NRx Pharmaceuticals Inc. (NASDAQ: NRXP) received FDA clearance to begin a clinical trial combining its drug NRX-101 with robotic-assisted transcranial magnetic stimulation for treating patients with depression and suicidality.

The placebo-controlled phase 2/3 trial, designated MIND1, will test NRX-101, which combines D-cycloserine and lurasidone, against placebo in patients receiving either active or sham transcranial magnetic stimulation. The study aims to enroll 240 participants at a U.S. academic teaching hospital and three HOPE Therapeutics clinic sites, with additional enrollment planned at two military treatment facilities.

NRx Defense Systems, a subsidiary of NRx Pharmaceuticals, will conduct the trial. Dr. Josh Brown, who serves as the company's Chief Medical Innovation Officer and Assistant Professor of Psychiatry at Harvard McLean Hospital, will serve as principal investigator. Brown previously led predecessor studies funded by the Defense Advanced Research Projects Agency.

Dr. Dennis McBride, a retired Navy captain and president of NRx Defense Systems, will lead the trial organizationally. McBride previously served as a program manager at the Defense Advanced Research Projects Agency.

The company stated it anticipates non-dilutive funding sources will support the trial, citing potential applications for military and first responder organizations. NRx has not disclosed the trial's timeline or expected costs.

NRx Pharmaceuticals develops treatments based on its NMDA platform for central nervous system disorders. The company's NRX-100 has received Fast Track Designation for treating suicidal ideation in depression, while NRX-101 has Breakthrough Therapy Designation for suicidal bipolar depression treatment.