5-HT1A receptor agonists(Serotonin 1a (5-HT1a) receptor agonists), 5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), 5-HT7 receptor antagonists(Serotonin 7 (5-HT7) receptor antagonists)

+ [4]

Therapeutic Areas

Other DiseasesInfectious DiseasesNervous System Diseases+ [1]

Active Indication

Bipolar DisorderDepressive DisorderSuicidal Ideation+ [6]

Inactive Indication-

Originator Organization

Avineuro Pharmaceuticals, Inc.

Active Organization

NeuroRx, Inc.NRX Pharmaceuticals, Inc.

Avineuro Pharmaceuticals, Inc.

+ [2]

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationFast Track (US), Breakthrough Therapy (US), Qualified Infectious Disease Product (US), Priority Review (US)

Structure

Molecular FormulaC3H6N2O2

InChIKeyDYDCUQKUCUHJBH-UWTATZPHSA-N

CAS Registry68-41-7

View All Structures (2)

Clinical Trials associated with Lurasidone/Cycloserine

NCT06128213 / Not yet recruitingPhase 2

An Open Label Study of NRX-101 for Patients With Acute Complicated Urinary Tract Infection Including Pyelonephritis

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.

Start Date31 Mar 2024

Sponsor / Collaborator

NeuroRx, Inc.

NCT03395392 / CompletedPhase 2/3

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.

Start Date12 May 2022

Sponsor / Collaborator

NeuroRx, Inc.

NCT03396068 / Active, not recruitingPhase 3

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.

Start Date01 Dec 2019

Sponsor / Collaborator

NeuroRx, Inc.

[+1]

100 Clinical Results associated with Lurasidone/Cycloserine

100 Translational Medicine associated with Lurasidone/Cycloserine

100 Patents (Medical) associated with Lurasidone/Cycloserine

Literatures (Medical) associated with Lurasidone/Cycloserine

01 Oct 2023·International Journal of Toxicology

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

Article

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

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.

01 May 2021·CNS DrugsQ2 · MEDICINE

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

Q2 · MEDICINE

Review

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

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.

01 Jan 2021·Chronic Stress

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

Review

Author: 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.

130

News (Medical) associated with Lurasidone/Cycloserine

18 Nov 2024

·www.prnewswire.com

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

Executive ChangeFast Track

14 Nov 2024

·www.prnewswire.com

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.)

Financial Statement

07 Nov 2024

·www.prnewswire.com

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

Financial StatementBreakthrough TherapyFast Track

100 Deals associated with Lurasidone/Cycloserine

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bipolar and Related Disorders	Phase 3	US	Alvogen, Inc.	05 Jun 2023
Bipolar Disorder	Phase 3	US	NeuroRx, Inc.	12 May 2022
Depressive Disorder	Phase 3	US	NeuroRx, Inc.	01 Dec 2019
Suicidal Ideation	Phase 3	-	Avineuro Pharmaceuticals, Inc.	-
Complicated urinary tract infection	Phase 2	-	NeuroRx, Inc.	31 Mar 2024
Pyelonephritis	Phase 2	-	NeuroRx, Inc.	31 Mar 2024
Nociceptive Pain	Phase 2	US	NeuroRx, Inc.	-
Stress Disorders, Post-Traumatic	Phase 2	US	NeuroRx, Inc.	-
Chronic Pain	IND Application	US	NRX Pharmaceuticals, Inc.	30 Aug 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


W89 (Biospace) Manual	Phase 2/3	Bipolar Disorder	-	NRX-101	(skrmlwelth) = NRX-101 and lurasidone both demonstrated > 50% response for treating bipolar depression with no difference seen on primary efficacy endpoint (MADRS) thxpkcpphc (gqjujbljzt ) View more	Positive	28 May 2024
				Lurasidone
NCT03395392 (PRNewswire) Manual	Phase 2	Depressive Disorder \| Suicidal Ideation	-	NRX-101	(nuusaaafot) = otfmznxjpn oepuiffmbv (lkpfsyltcc ) View more	Positive	06 May 2024
				Lurasidone	(nuusaaafot) = vkxgtteglt oepuiffmbv (lkpfsyltcc )
NCT02974010 (STABIL-B, CTgov)	Phase 2	Depressive Disorder	22	NRX-101+Ketamine (Ketamine Followed by NRX-101)	vwcdhusoon(obcybodqao) = dxytyzhmiz zrdpikodqb (wfqkruczvi, dgwogxvszc - bfaqfuyssq) View more	-	25 May 2021
				Lurasidone+Ketamine (Ketamine Followed by Lurasidone)	vwcdhusoon(obcybodqao) = qlunjwpbir zrdpikodqb (wfqkruczvi, pqehmhowek - zvljxdqlqo) View more
NCT02974010 (Corporate Publications) Manual	Phase 2	Depressive Disorder	20	Ketamine Hydrochloride+NRX-101	(iutmdyitxd) = Overall the drug was well tolerated, with no serious adverse events ubaajyebnj (vizgbebltu ) View more	Positive	30 May 2019
				Ketamine Hydrochloride+Lurasidone Hydrochloride

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Lurasidone/Cycloserine

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