NRX-101

June 22, 2026: NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) announced FDA approval of an Intermediate Population Expanded Access Protocol (compassionate use) for NRX-101, a fixed-dose combination of D-cycloserine (DCS) and lurasidone, to augment accelerated transcranial magnetic stimulation (TMS) for patients with treatment-resistant depression. The company said the protocol is intended for patients who cannot access its pivotal trial and will make GMP-manufactured NRX-101 available via physicians (initially charging only shipping and FDA-required data collection costs, not for the investigational drug).

NRx also noted it has initiated a pivotal clinical trial, the SPARC-TMS (Synaptic Plasticity Augmented Rapid Circuit Stimulation) study, evaluating NRX-101 as augmentation to mechanism-guided, neuronavigated robotic TMS to achieve remission from depression and suicidality, to be conducted in both civilian and military treatment facilities, with results to be reported in the future.

The release cites published clinical studies and real-world evidence suggesting DCS may enhance TMS effectiveness and highlights concerns around compounded DCS stability/impurity control.