine (NRX-100/NRX-101) and other CNS treatments. The company is preparing for commercial launch with anticipated approval of ANDA for KETAFREE in Summer 2026 and NDA for NRX-100 for suicidal ideation.
2. Interventional Psychiatry Clinic Services: Revenue generated from HOPE Therapeutics subsidiary operating interventional psychiatry clinics offering TMS treatments, ketamine therapies, and one-day depression treatment protocols. The company has opened five Florida clinic locations and completed acquisition of Dura Medical, Neurospa TMS, and Cohen & Associates, with coverage at more than 8 locations along Florida's West Coast.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing NMDA-receptor-targeting therapeutics for central nervous system disorders, primarily suicidal bipolar depression, treatment-resistant depression, and PTSD. Its lead candidates are NRX-100 (preservative-free IV ketamine) and NRX-101 (D-cycloserine/lurasidone combination). The company also operates HOPE Therapeutics, a subsidiary running interventional psychiatry clinics in Florida offering TMS, ketamine, and AI-guided combination therapies.

Product overview

NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of NMDA-based therapeutics for central nervous system disorders, with its core products being NRX-100 (preservative-free IV ketamine) for acute suicidal ideation and NRX-101 (D-cycloserine/lurasidone combination) for bipolar depression with suicidality. The company operates through its HOPE Therapeutics subsidiary, a network of interventional psychiatry clinics offering TMS and ketamine treatments augmented by AI-powered monitoring tools. The pipeline is advancing through parallel FDA pathways with ANDA for KETAFREE and NDA for NRX-100, supported by real-world evidence from over 70,000 ketamine patients.

Differentiator

Problem solved

Functional benefit

Brands

• HOPE Therapeutics: Subsidiary operating a network of interventional psychiatry clinics providing TMS and other treatments for depression and suicidality
• NRx Defense Systems
• KETAFREE
• ZYESAMI
• BriLife

Products and services

• NRX-100 (Preservative-Free IV Ketamine) Investigational preservative-free intravenous ketamine formulation (free of Benzethonium Chloride) for treating suicidal ideation in patients with depression and bipolar depression. Designed as the first FDA-approved medicine specifically for suicidal ideation beyond Electroconvulsive Therapy. Has received FDA Fast Track designation and is in development with a planned NDA submission.
• NRX-101 (D-cycloserine/Lurasidone Combination) Fixed-dose combination of D-cycloserine (partial NMDA antagonist) and lurasidone (5-HT2A antagonist) for treating bipolar depression with suicidality. Being developed as adjunctive therapy with TMS for treatment-resistant depression. First oral medication in FDA trials for suicidal bipolar depression and not classified as a controlled substance by the DEA. Holds FDA Breakthrough Therapy Designation, Special Protocol Agreement, and Biomarker Letter of Support.
• KETAFREE (Preservative-Free IV Ketamine ANDA) Preservative-free IV ketamine product under FDA review via Abbreviated New Drug Application (ANDA). Would be the first preservative-free ketamine formulation in a market estimated at $750 million per year. FDA accepted the ANDA with GDUFA goal date of July 29, 2026.
• HOPE Therapeutics Clinic Services Wholly-owned subsidiary operating a network of interventional psychiatry clinics in Florida offering TMS, ketamine treatments, one-day depression treatment protocols, and AI-guided TMS therapies directly to patients with treatment-resistant depression, bipolar depression, PTSD, and chronic pain. Expanded to five Florida locations including West Palm Beach, Sarasota, Naples, and Fort Myers.
• AI-Guided TMS Treatments at HOPE Clinics Transcranial Magnetic Stimulation treatments using Zeta Surgical's FDA-cleared AI-powered Zeta TMS Navigation System, providing sub-millimetric image guidance accuracy. Reduces TMS setup times to under two minutes without conventional fiducial markers. Available at HOPE Therapeutics clinics in Florida.
• ONE-D Depression Treatment Protocol One-day depression treatment protocol combining FDA-cleared Ampa device TMS with D-cycloserine and lisdexamfetamine, designed to achieve remission in single-day therapy for treatment-resistant depression patients. Offered at HOPE Therapeutics clinic locations.

Quantifiable outcome

• 34% remission rate with IV ketamine vs 26% with intranasal esketamine; 63% response rate vs 58%; IV ketamine patients approximately 50% more likely to achieve remission (OR 1.51, P<.001)
• +4 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

AI capability5 records

Feature4 records

Partnerships

Nine partnerships are on record, tiered core and minor.

