“Schizophrenia Pipeline Insight, 2025“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Schizophrenia Market.

The Schizophrenia Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Schizophrenia Pipeline Report:

• Companies across the globe are diligently working toward developing novel Schizophrenia treatment therapies with a considerable amount of success over the years.

• Schizophrenia companies working in the treatment market are Lundbeck, Intra-cellular Therapies, Sumitomo Pharma, Otsuka Pharma, Reviva Pharmaceuticals, Minerva Neurosciences, Karuna Therapeutics, Acadia Pharmaceuticals, Boehringer Ingelheim, Sunovion Pharmaceuticals (Sumitomo Pharma)/Otsuka Pharmaceutical, Lyndra Therapeutics, Laboratorios Farmacéuticos Rovi, Newron Pharmaceuticals, Cerevel Therapeutics, AstraZeneca, Eli Lilly and Company, Karuna Therapeutics, Neurocrine Biosciences, and others, are developing therapies for the Schizophrenia treatment

• Emerging Schizophrenia therapies in the different phases of clinical trials are- REXULTI/RXULTI, CAPLYTA, LONASEN, ABILIFY MYCITE, RP5063 (brilaroxazine), MIN-101 (roluperidone), KarXT (xanomeline-trospium), NUPLAZID (pimavanserin), ICELPERTIN (BI-425809), SEP-363856 (ulotaront), OKEDI (risperidone ISM), LYN-005, NW-3509/NW-3509A (evenamide), CVL-231 (emraclidine), Seroquel Sustained Release, Intramuscular Olanzapine Depot, Xanomeline and Trospium Chloride Capsules, NBI-1117568, and others are expected to have a significant impact on the Schizophrenia market in the coming years.

• In September 2025, The FDA approved an injectable extended-release risperidone suspension from Amneal Pharmaceuticals, referencing Janssen Biotech’s Risperdal Consta, for the treatment of schizophrenia. This extended-release formulation is now available in 12.5 mg, 25 mg, 37.5 mg, and 50 mg vials.

• In August 2025, BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company leveraging artificial intelligence to develop innovative neuroscience treatments, announced that it received favorable feedback from the FDA following a pre-sNDA meeting. Based on this guidance, the company believes its planned sNDA submission package will be adequate to support the filing, which is still on schedule for the first quarter of 2026.

• In May 2025, Neurocrine Biosciences initiated a Phase III registrational program to evaluate the investigational oral muscarinic M4 selective orthosteric agonist, NBI-1117568, for treating schizophrenia in adults. This double-blind, placebo-controlled trial will assess the therapy’s safety, tolerability, and efficacy in patients experiencing an acute exacerbation or relapse of schizophrenia symptoms. Approximately 280 participants are expected to be enrolled. The primary endpoint is the reduction in the Positive and Negative Syndrome Scale (PANSS) from baseline, with improvement in the Clinical Global Impression of Severity (CGI-S) scale as a key secondary endpoint.

• In May 2025, Vanda Pharmaceuticals reported that the FDA has accepted the New Drug Application (NDA) for Bysanti™ (milsaperidone) without raising any review concerns. The agency has scheduled February 21, 2026, as the decision date. Milsaperidone, a novel chemical entity and active metabolite of iloperidone, has demonstrated dose-dependent bioequivalence in clinical studies.

• In April 2025, CMG Pharmaceutical, a subsidiary of CHA Biotech, secured FDA approval for Mezofy (formerly Depipzo), an oral film therapy for schizophrenia. Formulated with aripiprazole, it dissolves in the mouth, improving adherence without requiring water.

• In March 2025, Vanda Pharmaceuticals Inc. has submitted a New Drug Application (NDA) to the FDA seeking marketing approval for Bysanti™ (milsaperidone) as a treatment for acute bipolar I disorder and schizophrenia, backed by several clinical studies demonstrating its safety and efficacy.

• In March 2025, LB Pharmaceuticals Inc., a clinical-stage biopharma company focused on developing innovative treatments for neuropsychiatric disorders such as schizophrenia, has shared new positive findings from its NOVA1 Phase 2 clinical trial of LB-102 in patients experiencing acute schizophrenia exacerbations. The data was presented at the 2025 Annual Congress of the Schizophrenia International Research Society (SIRS), currently taking place in Chicago.

• In February 2025, The September 2024 approval of xanomeline-trospium chloride (Cobenfy; Bristol Myers Squibb) marks the first novel schizophrenia treatment in 70 years. While some experts have welcomed the milestone, others remain cautious. Unlike traditional antipsychotics that target dopamine D2 receptors, this therapy works through muscarinic acetylcholine receptors, offering a distinct mechanism of action.

• In January 2025, German pharmaceutical leader Boehringer Ingelheim revealed that its investigational drug iclepertin, intended to treat cognitive impairment in schizophrenia patients, did not meet any primary or secondary endpoints across three Phase III trials. The CONNEX program results showed no significant cognitive or functional improvements over placebo after six months. However, the company noted that iclepertin maintained a favorable safety profile.

