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Recent Advances in the Bipolar Depression Treatment | Bipolar Depression Clinical Trials Analysis Review

Around 10+ key companies are developing Bipolar Depression therapies. Intra-cellular Therapies has its drug candidate in the Pre-registration stage. If approved, lumateperone can be an essential medicine for a broad group of patients suffering from these highly prevalent, chronic, complex conditions. With a handful of novel emerging therapies, pharmaceuticals have a lot more potential to explore in the field of Bipolar Depression.

Los Angeles, USA, July 27, 2021 (GLOBE NEWSWIRE) -- Recent Advances in the Bipolar Depression Treatment | Bipolar Depression Clinical Trials Analysis Review

Around 10+ key companies are developing Bipolar Depression therapies. Intra-cellular Therapies has its drug candidate in the Pre-registration stage. If approved, lumateperone can be an essential medicine for a broad group of patients suffering from these highly prevalent, chronic, complex conditions. With a handful of novel emerging therapies, pharmaceuticals have a lot more potential to explore in the field of Bipolar Depression.

DelveInsight’s “Bipolar Depression Pipeline Insight” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in the Bipolar Depression pipeline landscapes. It comprises Bipolar Depression pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Bipolar Depression therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Bipolar Depression pipeline products.

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Some of the key takeaways from the Bipolar Depression Pipeline Report

  • Major companies such as Intra-Cellular Therapies, NeuroRx, Inc., SAGE Therapeutics, Sumitomo Dainippon Pharma, Clexio Biosciences, Iltoo Pharma, AbbVie, Celon Pharma, COMPASS Pathways, and others are developing potential drug candidates to improve the Bipolar Depression treatment scenario.

  • In February 2021, Intra-Cellular Therapies submitted New Drug Applications (sNDAs) to treat depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults.

  • In May 2021, the US FDA has accepted for review its supplemental New Drug Applications (sNDAs) for lumateperone, an investigational agent for treating depressive episodes associated with bipolar I or II disorder (bipolar depression) monotherapy and as adjunctive therapy with lithium or valproate.

  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 17, 2021, for the applications. If approved, CAPLYTA has the potential to be an essential medicine for a broad group of patients suffering from these highly prevalent, chronic, complex conditions.

  • In January 2021, Celon Pharma reported positive top-line results from a Phase II study of Falkieri (proprietary esketamine dry powder inhalation) in the acute phase of treatment-resistant bipolar depression.

  • SAGE-217, a next-generation positive allosteric modulator (PAM) of GABAA receptors, is being evaluated in Phase II clinical development. Positive results were reported from the Phase II clinical trial, which demonstrated rapid and durable response to treatment as measured by the MADRS score and a statistically major enhancement compared to baseline at Day 15.

  • SEP-4199 is a non-racemic ratio of amisulpride enantiomers with the potential to be the first benzamide mood disorders treatment available in the U.S. Sunovion discovered that the pharmacology of amisulpride is enantiomer-specific and that increasing the ratio of R-amisulpride to S-amisulpride increases the potency for serotonin 5-HT7 receptors relative to dopamine D2 receptors.

Get an overview of pipeline landscape @ Bipolar Depression Clinical Trials Analysis

Bipolar Depression is a disabling chronic disease in which depression usually presents a higher risk of long-term functional impairment than mania.

Bipolar Depression Emerging Drugs

  • Lumateperone: Intra-Cellular Therapies

Lumateperone is a butyrophenone atypical antipsychotic developed by Intra-Cellular Therapies, licensed from Bristol-Myers Squibb, for the schizophrenia treatment, and currently in development for Bipolar Depression and other neurological indications. The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Applications (sNDAs) for lumateperone to treat depressive episodes associated with bipolar I or II disorder, as monotherapy and as adjunctive therapy with lithium or valproate. If approved, CAPLYTA has the potential to be a vital medicine for a broad group of patients suffering from these highly prevalent, chronic, complex conditions.

  • Ketamine Hydrochloride: NeuroRx, Inc.

NMDA antagonist drugs have increasingly been shown to alleviate symptoms of depression and suicidal ideation. NeuroRx has developed a sequential therapy comprising IV NRX-100 (ketamine HCL) for rapid stabilization 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. The company is currently recruiting participants for evaluating Ketamine Hydrochloride in Phase III clinical trials.

