Comprehensive TherapeuticDevelopment Pipeline for Bipolar Depression: 2025 

According to DelveInsight's evaluation, globally, the Bipolar Depression pipeline comprises 8+ key organizations continuously advancing 10+ Bipolar Depression treatment candidates, with analysis of Clinical Investigations, Therapeutics, Mechanism of Action, Administration Route, and Developments examined by DelveInsight.

"Bipolar Depression Pipeline Intelligence, 2025" analysis by DelveInsight outlines comprehensive intelligence into the present clinical development scenario and growth prospects across the Bipolar Depression Market.

The Bipolar Depression Pipeline analysis encompasses in-depth commercial and clinical evaluation of pipeline candidates from the pre-clinical developmental phase to the marketed phase. The analysis also includes a comprehensive description of compounds, encompassing the mechanism of action, clinical investigations, NDA approvals (if any), and product development activities including the technology, partnerships, mergers acquisition, funding, designations, and other product-related details.

Essential Highlights from the Bipolar Depression Pipeline Analysis:

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• Organizations across the globe are diligently advancing toward creating novel Bipolar Depression treatment candidates with a considerable amount of success over the years.

• Bipolar Depression Key stakeholders include - Autobahn Therapeutics, Allergan (AbbVie)/Gedeon Richter, Alkermes, Glaxo SmithKline (GSK), ELI Lilly and Company, Janssen Pharmaceuticals, Astellas Pharma Inc., Bristol Myers Squibb, Gedeon Richter Plc., H. Lundbeck A/S, Pfizer Inc., Novartis AG, Otsuka Holdings Co. Ltd, Validus Pharmaceuticals LLC, NeuroRx, Sunovion (Sumitomo Dainippon Pharma), COMPASS Pathways, SAGE Therapeutics, Forest Laboratories, Target Health Inc., Vanguard, Inc., AstraZeneca, Celon Pharma SA, Intra-Cellular Therapies, Inc., Arvid Carlsson Research AB, Solvay Pharmaceuticals, Shire, Intra-Cellular Therapies, Inc., and additional entities, are creating therapies for Bipolar Depression treatment

• Bipolar Depression Emerging candidates include - ABX-002, VRAYLAR (Cariprazine), LYBALVI (olanzapine, samidorphan L-malate), NRX-100, NRX-101, SEP-4199, COMP 360 (Psilocybin Therapy), Sage-217, cariprazine, Ketamine Hydrochloride, Lurasidone HCl, Quetiapine Fumarate (SEROQUEL), Esketamine, Lumateperone, Brexpiprazole, OSU6162, Bifeprunox, carbamazepine ER, ITI-007 (Lumateperone), Olanzapine Fluoxetine Combination (OFC), lamotrigine, FK949E, SM-13496, and additional candidates are anticipated to have a substantial impact on the Bipolar Depression market in the upcoming years.

• In January 2025, Autobahn Therapeutics, a biotech organization concentrated on creating restorative therapies for neuropsychiatric and neuroimmunologic disorders, has launched a Phase 2 clinical investigation for ABX-002, a potent oral thyroid hormone beta receptor (TRβ) selective agonist, as an adjunctive treatment for bipolar depression in adults. This investigation aims to establish both biological and clinical proof-of-concept, directing the organization's future clinical development approach.

• In April 2024, NRx Pharmaceuticals revealed encouraging outcomes from its Phase IIb/III clinical investigation comparing NRX-101 to lurasidone for treating suicidal bipolar depression. The outcomes showed a promising, though not yet statistically significant, 33% reduction in suicidality, along with a 70% reduction in akathisia symptoms (P=.076).

Bipolar Depression Background

Bipolar disorder represents a disabling chronic disease in which depression typically presents a higher risk of long-term functional impairment than mania. Persistent depression does not have a known cause. As with bipolar disorder, depression has hereditary factors and might also involve neurotransmitter imbalances in the brain.

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Emerging Bipolar Depression Compounds Under Various Phases of Clinical Development Include:

• ABX-002: Autobahn Therapeutics

• VRAYLAR (Cariprazine): Allergan (AbbVie)/Gedeon Richter

• LYBALVI (olanzapine, samidorphan L-malate): Alkermes

• NRX-100/ NRX-101: NeuroRx

• SEP-4199: Sunovion (Sumitomo Dainippon Pharma)

• COMP 360 (Psilocybin Therapy): COMPASS Pathways

• Sage-217: SAGE Therapeutics

• cariprazine: Forest Laboratories

• Ketamine Hydrochloride: Target Health Inc.

• Lurasidone HCl: Vanguard, Inc.

• Quetiapine Fumarate (SEROQUEL): AstraZeneca

• Esketamine: Celon Pharma SA

• Lumateperone: Intra-Cellular Therapies, Inc.

• Brexpiprazole: Otsuka America Pharmaceutical

• OSU6162: Arvid Carlsson Research AB

• Bifeprunox: Solvay Pharmaceuticals

• carbamazepine ER: Shire

• ITI-007 (Lumateperone): Intra-Cellular Therapies, Inc.

