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NRx Pharmaceuticals to discuss new NRX-101 pipeline indication for augmentation of Transcranial Magnetic Stimulation
As previously announced, low dose D-cycloserine has been associated with augmentation of the antidepressant and antisuicidal response achieved by Transcranial
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"As previously announced, low dose D-cycloserine has been associated with augmentation of the antidepressant and antisuicidal response achieved by Transcranial Magnetic Stimulation (TMS).NRx has amended its Investigational New Drug filing for NRX-101 (D-cycloserine/lurasidone) to include its use in association with TMS for the treatment of depression, including suicidal depression. This protocol will be available to patients both through a clinical trial and under NRx’s Expanded Access protocols.NRx currently has more than 25,000 manufactured investigational doses available WILMINGTON, Del., Dec. 03, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that it has amended its Investigational New Drug filing for NRX-101 (D-cycloserine/lurasidone) to include the use of NRX-101 in association with Transcranial Magnetic Stimulation (TMS) for the treatment of depression, including suicidal depression. In the third quarter, the Company identified a promising new indication for NRX-101 that potentially offers rapid path to commercialization for this Breakthrough Therapy-designated drug. Recent evidence suggests that NRX-101 may confer a significant added advantage to the clinical results of Transcranial Magnetic Stimulation. Cole and colleagues reported that patients randomized to D-cycloserine (DCS) vs. Placebo concurrent with TMS using a standard protocol experienced a greater than two-fold benefit in terms of reduction in symptoms of depression. Clinical response of 75% and remission of 40% was seen in the DCS-treated group.1 A substantial body of nonclinical literature has been published in subsequent years demonstrating that DCS at low doses exerts a neuroplasticity effect and causes dendritic sprouting in areas of the brain associated with depression. On November 4, 2025, Real World Data were presented in conjunction with use of a modern Theta Burst FDA-cleared TMS device and a one day TMS protocol, combined with a single administration of oral DCS. The authors reported 87% clinical response and 72% remission manifesting at 6 weeks after a single day of treatment on the Hamilton Depression Rating Scale with similar findings on other standard test measures.2 Nonclinical evidence suggests that D-cycloserine acts to augment neuroplasticity in association with T...