The goal of this clinical study is to test NRX101 in participants with complicated urinary tract infections including pyelonephritis. The main questions it aims to answer are:
Does NRX101 help participants resolve UTIs?
Is NRX101 safe for participants with UTIs?
Participants will be seen in a doctor's office approximately 6 times to:
Answer a short 10 item questionnaire.
Review of side effects
Urine tests
Blood draw (about 10 ml or 2 teaspoons)
Review of medications
Review any signs or symptoms of UTI
Vital signs and weight (including blood pressure, heart rate, respiratory rate, and temperature)
Review of medical history
This is an open-label study of NRX101, which means both you and your doctor know what drug you are taking. After the study is completed, researchers will look at the data to see if NRX101 helps participants with complicated UTI's.

开始日期2024-03-31

申办/合作机构

NeuroRx, Inc.

NCT03395392

/ Completed临床2/3期

A Randomized, Double-Blind Controlled Comparison of NRX-101 to Lurasidone for Adults With Bipolar Depression and Subacute Suicidal Ideation or Behavior

NMDA antagonist drugs have shown to reduce symptoms of depression and suicidal ideation. NeuroRx has developed NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for oral use in the treatment of bipolar depression with suicidal ideation. This study will test the hypothesis that NRX-101 is superior to lurasidone alone (standard of care) in maintaining remission from symptoms of depression (primary endpoint) and suicidal ideation or behavior (declared secondary endpoint) over a six week period of twice-daily oral dosing.

开始日期2022-05-12

申办/合作机构

NeuroRx, Inc.

NCT03396068

/ Active, not recruiting临床3期

NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Acute Suicidal Ideation and Behavior: The SBD-ASIB Study

NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression and suicidal ideation. NeuroRx has developed a sequential therapy consisting of IV NRX-100 (ketamine HCL) for rapid stabilization of symptoms of depression and suicidal ideation followed by oral NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for maintenance of stabilization from symptoms of depression and suicidal ideation. NRX-101 has been awarded Fast Track and Breakthrough Therapy Designation by the US Food and Drug Administration. The SevereBD study will test the hypothesis that NRX-101 is superior to lurasidone alone in maintaining remission from symptoms of depression (primary endpoint), clinical relapse (declared secondary endpoint), and suicidal ideation or behavior (declared secondary endpoint) over a six week period of twice-daily oral dosing.

开始日期2019-12-01

申办/合作机构

NeuroRx, Inc.

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100 项与鲁拉西酮/环丝氨酸相关的临床结果

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100 项与鲁拉西酮/环丝氨酸相关的转化医学

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100 项与鲁拉西酮/环丝氨酸相关的专利（医药）

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项与鲁拉西酮/环丝氨酸相关的文献（医药）

2023-10-01·International journal of toxicology

NRX-101, a Rapid-Acting Anti-Depressant, Does Not Cause Neurotoxicity Following Ketamine Administration in Preclinical Models

Article

作者: Jordan, William ; Sapko, Michael T. ; Siegel, Richard ; Javitt, Jonathan

Agents that act at the N-methyl-D-aspartate receptor (NMDAR), such as ketamine, have gained increasing attention as rapid-acting antidepressants; however, their use has been limited by potential neurotoxicity. Recent FDA guidance requires a demonstration of safety on histologic parameters prior to the initiation of human studies. D-cycloserine (DCS) is a partial NMDA agonist that, along with lurasidone, is being investigated as a treatment for depression. The current study was designed to investigate the neurologic safety profile of DCS. To this end, female Sprague Dawley rats (n = 106) were randomly divided into 8 study groups. Ketamine was administered via tail vein infusion. DCS and lurasidone were administered via oral gavage in escalating doses to a maximum of 2000 mg/kg DCS. To ascertain toxicity, dose escalation with 3 different doses of D-cycloserine/lurasidone was given in combination with ketamine. MK-801, a known neurotoxic NMDA antagonist, was administered as a positive control. Brain tissue was sectioned and stained with H&E, silver, and Fluoro-Jade B stains. No fatalities were observed in any group. No microscopic abnormalities were found in the brain of animal subjects given ketamine, ketamine followed by DCS/lurasidone, or DCS/lurasidone alone. Neuronal necrosis, as expected, was seen in the MK-801 (positive control) group. We conclude that NRX-101, a fixed-dose combination of DCS/lurasidone, when administered with or without prior infusion of IV ketamine was tolerated and did not induce neurotoxicity, even at supratherapeutic doses of DCS.

