DelveInsight’s, “Major Depressive Disorder Pipeline Insight, 2022,” report provides comprehensive insights about 75+ companies and 75+ pipeline drugs in the Major Depressive Disorder pipeline landscape. It covers the pipeline drug profiles, including Major Depressive Disorder clinical trials 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.
In the Major Depressive Disorder Pipeline Report, a detailed description of the drug is given which includes the mechanism of action of the drug, clinical studies, Major Depressive Disorder 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.
Key takeaways from Major Depressive Disorder Pipeline Insight Report
- 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.
- The Leading major depressive disorder companies such as GH Research, Praxis Precision Medicines, AbbVie, Luye Pharma Group, Gedeon Richter, Intra-Cellular Therapies, Bristol-Myers Squibb, Relmada Therapeutics, SAGE Therapeutics, Janssen Research & Development, Minerva Neurosciences, Takeda, Neurocrine Biosciences, Pherin Pharmaceuticals, XWPharma, Reviva Pharmaceuticals, Gate Neurosciences, Sirtsei Pharmaceuticals Seelos Therapeutics, Chase Therapeutics, Clexio Biosciences Ltd, VistaGen Therapeutics, Neuralstem, BioLite, Neurocrine Biosciences, MindMed, BioGen, Alector and Chase Therapeutics, Cybin others are evaluating novel major depressive disorder treatment drugs candidate to improve the treatment landscape.
- Key major depressive disorder pipeline therapies in various stages of development include AXS-05, LY-03005, MIN-202, SAGE-217, REL-1017, CAPLYTA, PRAX 114, GH001, NBI-1065845, PH 10A, XW 10508 RP-5063, Zelquistinel, Apimostinel, SP-624, SLS-002, CTC-501 CLE-100, AV 101, OPC-64005, PDC 1421, NBI-1065845, MM-120, Zuranolone, AL001, SPL026, CTC-413, CYB003, GH001 and others.
- 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.
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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.
Latest Breakthroughs of Major Depressive Disorder Treatment Landscape
- In August 2022, Relmada Therapeutics announced the Food and Drug Administration (FDA) granted Fast Track designation to REL-1017 (esmethadone) as a monotherapy for the treatment of major depressive disorder (MDD). REL-1017 is a novel N-methyl-D-aspartate receptor (NMDAR) channel blocker. The investigational treatment is administered orally once daily and is designed to target hyperactive GluN1-GluN2D NMDAR channels while maintaining physiological glutamatergic neurotransmission.
- In June 2022, Cybin received FDA IND Clearance for its Phase I/IIa clinical trial evaluating CYB003 for the potential treatment of Major Depressive Disorder.
- In June 2022, Biogen and Sage Therapeutics announced that the Phase III SKYLARK Study of zuranolone, an investigational oral drug being evaluated in women with postpartum depression (PPD), met its primary and all key secondary endpoints. Women treated with zuranolone 50 mg (n=98) demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms at Day 15, the primary endpoint, compared to placebo (n=97) as measured by a change from baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score.
- In October 2021, Small Pharma granted Fast-Track Designation from the UK regulator for SPL026 DMT-Assisted therapy for Major Depressive Disorder.
- In October 2021, Chase Therapeutics announced $20 million Series B financing to advance clinical trials in parkinson’s disease and Major Depressive Disorder. The proceeds of the Series B will support Phase 3 pivotal trials for CTC-501 for the treatment of Major Depressive Disorder (MDD) and CTC-413 for the treatment of Parkinson’s disease (PD) as well as completion of the development and validation of a diagnostic product for Parkinson’s Disease.
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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.
DelveInsight’s Major Depressive Disorder Pipeline Report covers around 75+ products under different phases of clinical development-
- 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
Scope of the Major Depressive Disorder Pipeline Report
- Coverage- Global
- Major Depressive Disorder Therapeutic Assessment: Product Type, Route of Administration, Molecule Type
- Major Depressive Disorder Companies- GH Research, Praxis Precision Medicines, AbbVie, Luye Pharma Group, Gedeon Richter, Intra-Cellular Therapies, Bristol-Myers Squibb, Relmada Therapeutics, SAGE Therapeutics, Janssen Research & Development, Minerva Neurosciences, Takeda, Neurocrine Biosciences, Pherin Pharmaceuticals, XWPharma, Reviva Pharmaceuticals, Gate Neurosciences, Sirtsei Pharmaceuticals Seelos Therapeutics, Chase Therapeutics, Clexio Biosciences Ltd, VistaGen Therapeutics, Neuralstem, BioLite, Neurocrine Biosciences, MindMed, BioGen, Alector and Chase Therapeutics, Cybin others
- Major Depressive Disorder Therapies- AXS-05, LY-03005, MIN-202, SAGE-217, REL-1017, CAPLYTA, PRAX 114, GH001, NBI-1065845, PH 10A, XW 10508 RP-5063, Zelquistinel, Apimostinel, SP-624, SLS-002, CTC-501 CLE-100, AV 101, OPC-64005, PDC 1421, NBI-1065845, MM-120, Zuranolone, AL001, SPL026, CTC-413, CYB003, GH001 and others.
Table of Content
- Introduction
- Major Depressive Disorder Executive Summary
- Major Depressive Disorder Major Depressive Disorder: Overview
- Major Depressive Disorder Pipeline Therapeutics
- Major Depressive Disorder Pipeline 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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