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Bipolar Depression Emerging drugs and Key Players

Bipolar Disorder Manic Depression Pipeline Insight

Bipolar Disorder (Manic Depression) Overview

Bipolar Disorder (Manic Depression) Pipeline Insight, 2020” report by DelveInsight outlays comprehensive insights of present clinical development scenario and growth prospects across the Bipolar Disorder (Manic Depression) market. A detailed picture of the Bipolar Disorder (Manic Depression) pipeline landscape is provided, which includes the disease overview and Bipolar Disorder (Manic Depression) treatment guidelines. The assessment part of the report embraces in-depth Bipolar Disorder (Manic Depression) commercial assessment and clinical assessment of the Bipolar Disorder (Manic Depression) pipeline products from the pre-clinical developmental phase to the marketed phase. In the report, a detailed description of the drug is proffered including mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Bipolar Disorder (Manic Depression) collaborations, licensing, mergers and acquisition, funding, designations, and other product-related details.

Companies across the globe are diligently working toward the development of novel treatment therapies with a considerable amount of success over the years. Key players, such as Celon Pharma, Otsuka Pharmaceutical, NeuroRx, etc., are developing therapies for the treatment of Bipolar Depression.

Lumateperone (also known as ITI-007), is an investigational orally available, first-in-class small molecule that provides selective and simultaneous modulation of serotonin, dopamine, and glutamate—three neurotransmitter pathways implicated in severe mental illness. It in an investigational new drug that was under review with the FDA for the treatment of schizophrenia. Recently in December 2019, it has been approved by the US FDA for the treatment of schizophrenia in adult, under trade name Caplyta. The lumateperone clinical trial program in bipolar depression includes three Phase III trials. Two trials, Study 401 and Study 404, evaluated lumateperone as monotherapy and the third trial, Study 402, is evaluating lumateperone as an adjunctive therapy to lithium or valproate.

NeuroRx has developed a sequential therapy consisting of intravenous 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 is a proprietary, oral fixed-dose combination of two FDA-approved drugs: D-cycloserine, an NMDA receptor modulator; and Lurasidone (Latuda), a 5-HT2a receptor antagonist. NRX-100 is ketamine (an anesthetic approved for surgical procedures, not approved for psychiatric indications) that is administered intravenously.

NeuroRx’s investigational treatment approach begins with a single infusion of NRX-100 (ketamine), followed by approximately six weeks of daily oral NRX-101. Currently the therapy is under investigation in phase III clinical trial for rapid stabilization of acute suicidal ideation and behavior in patients with bipolar depression. Additionally, the company is also initiating a Phase IIb/III clinical trial of NRX-100/NRX-101 for the treatment of Bipolar Depression in patients with Acute Suicidal Ideation and Behavior (ASIB). Falkieri (Esketamine DPI/Esketamine dry powder Inhaler) is an esketamine formulation and acts as an NMDA antagonist. The antidepressant activity of ketamine is established recently, even though it is majorly used in anesthesia. Esketamine as in form S-enantiomer is pharmacologically 3–4 times more potent to R-enantiomer.

The goal of the project is to develop an innovative and convenient formulation for the patients to use Esketamine. The molecule has received approval by US FDA in March 2019, under the brand name Spravato, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them. The FDA granted this approval of Spravato to Janssen Pharmaceuticals.

Bipolar Disorder Emerging Drugs

  1. Abilify (Aripiprazole): Otsuka Pharmaceutical
  2. Lumateperone/ITI-007: Intra-cellular Therapies
  3. NRX-100/NRX-101: NeuroRx
  4. Psilocybin: COMPASS Pathways
  5. Zuranolone (SAGE-217): Sage Therapeutics
  6. SEP-4199: Sunovion/Sumitomo Dainippon Pharma
  7. ILT101: Iltoo Pharma
  8. Falkieri (Esketamine DPI): Celon Pharma

Scope of the report

  • The Bipolar Disorder (Manic Depression) report provides an overview of therapeutic pipeline activity and therapeutic assessment of the products by development stage, product type, route of administration, molecule type, and MOA type for Bipolar Disorder (Manic Depression) across the complete product development cycle, including all clinical and nonclinical stages.
  • It comprises of detailed profiles of Bipolar Disorder (Manic Depression) therapeutic products with key coverage of developmental activities, including technology, collaborations, licensing, mergers and acquisition, funding, designations and other product-related details
  • Detailed Bipolar Disorder (Manic Depression) research and development progress and trial details, results wherever available, are also included in the pipeline study.
  • Coverage of dormant and discontinued pipeline projects along with the reasons if available across Bipolar Disorder (Manic Depression).

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Table of contents

1. Report Introduction

2. Bipolar Disorder (Manic Depression) 

2.1. Overview

2.2. History

2.3. Bipolar Disorder (Manic Depression) Symptoms

2.4. Causes


2.6. Bipolar Disorder (Manic Depression) Diagnosis

2.6.1. Diagnostic Guidelines

3. Bipolar Disorder (Manic Depression) Current Treatment Patterns

3.1. Bipolar Disorder (Manic Depression) Treatment Guidelines

4. Bipolar Disorder (Manic Depression) – DelveInsight’s Analytical Perspective

4.1. In-depth Commercial Assessment

4.1.1. Bipolar Disorder (Manic Depression) companies collaborations, Licensing, Acquisition -Deal Value Trends Assessment Summary

4.1.2. Bipolar Disorder (Manic Depression) Collaboration Deals Company-Company Collaborations (Licensing / Partnering) Analysis Company-University Collaborations (Licensing / Partnering) Analysis Bipolar Disorder (Manic Depression) Acquisition Analysis

5. Therapeutic Assessment

5.1. Clinical Assessment of Pipeline Drugs

5.1.1. Assessment by Phase of Development

5.1.2. Assessment by Product Type (Mono / Combination) Assessment by Stage and Product Type

5.1.3. Assessment by Route of Administration Assessment by Stage and Route of Administration

5.1.4. Assessment by Molecule Type Assessment by Stage and Molecule Type

5.1.5. Assessment by MOA Assessment by Stage and MOA

5.1.6. Assessment by Target Assessment by Stage and Target

6. Bipolar Disorder (Manic Depression) Late Stage Products (Phase-III)

7. Bipolar Disorder (Manic Depression) Mid Stage Products (Phase-II)

8. Early Stage Products (Phase-I)

9. Pre-clinical Products and Discovery Stage Products

10. Inactive Products

11. Dormant Products

12. Bipolar Disorder (Manic Depression) Discontinued Products

13. Bipolar Disorder (Manic Depression) Product Profiles

13.1. Drug Name: Company

13.1.1. Product Description Product Overview Mechanism of action

13.1.2. Research and Development Clinical Studies

13.1.3. Product Development Activities Collaboration Agreements Acquisition Patent Detail

13.1.4. Tabulated Product Summary General Description Table

Detailed information in the report?

14. Bipolar Disorder (Manic Depression) Key Companies

15. Bipolar Disorder (Manic Depression) Key Products

16. Dormant and Discontinued Products

16.1. Dormant Products

16.1.1. Reasons for being dormant

16.2. Discontinued Products

16.2.1. Reasons for the discontinuation

17. Bipolar Disorder (Manic Depression) Unmet Needs

18. Bipolar Disorder (Manic Depression) Future Perspectives

19. Bipolar Disorder (Manic Depression) Analyst Review  

20. Appendix

21. Report Methodology

By sthakur

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