• In January 2025, Segal Trials, a private clinical research organization focused on acute schizophrenia and other psychiatric conditions, has shared its enrollment performance data from its involvement in NOVA—a Phase 2 dose-finding study in adults with acute schizophrenia assessing LB-102, a once-daily oral small molecule and potential first-in-class benzamide antipsychotic.

Schizophrenia Overview

Schizophrenia is a chronic and severe mental disorder that affects how a person thinks, feels, and behaves. It is characterized by symptoms such as hallucinations, delusions, disorganized thinking, and impaired social or occupational functioning. The exact cause is unknown, but a combination of genetic, brain chemistry, and environmental factors is believed to contribute. Schizophrenia typically emerges in late adolescence or early adulthood and requires long-term treatment, often combining antipsychotic medications and psychosocial therapies, to manage symptoms and improve quality of life.

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Emerging Schizophrenia Drugs Under Different Phases of Clinical Development Include:

• REXULTI/RXULTI: Lundbeck

• CAPLYTA: Intra-cellular Therapies

• LONASEN: Sumitomo Pharma

• ABILIFY MYCITE: Otsuka Pharma

• RP5063 (brilaroxazine): Reviva Pharmaceuticals

• MIN-101 (roluperidone): Minerva Neurosciences

• KarXT (xanomeline-trospium): Karuna Therapeutics

• NUPLAZID (pimavanserin): Acadia Pharmaceuticals

• ICELPERTIN (BI-425809): Boehringer Ingelheim

• SEP-363856 (ulotaront): Sunovion Pharmaceuticals (Sumitomo Pharma)/Otsuka Pharmaceutical

• OKEDI (risperidone ISM): Laboratorios Farmacéuticos Rovi

• LYN-005: Lyndra Therapeutics

• NW-3509/NW-3509A (evenamide): Newron Pharmaceuticals

• CVL-231 (emraclidine): Cerevel Therapeutics

• Seroquel Sustained Release: AstraZeneca

• Intramuscular Olanzapine Depot: Eli Lilly and Company

• Xanomeline and Trospium Chloride Capsules: Karuna Therapeutics

• NBI-1117568: Neurocrine Biosciences

Schizophrenia Emerging Therapy Assessment:

Olanzapine LAI (TEV-’749): Teva Pharmaceutical Industries/Royalty Pharma/MedinCell

TEV-’749 is an investigational, once-monthly, long-acting subcutaneous injection of the second-generation antipsychotic olanzapine, which has not been approved by any regulatory authority for any use, and its safety and efficacy remain unestablished. Teva’s schizophrenia portfolio has gained momentum with TEV-’749 (olanzapine), a once-monthly subcutaneous long-acting injectable.

• In 2024–2025, results from the Phase III SOLARIS trial showed that TEV-’749 met its primary endpoint by significantly improving PANSS scores at 8 weeks, along with demonstrating positive effects on social functioning and quality of life.

• By March 2025,over 92% of patients reported satisfaction with the initiation regimen and dosing schedule.

• Teva entered a funding agreement with Royalty Pharma in November 2023, securing up to USD 125 million to advance TEV-’749′s clinical development.

Ulotaront (SEP-363856): SumitomoPharma/OtsukaPharmaceuticals

Ulotaront (SEP-363856) is a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A agonist activity, which is a small molecule oral agent that does not bind to dopamine D2 or serotonin 5-HT2A receptors. Ulotaront is being jointly developed and commercialized as part of a collaboration between Sumitomo Pharma, its US subsidiary Sumitomo Pharma America (SMPA), and Otsuka. SMPA discovered ulotaront in collaboration with PsychoGenics based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. Currently, Ulotaront is being investigated in late-stage development for schizophrenia and Generalized Anxiety Disorder (GAD) in Japan, while adjunctive major depressive disorder, schizophrenia, and GAD in the US.

Brilaroxazine (RP-5063): Reviva Pharmaceuticals

Brilaroxazine (RP-5063) is a new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and other psychiatric disorders. RP-5063 is a multimodal modulator of the serotonin 5-HT1A, 5-HT2A, 5-HT2B, and 5-HT7 receptors and D2, D3, and D4 dopamine receptors in clinical development for multiple neuropsychiatric indications,. Additionally, the drug candidate is also being investigated for bipolar disorder, major depressive disorder (MDD), attention deficit/hyperactivity disorder (ADHD), and inflammatory diseases (including pulmonary arterial hypertension, idiopathic pulmonary fibrosis, and psoriasis). The Phase III RECOVER-2 trial of brilaroxazine in schizophrenia is expected to begin in mid-2025, pending additional financing, with topline results anticipated in Q3 2026 with potential NDA submission in Q4 2026.

