NRX-100 Advances Toward FDA Approval: 70,000-Patient Dataset Reshapes Ketamine Treatment Evidence

NRx Pharmaceuticals (NRXP) has submitted a landmark dataset to the U.S. Food and Drug Administration, marking a significant milestone in the accelerated approval pathway for NRX-100, a preservative-free ketamine formulation designed for depression and suicidal ideation.

The Clinical Gap and Treatment Urgency

Suicidal ideation represents one of psychiatry’s most pressing unmet medical needs, with electroconvulsive therapy remaining the only FDA-approved intervention. Off-label ketamine use has gained substantial traction across military installations, veteran care facilities, and specialized private practices, demonstrating rapid reduction in suicidal thoughts. However, the absence of an approved pharmaceutical formulation has left many patients without standardized treatment options.

Real-World Evidence Reaches Critical Scale

The FDA submission draws from over 70,000 patient cases treated with ketamine or esketamine, compiled through Osmind’s nationwide electronic health records infrastructure. This database encompasses approximately one million clinical sessions and hundreds of millions of discrete data points measuring both safety profiles and therapeutic effectiveness. An interim analysis of 20,000 patients revealed consistent, rapid improvements in depressive symptoms and suicidality measures, aligning with findings from controlled clinical trials.

Regulatory Momentum and Policy Evolution

NRX-100 previously secured Fast Track Designation from the FDA for treating suicidal ideation in both major depressive disorder and bipolar depression. A pivotal regulatory shift occurred in September 2025, when the FDA updated guidelines to permit submission of de-identified real-world evidence for approval decisions. This policy change directly enabled NRx to leverage Osmind’s comprehensive patient database for regulatory review, potentially strengthening the accelerated approval case through real-world validation at scale.

Complementary Pipeline Strategy

Beyond NRX-100, NRx is developing NRX-101, an oral combination therapy pairing D-cycloserine with lurasidone, which carries Breakthrough Therapy Designation for suicidal bipolar depression. Together, these candidates form an NMDA-receptor-targeting platform addressing central nervous system disorders, with the dual approach potentially expanding treatment options across patient populations.

Market Positioning

Over the past year, NRXP stock has fluctuated between $1.58 and $5.01 per share. In pre-market trading, the stock moved to $2.19, reflecting a 2.82% gain following the announcement. The advancement of NRX-100 through regulatory channels represents a significant catalyst for the company as it pursues approval for one of psychiatry’s most challenging clinical indications.