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DelveInsight’s “Major Depressive Disorder Pipeline Insight 2025” report offers detailed information on over 75 companies and over 75 pipeline drugs in the Major Depressive Disorder treatment landscape. It includes profiles of Major Depressive Disorder pipeline drugs, covering clinical and nonclinical stage products. It also evaluates Major Depressive Disorder pipeline therapies by product category, development stage, administration route, and molecular type. Additionally, it highlights discontinued pipeline products in this area.
Explore the newest medications and therapeutic options in the Major Depressive Disorder Pipeline. Access DelveInsight's thorough report immediately! @ Major Depressive Disorder Pipeline Outlook
Key Highlights from the Major Depressive Disorder Pipeline Report
On 05 November 2025, Syndeio Biosciences Inc. revealed a clinical trial to assess if GATE-251 is effective for treating depression in adults, along with its safety profile.
On 04 November 2025, Mind Medicine Inc. launched a study recruiting about 140 adult participants aged 18 to 74 with a DSM-5 confirmed primary diagnosis of MDD, a minimum MADRS score of 26 and CGI-S score of 4 at screening and baseline, excluding those with significant medical or psychiatric histories.
On 03 November 2025, Sirtsei Pharmaceuticals Inc. began a Phase 2B clinical study comparing the efficacy and safety of SP-624 against placebo for adults with Major Depressive Disorder.
DelveInsight’s Major Depressive Disorder pipeline report showcases a dynamic field with over 75 active participants advancing over 75 pipeline treatments for Major Depressive Disorder care.
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, and others.
Promising Major Depressive Disorder Pipeline Therapies include NMRA-335140 Aticaprant, NBI-1065845, CYB003, Azetukalner, GW679769, BHV-7000, and others.
Keep up-to-date with the latest Major Depressive Disorder pipeline developments. Obtain details on clinical studies, novel therapies, and top companies via DelveInsight @ Major Depressive Disorder Medication
Major Depressive Disorder Overview
Major Depressive Disorder (MDD), commonly known as clinical depression, is a serious health issue that can influence multiple aspects of daily life. It affects emotions and actions, as well as bodily functions like eating and sleeping. The precise origin of MDD remains unclear, but various elements can heighten the likelihood of its onset. Symptoms must persist for at least 2 weeks, with at least one being either low mood or diminished enjoyment. MDD is typically managed through pharmaceuticals and counseling. Certain lifestyle changes may also alleviate specific symptoms.
Major Depressive Disorder Emerging Drugs Profile
SAGE-217: Sage Therapeutics
SAGE-217 is an experimental, oral, innovative compound in development for depression. SAGE-217 acts as an investigational oral neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM). The GABA pathway is the primary inhibitory system in the brain and central nervous system (CNS), playing a key role in regulating CNS activity. Biogen and Sage Therapeutics have filed a new drug application (NDA) with the FDA for zuranolone aimed at treating major depressive disorder (MDD).
REL-1017: Relmada Therapeutics Inc.
REL-1017, a new chemical entity and unique NMDAR channel inhibitor that favors overactive channels linked to MDD. The U.S. Food and Drug Administration (FDA) has awarded Fast Track status to REL-1017 for use as an additional therapy for MDD. REL-1017 has progressed to its Phase 3 registration program as an adjunctive treatment for MDD.
Seltorexant: Minerva Sciences
Seltorexant is a pioneering selective orexin 2 receptor blocker in development for insomnia and associated mood conditions. Insomnia involves recurrent challenges with falling asleep, staying asleep, or sleep quality despite sufficient time and conditions, leading to daytime dysfunction. Clinical trials are underway for major depressive disorder in the Phase III stage.
SP-624: Sirtsei Pharmaceuticals, Inc.
SP-624 is under investigation in Phase II for major depressive disorder treatment compared to placebo by Sirtsei Pharmaceuticals, Inc.
SPL026: Small Pharma
SPL026 (DMT) is a natural psychedelic tryptamine present in plants and mammalian brains. Research indicates DMT may provide quick-onset and enduring antidepressant benefits. DMT stands out for its brief psychedelic duration (< 30 minutes), enabling concise sessions and potential outpatient clinic supervision. Small Pharma is progressing a series of DMT-based treatments and spearheading the first global DMT trial for depression, in partnership with Imperial College London.
PDC-1421: BioLite Inc.
PDC-1421 (BLI-1005) is a Norepinephrine plasma membrane transport protein inhibitor developed by BioLite Inc. for major depressive disorder. The drug is currently in Phase II development.
The Major Depressive Disorder Pipeline Report Provides Insights into
The report offers comprehensive details on organizations creating therapies for Major Depressive Disorder, including the total therapies per company.
It examines diverse therapeutic candidates divided into early, mid, and late development phases for Major Depressive Disorder Medication.
Major Depressive Disorder Companies are focused on specialized therapeutic advancement, with active and inactive (dormant or terminated) projects.
Major Depressive Disorder Drugs in progress, classified by development stage, delivery method, target receptor, standalone or combined therapy, unique action mechanisms, and molecular category.
In-depth examination of partnerships (corporate-corporate and corporate-academic), licensing arrangements, and funding information for future Major Depressive Disorder market expansion.
Discover innovative therapies and trials in the Major Depressive Disorder Medication. Obtain DelveInsight's comprehensive 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.
The Major Depressive Disorder pipeline report provides the therapeutic evaluation of 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
Reveal the future of Major Depressive Disorder Medication. Learn about novel medications, pipeline advancements, and key companies through DelveInsight's expert review @ 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 most current information on Major Depressive Disorder Medication and clinical trials. Download DelveInsight's detailed pipeline report today! @ Major Depressive Disorder Companies, Key Products and Unmet Needs
Table of Contents
Introduction
Executive Summary
Major Depressive Disorder: Overview
Pipeline Therapeutics
Therapeutic Assessment
Major Depressive Disorder – DelveInsight’s Analytical Perspective
Late Stage Products (Preregistration)
SAGE-217: Sage Therapeutics
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
SP-624: Sirtsei Pharmaceuticals, Inc.
Drug profiles in the detailed report…..
Early Stage Products (Phase I/II)
SPL026: Small Pharma
Drug profiles in the detailed report…..
Preclinical Stage Products
Drug Name: Company name
Drug profiles in the detailed report…..
Inactive Products
Major Depressive Disorder Key Companies
Major Depressive Disorder Key Products
Major Depressive Disorder- Unmet Needs
Major Depressive Disorder- Market Drivers and Barriers
Major Depressive Disorder- Future Perspectives and Conclusion
Major Depressive Disorder Analyst Views
Major Depressive Disorder Key Companies
Appendix
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