Schizophrenia Clinical Trial Pipeline Accelerates as 55+ Pharma Companies Rigorously Develop Drugs for Market Entry | DelveInsight

DelveInsight's "Schizophrenia Pipeline Insight 2025" report provides comprehensive insights about 55+ companies and 60+ pipeline drugs in the Schizophrenia pipeline landscape. It covers the Schizophrenia Pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Schizophrenia Pipeline Therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Schizophrenia Pipeline Report

* On December 11, 2025, Otsuka Pharmaceutical Development & Commercialization Inc . conducted a study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. In the 8-week treatment period, participants were treated with SEP-363856 while continuing to take the full dose of their pre-switch antipsychotic. After the end of the treatment period, participants were required to complete the follow-up visit, 7 days after the last dose of SEP-363856.
* On December 10, 2025, Bristol-Myers Squibb initiated a phase 3, Randomized, Two-part Study With a 5-week Double-blind Part (Randomized, Parallelgroup, Placebo-controlled) Followed by a 52-week Open-label Extension Part to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Patients With Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) Schizophrenia.
* On December 10, 2025- Karuna Therapeutics announced a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 plus-minus 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily [BID]) in subjects with schizophrenia.
* DelveInsight's Schizophrenia Pipeline report depicts a robust space with 55+ active players working to develop 60+ pipeline therapies for Schizophrenia treatment.
* The leading Schizophrenia Companies such as Sunovion Pharmaceuticals, Denovo BioPharma, Karuna Therapeutics, Boehringer Ingelheim, Merck Sharp & Dohme, MapLight Therapeutics, Valentech LLC, Addex Therapeutics, Biodexa Pharmaceuticals, Autifony Therapeutics, Vanda Pharmaceuticals, Luye Pharma, Reviva Pharmaceuticals, SyneuRx, Avanir Pharmaceuticals, Newron Pharmaceuticals, Celon Pharma, Delpor, Zhejiang Jingxin Pharmaceutical, Sirtsei Pharmaceuticals, and others.
* Promising Schizophrenia Therapies such as Brexpiprazole, ICLEPERTIN (BI-425809), KarXT (Xanomeline-Trospium), NUPLAZID (pimavanserin), MK-5720, NaBen, Brilaroxazine (RP-5063), ULOTARONT (SEP-363856), LUVADAXISTAT (NBI 1165844/TAK 831), Roluperidone (MIN-101), BXCL501 80, TV-44749, Evenamide (NW-3509/NW-3509A), LYN-005 (risperidone, weekly), OKEDI (risperidone ISM), Emraclidine (CVL-231) , and others.

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The Schizophrenia Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The Schizophrenia Pipeline Report also highlights the unmet needs with respect to the Schizophrenia.

Schizophrenia Overview

Schizophrenia is a chronic, severe mental disorder that affects how a person thinks, feels, and behaves. It is characterized by episodes of psychosis, which involve disturbances in thought processes, perceptions, emotional responsiveness, and social interactions. Schizophrenia affects about 1% of the population worldwide and typically manifests in late adolescence or early adulthood. The exact cause of schizophrenia is not fully understood, but it is believed to result from a complex interplay of genetic, environmental, and neurobiological factors.

Schizophrenia Emerging Drugs Profile

* Ulotaront: Sunovion Pharmaceuticals

SEP-363856 is a TAAR1 agonist with 5-HT1A agonist activity that is under investigation for the treatment of schizophrenia and other psychiatric conditions. Sunovion discovered SEP-363856 in collaboration with PsychoGenics based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. Research has shown that ulotaront results in a greater reduction from baseline in the PANSS total score than placebo. Treatment with ulotaront, as compared with placebo, was also associated with an improvement in sleep quality. Currently, the drug is in the Phase III stage of its development for the treatment of Schizophrenia

* Emraclidine: Abbvie

Emraclidine is a selective M4 receptor PAM, meaning it selectively targets the M4 receptor to harness the anti-psychotic effect believed to be associated with this receptor while minimizing the side effects associated with other pan-muscarinic agonists. The company believes emraclidine has the potential to provide a significant medical advancement as the muscarinic acetylcholine pathway has long been associated with mediation of neurotransmitter imbalance and psychosis. Emraclidine is the only selective M4 receptor PAM currently in clinical development. Currently, the drug is in the Phase II stage of its development for the treatment of Schizophrenia.