• Olanzapine Fluoxetine Combination (OFC): Eli Lilly and Company

• lamotrigine: GlaxoSmithKline

• FK949E: Astellas Pharma Inc

• SM-13496: Sumitomo Pharma Co., Ltd.

Administration Route

Bipolar Depression pipeline analysis delivers the therapeutic evaluation of pipeline compounds by Administration Route. Products have been organized under various administration routes, including

• Oral

• Parenteral

• Intravitreal

• Subretinal

• Topical

Molecular Classification

Products have been organized under various molecular classifications, including

• Monoclonal Antibody

• Peptides

• Polymer

• Small molecule

• Gene therapy

Bipolar Depression Pipeline Therapeutics Evaluation

• Bipolar Depression Evaluation by Product Type

• Bipolar Depression By Stage and Product Type

• Bipolar Depression Evaluation by Administration Route

• Bipolar Depression By Stage and Administration Route

• Bipolar Depression Evaluation by Molecular Type

• Bipolar Depression by Stage and Molecular Type

DelveInsight's Bipolar Depression Analysis encompasses around 10+ products under various phases of clinical development including

• Late-phase products (Phase III)

• Mid-phase products (Phase II)

• Early-phase product (Phase I)

• Pre-clinical and Discovery phase candidates

• Discontinued & Inactive candidates

• Administration Route

Key Organizations in the Bipolar Depression Therapeutics Market Include:

Key organizations creating therapies for Bipolar Depression are - Allergan (AbbVie)/Gedeon Richter, Sunovion Pharmaceuticals (Sumitomo Dainippon Pharma), Intra-Cellular Therapies, NeuroRx, Sunovion (Sumitomo Dainippon Pharma), Lundbeck/Otsuka Pharmaceutical, Celon Pharma, COMPASS Pathways and additional entities

Bipolar Depression Pipeline Evaluation:

The Bipolar Depression pipeline analysis delivers intelligence into

• The analysis delivers comprehensive intelligence about organizations that are creating therapies for the treatment of Bipolar Depression with aggregate therapies created by each organization for the same indication.

• It evaluates various therapeutic candidates categorized into early-phase, mid-phase, and late-phase of development for Bipolar Depression Treatment.

• Bipolar Depression key organizations are engaged in targeted therapeutics development with corresponding active and inactive (dormant or terminated) projects.

• Bipolar Depression Drugs in development classified by developmental phase, administration route, target receptor, monotherapy or combination therapy, various mechanisms of action, and molecular classification.

• Comprehensive analysis of partnerships (company-company partnerships and company-academia partnerships), licensing agreements and financial arrangements for future progression of the Bipolar Depression market. The analysis is constructed using data and intelligence traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Additional Bipolar Depression product details are included in the analysis. Download the Bipolar Depression pipeline analysis to learn more about emerging Bipolar Depression candidates https://www.delveinsight.com/sample-request/bipolar-depression-pipeline-insight?utm_source=sites&utm_medium=promotion&utm_campaign=kkpr

Bipolar Depression Pipeline Market Growth Drivers

• Demand for innovative technologies

• Rising awareness regarding mental disorders

Bipolar Depression Pipeline Market Constraints

• Limited randomized controlled trials (RCTs) of acute Bipolar Depression

• Stringent pricing and reimbursement policies

Parameters of Bipolar Depression Pipeline Drug Intelligence

• Coverage: Global

• Key Bipolar Depression Companies: Autobahn Therapeutics, Allergan (AbbVie)/Gedeon Richter, Alkermes, Glaxo SmithKline (GSK), ELI Lilly and Company, Janssen Pharmaceuticals, Astellas Pharma Inc., Bristol Myers Squibb, Gedeon Richter Plc., H. Lundbeck A/S, Pfizer Inc., Novartis AG, Otsuka Holdings Co. Ltd, Validus Pharmaceuticals LLC, NeuroRx, Sunovion (Sumitomo Dainippon Pharma), COMPASS Pathways, SAGE Therapeutics, Forest Laboratories, Target Health Inc., Vanguard, Inc., AstraZeneca, Celon Pharma SA, Intra-Cellular Therapies, Inc., Arvid Carlsson Research AB, Solvay Pharmaceuticals, Shire, Intra-Cellular Therapies, Inc., and additional entities

• Key Bipolar Depression Therapies: ABX-002, VRAYLAR (Cariprazine), LYBALVI (olanzapine, samidorphan L-malate), NRX-100, NRX-101, SEP-4199, COMP 360 (Psilocybin Therapy), Sage-217, cariprazine, Ketamine Hydrochloride, Lurasidone HCl, Quetiapine Fumarate (SEROQUEL), Esketamine, Lumateperone, Brexpiprazole, OSU6162, Bifeprunox, carbamazepine ER, ITI-007 (Lumateperone), Olanzapine Fluoxetine Combination (OFC), lamotrigine, FK949E, SM-13496, and additional candidates

• Bipolar Depression Therapeutic Evaluation: Bipolar Depression current marketed and Bipolar Depression emerging candidates

• Bipolar Depression Market Dynamics: Bipolar Depression market drivers and Bipolar Depression market constraints

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