Clozaril

(Clozapine)

ApprovedSmall molecule

Clozapine is used to treat severe schizophrenia and reduce the risk of suicide in people with schizophrenia or similar conditions. It's typically prescribed when other antipsychotic medications haven't worked well.[2] Clozaril is currently approved and in use across 14 indications[4].[1]

Clozaril is one of 309 small molecule programs targeting Clozapine. It is currently in Approved.

Indications

Total Trials

Active Trials

308

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

ClozapineWithdrawn

Parkinson DiseaseActive, not recruiting

Schizoaffective DisorderActive, not recruiting

PsychosisActive, not recruiting

Panic DisorderActive, not recruiting

NeutropeniaActive, not recruiting

Schizophenia DisorderRecruiting

Bipolar DisorderUnknown status

SchizophreniaRecruiting

Intellectual DisabilityActive, not recruiting

ClozapineApproved

Withdrawn

Parkinson DiseasePreclinical

Active, not recruiting

Schizoaffective DisorderApproved

Active, not recruiting

PsychosisApproved

Active, not recruiting

Panic DisorderApproved

Active, not recruiting

NeutropeniaPreclinical

Active, not recruiting

Schizophenia DisorderApproved

Recruiting

Bipolar DisorderApproved

Unknown status

SchizophreniaApproved

Recruiting

Intellectual DisabilityPhase 2

Active, not recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Clozaril

LLife Extension Foundation Inc.

Approved

26 2

Resotran

Takeda

Preclinical

1 3

Inapsine

Jazz Pharmaceuticals

Preclinical

1 4

Depakote

Ibrance

Lunesta

3 7

Luvox

SSolvay Pharmaceuticals

Preclinical

1 8

Catapres

Boehringer Ingelheim

Preclinical

1 9

Rapamune

PPrism Pharmaceuticals

Preclinical

1 10

Persantine

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

ApprovedRecruiting

Schizophrenia

NCT02639702

Q2 2028

Post-ApprovalRecruiting

Schizophrenia

NCT05958875

Phase 3Recruiting

Major Depressive Disorder

NCT05603104

Q4 2028

Post-ApprovalRecruiting

Schizophrenia

NCT05208190

Q4 2029

Post-ApprovalRecruiting

Schizophrenia

NCT05316883

Clinical

Trials by Indication[1]

Schizophrenia26 trials

Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

Terminated·HHarvard Medical School (HMS and HSDM)·Phase 4·NCT00169039·66 enrolled

Clozapine for Cannabis Use in Schizophrenia

Completed·—·Phase 4·NCT01639872·49 enrolled

Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

Completed·NNorthwell Health·Phase 1/2·NCT00042224·39 enrolled

Show 23 more trials

The Effect of a Six Week Intensified Pharmacological Treatment for Schizophrenia Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Recruiting·—·Phase 4·NCT05958875·418 enrolled

SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia

Unknown status·SShanghai Mental Health Center·Phase 3·NCT04528095·162 enrolled

Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial

Recruiting·NNew York State Psychiatric Institute·Phase 4·NCT05208190·280 enrolled

Treatment of Schizophrenia and Comorbid Cannabis Use Disorder: Comparing Clozapine to Treatment-as-Usual

Completed·—·Phase 4·NCT00498550·31 enrolled

A Study Comparing the Efficacy and Tolerability of Ziprasidone vs. Clozapine for the Treatment of Schizophrenia in Patients Who Continue to Have Symptoms on or Cannot Tolerate Other Antipsychotic Drugs

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00649844·147 enrolled

Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia

Completed·HHarvard Medical School (HMS and HSDM)·Phase 4·NCT00169065·38 enrolled

CATIE- Schizophrenia Trial

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00014001·1,600 enrolled

Response to Clozapine in Treatment Resistant Schizophrenia: A Longitudinal Magnetic Resonance Spectroscopy Study