2021-05-01·CNS drugs2区 · 医学

Novel Glutamatergic Modulators for the Treatment of Mood Disorders: Current Status

2区 · 医学

Review

作者: Zarate, Carlos A ; Park, Lawrence T ; Henter, Ioline D

The efficacy of standard antidepressants is limited for many patients with mood disorders such as major depressive disorder (MDD) and bipolar depression, underscoring the urgent need to develop novel therapeutics. Both clinical and preclinical studies have implicated glutamatergic system dysfunction in the pathophysiology of mood disorders. In particular, rapid reductions in depressive symptoms have been observed in response to subanesthetic doses of the glutamatergic modulator racemic (R,S)-ketamine in individuals with mood disorders. These results have prompted investigation into other glutamatergic modulators for depression, both as monotherapy and adjunctively. Several glutamate receptor-modulating agents have been tested in proof-of-concept studies for mood disorders. This manuscript gives a brief overview of the glutamate system and its relevance to rapid antidepressant response and discusses the existing clinical evidence for glutamate receptor-modulating agents, including (1) broad glutamatergic modulators ((R,S)-ketamine, esketamine, (R)-ketamine, (2R,6R)-hydroxynorketamine [HNK], dextromethorphan, Nuedexta [a combination of dextromethorphan and quinidine], deudextromethorphan [AVP-786], axsome [AXS-05], dextromethadone [REL-1017], nitrous oxide, AZD6765, CLE100, AGN-241751); (2) glycine site modulators (D-cycloserine [DCS], NRX-101, rapastinel [GLYX-13], apimostinel [NRX-1074], sarcosine, 4-chlorokynurenine [4-Cl-KYN/AV-101]); (3) subunit (NR2B)-specific N-methyl-D-aspartate (NMDA) receptor antagonists (eliprodil [EVT-101], traxoprodil [CP-101,606], rislenemdaz [MK-0657/CERC-301]); (4) metabotropic glutamate receptor (mGluR) modulators (basimglurant, AZD2066, RG1578, TS-161); and (5) mammalian target of rapamycin complex 1 (mTORC1) activators (NV-5138). Many of these agents are still in the preliminary stages of development. Furthermore, to date, most have demonstrated relatively modest effects compared with (R,S)-ketamine and esketamine, though some have shown more favorable characteristics. Of these novel agents, the most promising, and the ones for which the most evidence exists, appear to be those targeting ionotropic glutamate receptors.

2021-01-01·Chronic stress (Thousand Oaks, Calif.)

Emerging Therapeutics Based on the Amino Acid Neurotransmitter System: An Update on the Pharmaceutical Pipeline for Mood Disorders

Review

作者: Hecking, Julia ; Davoudian, Pasha A. ; Wilkinson, Samuel T.

Mood disorders represent a pressing public health issue and significant source of disability throughout the world. The classical monoamine hypothesis, while useful in developing improved understanding and clinical treatments, has not fully captured the complex nature underlying mood disorders. Despite these shortcomings, the monoamine hypothesis continues to dominate the conceptual framework when approaching mood disorders. However, recent advances in basic and clinical research have led to a greater appreciation for the role that amino acid neurotransmitters play in the pathophysiology of mood disorders and as potential targets for novel therapies. In this article we review progress of compounds that focus on these systems. We cover both glutamate-targeting drugs such as: esketamine, AVP-786, REL-1017, AXS-05, rapastinel (GLYX-13), AV-101, NRX-101; as well as GABA-targeting drugs such as: brexanolone (SAGE-547), ganaxolone, zuranolone (SAGE-217), and PRAX-114. We focus the review on phase-II and phase-III clinical trials and evaluate the extant data and progress of these compounds.

