Schizophrenia FDA Approvals, Clinical Trials, Emerging Drugs, Pipeline Insights and Companies | DelveInsight

Schizophrenia FDA Approvals, Clinical Trials, Emerging Drugs, Pipeline Insights and Companies | DelveInsight

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

 

Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Schizophrenia Treatment Landscape. Click here to read more @ Schizophrenia Pipeline Outlook

 

Key Takeaways from the Schizophrenia Pipeline Report

  • In January 2025:- LB Pharmaceuticals Inc.:- This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to evaluate the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. To determine whether LB-102 administered to patients with acutely exacerbated schizophrenia demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo at 28 days.
  • In January 2025:- Click Therapeutics Inc.: The purpose of the proposed study is to evaluate the efficacy and safety of two prescription digital therapeutics as an adjunct treatment to SOC in participants 18 years of age or older diagnosed with experiential negative symptoms of schizophrenia.
  • In January 2025:- Cerevel Therapeutics Inc.:- The primary purpose of this study is to assess the long-term safety and tolerability of oral emraclidine in adult participants with schizophrenia.
  • In January 2025:- Spinogenix:- This Phase 2 study will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia. This is a randomized, placebo-controlled study of SPG302 administered once daily for six weeks. This study will entail five visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.
  • 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 x 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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Schizophrenia Emerging Drugs Profile

 

  • LYN-005: Lyndra Therapeutics

LYN-005 is an innovative, long-acting oral formulation of risperidone being developed by Lyndra Therapeutics for the treatment of schizophrenia and schizoaffective disorders. This medication is designed to be taken once a week, significantly reducing the pill burden associated with daily dosing regimens. The development of LYN-005 aims to enhance medication adherence and improve therapeutic outcomes for patients who struggle with consistent daily medication intake.

 

  • 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.

 

  • HS-10380: Jiangsu Hansoh Pharmaceutical

HS10380 is an investigational antipsychotic drug developed by Jiangsu Hansoh Pharmaceutical and Shanghai Hansoh Biomedical. This novel compound is being researched for its potential to treat psychiatric disorders, primarily schizophrenia and related conditions. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of Schizophrenia.

 

  • KYN-5356: Kynexis

KYN-5356 is a clinical-stage small molecule developed by Kynexis Pharmaceuticals, targeting the enzyme Kynurenine Aminotransferase II (KAT-II), a key component in the kynurenine pathway. This pathway is involved in the production of neuroactive metabolites, which play a role in neurological disorders such as schizophrenia. By inhibiting KAT-II, KYN-5356 reduces the production of kynurenic acid, a metabolite that blocks NMDA receptors and has been linked to cognitive impairment. KYN-5356 is being developed specifically for treating cognitive impairment associated with schizophrenia (CIAS), aiming to restore cognitive function by modulating glutamatergic neurotransmission through this targeted inhibition.

 

Learn more about Schizophrenia Drugs opportunities in our groundbreaking Schizophrenia Research and development projects @ Schizophrenia Unmet Needs

 

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

 

Discover the latest advancements in Schizophrenia treatment by visiting our website. Stay informed about how we’re transforming the future of neurology @ Schizophrenia Market Drivers and Barriers, and Future Perspectives

 

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

 

For a detailed overview of our latest research findings and future plans, read the full details of Schizophrenia Pipeline on our website @ Schizophrenia Emerging Drugs and Companies

 

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. LYN-005: Lyndra Therapeutics
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. Emraclidine: Abbvie
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. KYN-5356: Kynexis
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. Drug Name: Company Name
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Schizophrenia Key Companies
  21. Schizophrenia Key Products
  22. Schizophrenia- Unmet Needs
  23. Schizophrenia- Market Drivers and Barriers
  24. Schizophrenia- Future Perspectives and Conclusion
  25. Schizophrenia Analyst Views
  26. Schizophrenia Key Companies
  27. Appendix

 

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