  • Zuranolone: SAGE Therapeutics

Zuranolone is an investigational medication under development by SAGE Therapeutics to treat depressive disorders and various other indications. It is a synthetic, orally active, inhibitory pregnane neurosteroid and acts as a positive allosteric modulator of the GABAA receptor. Sage’s Phase II open-label ARCHWAY Study evaluated the safety and activity of SAGE-217 in 35 adult men and women with moderate to severe bipolar I/II disorder with a major depressive episode. The trial demonstrated rapid and durable response to treatment as measured by the MADRS score and a statistically major enhancement compared to baseline at Day 15. The effect was maintained through the end of the follow-up period at Day 42.

  • The average change from baseline in MADRS total score was 15.5 points at Day 15 (n=23; p<0.0001) and 16.4 points at Day 42.

  • At Day 15 (n=23), 43.5% of patients receiving SAGE-217 achieved remission (MADRS =12) with an additional 4% achieving response (=50% reduction in MADRS Total score).

For further information, refer to the detailed report @ Bipolar Depression Pipeline Therapeutics

Scope of Bipolar Depression Pipeline Drug Insight

  • Coverage: Global

  • Major Players: 10+ Key Players

  • Prominent Players: Intra-Cellular Therapies, NeuroRx, Inc., SAGE Therapeutics, Sumitomo Dainippon Pharma, Clexio Biosciences, Iltoo Pharma, AbbVie, Celon Pharma, COMPASS Pathways, and many others.

  • Key Drugs Profiles: 10+ Products

  • Phases:

· Bipolar Depression Therapies Late-stage (Phase III)
· Bipolar Depression Therapies Mid-stage (Phase II)
· Bipolar Depression Therapies Early-stage (Phase I)
· Bipolar Depression Pre-clinical stage and Discovery candidates
· Discontinued and Inactive candidates

  • Mechanism of Action:

· GABA A receptor modulators
· Dopamine D2 receptor antagonists
· Interleukin-2 replacements
· NMDA receptor modulators
· Serotonin 2A receptor antagonists

  • Molecule Types:

· Gene therapy
· Monoclonal Antibody
· Peptides
· Polymer
· Small molecule

  • Route of Administration:

· Intramuscular
· Oral
· Intravenous
· Subcutaneous
· Topical

  • Product Types:

· Monotherapy
· Combination
· Mono/Combination

Key Questions regarding Current Bipolar Depression Treatment Landscape and Emerging Therapies Answered in the Pipeline Report

  • What are the current options for Bipolar Depression treatment?

  • How many companies are developing therapies for the treatment of Bipolar Depression?

  • How many are Bipolar Depression emerging therapies in the early-stage, mid-stage, and late development stages to treat Bipolar Depression?

  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and significant licensing activities that will impact the Bipolar Depression market?

  • Which are the dormant and discontinued products and the reasons for the same?

  • What is the unmet need for current therapies for the treatment of Bipolar Depression?

  • What are the current novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing Bipolar Depression therapies?

  • What are the critical designations that have been granted for the emerging therapies for Bipolar Depression?

  • How many patents are granted and pending for the emerging therapies to treat Bipolar Depression?

Table of Contents

1

Bipolar Depression Report Introduction

2

Bipolar Depression Executive Summary

3

Bipolar Depression Overview

4

Bipolar Depression – DelveInsight’s Analytical Perspective In-depth Commercial Assessment

5

Bipolar Depression Pipeline Therapeutics

6

Bipolar Depression Late Stage Products (Preregistration)

6.1

Lumateperone: Intra-Cellular Therapies

7

Bipolar Depression Late Stage Products (Phase III)

7.1

NRX100: NeuroRx, Inc.

8

Bipolar Depression Mid Stage Products (Phase II)

8.1

Zuranolone: SAGE Therapeutics

8.2

SEP-4199: Sumitomo Dainippon Pharma

9

Bipolar Depression Early Stage Products (Phase I)

9.1

CLE 100: Clexio Biosciences

10

Bipolar Depression Preclinical and Discover Stage Products

11

Bipolar Depression Therapeutic Assessment

12

Bipolar Depression Inactive Products

13

Bipolar Depression Key Companies

14

Bipolar Depression Key Products

15

Bipolar Depression Unmet Needs

16

Bipolar Depression Market Drivers and Barriers

17

Bipolar Depression Future Perspectives and Conclusion

18

Bipolar Depression Analyst Views

19

Appendix

20

About DelveInsight

Get a customized pipeline report @ Bipolar Depression Drugs Pipeline Report

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About DelveInsight
DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also provides Healthcare Consulting services comprising credible market analysis that will help accelerate the business growth and overcome challenges with a practical approach.

CONTACT: Contact Us: Shruti Thakur info@delveinsight.com +1(919)321-6187 www.delveinsight.com