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.

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...

2024年5月28日 · NRX-101 was associated with 58% relative reduction in time to sustained remission from suicidality as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) when stratified by sex, mood...

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 ...

We focus on serious, life-threatening conditions with major unmet medical needs. Our growing pipeline is powered by our proprietary, dual-targeted mechanism of action, which safely modulates the NMDA and 5HT2A receptors.

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 ...

15 小时之前 · NRX-100 was previously granted Fast Track Designation by FDA in combination with use of NRX-101. Ketamine efficacy data from four clinical trials are intended to support the filing.

15 小时之前 · NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced its financial results for the quarter and year ended ...

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 …

12 小时之前 · Critically, NRX-101 demonstrated a reduction in symptoms of suicidality and is the first oral antidepressant to reduce symptoms of akathisia, a potentially lethal side effect of nearly all ...

2024年5月28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4月30日 · NRX-101 is first oral antidepressant to show 33% advantage in sustained remission in suicidality (not statistically significant at this sample size) and 75% advantage in relief from Akathisia...

2018年11月15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。

1 天前 · NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI. NRx has recently initiated a New Drug Application filing for NRX ...

2018年5月7日 · NRX-101 is a patented, oral, fixed-dose combination of two FDA approved drugs: d-cycloserine, a N-methyl-D-aspartate (NMDA) receptor modulator, and lurasidone, a 5-HT2a receptor antagonist. NeuroRx’s investigational treatment approach begins with a single dose of NRX-100 (ketamine), an FDA-approved anesthetic, for initial stabilization ...

2023年12月18日 · The FDA has accepted an Investigational New Drug (IND) application for NRX-101, a combination of D-cycloserine (DCS) and lurasidone for the potential treatment of patients with complicated urinary tract infections (UTIs), announced NRx Pharmaceuticals, the developer of the compound, in a news release. 1

2024年1月16日 · NRX-101 is a fixed-dose combination of the broad-spectrum antibiotic D-cycloserine and lurasidone. The FDA has granted Fast Track and Qualified Infectious Disease Product (QIDP) designations to NRX-101 for complicated UTI and pyelonephritis, according to NRx Pharmaceuticals, the developer of the treatment. 1.

9 小时之前 · NRX-100 was previously granted Fast Track Designation by FDA in combination with use of NRX-101. Ketamine efficacy data from four clinical trials are intended to support the filing.

2018年12月13日 · NRX-101 is a patented, oral, fixed-dose combination of D-cycloserine (DCS), an NMDA antagonist, and lurasidone, which has 5-HT2a receptor antagonist activity. In contrast with all currently approved antidepressant drugs, which primarily raise serotonin levels in the brain, DCS is shown to raise levels of two neurotransmitters: glutamate and ...