Schizophrenia Pipeline Insight

DelveInsight’s, “Schizophrenia – Pipeline Insight, 2022,” report provides comprehensive insights about 70+ companies and 70+ pipeline drugs in Schizophrenia 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

Schizophrenia Understanding

Schizophrenia: Overview

Schizophrenia causes psychosis and is associated with considerable disability and may affect all areas of life including personal, family, social, educational, and occupational functioning. It is thought that an interaction between genes and a range of environmental factors may cause schizophrenia. Psychosocial factors may also affect the onset and course of schizophrenia. Heavy use of cannabis is associated with an elevated risk of the disorder. Schizophrenia is characterized by significant impairments in the way reality is perceived and changes in behaviour related to: Persistent delusions, persistent hallucinations, experiences of influence, control or passivity, disorganized thinking, highly disorganized behavior, “negative symptoms” such as very limited speech, extreme agitation or slowing of movements etc. diagnosis of schizophrenia is reached through an assessment of patient-specific signs and symptoms like delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behavior, and negative symptoms. Treatment is usually lifelong and often involves a combination of medications, psychotherapy and coordinated speciality care services.

 

"Schizophrenia - Pipeline Insight, 2022" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Schizophrenia pipeline landscape is provided which includes the disease overview and Schizophrenia treatment guidelines. The assessment part of the report embraces, in depth Schizophrenia 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, Schizophrenia collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

  • In Feb 2022, Neumora Expands Precision Neuroscience Pipeline with Novel M4 Receptor Modulator Program Through Exclusive License Agreement with Vanderbilt University.
  • In Feb 2022, Digestome Therapeutics, a biotech company developing first-in-class therapeutics that stimulate the central nervous system (CNS) via the gut-brain-axis, announced today the completion of an exclusive out-licensing agreement of DGX-001 in the greater China territory with Zhongze Therapeutics.
  • In August 2021, Teva and MedinCell Announce FDA Acceptance of New Drug Application for TV-46000/mdc-IRM as a Treatment for Patients with Schizophrenia.

Schizophrenia Emerging Drugs Chapters

This segment of the Schizophrenia 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.

 

Schizophrenia Emerging Drugs

 

Ulotaront: Otsuka Pharmaceutical

Ulotaront (SEP-363856), one of the first of a new class of CNS-active compounds, is an agonist at trace amine-associated receptor 1 (TAAR1) as well as serotonin 5-HT1A receptors. TAAR1 is a G-protein-coupled receptor expressed in cortical, limbic, and midbrain monoaminergic regions that modulate dopaminergic, serotonergic, and glutamatergic activity. In contrast to first- and second-generation antipsychotics, the efficacy of ulotaront is not mediated by blockade of D2 or 5-HT2A receptors. Ulotaront has demonstrated positive effects in rodent models assessing endophenotypes of schizophrenia, including phencyclidine (PCP)-induced hyperactivity, prepulse inhibition, and PCP-induced deficits in social interaction and cognition. An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects with Schizophrenia. It’s currently in phase III stage of development.

 

Luvadaxistat: Takeda

Luvadaxistat is a potential first-in-class, investigational, oral, selective inhibitor with a high binding affinity to d-amino acid oxidase (DAAO). It targets glutamate, an abundant neurotransmitter in the brain. In schizophrenia, N-methyl D-aspartate (NMDA) receptor hypofunction on PV+ gamma-aminobutyric acid (GABA) interneurons results in disinhibition of cortical or hippocampal glutamate neurons projecting to the pyramidal neurons. The cortical disturbances account for the negative/cognitive symptoms of schizophrenia, while the downstream subcortical dopamine release manifests as the positive symptoms of the disorder. A Phase II Randomized, Double-Blind, Placebo-Controlled, cross-Over Study to Evaluate Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of TAK-831 in Adult Subjects With Schizophrenia is ongoing.

 

CY6463: Cyclerion Therapeutics

CY6463 is the first CNS-penetrant sGC stimulator to be developed as a symptomatic and potentially disease-modifying therapy for serious CNS diseases. The nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP) signaling pathway is a fundamental mechanism that precisely controls key aspects of physiology throughout the body. Cyclerion Therapeutics has initiated a double-blinded, randomized, placebo-controlled, multiple-ascending-dose Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants with Stable Schizophrenia. 

 

AVP 786: Avanir Pharmaceuticals

Deudextromethorphan (AVP 786) is a combination product of a deuterium-containing analogue of dextromethorphan and an ultra-low dose of quinidine, that is being developed by Avanir Pharmaceuticals (a subsidiary of Otsuka Pharmaceuticals), under a license from Concert Pharmaceuticals, for the treatment of psychiatric and Neurological Indications. Currently it is being evaluated in phase II/III stage of development for the treatment of schizophrenia.

