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Report Overview

Schizophrenia, a severe and chronic mental disorder, profoundly affects thinking, perception, emotions, and social functioning, often leading to long-term disability and reduced quality of life. According to Manassa Hany et al., 2024, it impacts approximately 1% of the global population and ranks among the top 10 global disability causes. It is characterized by hallucinations, delusions, cognitive impairments, and social withdrawal. Schizophrenia places a significant burden on patients, caregivers, and healthcare systems. Current therapies include antipsychotics, psychosocial interventions, and adjunctive treatments, while research increasingly focuses on novel mechanisms such as glutamatergic modulation, gene-targeted therapies, and personalized medicine. According to the schizophrenia pipeline analysis by Expert Market Research, the global schizophrenia drug pipeline is expanding rapidly, driven by rising prevalence, unmet therapeutic needs, and technological advancements, indicating strong growth potential in the coming years.

  • Major companies involved in the schizophrenia pipeline analysis include Neurocrine Biosciences, Spinogenix, and others.

  • Leading drugs currently in the pipeline include NBI-1117568, SPG302, LY03020, and others.

  • The pipeline shows significant growth driven by novel antipsychotics, targeted therapies addressing negative and cognitive symptoms, and increased focus on personalized medicine, enhancing treatment efficacy and patient outcomes.

Report Coverage

The Schizophrenia Pipeline Analysis Report by Expert Market Research gives comprehensive insights into schizophrenia therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for schizophrenia. The schizophrenia report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The schizophrenia pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with schizophrenia treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to schizophrenia.

Schizophrenia Pipeline Analysis by Drug Class

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Schizophrenia Pipeline Outlook

Schizophrenia is a chronic, severe mental disorder affecting how a person thinks, feels, and behaves. It often manifests through hallucinations, delusions, disorganized thinking, and cognitive impairments, significantly impacting social and occupational functioning. The exact cause is unclear but involves genetic, neurochemical, and environmental factors.

Schizophrenia treatments focus on antipsychotic medications, psychosocial therapies, and supportive care to reduce symptoms, improve daily functioning, and prevent relapses. In September 2024, the FDA approved Cobenfy (xanomeline and trospium chloride) as the first oral antipsychotic targeting cholinergic receptors, offering a novel mechanism and an alternative to traditional dopamine-based therapies.

Schizophrenia Epidemiology

Schizophrenia remains a significant global health concern. According to Manassa Hany et al., it affects approximately 1% of the global population. As reported by Boehringer Ingelheim International GmbH, over 24 million people worldwide are living with schizophrenia. In the United States, prevalence estimates vary from 0.3% to 5.11% across different population groups, according to Molly T. Finnerty et al., 2025. Additionally, Sangath highlights that in India, more than 3.5 million individuals are affected, with rising cases linked to aging and chronic disease burdens. These figures underscore the urgent need for advancements in the schizophrenia drug pipeline.

Schizophrenia – Pipeline Therapeutic Assessment

This section of the report covers the analysis of schizophrenia drug candidates based on several segmentations, including:

By Phase

The pipeline assessment report covers 50+ drug analyses based on phase:

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Drug Class

The schizophrenia pipeline analysis report covers 50+ drug analyses based on drug classes:

  • Small Molecules
  • Monoclonal Antibodies
  • Peptides

By Route of Administration

The pipeline assessment report covers 50+ drug analyses based on the route of administration.

  • Oral
  • Parenteral
  • Others

Schizophrenia Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II, with 30%, covers a major share of the total schizophrenia clinical trials, representing the largest share of the Schizophrenia drug pipeline. It is followed by phase III at 27%, phase IV at 24%, and phase I at 16%. This well-balanced distribution across clinical development stages underscores strong innovation and advancement, supporting growth and expanding therapeutic options in the schizophrenia market.

Schizophrenia Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the schizophrenia pipeline analysis include small molecules, monoclonal antibodies, and peptides. The schizophrenia report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for schizophrenia. Second-generation antipsychotics continue to dominate the schizophrenia drug pipeline, focusing on improving efficacy and patient adherence. For instance, TEV-'749, a small molecule, subcutaneous long-acting injectable formulation of olanzapine, is under evaluation in the Phase 3 SOLARIS trial, showing improvements in social functioning and quality of life. Similarly, UZEDY® (risperidone), a small molecule extended-release injectable formulation, is being studied for enhanced adherence and real-world effectiveness in adult patients.

