Major Depressive Disorder Clinical Trial Pipeline | 75+ Companies Pioneering the Future of Treatment

Major pharmaceutical companies are working to advance the pipeline space and unlock the future growth potential of the Major Depressive Disorder treatment landscape.

DelveInsight's 'Major Depressive Disorder Pipeline Insight 2024' report provides comprehensive global coverage of pipeline Major Depressive Disorder therapies in various stages of clinical development. Major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Major Depressive Disorder pipeline domain.

For Major Depressive Disorder emerging drugs, the Major Depressive 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 Major Depressive Disorder Pipeline Report
• DelveInsight's Major Depressive Disorder Pipeline analysis depicts a robust space with 75+ active players working to develop 75+ pipeline drugs for Major Depressive Disorder treatment.
• The leading Major Depressive Disorder companies include GH Research, Praxis Precision Medicines, AbbVie, Gedeon Richter, Intra-Cellular Therapies, Bristol-Myers Squibb, Relmada Therapeutics, SAGE Therapeutics, Janssen Research & Development, Minerva Neurosciences, Takeda, Neurocrine Biosciences, Pherin Pharmaceuticals, Forest Laboratories, Otsuka Pharmaceuticals, Axsome Therapeutics, Luye Pharma, BioLite Inc., VistaGen Therapeutics, BioVentures, Sirstei Pharmaceuticals, Alto Neuroscience, Chase Therapeutics, Neumora Therapeutics, BlackThorn Therapeutics, Fabre-Kramer Pharmaceuticals, Novartis, and others are evaluating their lead assets to improve the Major Depressive Disorder treatment landscape.
• Key Major Depressive Disorder pipeline therapies in various stages of development include AXS-05, Vraylar, Zuranolone, LY03005, MIN-202, REL-1017, ABV-1504, PH10, PRAX-114, CAPLYTA, and others.
• In January 2025, the FDA approved Johnson & Johnson's supplemental New Drug Application for Spravato (esketamine) CIII nasal spray, making it the first and only monotherapy for adults with major depressive disorder (MDD) who have not responded adequately to at least two oral antidepressants.
• In January 2025, Neumora Therapeutics, Inc. announced results from the Phase 3 KOASTAL-1 Study of navacaprant for treating major depressive disorder (MDD). This study is the first of three Phase 3 trials in the pivotal KOASTAL program.
• On November 12, 2024, Magstim, a global leader in neuroscience and mental health treatment, received FDA clearance for its Horizon Inspire System. This advanced transcranial magnetic stimulation (TMS) technology is designed to assist physicians, nurse practitioners, clinicians, and researchers in treating patients with major depressive disorder (MDD), obsessive-compulsive disorder (OCD), and anxious depression.
• On November 5, 2024, the U.S. FDA approved an Investigational New Drug (IND) application from Damona Pharmaceuticals, enabling the company to begin a Phase I trial of DPX-101. The drug is designed to treat cognitive disabilities in major depressive disorder and other brain disorders.

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Major Depressive Disorder Overview
Major Depressive Disorder (MDD) is one of the most prevalent psychiatric conditions and is projected by the World Health Organization to become the leading cause of disease burden in high-income countries by 2032. Characterized by persistent sadness, loss of interest or pleasure, fatigue, changes in appetite and sleep, and, in severe cases, suicidal thoughts, MDD significantly disrupts daily life and psychosocial functioning.

As a complex and widespread disorder, MDD presents challenges for both patients and healthcare providers. The primary treatment goal is achieving remission, which requires continuous symptom monitoring to assess response and potential treatment resistance. Advancements in disease understanding, novel therapeutic developments, and patient-centered treatment approaches are expected to improve outcomes in the coming years.

Also known as clinical depression, MDD affects mood, behavior, and various physical functions, including appetite and sleep. While its exact cause remains unclear, multiple risk factors contribute to its development. Symptoms must persist for at least two weeks, with either a depressed mood or loss of interest or pleasure as a key feature. Treatment typically involves a combination of medication and psychotherapy, with lifestyle modifications playing a supportive role in symptom management.

