Schizophrenia
Recent clinical, regulatory, research and industry developments relating to this disease.
Mapping the genetic landscape across 14 psychiatric disorders.
Market withdrawal: Olanzapine Apotex (EMA)
IUPHAR themed review: The gut microbiome in schizophrenia.
Population-Based Risk of Psychiatric Disorders Associated With Recurrent Copy Number Variants.
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 6 clinical trials expected to report results, the earliest in Q4 2026.
- Active recent publication activity, including 1 notable finding.
- 1 safety action from EMA issued.
- 4 industry developments reported.
- Q4 2026PsyCARE Trial - "Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis : A Prospective Randomised Controlled Trial "
- Q4 2027A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Study to Evaluate Efficacy of Roluperidone on Negative Symptoms in Adult Subjects With Schizophrenia, Followed by a 40-Week, Randomized, Double-Dummy Phase to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
- Q4 2029Cerebellar-cortical Circuitry and Prediction of Treatment Response in Early Psychosis
- Q1 2030A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
- Q4 2031A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia
Research HighlightsViewHide
- 2025-12-10Mapping the genetic landscape across 14 psychiatric disorders.Grotzinger AD · 2026
- 2026-02-19Glutamate Metabotropic Receptors-Linked Postsynaptic Density Proteins: An Emergent Hub for Antipsychotics' Regulation of Synaptic Plasticity and Metaplasticity.Barone A · 2026
- 2025-08-27Extracellular matrix dysfunction and synaptic alterations in schizophrenia.Unzueta-Larrinaga P · 2026
Clinical MilestonesView all 12Hide
- 2026-07-31An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum DisorderResults expected Q2 2032
- 2026-06-23A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum DisorderResults expected Q1 2030
- 2026-06-15A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Study to Evaluate Efficacy of Roluperidone on Negative Symptoms in Adult Subjects With Schizophrenia, Followed by a 40-Week, Randomized, Double-Dummy Phase to Evaluate the Relapse Rate of Roluperidone and Antipsychotic MedicationsResults expected Q4 2027
- 2026-06-05A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With SchizophreniaResults expected Q4 2031
- 2026-05-26Cerebellar-cortical Circuitry and Prediction of Treatment Response in Early PsychosisResults expected Q4 2029
- 2026-06-08The Effect of Metformin Treatment on Cognitive Impairment in Individuals With Schizophrenia: A 24-week Multicentre Randomised Controlled TrialCompleted
- 2026-02-01A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's DiseaseCompleted
- 2025-11-12A Randomized Controlled Trial to Evaluate Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With SchizophreniaCompleted
- 2025-08-15Efficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar DisorderCompleted
- 2026-12-31A Multidose, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective DisorderWithdrawn
- 2026-01-23An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine Versus Non-Clozapine Antipsychotics in Individuals With Treatment-resistant SchizophreniaTerminated
Industry & MarketViewHide
- 2026-07-27MapLight shares sink on mixed phase 2 schizophrenia readoutTrial news · Fierce Biotech
- 2026-04-02Alto Neuroscience shelves schizophrenia cognitive impairment program after Phase 2 missTrial news · Endpoints News
- 2026-06-23Long‑Range Gene Networks Uncover 641 New Schizophrenia‑Associated GenesIndustry · GEN News
- 2026-04-03A gene mutation may trap the brain in the wrong reality in schizophrenia patientsIndustry · Science Daily
Regulatory UpdatesViewHide
- 2025-08-12Market withdrawal — OlanzapineOlanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
- 2026-12-31ClinicalA Multidose, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective DisorderWithdrawn
- 2026-07-31ClinicalAn Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum DisorderResults expected Q2 2032
- 2026-07-27IndustryMapLight shares sink on mixed phase 2 schizophrenia readoutTrial news · Fierce Biotech
- 2026-06-23IndustryLong‑Range Gene Networks Uncover 641 New Schizophrenia‑Associated GenesIndustry · GEN News
- 2026-06-23ClinicalA Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum DisorderResults expected Q1 2030