Schizophrenia Clinical Trials – Key Players

The EMR report for the schizophrenia pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed schizophrenia therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in schizophrenia clinical trials:

  • Neurocrine Biosciences
  • Spinogenix
  • Luye Pharma Group Ltd.
  • Otsuka Pharmaceutical Co., Ltd.
  • Alto Neuroscience
  • Kynexis B.V.
  • Vigonvita Life Sciences
  • AbbVie
  • Qilu Pharmaceutical Co., Ltd.
  • MapLight Therapeutics
  • Bristol-Myers Squibb
  • Karuna Therapeutics

Schizophrenia – Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for schizophrenia. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of schizophrenia drug candidates.

Drug: NBI-1117568

NBI-1117568, sponsored by Neurocrine Biosciences, is a first-in-class oral muscarinic M4 selective orthosteric agonist, currently under investigation for schizophrenia treatment. This Phase 3, multicenter, double-blind, placebo-controlled study aims to evaluate the efficacy of NBI-1117568 in delaying the relapse of schizophrenia symptoms in adults who have achieved a stable response after open-label treatment. The study is examining both the safety and tolerability of the drug, which works by selectively targeting M4 muscarinic receptors to modulate neurotransmission, potentially reducing side effects associated with traditional therapies. Administration is oral, with study completion estimated by July 2029.

Drug: SPG302

SPG302 is being developed by Spinogenix as a first-in-class, once-daily oral regenerative therapy targeting schizophrenia. This Phase 2 study is evaluating its safety, efficacy, tolerability, and pharmacodynamics in adults with a primary diagnosis of schizophrenia. SPG302 works by restoring synapses, the essential connections between neurons, which may improve cognitive, motor, and memory functions. The randomized, placebo-controlled study involves weekly site visits while participants take the drug at home over six weeks. The study started in August 2024, with completion estimated in February 2026, enrolling 32 participants.

Drug: LY03020

LY03020 is an oral extended-release tablet being developed by Luye Pharma Group Ltd. and is currently undergoing a Phase 1 multiple ascending dose (MAD) study. This randomized, double-blind, placebo-controlled trial is examining the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adults and subjects with stable schizophrenia. LY03020 is a dual-action drug targeting TAAR1 and 5-HT2CR receptors. By activating TAAR1, it reduces dopamine and serotonin release, while 5-HT2CR modulation helps alleviate negative symptoms and metabolic side effects. The study, which started in August 2025, is expected to be completed by February 2026.

*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*

Key Questions Answered in the Schizophrenia Pipeline Insight Report

  • Which companies/institutions are leading the schizophrenia drug development?
  • Which company is leading the schizophrenia pipeline development activities?
  • What is the current schizophrenia commercial assessment?
  • What are the opportunities and challenges present in the schizophrenia pipeline landscape?
  • What is the efficacy and safety profile of schizophrenia pipeline drugs?
  • Which company is conducting major trials for schizophrenia drugs?
  • Which companies/institutions are involved in schizophrenia collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in schizophrenia?

Reasons To Buy This Report

The Schizophrenia Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for schizophrenia. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into schizophrenia collaborations, regulatory environments, and potential growth opportunities.

Related Reports

Global Clinical Trials Market

Schizophrenia Drugs Market

Schizophrenia Market

Schizophrenia Epidemiology Forecast

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

Scope of the Report

Details

Drug Pipeline by Clinical Trial Phase

  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

Route of Administration

  • Oral
  • Parenteral
  • Others

Drug Classes

  • Small Molecules
  • Monoclonal Antibodies
  • Peptides

Leading Sponsors Covered

  • Neurocrine Biosciences
  • Spinogenix
  • Luye Pharma Group Ltd.
  • Otsuka Pharmaceutical Co., Ltd.
  • Alto Neuroscience
  • Kynexis B.V.
  • Vigonvita Life Sciences
  • AbbVie
  • Qilu Pharmaceutical Co., Ltd.
  • MapLight Therapeutics
  • Bristol-Myers Squibb
  • Karuna Therapeutics

Geographies Covered

  • North America
  • Europe
  • Asia Pacific
  • Others

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