Find out more about Major Depressive Disorder medication @ https://www.delveinsight.com/report-store/major-depressive-disorder-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Major Depressive Disorder Treatment Analysis: Drug Profile
SAGE-217: Sage Therapeutics
SAGE-217 is an investigational, oral, novel medicine in development for depression. SAGE-217 is an investigational oral neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system (CNS), and contributes significantly to regulating CNS function. Biogen and Sage Therapeutics have submitted a new drug application (NDA) to the FDA for zuranolone for the treatment of major depressive disorder (MDD).

REL-1017: Relmada Therapeutics, Inc
REL-1017, an NCE and novel NMDAR channel blocker with a preference for hyperactive channels associated with MDD. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for REL-1017 as an adjunctive treatment of MDD. REL-1017, has entered its Phase 3 registration program as an adjunctive treatment for MDD.

Seltorexant: Minerva Sciences
Seltorexant is an innovative selective orexin 2 receptor antagonist under development for the treatment of insomnia and related mood disorders. Insomnia is the repeated difficulty with sleep initiation, maintenance or quality that occurs despite adequate time and opportunity for sleep, resulting in daytime impairment. The clinical trials are being carried out for the treatment of major depressive disorder in phase III stage of development.

SP-624: Sirtsei Pharmaceuticals, Inc.
SP-624 is being studied in phase II stage of development for the treatment of major depressive disorder in comparison with placebo by Sirtsei Pharmaceuticals, Inc.

Key Major Depressive Disorder Therapies and Companies
• AXS-05: Axsome Therapeutics
• Vraylar (Cariprazine): AbbVie
• Zuranolone (SAGE-217/BIIB125): SAGE Therapeutics
• LY03005: Luye Pharma
• MIN-202 (Seltorexant): Janssen Pharmaceuticals/Minerva Neurosciences
• REL-1017: Relmada Therapeutics
• ABV-1504: BioLite Inc.
• PRAX-114: Praxis Precision Medicines
• CAPLYTA (Lumateperone): Intra-Cellular Therapies

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

Major Depressive 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
• Subcutaneous
• Intravenous
• Intramuscular

By Molecule Type
• Bispecific Antibody
• Peptides
• Small molecule
• Gene therapy

Scope of the Major Depressive Disorder Pipeline Report
• Coverage: Global
• Key Major Depressive Disorder Companies: GH Research, Praxis Precision Medicines, AbbVie, Gedeon Richter, Intra-Cellular Therapies, Bristol-Myers Squibb, Relmada Therapeutics, SAGE Therapeutics, Janssen Research & Development, Minerva Neurosciences, Takeda, Neurocrine Biosciences, Pherin Pharmaceuticals, Forest Laboratories, Otsuka Pharmaceuticals, Axsome Therapeutics, Luye Pharma, BioLite Inc., VistaGen Therapeutics, BioVentures, Sirstei Pharmaceuticals, Alto Neuroscience, Chase Therapeutics, Neumora Therapeutics, BlackThorn Therapeutics, Fabre-Kramer Pharmaceuticals, Novartis, and others.
• Key Major Depressive Disorder Pipeline Therapies: AXS-05, Vraylar, Zuranolone, LY03005, MIN-202, REL-1017, ABV-1504, PH10, PRAX-114, CAPLYTA, and others.

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

Table of Contents
1. Introduction
2. Executive Summary
3. Major Depressive Disorder Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Major Depressive Disorder Pipeline Therapeutics
6. Major Depressive Disorder Pipeline: Late-Stage Products (Phase III)
7. Major Depressive Disorder Pipeline: Late-Stage Products (Phase III)
8. Major Depressive Disorder Pipeline: Mid-Stage Products (Phase II)
9. Major Depressive 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

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Healthcare Consulting
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About DelveInsight
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This release was published on openPR.