NRx Pharmaceuticals announced that the U.S. Food and Drug Administration cleared the company to initiate a Phase 2/3 clinical trial evaluating NRX-101 in patients with treatment-resistant major depressive disorder and suicidality receiving active or sham transcranial magnetic stimulation. The study is expected to enroll 240 participants across academic, HOPE Therapeutics and military treatment facility sites.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for treating central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The company is developing NRX-100, a preservative-free intravenous ketamine, and NRX-101, an oral D-cycloserine and lurasidone combination. NRX-100 has been awarded Fast Track Designation for treating suicidal ideation in depression, including bipolar depression.
NRX-101 has been awarded Breakthrough Therapy Designation for treating suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for treating suicidal ideation in patients with depression, including bipolar depression. These designations reflect the FDA’s recognition of the drugs’ potential to address serious unmet medical needs in patients at risk of suicide.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.financialcontent.com/article/nnwire-2026-5-7-investornewsbreaks-nrx-pharmaceuticals-inc-nasdaq-nrxp-receives-fda-clearance-for-depression-and-suicidality-trial