151

项与鲁拉西酮/环丝氨酸相关的新闻（医药）

2024-11-18

·PRNewswire

NRx Pharmaceuticals (NASDAQ:NRXP) Appoints Michael Abrams as Chief Financial Officer

Industry veteran with extensive experience in key areas of focus Interim-CFO Richard Narido to focus on HOPE Therapeutics acquisition opportunities WILMINGTON, Del., Nov. 18, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced it has appointed Michael Abrams as its permanent Chief Financial Officer. Mr. Abrams succeeds Interim-CFO Richard Narido, who will continue to support the Company's financial function and other projects. Continue Reading HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.) "We are delighted to welcome Mike to the NRx team. Mike's combination of public company CFO experience in the biotechnology sector, together with investment banking expertise is ideally suited to NRx's needs as we aim to become a revenue generating, profitable biotechnology company," said Dr. Jonathan Javitt, Chairman, CEO and Chief Scientist of NRx Pharmaceuticals. "Additionally, we thank Rich for his outstanding service to the Company as our Interim-CFO and look forward to his ongoing contributions as HOPE Therapeutics continues to grow its business." Mr. Abrams commented "I'm delighted to join NRx at this critical juncture in the Company's evolution. Evolving from a pre-revenue biotechnology company into a profitable enterprise is both a tremendous opportunity and challenge. I look forward to helping grow the Company with the NRx team." Michael Abrams is a senior finance professional with almost three decades of experience as an executive officer, investment banker, director and senior advisor, which includes serving as the Chief Financial Officer of Arch Therapeutics, RiseIT Solutions. and FitLife Brands. Mr. Abrams has deep experience across multiple functional areas including, but not limited to, financial operations, accounting, mergers and acquisitions, financial engineering, capital raising and shareholder communications. He earned his MBA with Honors from the University of Chicago Booth School of Business following his BBA with Honors from the University of Massachusetts at Amherst, where he was named a William F. Field alumni scholar. About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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 announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality. About HOPE Therapeutics, Inc. HOPE Therapeutics, Inc. () is a development stage healthcare delivery company developing a best-in-class network of precision psychiatry clinics that intends to offer ketamine transcranial magnetics stimulation (TMS) and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. Notice Regarding Forward-Looking Statements The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, liquidity, Hope Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund the Hope Therapeutics acquisitions, and the Company's ability to spin-off Hope Therapeutics. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at . Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise. For further information: Matthew Duffy Chief Business Officer, NRx Pharmaceuticals Co-Chief Executive Officer, HOPE Therapeutics, Inc. [email protected] SOURCE NRx Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

高管变更快速通道

2024-11-14

·PRNewswire

NRx Pharmaceuticals (NASDAQ:NRXP) Reports Third Quarter and Year to Date 2024 Financial Results and Provides Business Update

On track to file New Drug Applications (NDAs) for NRX-100 (IV Ketamine) in treating suicidal ideation in depression, including bipolar depression and NRX-101 (Oral D-Cycloserine/Lurasidone) for Accelerated Approval in bipolar depression with suicidality or akathisia by year end 2024 with 2025 PDUFA date forecast. HOPE Therapeutics acquiring Interventional Psychiatry Clinics; key to developing a best-in-class network of care to prevent suicide, continues to expect first revenue by year-end 2024. 74% reduction in net operating losses compared to 3rd quarter 2023 with profitability forecast in 2025 from HOPE Therapeutics and from sales of medication. Management to host a conference call November 18, 2024 at 4:30 PM ET WILMINGTON, Del., Nov. 14, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced its financial results for the quarter and year to date ended September 30, 2024 and provided a business update. Key Clinical and Business Activities Continue Reading Akathisia rating by study day: A consistent effect is seen commencing at the first post-randomization visit and continued throughout the study (Mixed Model Repeated Measures Regression Effect size =.37; P=0.025). HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)

财报

2024-11-07

·PRNewswire

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) to Report Third Quarter and Year to Date 2024 Financial Results on November 14, 2024

