Major Depressive Disorder Clinical Trial Pipeline Expands as 75+ Companies Driving Innovation in the Therapeutics | DelveInsight

DelveInsight's "Major Depressive Disorder Pipeline Insight 2026" report provides comprehensive insights about 75+ companies and 75+ pipeline drugs in the 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.

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Key Takeaways from the Major Depressive Disorder Pipeline Report

* On February 24, 2026- AbbVie announced a study will assess the changes in disease activity and adverse events of oral Icalcaprant in adult participants with major depressive disorder who are currently experiencing a major depressive episode (MDE). Icalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with major depressive disorder. Participants are placed in 1 of 3 groups, called treatment arms. There is a 1 in 3 chance that a participant will be assigned to placebo treatment. Around 195 adult participant with major depressive disorder will be enrolled in approximately 35 sites in North America.
* On February 18, 2026- Otsuka Pharmaceutical Development & Commercialization, Inc . conducted a phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Flexible Doses of SEP-363856 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder.
* On February 13, 2026- Takeda initiated a Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once-Daily Oral Administration of Vortioxetine in Japanese Pediatric Patients 12 to 17 Years of Age With Major Depressive Disorder (MDD). The overall time each participant will be in the study is about 20 weeks. This includes up to 15 days (about 2 weeks) to check who can take part, a 14-week period where everyone receives vortioxetine or a placebo, and after that, a 4-week period to check for any side effects after treatment.
* On February 13, 2026- Janssen Research & Development LLC initiated a study is to evaluate how well JNJ-89495120 works (anti-depressant effects) and how well it is tolerated as compared to placebo on reducing the symptoms of depression in participants with major depressive disorder (MDD).
* On February 10, 2026- Neumora Therapeutics Inc . announced a study will evaluate the effects of NMRA-335140 (formerly BTRX-335140) on symptoms of depression in participants with Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 35 days), and a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo). At the completion of the 6-week Treatment Period, participants who complete the study, provide informed consent, and meet the eligibility criteria may enter an open-label extension study (NMRA-335140-501).
* 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.

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Major Depressive Disorder Overview

Major Depressive Disorder (MDD), also referred to as clinical depression, is a significant medical condition that can affect many areas of your life. It impacts mood and behavior as well as various physical functions, such as appetite and sleep. The exact cause of MDD isn't known. However, there are several factors that can increase the risk of developing the condition. Symptoms must occur for a period of 2 or more weeks and at least one symptom is either depressed mood or loss of interest or pleasure. MDD is often treated with medication and psychotherapy. Some lifestyle adjustments can also help ease certain symptoms.

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 Medication.
* 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

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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

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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

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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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