NRx Pharmaceuticals (NASDAQ: NRXP) amended its Investigational New Drug filing for the oral D‑cycloserine/lurasidone combination, NRX‑101, to include use in conjunction with transcranial magnetic stimulation (TMS) for the treatment of depression, including suicidal depression. The amendment was filed on December 3 2025 and expands the drug’s potential therapeutic profile.
Clinical data supporting the amendment show a marked improvement in patient outcomes. In a recent study, patients receiving NRX‑101 alongside a standard TMS protocol achieved a 75 % clinical response rate and a 40 % remission rate at six weeks. Real‑world data from November 4, 2025, reported an even higher 87 % response and 72 % remission, underscoring the drug’s potential to enhance TMS efficacy.
NRX‑101 already holds FDA Breakthrough Therapy designation for suicidal bipolar depression, a status that can accelerate regulatory review. By adding a TMS indication, NRx positions the drug as a rapid‑action combination therapy that could shorten the time to market and broaden its addressable patient base, potentially capturing over one million U.S. patients who receive TMS annually by 2030.
The amendment dovetails with NRx’s broader strategy of building a network of interventional psychiatry clinics through its HOPE Therapeutics subsidiary. HOPE is expanding its clinic footprint and developing a digital therapeutic platform to support NMDA‑targeted treatments, creating a synergistic ecosystem that can deliver NRX‑101 and TMS together in a coordinated care model.
NRx has already manufactured more than 25,000 investigational doses of NRX‑101 and plans a controlled trial of approximately 120 participants to validate the combination’s efficacy. The company also offers expanded access protocols to provide early treatment to patients who qualify under the new IND amendment.
The combination of NRX‑101 with TMS could give NRx a competitive edge over traditional SSRIs, which typically achieve a 30 % remission rate. By potentially delivering higher response and remission rates, the drug may attract clinicians seeking more effective, rapid‑acting options for treatment‑resistant and suicidal depression, thereby strengthening NRx’s market position and accelerating its path to commercialization.
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