* CY 6463: 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. As an sGC stimulator, CY6463 acts as a positive allosteric modulator to sensitize the sGC enzyme to NO, increase the production of cGMP, and thereby amplify endogenous NO signaling. By compensating for deficient NO-sGC-cGMP signaling, CY6463 and other sGC stimulators may have broad therapeutic potential as a treatment to improve cognition and function in people with serious CNS diseases. Currently, the drug is in the Phase I stage of its development for the treatment of Schizophrenia.

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The Schizophrenia Pipeline report provides insights into:-

* The report provides detailed insights about companies that are developing therapies for the treatment of Schizophrenia with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Schizophrenia Treatment.
* Schizophrenia Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Schizophrenia Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Schizophrenia market.

Schizophrenia Companies

Sunovion Pharmaceuticals, Denovo BioPharma, Karuna Therapeutics, Boehringer Ingelheim, Merck Sharp & Dohme, MapLight Therapeutics, Valentech LLC, Addex Therapeutics, Biodexa Pharmaceuticals, Autifony Therapeutics, Vanda Pharmaceuticals, Luye Pharma, Reviva Pharmaceuticals, SyneuRx, Avanir Pharmaceuticals, Newron Pharmaceuticals, Celon Pharma, Delpor, Zhejiang Jingxin Pharmaceutical, Sirtsei Pharmaceuticals and others.

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,

* Intravenous
* Subcutaneous
* Oral
* Intramuscular

Schizophrenia Products have been categorized under various Molecule types such as,

* Monoclonal antibody
* Small molecule
* Peptide

From emerging drug candidates to competitive intelligence, the Schizophrenia Pipeline Report covers it all - check it out now @ Schizophrenia Market Drivers and Barriers, and Future Perspectives [https://www.delveinsight.com/sample-request/schizophrenia-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Scope of the Schizophrenia Pipeline Report

* Coverage- Global
* Schizophrenia Companies- Sunovion Pharmaceuticals, Denovo BioPharma, Karuna Therapeutics, Boehringer Ingelheim, Merck Sharp & Dohme, MapLight Therapeutics, Valentech LLC, Addex Therapeutics, Biodexa Pharmaceuticals, Autifony Therapeutics, Vanda Pharmaceuticals, Luye Pharma, Reviva Pharmaceuticals, SyneuRx, Avanir Pharmaceuticals, Newron Pharmaceuticals, Celon Pharma, Delpor, Zhejiang Jingxin Pharmaceutical, Sirtsei Pharmaceuticals and others.
* Schizophrenia Therapies- Brexpiprazole, ICLEPERTIN (BI-425809), KarXT (Xanomeline-Trospium), NUPLAZID (pimavanserin), MK-5720, NaBen, Brilaroxazine (RP-5063), ULOTARONT (SEP-363856), LUVADAXISTAT (NBI 1165844/TAK 831), Roluperidone (MIN-101), BXCL501 80, TV-44749, Evenamide (NW-3509/NW-3509A), LYN-005 (risperidone, weekly), OKEDI (risperidone ISM), Emraclidine (CVL-231) , and others.
* Schizophrenia Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Schizophrenia Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Contents

* Introduction
* Executive Summary
* Schizophrenia: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Schizophrenia- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Ulotaront: Sunovion Pharmaceuticals
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* Emraclidine: AbbVie
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* CY 6463: Cyclerion Therapeutics
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* Inactive Products
* 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

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