Bipolar Disorder Clinical Trials Analysis 2025 Novel Mechanisms and Digital Therapeutics Drive Innovation | DelveInsight

DelveInsight's "Bipolar Disorder - Clinical Trials Analysis, 2025" reviews a dynamic pipeline aiming to address the unmet needs of patients struggling with recurring episodes of mania and depression. While mood stabilizers and atypical antipsychotics remain the standard of care, ongoing research is shifting toward therapies with improved efficacy, tolerability, and long-term outcomes.

Emerging trials are evaluating glutamatergic modulators, neurosteroids, and anti-inflammatory agents that target underlying neurobiological pathways beyond traditional dopaminergic and serotonergic systems. Combination strategies are also under study to reduce relapse rates and improve cognitive function, a major burden in bipolar disorder management.

In parallel, digital therapeutics and neuromodulation approaches, such as transcranial magnetic stimulation (TMS), are entering the clinical space, offering adjunctive options to enhance adherence and real-time mood monitoring. With several late-stage candidates and technology-enabled therapies advancing, the bipolar disorder landscape is on course for more personalized and effective treatment solutions in the years ahead.

Explore the full pipeline analysis for bipolar disorder and uncover key opportunities @ https://www.delveinsight.com/report-store/bipolar-disorder-manic-depression-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

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 July 2025, BioXcel Therapeutics submitted a pre-sNDA meeting package to the FDA for IGALMI®, aiming to expand its label for outpatient (at-home) use in treating acute agitation associated with bipolar disorders and schizophrenia. The meeting is scheduled for August 20, 2025.
• 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, formerly known as manic depression, is a mental health condition characterized by extreme mood swings between periods of mania or hypomania (emotional highs) and depression (emotional lows). These mood changes can impact sleep, energy levels, behavior, and daily functioning. There are three main types: Bipolar I, which involves severe manic episodes; Bipolar II, marked by depressive episodes and milder hypomania; and Cyclothymic Disorder, characterized by long-term fluctuations between hypomanic and depressive symptoms. During manic episodes, individuals may experience heightened energy, risky behaviors, and racing thoughts, while depressive phases include sadness, fatigue, and difficulty concentrating.

The disorder is influenced by genetic, biological, and environmental factors, with family history increasing risk. It involves dysregulated brain circuits and neurotransmitter imbalances, particularly in serotonin, dopamine, and norepinephrine. Treatment typically includes mood stabilizers, anticonvulsants, atypical antipsychotics, and antidepressants (with caution), as well as psychotherapy like cognitive-behavioral therapy (CBT) and lifestyle changes. Severe cases may require electroconvulsive therapy (ECT), and consistent treatment is crucial for symptom management and improved quality of life.

Find out more about Bipolar Disorder medication @ https://www.delveinsight.com/report-store/bipolar-disorder-manic-depression-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

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.

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
https://www.delveinsight.com/consulting-services

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. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

This release was published on openPR.