NRX-101

NRX-101 is an investigational oral fixed-dose combination of D-cycloserine and lurasidone developed for severe bipolar depression with suicidal ideation/behavior and related depression settings. The program has FDA Breakthrough Therapy designation and active IND-based clinical development, including TMS augmentation protocols. It is not yet approved for the discussed indications.

Drug Class

Investigational fixed-dose NMDA modulator plus 5-HT2A antagonist combination

Approval Status

Investigational candidate under IND with FDA Breakthrough Therapy designation; no approved marketing status for these indications.

Mechanism of Action

Dual mechanism targeting NMDA and 5-HT2A receptors, with reported synergistic antidepressant effects and mitigation of psychomimetic side effects.