Roluperidone (MIN-101/MT-210):Minerva Neurosciences/Mitsubishi Tanabe Pharma

Minerva Neurosciences is developing roluperidone (MIN-101) to treat negative symptoms of schizophrenia that persist chronically for a lifetime and can contribute to poor quality of life and functional outcomes. The drug can block serotonin and sigma receptors, two receptors in the brain that are involved in regulating mood, cognition, sleep, and anxiety. The company holds the license to roluperidone from Mitsubishi Tanabe Pharma Corporation with the rights to develop, sell, and import roluperidone (MT-210) globally. The drug candidate has completed Phase III (US) for negative symptoms of schizophrenia.

Schizophrenia 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

• Oral

• Parenteral

• Intravenous

• Subcutaneous

• Topical

Schizophrenia Molecule Type

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

• Monoclonal Antibody

• Peptides

• Polymer

• Small molecule

• Gene therapy

Schizophrenia Pipeline Therapeutics Assessment

• Schizophrenia Assessment by Product Type

• Schizophrenia By Stage and Product Type

• Schizophrenia Assessment by Route of Administration

• Schizophrenia By Stage and Route of Administration

• Schizophrenia Assessment by Molecule Type

• Schizophrenia by Stage and Molecule Type

DelveInsight’s Schizophrenia Report covers around 60+ products under different phases of clinical development like

• Late-stage products (Phase III)

• Mid-stage products (Phase II)

• Early-stage product (Phase I)

• Pre-clinical and Discovery stage candidates

• Discontinued & Inactive candidates

• Route of Administration

Further Schizophrenia product details are provided in the report. Download the Schizophrenia pipeline report to learn more about the emerging Schizophrenia therapies

Some of the key companies in the Schizophrenia Therapeutics Market include:

Key companies developing therapies for Schizophrenia are – Otsuka Pharmaceutical Co., Ltd., AstraZeneca, Sumitomo Dainippon Pharma, Johnson & Johnson, Bristol-Myers Squibb, Eli Lilly and Company, Alkermes Plc, Vanda Pharmaceuticals Inc., and others.

Schizophrenia Pipeline Analysis:

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 key 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.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Schizophrenia drugs and therapies

Schizophrenia Pipeline Market Drivers

• Increasing popularity among individuals for long-acting injectable (LAI) antipsychotics are key factors driving growth of the global schizophrenia drugs market.

Schizophrenia Pipeline Market Barriers

• WHO’s Comprehensive Mental Health Action Plan 2013- 2030 will further enhance the awareness about mental health by ensuring 100 million more people have access to quality and affordable care for mental health conditions.

Scope of Schizophrenia Pipeline Drug Insight

• Coverage: Global

• Key Schizophrenia Companies: Lundbeck, Intra-cellular Therapies, Sumitomo Pharma, Otsuka Pharma, Reviva Pharmaceuticals, Minerva Neurosciences, Karuna Therapeutics, Acadia Pharmaceuticals, Boehringer Ingelheim, Sunovion Pharmaceuticals (Sumitomo Pharma)/Otsuka Pharmaceutical, Lyndra Therapeutics, Laboratorios Farmacéuticos Rovi, Newron Pharmaceuticals, Cerevel Therapeutics, AstraZeneca, Eli Lilly and Company, Karuna Therapeutics, Neurocrine Biosciences, and others

• Key Schizophrenia Therapies: REXULTI/RXULTI, CAPLYTA, LONASEN, ABILIFY MYCITE, RP5063 (brilaroxazine), MIN-101 (roluperidone), KarXT (xanomeline-trospium), NUPLAZID (pimavanserin), ICELPERTIN (BI-425809), SEP-363856 (ulotaront), OKEDI (risperidone ISM), LYN-005, NW-3509/NW-3509A (evenamide), CVL-231 (emraclidine), Seroquel Sustained Release, Intramuscular Olanzapine Depot, Xanomeline and Trospium Chloride Capsules, NBI-1117568, and others

• Schizophrenia Therapeutic Assessment: Schizophrenia current marketed and Schizophrenia emerging therapies

• Schizophrenia Market Dynamics: Schizophrenia market drivers and Schizophrenia market barriers

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Table of Contents

1. Schizophrenia Report Introduction

2. Schizophrenia Executive Summary

3. Schizophrenia Overview

4. Schizophrenia- Analytical Perspective In-depth Commercial Assessment

5. Schizophrenia Pipeline Therapeutics

6. Schizophrenia Late Stage Products (Phase II/III)

7. Schizophrenia Mid Stage Products (Phase II)

8. Schizophrenia Early Stage Products (Phase I)

9. Schizophrenia Preclinical Stage Products

10. Schizophrenia Therapeutics Assessment

11. Schizophrenia Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Schizophrenia Key Companies

14. Schizophrenia Key Products

15. Schizophrenia Unmet Needs

16 . Schizophrenia Market Drivers and Barriers

17. Schizophrenia Future Perspectives and Conclusion

18. Schizophrenia Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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