Major Depressive Disorder Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

Major Depressive Disorder Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “Major Depressive Disorder Pipeline Insight 2025” report provides comprehensive insights about 75+ companies and 75+ pipeline drugs in Major Depressive Disorder pipeline landscape. It covers the Major Depressive Disorder pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Major Depressive Disorder pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Discover the latest drugs and treatment options in the Major Depressive Disorder Pipeline. Dive into DelveInsight’s comprehensive report today! @ Major Depressive Disorder Pipeline Outlook

Key Takeaways from the Major Depressive Disorder Pipeline Report

  • In April 2025, Cybin IRL Limited announced a study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.
  • In April 2025, Janssen Research & Development LLC conducted a study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD).
  • DelveInsight’s Major Depressive Disorder pipeline report depicts a robust space with 75+ active players working to develop 75+ pipeline therapies for Major Depressive Disorder treatment.
  • The leading Major Depressive Disorder Companies such as 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 and others.
  • Promising Major Depressive Disorder Pipeline Therapies such as NMRA-335140 Aticaprant, NBI-1065845, CYB003, Azetukalner, GW679769, BHV-7000 and others.

Stay ahead with the most recent pipeline outlook for Major Depressive Disorder. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Major Depressive Disorder Treatment Drugs

Major Depressive Disorder Emerging Drugs 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.

  • SPL026: Small Pharma

SPL026 (DMT), is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (< 30mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics. Small Pharma is advancing a pipeline of DMT-based therapies and is leading the world’s first DMT clinical trial for depression, in collaboration with Imperial College London.

  • PDC-1421: BioLite Inc.

PDC-1421 (BLI-1005) is a Norepinephrine plasma membrane transport protein inhibitor being developed by BioLite Inc, for the treatment of major depressive disorder. The drug is currently in phase II stage of development.

The Major Depressive Disorder Pipeline Report Provides Insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Major Depressive 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 Major Depressive Disorder Treatment.
  • Major Depressive Disorder Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Major Depressive 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 Major Depressive Disorder market

Explore groundbreaking therapies and clinical trials in the Major Depressive Disorder Pipeline. Access DelveInsight’s detailed report now! @ New Major Depressive Disorder Drugs

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 and others.

Major Depressive 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
  • Subcutaneous
  • Intravenous
  • Intramuscular

Major Depressive Disorder Products have been categorized under various Molecule types such as

  • Bispecific Antibody
  • Peptides
  • Small molecule
  • Gene therapy

Unveil the future of Major Depressive Disorder Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Major Depressive Disorder Market Drivers and Barriers

Scope of the Major Depressive Disorder Pipeline Report

  • Coverage- Global
  • 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 and others.
  • Major Depressive Disorder Pipeline Therapies- NMRA-335140 Aticaprant, NBI-1065845, CYB003, Azetukalner, GW679769, BHV-7000 and others.
  • Major Depressive Disorder Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Major Depressive Disorder Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Get the latest on Major Depressive Disorder Therapies and clinical trials. Download DelveInsight’s in-depth pipeline report today! @ Major Depressive Disorder Companies, Key Products and Unmet Needs

Table of Content

  1. Introduction
  2. Executive Summary
  3. Major Depressive Disorder: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Major Depressive Disorder – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Preregistration)
  8. SAGE-217: Sage Therapeutics
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. SP-624: Sirtsei Pharmaceuticals, Inc.
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I/II)
  14. SPL026: Small Pharma
  15. Drug profiles in the detailed report…..
  16. Preclinical Stage Products
  17. Drug Name: Company name
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Major Depressive Disorder Key Companies
  21. Major Depressive Disorder Key Products
  22. Major Depressive Disorder- Unmet Needs
  23. Major Depressive Disorder- Market Drivers and Barriers
  24. Major Depressive Disorder- Future Perspectives and Conclusion
  25. Major Depressive Disorder Analyst Views
  26. Major Depressive Disorder Key Companies
  27. Appendix

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