Unknown status·CCentre for Addiction and Mental Health··NCT02714894·108 enrolled

Biomarkers in Clozapine-responding Schizophrenia

Recruiting·JJimmi Nielsen·Phase 4·NCT05316883·200 enrolled

A Long Term Study of Clozapine in Patients With Treatment-resistant Schizophrenia

Completed· Novartis logo

Novartis·Phase 2·NCT00154258·19 enrolled

Clozapine Versus Amisulpride in Treatment-resistant Schizophrenia Patients

Withdrawn·GGeha Mental Health Center·N/A·NCT01448499

Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

Terminated·HHarvard Medical School (HMS and HSDM)·Phase 4·NCT00169091·32 enrolled

Glycine and D-Cycloserine in Schizophrenia

Withdrawn·MMassachusetts General Hospital·Phase 3·NCT00000372

Treating Drug-Resistant Childhood Schizophrenia

Completed·NNorthwell Health·Phase 4·NCT00048828·41 enrolled

Comparison of Maintenance ECT Versus Clozapine in Treatment-resistant Schizophrenia

Completed·—·Phase 4·NCT03807882·60 enrolled

Characterizing Response to Antipsychotics in Schizophrenia

Unknown status·TThe Royal Ottawa Mental Health Centre··NCT06159322·40 enrolled

Adjunctive Low-dose Metformin in Patients With Schizophrenia and Metabolic Abnormalities

Completed·TTaipei Medical University WanFang Hospital·Phase 4·NCT02751307·55 enrolled

Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia

Completed·UUniversity of Massachusetts, Worcester·Phase 4·NCT00981526·66 enrolled

Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT02600741·296 enrolled

A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia

Completed· Novartis logo

Novartis·Phase 3·NCT00250575·43 enrolled

The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia

Completed·SShanghai Mental Health Center·Phase 4·NCT03772951·154 enrolled

First Episode Schizophrenia and Cannabis-Related Disorder Study

Completed·—·N/A·NCT00573287·14 enrolled

Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia: A Pilot, Double-Blind, Randomized Controlled Trial

Recruiting·CCentre for Addiction and Mental Health·Approved·NCT02639702·30 enrolled

Clozapine5 trials

CLOZAPINE Response in Biotype-1

Recruiting·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT04580134·524 enrolled

Pharmacokinetics of Clozapine and Norclozapine and the Effect of Pantoprazole

Completed·UUniversiti Sains Malaysia·Phase 1·NCT07262736·33 enrolled

Study of the Effect of Dosing on Clozapine Levels

Withdrawn·UUniversity of British Columbia·Phase 4·NCT02286206

Show 2 more trials

F-18 Altanserin PET Study of Patients Receiving Clozapine

Unknown status·SSeoul National University Bundang Hospital·N/A·NCT01398189·12 enrolled

The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring.

Completed·AAnders Fink-Jensen, MD, DMSci·Phase 4·NCT02625103·48 enrolled

Bipolar Disorder4 trials

Observation of Clozapine Treatment Safety in Bipolar Disorder.

Enrolling by invitation·MMedical University of Gdansk··NCT06011460·30 enrolled

Clozapine vs. Placebo in Treatment-Refractory Bipolar Disorder in Children and Adolescents

Completed·NNational Institute of Mental Health (NIMH)·Phase 3·NCT00036582·116 enrolled

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Show 1 more trial

Clozapine Versus Other Atypical Antipsychotics for Bipolar Disorder

Unknown status·HHospital de Clinicas de Porto Alegre·Phase 4·NCT02562287·54 enrolled

Tic Disorder2 trials

Comparison of Clozapine vs Olanzapine in Childhood-Onset Psychotic Disorders

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00001656·25 enrolled

Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder

Unknown status·—·Phase 4·NCT03857581·100 enrolled

Aggression2 trials

Clozapine IM and Aggression in Schizophrenic Patients

Withdrawn·—·Phase 3·NCT00189995

Clozapine and Olanzapine Treatment of Aggression

Completed·NNathan Kline Institute for Psychiatric Research·N/A·NCT01123408·110 enrolled

