• D-Cycloserine (DCS) has been reported to augment the effect of Transcranial Magnetic Stimulation (TMS) in remission from depression and suicidality in several published clinical studies.
  • NRx Pharmaceuticals is developing NRX-101, a fixed dose combination of DCS+lurasidone for the augmentation of TMS and has initiated a pivotal clinical trial in both civilian and military treatment facilities.
  • The Expanded Access protocol is designed to make NRX-101 available under FDA-authorized compassionate care mechanisms for patients who cannot access the pivotal trial.
  • Physicians who wish to provide NRX-101 in association with accelerated TMS for patients with Treatment-Resistant Depression may register at www.nrxpharma.com/EAP

WILMINGTON, Del., June 22, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a biopharmaceutical company that focuses on neuroplastic therapies for depression, PTSD, and related conditions, today announces the approval by FDA of an Intermediate Population Expanded Access Protocol for the use of NRX-101, a fixed dose combination of D-cycloserine (DCS) and lurasidone for the augmentation of accelerated Transcranial Magnetic Stimulation (TMS). Expanded Access Protocols are part of FDA’s compassionate care approach to making investigational drugs available to patients with serious or life-threatening medical conditions.

In recent years, there have been multiple scientific reports which suggest that DCS may enhance the effectiveness of TMS in treating Treatment Resistant Depression and Suicidality.2,3 DCS has been demonstrated to have potent neuroplastic effects in laboratory studies. Neuroplasticity is the scientific term for the creation of new connections or synapses between brain cells and is believed to be key to the reversal of depression and suicidality. The Company has announced initiation of a pivotal clinical trial (the Synaptic Plasticity Augmented Rapid Circuit Stimulation (SPARC-TMS) study) to assess the effect of NRX-101 in augmenting TMS to achieve remission from Depression and Suicidality in patients being treated with mechanism-guided augmentation of neuronavigated robotic TMS, a study that will be conducted in both civilian and military treatment facilities.

While the use of DCS is increasingly discussed and adopted within the professional community based on Real World Evidence, the doses required are below the dose of DCS that is currently marketed and sold for the treatment of tuberculosis (the currently approved indication), which has led to an increasing use of compounded versions of DCS. Compounded drugs are neither supervised nor approved by the US FDA. In the case of DCS, compounding is particularly challenging because the DCS pharmaceutical ingredient is highly susceptible to degradation without special formulation processes. When NRx first developed NRX-101, two years of research and development was required to properly control impurities and achieve long-term stability. Compounded drugs (except those eligible for 503b manufacture, which DCS is not) are not assessed for stability and impurities by compounding pharmacists, who lack the chromatography equipment required for FDA Good Manufacturing Practices (GMP) controls. Accordingly, NRx Pharmaceuticals has elected to make NRX-101 available to physicians and their patients under the Expanded Access Protocol while pivotal clinical trials are underway in an effort to assure that this potentially life-saving drug is immediately available for patients who qualify. Initially, the Company will be charging only for shipping and FDA-required data collection costs, but not for the investigational drug.