Major Depressive Disorder – Pipeline Insight, 2025

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 pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Major Depressive Disorder Understanding

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 - Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Wilson’s Disease pipeline landscape is provided which includes the disease overview and Major Depressive Disorder treatment guidelines. The assessment part of the report embraces, in depth Major Depressive Disorder commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Major Depressive Disorder collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Major Depressive Disorder R&D. The therapies under development are focused on novel approaches to treat/improve Major Depressive Disorder.

Major Depressive Disorder Emerging Drugs Chapters

This segment of the Major Depressive Disorder report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Major Depressive Disorder Emerging Drugs

• 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.

Further product details are provided in the report……..

Major Depressive Disorder: Therapeutic Assessment

This segment of the report provides insights about the different Major Depressive Disorder drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Major Depressive Disorder

There are approx. 75+ key companies which are developing the therapies for Major Depressive Disorder. The companies which have their Major Depressive Disorder drug candidates in the most advanced stage, i.e. Preregistration include SAGE Therapeutics.

• Phases

DelveInsight’s report covers around 75+ products under different phases of clinical development like

• 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
• Route of Administration

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
• Molecule Type

Products have been categorized under various Molecule types such as

• Bispecific Antibody
• Peptides
• Small molecule
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Major Depressive Disorder: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Major Depressive Disorder therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Major Depressive Disorder drugs.

Major Depressive Disorder Report Insights

• Major Depressive Disorder Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Major Depressive Disorder Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Major Depressive Disorder drugs?
• How many Major Depressive Disorder drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Major Depressive Disorder?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Major Depressive Disorder therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Major Depressive Disorder and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• 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

Key Products

• AXS-05
• LY-03005
• MIN-202
• SAGE-217
• REL-1017
• CAPLYTA
• Vraylar
• PRAX 114
• GH001
• NBI-1065845
• PH 10A

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