NRx Pharmaceuticals, Inc. (NRXP) announced that it has licensed and submitted real-world evidence from more than 70,000 patients treated with ketamine or esketamine for depression and suicidal ideation to the U.S. FDA in support of accelerated approval of NRX-100 (preservative-free ketamine).
Suicidal ideation remains a major unmet need in psychiatry, with no FDA-approved medicines currently available. Electroconvulsive therapy is the only approved intervention, leaving patients with limited options. Ketamine has been widely adopted off label in military, veterans, and private practice settings, showing rapid reductions in suicidal thoughts.
Clinical Evidence and FDA Pathway
NRX-100 has been granted Fast Track Designation for suicidal ideation in depression and bipolar depression. The real-world dataset, provided by Osmind's nationwide electronic medical records platform, includes nearly one million treatment sessions and hundreds of millions of data points on safety and effectiveness. Preliminary analysis of a 20,000-patient subset showed rapid resolution of depression and suicidality, consistent with prior randomized data.
Regulatory Significance
In September 2025, the FDA updated its policy to allow submission of de-identified real-world evidence, enabling NRx to leverage Osmind's dataset for regulatory review. The company believes the full 70,000 patient analysis will demonstrate clinically meaningful outcomes and support accelerated approval of NRX-100.
Pipeline and Strategy
NRx is also advancing NRX-101, an oral D-cycloserine/ lurasidone combination, which has Breakthrough Therapy Designation for suicidal bipolar depression. Together, NRX-100 and NRX-101 form the company's NMDA-based platform targeting central nervous system disorders.
NRXP has traded between $1.58 and $5.01 over the past year. The stock is currently trading in the pre-market at $2.19, up 2.82%.
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