Schizophrenia Pipeline Insight and Clinical Trials Analysis and NDA Approvals | 70+ Companies and 70+ Drugs

January 27 02:49 2023
Schizophrenia Pipeline Insight and Clinical Trials Analysis and NDA Approvals | 70+ Companies and 70+ Drugs

DelveInsight’s, “Schizophrenia Pipeline Insight, 2023,” 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.


Key takeaways from the Schizophrenia Pipeline Insight Report


  • DelveInsight’s Schizophrenia pipeline report depicts a robust space with 70+ active players working to develop 70+ pipeline therapies for Schizophrenia treatment.


  • The leading Schizophrenia Companies includes 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, and others.


  • Promising Schizophrenia pipeline therapies in the early stages of development include CAD-9303, and CVL 231 in Phase I of clinical trials.


  • Out of emerging therapies, SEP-363856 is in Phase III of clinical development, whereas, AVP-786 is in Phase II/III stage of trials. Similarly, MK-8189 is undergoing Phase II developmental phase for Schizophrenia.


To explore more information on the latest breakthroughs in the Schizophrenia Pipeline treatment landscape of the report, click here @ Schizophrenia Pipeline Outlook


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.


Recent Developments Activities in the Schizophrenia Treatment Landscape

  • 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.


Request a sample and discover the recent advances in Schizophrenia Ongoing Clinical Trial Analysis and Medications, click here @ Schizophrenia Treatment Landscape


Schizophrenia Emerging Drugs Profile


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.


Schizophrenia Pipeline Therapeutics Assessment

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.


For further information, refer to the detailed Schizophrenia Unmet Needs, Schizophrenia Market Drivers, and Market Barriers, click here for Schizophrenia Ongoing Clinical Trial Analysis


Scope of the Schizophrenia Pipeline Report


  • Coverage- Global
  • Schizophrenia Companies- 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, and others.


  • Schizophrenia Pipeline Therapies- CAD-9303, and CVL 231, and others.


  • Schizophrenia Pipeline Therapies- Product Type, Molecule Type, Mechanism of Action, Route of Adminsitration


Dive deep into rich insights for drugs for Schizophrenia Market Drivers and Schizophrenia Market Barriers, click here @ Schizophrenia Unmet Needs and Analyst Views


Table of Content

  1. Introduction
  2. Executive Summary
  3. Schizophrenia: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Schizophrenia – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Ulotaront: Otsuka Pharmaceutical
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II/III)
  11. Deudextromethorphan: Avanir Pharmaceuticals
  12. Drug profiles in the detailed report…..
  13. Mid Stage Products (Phase II)
  14. Luvadaxistat: Takeda
  15. Drug profiles in the detailed report…..
  16. Early Stage Products (Phase I/II)
  17. SP-624: Sirtsei Pharmaceuticals
  18. Drug profiles in the detailed report…..
  19. Early Stage Products (Phase I)
  20. CY6463: Cyclerion Therapeutics
  21. Drug profiles in the detailed report…..
  22. Preclinical and Discovery Stage Products
  23. Psychiatric disorder therapies  : Cardiff University/Takeda
  24. Drug profiles in the detailed report…..
  25. Inactive Products
  26. Schizophrenia Key Companies
  27. Schizophrenia Key Products
  28. Schizophrenia – Unmet Needs
  29. Schizophrenia – Market Drivers and Barriers
  30. Schizophrenia – Future Perspectives and Conclusion
  31. Schizophrenia Analyst Views
  32. Schizophrenia Key Companies
  33. Appendix


Got Queries? Find out the related information on Schizophrenia Mergers and acquisitions, Schizophrenia licensing activities @ Schizophrenia Emerging Drugs, and Recent Trends


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