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

Schizophrenia: Therapeutic Assessment

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

 

Major Players in Schizophrenia

There are approx. 70+ key companies which are developing the therapies for Schizophrenia. The companies which have their Schizophrenia drug candidates in the most advanced stage, i.e. phase III include, Otsuka Pharmaceutical.

 

Phases

DelveInsight’s report covers around 70+ 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

Schizophrenia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as 

  • Inhalation
  • Inhalation/Intravenous/Oral
  • Intranasal
  • Intravenous
  • Intravenous/ Subcutaneous
  • NA
  • Oral
  • Oral/intranasal/subcutaneous
  • Parenteral
  • Subcutaneous

 

Molecule Type

Products have been categorized under various Molecule types such as

  • Antibody
  • Antisense oligonucleotides
  • Immunotherapy
  • Monoclonal antibody
  • Peptides
  • Protein
  • Recombinant protein
  • Small molecule
  • Stem Cell
  • Vaccine

 

Product Type

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

Schizophrenia: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Schizophrenia 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 Schizophrenia drugs.

Schizophrenia Report Insights

  • Schizophrenia Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Schizophrenia 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 Schizophrenia drugs?
  • How many Schizophrenia drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Schizophrenia?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Schizophrenia 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 Schizophrenia and their status?
  • What are the key designations that have been granted to the emerging drugs?

Introduction

Executive Summary

Schizophrenia: Overview

  • Causes
  • Mechanism of Action
  • Signs and Symptoms
  • Diagnosis
  • Disease Management

Pipeline Therapeutics

  • Comparative Analysis

Therapeutic Assessment

  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type

Schizophrenia – DelveInsight’s Analytical Perspective

Late Stage Products (Phase III)

  • Comparative Analysis

Ulotaront: Otsuka Pharmaceutical

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Mid Stage Products (Phase II/III)

  • Comparative Analysis

Deudextromethorphan: Avanir Pharmaceuticals

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Mid Stage Products (Phase II)

  • Comparative Analysis

Luvadaxistat: Takeda

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Early Stage Products (Phase I/II)

  • Comparative Analysis

SP-624: Sirtsei Pharmaceuticals

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Early Stage Products (Phase I)

  • Comparative Analysis

CY6463: Cyclerion Therapeutics

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Preclinical and Discovery Stage Products

  • Comparative Analysis

Psychiatric disorder therapies  : Cardiff University/Takeda

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Inactive Products

  • Comparative Analysis

Schizophrenia Key Companies

Schizophrenia Key Products

Schizophrenia - Unmet Needs

Schizophrenia - Market Drivers and Barriers

Schizophrenia - Future Perspectives and Conclusion

Schizophrenia Analyst Views

Schizophrenia Key Companies

Appendix

List of Table

Table 1: Total Products for Schizophrenia

Table 2: Late Stage Products

Table 3: Mid Stage Products

Table 4: Early Stage Products

Table 5: Pre-clinical & Discovery Stage Products

Table 6: Assessment by Product Type

Table 7: Assessment by Stage and Product Type

Table 8: Assessment by Route of Administration

Table 9: Assessment by Stage and Route of Administration

Table 10: Assessment by Molecule Type

Table 11: Assessment by Stage and Molecule Type

Table 12: Inactive Products

List of Figures

Figure 1: Total Products for Schizophrenia

Figure 2: Late Stage Products                             

Figure 3: Mid Stage Products

Figure 4: Early Stage Products

Figure 5: Preclinical and Discovery Stage Products

Figure 6: Assessment by Product Type

Figure 7: Assessment by Stage and Product Type

Figure 8: Assessment by Route of Administration

Figure 9: Assessment by Stage and Route of Administration

Figure 10: Assessment by Molecule Type

Figure 11: Assessment by Stage and Molecule Type

Figure 12: Inactive Products   

• Otsuka Pharmaceutical Development & Commercialization, Inc.
• Gedeon Richter Ltd.
• Neurocrine Bioscience
• Takeda Pharmaceutical Company
• Memory Pharmaceuticals
• Hoffmann-La Roche
• Neurocrine Biosciences
• H. Lundbeck
• Organon and Co
• Meiji Seika Pharma Co., Ltd.
• SK Life Science, Inc.
• Novartis Pharmaceuticals
• Vanda Pharmaceuticals
• Alkermes, Inc.
• Solvay Pharmaceuticals
• Sumitomo Dainippon Pharma Co., Ltd.
• Mitsubishi Tanabe Pharma Corporation
• SyneuRx International (Taiwan) Corp
• BioXcel Therapeutics Inc
• Cognitive Research Corporation
• Amarex Clinical Research
• Forum Pharmaceuticals Inc
• Amneal Pharmaceuticals, LLC
• Accutest Research Laboratories (I) Pvt. Ltd.
• Eli Lilly and Company
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C
• Janssen, LP
• Delpor, Inc.
• Cerevel Therapeutics, LLC
• Zogenix, Inc.
• Reviva Pharmaceuticals
• Alkermes, Inc.
• Karuna Therapeutics

 

 

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