Major Depressive Disorder - Pipeline Insight, 2021

Major Depressive Disorder - Pipeline Insight, 2021

  • May 2021 •
  • 120 pages •
  • Report ID: 6089312 •
  • Format: PDF
“Major Depressive Disorder – Pipeline Insight, 2021,” report provides comprehensive insights about 50+ companies and 50+ 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 as depression, is a serious medical illness that disrupts a person’s mood, behavior, thought processes, apart from degrading the physical health. It should not be mistaken for the passing feelings of unhappiness that everyone experiences, nor should it be confused with the intense grief brought about by the death of a loved one. Sadness and grief are normal reactions to life stresses. With time, and usually without medical treatment, sadness and grief lift, and people go on with their lives. By contrast, without specialized medical treatment, depression often persists. But with effective treatment, a large majority of people improve significantly. In most instances, MDD is a recurrent, episodic illness. Depression does not have a single cause. It can be triggered, or it may occur spontaneously without being associated with a life crisis, physical illness or other risk. Clinical suspicion is key to the diagnosis of MDD. Patients should be asked about depressed mood and/or lack of interest or pleasure when they present with nonspecific symptoms suggestive of depression. Clinicians should evaluate the patient for the following features: onset, duration, accompanying psychological symptoms, possible psychosocial precipitating factors (e.g., relationship problems, work-related stressors, or living conditions), and the effect of these symptoms on the patient’s daily life and function. Brain chemistry may contribute to an individual’s depression and may factor into their treatment. Antidepressants may produce some improvement within the first week or two of use yet full benefits may not be seen for two to three months.

"Major Depressive Disorder - Pipeline Insight, 2021" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Major Depressive Disorder 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
• AXS-05: Axsome Therapeutics
AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system (CNS) disorders. It utilizes Axsome’s technology of combining bupropion and dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. The U.S. Food and Drug Administration (FDA) has granted Priority Review to Axsome Therapeutics’ AXS-05 (dextromethorphan-bupropion).

• Cariprazine: Allergan
Cariprazine (VRAYLAR) is an oral, once daily atypical antipsychotic approved for the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder, with a recommended dose range of 3 to 6 mg/day, and for the treatment of schizophrenia in adults, with a recommended dose range of 1.5 to 6 mg/day. The drug is being evaluated in Phase III clinical trials for the treatment of patients with major depressive disorder.

• SAGE-217: SAGE therapeutics
SAGE-217 is a novel, highly potent and selective, next-generation, an oral, positive allosteric modulator that has been optimized for selectivity to synaptic and extrasynaptic GABAA receptors. The Binding sites for NASs are distinct from the recognition sites for GABA, benzodiazepines, and barbiturates. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system (CNS), and contributes significantly to regulating CNS function. SAGE-217 is currently being developed for major depressive disorder (MDD) and certain other mood and movement disorders.

• Seltorexant: Janssen Research & Development
Seltorexant (former developmental code names MIN-202, JNJ-42847922, JNJ-922) is a selective, small-molecule antagonist of the OX2 receptor that is under development by Minerva Neurosciences and Johnson & Johnson’s Janssen Pharmaceutica for the treatment of insomnia and major depressive disorder (MDD). The clinical trials are being carried out for the treatment of major depressive disorder in phase III stage of development.

• Brexpiprazole: Otsuka Pharmaceutical
Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck in Phase III stage of development. The mechanism of action for brexpiprazole in the adjunctive treatment of major depressive disorder or schizophrenia is not fully understood. However, the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. Brexpiprazole exhibits high affinity (sub-nanomolar) for these receptors as well as for noradrenaline alpha1B/2C receptors.

• PRAX 114: Praxis Precision Medicines
PRAX 114 is an orally administered GABAA positive allosteric modulator (PAM) , being developed by Praxis Precision Medicines, for the treatment of epilepsy, depression (depressive disorders in developmental table) and major depressive disorder.

• SEP 4199: Sunovion Pharmaceuticals
SEP 4199 is a therapeutic candidate being developed by Sunovion Pharmaceuticals. It is a non-racemic ratio of amisulpride enantiomers. The investigational oral medicine is said to have increased potency for serotonin 5-HT7 receptors relative to dopamine D2 receptors. SEP-4199 was designed to increase levels of serotonin 5-HT7 activity intended to enhance antidepressant efficacy and produce reduced levels of D2 receptor occupancy appropriate for the treatment of bipolar depression.
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. 50+ 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, Axsome Therapeutics.
• Phases
This report covers around 50+ 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
• Parenteral
• Intravenous
• Subcutaneous
• Topical

• Molecule Type
Products have been categorized under various Molecule types such as
• Monoclonal Antibody
• Peptides
• Polymer
• 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?