Home/Pipeline/NRX-100

NRX-100

Treatment-Resistant Depression with Suicidality

ANDA/NDA FiledRegulatory Review

Key Facts

Indication
Treatment-Resistant Depression with Suicidality
Phase
ANDA/NDA Filed
Status
Regulatory Review
Company

About NRx Pharmaceuticals

NRx Pharmaceuticals is a clinical-stage biotech focused on developing lifesaving treatments for suicidal bipolar depression and PTSD, conditions with no currently approved pharmacotherapies. Its core strategy is built on a proprietary NMDA receptor modulation platform, designed to deliver antidepressant efficacy while reducing the suicidality and akathisia associated with standard treatments. The company has achieved significant regulatory momentum, with NRX-101 holding FDA Fast Track and Breakthrough Therapy designations. NRx is advancing a pipeline of neuroplastic therapies and pursuing strategic initiatives, including an ANDA for preservative-free ketamine (NRX-100), to address acute and chronic psychiatric crises.

View full company profile