- 2026-06-15ClinicalA 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Study to Evaluate Efficacy of Roluperidone on Negative Symptoms in Adult Subjects With Schizophrenia, Followed by a 40-Week, Randomized, Double-Dummy Phase to Evaluate the Relapse Rate of Roluperidone and Antipsychotic MedicationsResults expected Q4 2027
- 2026-06-08ClinicalThe Effect of Metformin Treatment on Cognitive Impairment in Individuals With Schizophrenia: A 24-week Multicentre Randomised Controlled TrialCompleted
- 2026-06-05ClinicalA Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With SchizophreniaResults expected Q4 2031
- 2026-05-26ClinicalCerebellar-cortical Circuitry and Prediction of Treatment Response in Early PsychosisResults expected Q4 2029
- 2026-04-20ClinicalPsyCARE Trial - "Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis : A Prospective Randomised Controlled Trial "Results expected Q4 2026
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approval — indicated for maintenance treatment of schizophrenia in adult patients stabilised withpal… (2024)
Approval — Treatment of schizophrenia in adults for whom tolerability and effectiveness has been est… (2022)
Approval — Rxulti is indicated for the treatment of schizophrenia in adult and adolescents aged 13 y… (2018)
Approval — Reagila is indicated for the treatment of schizophrenia in adult patients. (2017)
Approval — Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adol… (2015)
Clinical trials
The current development programme across all trial phases.
Evidence coverage
How much of this condition's readable clinical evidence the confidence engine has incorporated, across its most-studied treatments. This measures coverage of the evidence base — not whether any treatment works.
Largest gap: no meaningful change (6, trial-readability).
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes8
- Schizophrenia37
- Mental Disorders14
- Bipolar Disorder12
- Major Depressive Disorder8
- Attention Deficit Disorder with Hyperactivity5
- Brain5
- Autism Spectrum Disorder4
- Psychiatry4
Leading journals6
- Molecular psychiatry12
- Schizophrenia bulletin4
- Translational psychiatry4
- Nature3
- Psychological medicine3
- Biomolecules2
Leading researchers8
- Børglum AD4
- Andreassen OA3
- Bybjerg-Grauholm J3
- Faraone SV3
- Genovese G3
- Hirano Y3
- Hougaard DM3
- Liu C3
Affiliations (unnormalised)6
- Harvard Medical School7
- School of Medicine7
- Stanley Center for Psychiatric Research7
- University of Oxford7
- Institute of Psychiatry6
- McLean Hospital5
Disease biology
Key proteins & gene products studied in this disease. Number shows shared papers.
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Schizophrenia is a severe psychotic disorder marked by withdrawal from reality, delusions, hallucinations, emotional disharmony, and regressive behavior. The supplied literature also frames it as a common, burdensome, and costly psychiatric disorder in adults worldwide.
The grounding supports a neurobiological disorder with structural and circuit-level abnormalities rather than a purely functional psychosis. Reported findings include ventricular enlargement, reduced cortical and hippocampal volume, preferential temporal lobe involvement, altered cerebral asymmetry, and reduced neuropil and neuronal size. The literature also emphasizes disrupted cortical-subcortical-cerebellar connectivity and cognitive dysmetria, along with genetic and molecular investigation involving transcriptome changes, single-nucleotide polymorphisms, neuronal plasticity, and NMDA/AMPA-related glutamatergic mechanisms.
The supplied material supports epidemiologic variation in prevalence and the use of migrant and special-group studies, but it does not identify specific risk factors. It also notes genetic association work and heritability-oriented endophenotype research, but not concrete individual risk factors.
Antipsychotic drugs are described as the treatment of choice for acute schizophrenia. The evidence base in the grounding focuses on oral antipsychotics and their comparative efficacy, tolerability, and metabolic effects, indicating pharmacologic treatment with antipsychotic medication as the standard modality. The material does not support more specific treatment recommendations beyond the antipsychotic drug class.
AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
A severe emotional disorder of psychotic depth characteristically marked by a retreat from reality with delusion formation, HALLUCINATIONS, emotional disharmony, and regressive behavior.
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.