DelveInsight’s “Bipolar Disorder Pipeline Insight 2025” report provides comprehensive insights about 20+ companies and 20+ pipeline drugs in the Bipolar Disorder pipeline landscape. It covers the Bipolar Disorder Pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Bipolar Disorder Pipeline Therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Curious about the latest updates in the Bipolar Disorder Pipeline? Click here to explore the therapies and trials making headlines @ Bipolar Disorder Pipeline Outlook Report

Key Takeaways from the Bipolar Disorder Pipeline Report

• On 09 October 2025, Xenon Pharmaceuticals Inc. announced a phase 3 study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).
• DelveInsight’s Bipolar Disorder Pipeline report depicts a robust space with 20+ active players working to develop 20+ pipeline therapies for Bipolar Disorder treatment.
• The leading Bipolar Disorder Companies such as Lyndra Therapeutics, Alzamend Neuro, Inc., SK Bio-Pharmaceuticals, Reviva Pharmaceuticals, COMPASS Pathways, NRx Pharmaceuticals, Sage Therapeutics, Neumora Therapeutics, and Vanda Pharmaceuticals and others.
• Promising Bipolar Disorder Therapies such as Quetiapine fumarate (Seroquel) SR, Azetukalner, Aripiprazole, Valproate, BHV-7000, Risperidone, Ziprasidone, ABBV-932, and others.

Want to know which companies are leading innovation in Bipolar Disorder? Dive into the full pipeline insights @ Bipolar Disorder Clinical Trials Assessment

The Bipolar Disorder Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The Bipolar Disorder Pipeline Report also highlights the unmet needs with respect to the Bipolar Disorder.

Bipolar Disorder Overview

Bipolar disorder, formerly known as manic depression, is a mental health condition characterized by extreme mood swings that include emotional highs (mania or hypomania) and lows (depression). These mood swings can affect sleep, energy levels, behavior, and the ability to carry out day-to-day tasks. Bipolar disorder is a chronic condition that requires lifelong management. It is classified into several types: Bipolar I, marked by manic episodes lasting at least seven days or by manic symptoms severe enough to require immediate hospital care; Bipolar II, defined by a pattern of depressive episodes and hypomanic episodes, which are less severe than full-blown manic episodes; and Cyclothymic Disorder, characterized by periods of hypomanic and depressive symptoms lasting for at least two years.

Bipolar Disorder Emerging Drugs Profile

• LYN-005: Lyndra Therapeutics

LYN-005 Risperidone is one of the most prescribed treatments for patients with schizophrenia and bipolar disorders LYN-005 is the Lyndra’s lead product candidate, oral weekly risperidone (LYN-005), is being developed for the treatment of people living with schizophrenia and bipolar 1 disorder. Lyndra Therapeutics announced positive data from the STARLYNG-1 (LYN-005-C-301) study, comparing the pharmacokinetic (PK) profile of oral weekly risperidone (LYN-005) with immediate-release Risperdal administered daily to adults living with schizophrenia and schizoaffective disorder. The study also met its secondary endpoints for safety and Positive and Negative Syndrome Scale (PANSS) score, a score used for measuring symptom severity in schizophrenia. Oral weekly risperidone (LYN-005) was generally safe and well tolerated. Currently the drug is in Phase III stage of development for the treatment of bipolar disorder.

• AL001: Alzamend Neuro, Inc.

AL001, is a patented ionic cocrystal technology delivering a therapeutic combination of lithium, proline and salicylate, for the treatment of AD, bipolar disorder, MDD, and PTSD. AL001 recently completed the clinical portion of Phase IIA trials and announced topline data in June 2023. Based on our preclinical data, AL001 treatment prevents cognitive deficits, depression, and irritability in APPSWE/PS1dE9 mice, and is superior in improving associative learning and memory and irritability compared with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer’s, bipolar disorder, MDD and PTSD in humans. Currently the drug is in Phase II stage of development for the treatment of bipolar disorder.

• SKL-PSY: SK Bio-Pharmaceuticals

SKL-PSY is a novel candidate being developed by SK Bio-Pharmaceuticals. In October 2011, SK biopharmaceuticals announced that they have entered into a research and development agreement with Medicilon, of Shanghai, China, for their novel new small molecule SKL-PSY that is being developed for the treatment of depression and bipolar disorder. SK Biopharmaceuticals and Shanghai Medicilon have been conducting various preclinical experiments for SKL-PSY since 2011. Unlike currently-marketed antidepressants that can require 2-4 weeks to become effective, SKL-PSY has a relatively quick onset of therapeutic effects in animal models of depressive and manic states. Currently, the drug is in Phase I stage of its development for the treatment of bipolar disorder.

If you’re tracking ongoing Bipolar Disorder Clinical trials, this press release is a must-read. Tap to see the breakthroughs @ Bipolar Disorder Treatment Drugs

The Bipolar Disorder Pipeline report provides insights into:-

• The report provides detailed insights about companies that are developing therapies for the treatment of Bipolar Disorder with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Bipolar Disorder Treatment.
• Bipolar Disorder Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Bipolar Disorder Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Bipolar Disorder market.

Bipolar Disorder Companies

Lyndra Therapeutics, Alzamend Neuro, Inc., SK Bio-Pharmaceuticals, Reviva Pharmaceuticals, COMPASS Pathways, NRx Pharmaceuticals, Sage Therapeutics, Neumora Therapeutics, and Vanda Pharmaceuticals and others.

Bipolar Disorder Pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as,

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Bipolar Disorder Products have been categorized under various Molecule types such as,

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

From emerging drug candidates to competitive intelligence, the Bipolar Disorder Pipeline Report covers it all – check it out now @ Bipolar Disorder Market Drivers and Barriers, and Future Perspectives

Scope of the Bipolar Disorder Pipeline Report

• Coverage- Global
• Bipolar Disorder Companies- Lyndra Therapeutics, Alzamend Neuro, Inc., SK Bio-Pharmaceuticals, Reviva Pharmaceuticals, COMPASS Pathways, NRx Pharmaceuticals, Sage Therapeutics, Neumora Therapeutics, and Vanda Pharmaceuticals and others.
• Promising Bipolar Disorder Therapies- Quetiapine fumarate (Seroquel) SR, Azetukalner, Aripiprazole, Valproate, BHV-7000, Risperidone, Ziprasidone, ABBV-932, and others.
• Bipolar Disorder Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Bipolar Disorder Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Stay ahead in Healthcare Research – discover what’s next for the Bipolar Disorder Treatment landscape in this detailed analysis @ Bipolar Disorder Emerging Drugs and Major Players

Table of Contents

1. Introduction
2. Executive Summary
3. Bipolar Disorder: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Bipolar Disorder – DelveInsight’s Analytical Perspective
7. Late Stage Products (Phase III)
8. LYN-005: Lyndra Therapeutics
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. AL001: Alzamend Neuro, Inc.
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. SKL-PSY: SK Bio-Pharmaceuticals
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. Drug Name: Company Name
18. Drug profiles in the detailed report…..
19. Inactive Products
20. Bipolar Disorder Key Companies
21. Bipolar Disorder Key Products
22. Bipolar Disorder- Unmet Needs
23. Bipolar Disorder- Market Drivers and Barriers
24. Bipolar Disorder- Future Perspectives and Conclusion
25. Bipolar Disorder Analyst Views
26. Bipolar Disorder Key Companies
27. Appendix

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