WILMINGTON, Del. , Nov. 7, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will release its third quarter and year to date 2024 financial results after the market closes on Thursday, November 14, 2024, via press release, which will be available on the Company's website at . The Company will host a conference call to discuss the financial results as well as provide a corporate update at 4:30pm ET the same day. A live webcast of the conference call will be available on the Company's website at . Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically +1-800-717-1738 or internationally +1-646-307-1865. About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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 announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality. About HOPE Therapeutics, Inc. HOPE Therapeutics, Inc. () is a healthcare delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. Notice Regarding Forward-Looking Statements The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at . Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise. For further information: Matthew Duffy Chief Business Officer, NRx Pharmaceuticals Co-Chief Executive Officer, HOPE Therapeutics, Inc. [email protected] SOURCE NRx Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

财报突破性疗法快速通道

100 项与鲁拉西酮/环丝氨酸相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
双相情感障碍及相关疾病	临床3期	美国	Alvogen, Inc.	2023-06-05
躁郁症	临床3期	美国	NeuroRx, Inc.	2022-05-12
抑郁症	临床3期	美国	NeuroRx, Inc.	2019-12-01
自杀意念	临床3期	美国	NeuroRx, Inc.	2019-12-01
复杂的尿路感染	临床2期	-	NeuroRx, Inc.	2024-03-31
肾盂肾炎	临床2期	-	NeuroRx, Inc.	2024-03-31
伤害性疼痛	临床2期	美国	NeuroRx, Inc.	-
创伤后应激障碍	临床2期	美国	NeuroRx, Inc.	-
慢性疼痛	临床申请	美国	NRX Pharmaceuticals, Inc.	2023-08-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


W89 (Biospace) 人工标引	临床2/3期	躁郁症	-	NRX-101	製餘鏇顧餘衊鏇醖醖壓(膚觸簾鏇願齋窪鏇構鹽) = NRX-101 and lurasidone both demonstrated > 50% response for treating bipolar depression with no difference seen on primary efficacy endpoint (MADRS) 製淵窪製醖選蓋製鹹網 (窪憲餘淵願齋獵醖獵膚 ) 更多	积极	2024-05-28
				Lurasidone
NCT03395392 (PRNewswire) 人工标引	临床2期	抑郁症 \| 自杀意念	-	NRX-101	膚窪夢窪願糧襯築襯壓(築衊鬱齋衊餘壓壓範鏇) = 選鏇顧鏇網遞夢積願繭衊窪選鹹顧壓醖蓋膚淵 (窪簾構齋獵醖醖獵艱製 ) 更多	积极	2024-05-06
				Lurasidone	膚窪夢窪願糧襯築襯壓(築衊鬱齋衊餘壓壓範鏇) = 製觸襯鏇獵襯膚製積憲衊窪選鹹顧壓醖蓋膚淵 (窪簾構齋獵醖醖獵艱製 )
NCT02974010 (STABIL-B, CTgov)	临床2期	抑郁症	22	NRX-101+Ketamine (Ketamine Followed by NRX-101)	簾廠淵壓鏇積艱窪鹽蓋(簾齋襯齋壓蓋願憲簾範) = 範襯窪艱衊築淵鑰鹹憲網蓋艱簾餘襯網鹹繭衊 (製鏇餘範襯齋窪鬱襯願, 1.95) 更多	-	2021-05-25
				Lurasidone+Ketamine (Ketamine Followed by Lurasidone)	簾廠淵壓鏇積艱窪鹽蓋(簾齋襯齋壓蓋願憲簾範) = 遞膚網壓廠鏇鏇獵糧鬱網蓋艱簾餘襯網鹹繭衊 (製鏇餘範襯齋窪鬱襯願, 2.95) 更多
NCT02974010 (Corporate Publications) 人工标引	临床2期	抑郁症	20	Ketamine Hydrochloride+NRX-101	觸餘壓衊淵製觸蓋鏇製(鹽鹽鬱膚範鬱壓築範構) = Overall the drug was well tolerated, with no serious adverse events 範獵願襯鹹願窪廠網網 (製壓襯顧繭蓋窪餘製顧 ) 更多	积极	2019-05-30
				Ketamine Hydrochloride+Lurasidone Hydrochloride