NRX-101 is a fixed-dose combination of D-Cycloserine and Lurasidone. It is the first drug in FDA trials for suicidal bipolar depression. NRx is currently investigating our approach in FDA clinical trials.

2024年3月4日 · NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a …

2024年5月6日 · Company plans to seek accelerated approval of NRX-101 for use in patients with bipolar depression at risk of akathisia while continuing to broaden the indication to all patients with bipolar ...

2023年8月13日 · Sequential treatment of a single infusion of ketamine followed by NRX-101 maintenance is a promising therapeutic approach for reducing depression and suicidal ideation in patients with bipolar depression who require hospitalization due to …

2024年6月28日 · NRX-101 is the Company's patented (Composition of Matter), oral combination of the NMDA antagonist D-cycloserine and lurasidone for bipolar depression. Data from two active control clinical...

2023年10月2日 · NRX-101, a fixed dose combination of D-cycloserine and lurasidone, has been granted Fast Track Designation, Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter...

2022年11月9日 · The company’s lead program NRX-101, a fixed-dose combination of D-cycloserine and lurasidone, targets the brain’s NMDA receptor and is being investigated in a Phase 3 trial under an FDA Special Protocol Agreement and Breakthrough Therapy Designation in patients with bipolar depression and suicidal ideation, an indication for which the only ...

2024年3月28日 · NRX-101, a fixed-dose combination of DCS and lurasidone, has been awarded Qualified Infectious Disease Product and Fast Track Designation by the FDA. In this study, we tested NRX-101 against the urinary tract pathogens Escherichia coli , Pseudomonas aeruginosa , Klebsiella pneumoniae , and Acinetobacter baumannii in cation-adjusted Mueller ...

2018年11月16日 · NRX-101能够成为首款获得FDA突破性疗法认证的口服速效抗抑郁药物的关键原因在于，其在多中心STABIL-B可行性研究中获得的临床数据，这项研究旨在评估NRX-101与lurasidone对照组相比的临床效果。

近日，该公司宣布，美国食品和药物管理局（FDA）已授予实验性药物NRX-101 (商品名Cyclurad )突破性药物资格（BTD*），用于治疗经氯胺酮或其他有效疗法初步稳定病情后的伴有急性自杀意念与行为（SBD）的重度双相抑郁症患者。 值得一提的是，NTX-101是第一种获得BTD的口服. NeuroRx 是一家临床阶段的生物制药公司，专注于开发靶向大脑NMDA受体的 速效抗抑郁药物（RAAD）。 近日，该公司宣布，美国食品和药物管理局（FDA）已授予实验性药物 NRX …