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.