Bipolar Disorder Pipeline: Innovative Advancements with 20+ Leading Companies Developing Cutting-Edge Therapies | DelveInsight

The Bipolar Disorder (Manic Depression) market is rapidly advancing and is fueled by groundbreaking research and innovative therapies from companies such as Lyndra Therapeutics, Alzamend Neuro, Inc., SK Bio-Pharmaceuticals, Reviva Pharmaceuticals, and COMPASS Pathways. These industry pioneers are transforming treatment strategies and redefining the future of bipolar disorder, bringing new hope to patients worldwide.

DelveInsight's "Bipolar Disorder Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Bipolar Disorder market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging Bipolar Disorder drugs, the Bipolar Disorder pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Bipolar Disorder Pipeline Report
• DelveInsight's Bipolar Disorder Pipeline analysis depicts a robust space with 20+ active players working to develop 20+ pipeline drugs for Bipolar Disorder treatment.
• The leading Bipolar Disorder companies include Lyndra Therapeutics, Alzamend Neuro, Inc., SK Bio-Pharmaceuticals, Reviva Pharmaceuticals, COMPASS Pathways, NRx Pharmaceuticals, Sage Therapeutics, Alzamend Neuro, Inc., Neumora Therapeutics, Vanda Pharmaceuticals, and others are evaluating their lead assets to improve the Bipolar Disorder treatment landscape.
• Key Bipolar Disorder pipeline therapies in various stages of development include LYN-005, AL001, SKL-PSY, RP5063, COMP360, NRX-101TM, SAGE-217, AL001, Navacaprant, VHX 896, and others.
• In March 2025, PharmaTher Holdings Ltd. announced the resubmission of its response to the complete response amendment for its FDA new drug application for Ketamine, addressing the minor deficiencies outlined in the FDA's complete response letter (CRL) dated October 22, 2024.
• In Feb 2025, the FDA accepted Teva Pharmaceuticals' supplemental New Drug Application (sNDA) for risperidone (Uzedy) extended-release injectable suspension for the maintenance treatment of bipolar I disorder in adults.
• In January 2025, Johnson & Johnson and Intra-Cellular Therapies announced a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Intra-Cellular Therapies, a biopharmaceutical company specializing in the development and commercialization of CNS disorder treatments, for $132.00 per share in cash, totaling approximately $14.6 billion in equity value.
• In December 2024, NRx Pharmaceuticals announced the submission of the first section of its New Drug Application (NDA) for NRX-100 (ketamine) to the FDA. NRX-100, which was granted Fast Track Designation in 2017, is being developed for use in combination with NRX-101 (D-cycloserine/lurasidone) to treat suicidal bipolar depression.

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Bipolar Disorder Overview
Bipolar disorder, previously known as manic depression, is a mental health condition characterized by extreme mood swings between emotional highs (mania or hypomania) and lows (depression). These fluctuations can affect sleep, energy, behavior, and daily functioning. It is a chronic condition with three main types: Bipolar I, marked by severe manic episodes; Bipolar II, characterized by depressive and less intense hypomanic episodes; and Cyclothymic Disorder, involving long-term periods of hypomanic and depressive symptoms.

During manic episodes, individuals may feel excessively energetic, engage in risky behaviors, and have racing thoughts. Hypomania is similar but milder. Depressive episodes involve sadness, fatigue, difficulty concentrating, and suicidal thoughts. Bipolar disorder results from genetic, biological, and environmental factors, with a family history increasing risk.

The condition involves dysregulated brain circuits, especially in the prefrontal cortex and limbic system, and neurotransmitter imbalances, particularly serotonin, dopamine, and norepinephrine. Diagnosis involves clinical evaluation, including symptom assessment and input from family members, to distinguish it from other mood disorders.

Treatment typically includes mood stabilizers (e.g., lithium), anticonvulsants, atypical antipsychotics, and antidepressants (used cautiously). Psychotherapy, especially cognitive-behavioral therapy (CBT), and lifestyle changes such as regular sleep and stress management, are also important. Severe cases may require electroconvulsive therapy (ECT). Consistent treatment is essential for managing symptoms and improving quality of life.

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Bipolar Disorder Treatment Analysis: Drug Profile
LYN-005: Lyndra Therapeutics
LYN-005, an oral weekly formulation of risperidone, is Lyndra Therapeutics' lead product candidate for treating schizophrenia and bipolar I disorder. The drug has shown promising results in the STARLYNG-1 (LYN-005-C-301) study, which compared the pharmacokinetic (PK) profile of weekly LYN-005 to daily immediate-release Risperdal in adults with schizophrenia and schizoaffective disorder. The study met its secondary endpoints, including safety and improvements in the Positive and Negative Syndrome Scale (PANSS) score, which measures schizophrenia symptom severity. LYN-005 was generally well tolerated. The drug is currently in Phase III trials for bipolar disorder treatment.

AL001: Alzamend Neuro, Inc.
AL001, an innovative ionic cocrystal combination of lithium, proline, and salicylate, is being developed for Alzheimer's disease (AD), bipolar disorder, major depressive disorder (MDD), and PTSD. After completing Phase IIA trials, Alzamend Neuro announced promising topline data in June 2023. Preclinical studies showed that AL001 effectively prevents cognitive deficits, depression, and irritability in animal models, outperforming lithium carbonate in improving learning, memory, and irritability. AL001 is currently in Phase II trials for bipolar disorder.

Key Bipolar Disorder Therapies and Companies
• LYN-005: Lyndra Therapeutics
• AL001: Alzamend Neuro, Inc.
• SKL-PSY: SK Bio-Pharmaceuticals
• Lumateperone/ITI-007 (Intra-Cellular Therapies)
• NRX-100/NRX-101 (NeuroRx)
• SEP-4199 (Sunovion/Sumitomo Dainippon Pharma)
• Brexpiprazole (Lundbeck/Otsuka Pharmaceutical)
• Falkieri (Celon Pharma)
• Psilocybin (COMPASS Pathways)

Learn more about the novel and emerging Bipolar Disorder pipeline therapies @ https://www.delveinsight.com/report-store/bipolar-disorder-manic-depression-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Bipolar Disorder Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

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

Scope of the Bipolar Disorder Pipeline Report
• Coverage: Global
• Key Bipolar Disorder Companies: Lyndra Therapeutics, Alzamend Neuro, Inc., SK Bio-Pharmaceuticals, Reviva Pharmaceuticals, COMPASS Pathways, NRx Pharmaceuticals, Sage Therapeutics, Alzamend Neuro, Inc., Neumora Therapeutics, Vanda Pharmaceuticals, and others.
• Key Bipolar Disorder Pipeline Therapies: LYN-005, AL001, SKL-PSY, RP5063, COMP360, NRX-101TM, SAGE-217, AL001, Navacaprant, VHX 896, and others.

Dive deep into rich insights for drugs used for Bipolar Disorder treatment; visit @ https://www.delveinsight.com/report-store/bipolar-disorder-manic-depression-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Bipolar Disorder Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Bipolar Disorder Pipeline Therapeutics
6. Bipolar Disorder Pipeline: Late-Stage Products (Phase III)
7. Bipolar Disorder Pipeline: Late-Stage Products (Phase III)
8. Bipolar Disorder Pipeline: Mid-Stage Products (Phase II)
9. Bipolar Disorder Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
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This release was published on openPR.