• Zeta Surgical, Inc.coreTechnology or Integration · 27 May 2026Strategic partnership deploying Zeta Surgical's FDA-cleared AI-powered Zeta TMS Navigation System at HOPE Therapeutics clinics. HOPE became first commercial site to deploy the technology, using sub-millimetric image guidance for transcranial magnetic stimulation. Partnership supports planned SPARC-TMS clinical trial combining NRX-101 with robotic-enabled TMS.
• NRx Defense SystemscoreStrategic or Co-development Partner · 15 April 2026Newly incorporated R&D subsidiary focused on developing robotic-enabled TMS combined with neuroplastic therapy for military and first responder applications. Led by Dr. Dennis McBride (former DARPA program manager and Navy Captain), partnering with Zeta Surgical to address five-fold increased risk of depression and PTSD in front-line troops.
• Emobot HealthcoreTechnology or Integration · 30 March 2026Strategic partnership deploying Emobot's EMOCARE AI-powered Depression Thermometer across HOPE Therapeutics clinic network. The smartphone-based passive monitoring platform achieves 90% concordance with clinician assessments and helps detect early relapse to improve treatment outcomes.
• Osmind, Inc.coreTechnology or Integration · 14 January 2026Licensed real-world evidence data from over 70,000 patients treated with ketamine for depression and suicidal ideation, including nearly 1 million treatment sessions and hundreds of millions of datapoints, to support FDA accelerated approval of NRX-100 under Fast Track designation.
• Relief Therapeutics Holding AGminorStrategic or Co-development Partner · 2 December 2025Historical partnership for global commercialization of ZYESAMI (aviptadil) for COVID-19 respiratory failure. Company has since focused on CNS disorders following ZYESAMI trial failures. Ongoing litigation with Relief regarding contract disputes.
• neurocare Group AGcoreStrategic or Co-development Partner · 17 November 2025Strategic partnership for neuroplastic treatment clinics, supporting the expansion of interventional psychiatry clinic network for depression and PTSD treatment.
• Ampa HealthcoreStrategic or Co-development Partner · 11 November 2025Partnership deploying first-in-Florida ONE-D protocol for treatment-resistant depression combining FDA-cleared Ampa device TMS with D-cyloserine and lisdexamfetamine, aiming to achieve remission in single-day therapy at multiple HOPE clinic locations.
• Dura MedicalcoreChannel Partner/ Reseller/ Distributor · 8 September 2025Completed acquisition of Dura Medical, a provider of interventional psychiatry services in Florida operating locations in Naples and Fort Myers. Revenue-generating and EBITDA positive. Founder Stephen Durand (US Army Veteran) appointed as Director of Florida Clinic Operations. Part of HOPE Therapeutics network expansion to 8+ locations.
• Neurospa TMS and Cohen & AssociatescoreChannel Partner/ Reseller/ Distributor · 8 September 2025Pending acquisitions to expand HOPE Therapeutics clinic network to more than 8 locations along Florida's West Coast, complementing existing Dura Medical locations.

Scale indicators11 records

Recent moves6 records

Expansion highlights8 records

Direct peers

• Johnson & Johnson (Janssen): Markets SPRAVATO (esketamine), the only FDA-approved ketamine-derived therapy for treatment-resistant depression. Directly competes with NRX-100/KETAFREE in the depression/suicidality space with established commercial infrastructure and payer coverage.
• Sage Therapeutics: Develops CNS therapeutics including ZURZUVAE (zuranolone) for postpartum depression. Comparable clinical-stage CNS biopharmaceutical company with similar regulatory and commercial challenges in depression treatment market.
• Axsome Therapeutics: Develops Auvelity (dextromethorphan/bupropion) for major depressive disorder. Direct competitor in CNS depression therapeutics with overlapping mechanism (NMDA receptor modulation) and similar small-cap public company profile.
• Neurospa TMS: Pending acquisition target of NRx that operates interventional psychiatry clinics in Florida offering TMS treatments for depression. Directly comparable clinic operations being integrated into HOPE Therapeutics network.

Emerging players

• Atai Life Sciences: Clinical-stage biopharmaceutical company developing psychedelic and NMDA-targeting therapies for depression and PTSD. Comparable pipeline focus on treatment-resistant depression and suicidality, with similar regulatory pathway through FDA.
• Compass Pathways: Pioneering psilocybin therapy for treatment-resistant depression. Comparable CNS-focused clinical-stage company targeting similar patient populations, with overlapping regulatory pathway and benefit from psychedelic medicine policy tailwinds.
• Mind Medicine (MindMed): Clinical-stage CNS company developing psychedelic-inspired therapies including LSD-based treatments for anxiety and depression. Similar clinical-stage CNS profile, target indications, and regulatory pathway as NRx.
• GH Research: Clinical-stage biopharmaceutical company developing mebufotenin (5-HT2A agonist) therapies for treatment-resistant depression. Overlapping mechanism (5-HT2A modulation) and similar target patient population with bipolar depression/suicidality.

Broad incumbents

• Eli Lilly: Major pharmaceutical company with established CNS franchise including antidepressant portfolio and active NMDA/glutamate research programs. Represents broader competitive threat and potential acquirer of NMDA-targeting assets.

Others

• Osmind: Neuropsychiatry technology and medical records platform from which NRx licenses real-world evidence data on 70,000+ ketamine patients. Ecosystem partner providing data infrastructure rather than direct competitive threat.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/NRxPharma
• Facebookfacebook.com/NRxPharma
• LinkedInlinkedin.com/company/nrx-pharma

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries4 records

Funding overview

Funding rounds14 records

Investors9 records

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M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about NRx Pharmaceuticals