16 more indications

Malignancies1 trial

Clozapine and Haematologic Malignancies: Observational and Retrospective Study Using the WHO Pharmacovigilance Database

Unknown status·UUniversity Hospital, Caen··NCT04074213·1,000,000 enrolled

Intellectual disability1 trial

Study to Compare Clozapine vs Treatment as Usual in People With Intellectual Disability & Treatment-resistant Psychosis

Active, not recruiting·FFundación Pública Andaluza para la gestión de la Investigación en Sevilla·Phase 2·NCT04529226·75 enrolled

Genetic Polymorphism1 trial

Clozapine Plasma Levels and the Relationship to the Genetic Polymorphism in Shizophrenic Patients

Completed·TTirat Carmel Mental Health Center·Phase 4·NCT01663077·20 enrolled

Neutropenia1 trial

Biomarker and Safety Study of Clozapine in Patients With Benign Ethnic Neutropenia (BEN)

Completed·UUniversity of Maryland, Baltimore·N/A·NCT02404155·274 enrolled

Parkinson's Disease1 trial

A Clinical Study of the Safety and Efficacy of Chemogenetics Therapy in the Treatment of Parkinson's Disease

Not yet recruiting·RRuijin Hospital·Phase 1·NCT07085195·6 enrolled

Panic Disorder1 trial

Evaluation of Clonazepam and Paroxetine for Panic Disorder With Depression

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00031317·60 enrolled

Developmental Delay1 trial

Atypical Neuroleptic Drugs in People With Mental Retardation/Developmental Delay

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00065273·50 enrolled

Drug Monitoring1 trial

Therapeutic Drug Monitoring for Individualized Clozapine Therapy

Unknown status·SSeoul National University Hospital··NCT03523741·100 enrolled

Antipsychotics1 trial

Switching Antipsychotics: Abrupt Discontinuation Versus Overlap

Completed·CCentre for Addiction and Mental Health·Phase 4·NCT02640300·33 enrolled

Inflammatory Response1 trial

An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine

Terminated·OOhio State University·Phase 4·NCT05741502·5 enrolled

Psychosis1 trial

Study of Clozapine for the Treatment of Psychosis in Patients With Idiopathic Parkinson's Disease

Completed·—·N/A·NCT00004826·60 enrolled

Drug1 trial

An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)

Completed·OOrganon and Co··NCT01498770·42 enrolled

Treatment1 trial

Clozapine for Treatment-Resistant Mania

Completed·NNational Institute of Mental Health (NIMH)·Phase 2·NCT00029458·42 enrolled

Major Depressive Disorder1 trial

Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure

Recruiting·—·Phase 3·NCT05603104·1,254 enrolled

Schizophenia Disorder1 trial

Biomarkers to Enhance Early Schizophrenia Treatment

Recruiting·NNorthwell Health·Approved·NCT06969755·180 enrolled

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 26, 1989

CLOZARIL

NDA NDA019758

May 30, 2007

FAZACLO ODT

NDA NDA021590

Feb 6, 2013

VERSACLOZ

NDA NDA203479

Sources

References

[1]
ClinicalTrials.gov — 55 trial records for Clozapine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Clozaril drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Clozapine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Clozapine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA203479). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Clozaril. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Life Extension Foundation Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dopamine D2 Receptor Antagonist; Serotonin 2a (5-Ht2a) Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: LLife Extension Foundation Inc.

Patent Landscape[6]

Patent Cliff

May 1, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8057811May 1, 2028

Clozaril

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q2 2028

Q4 2028

Q4 2029

Trials by Indication[1]

Schizophrenia26 trials

Clozapine5 trials

Bipolar Disorder4 trials

Tic Disorder2 trials

Aggression2 trials

Malignancies1 trial

Intellectual disability1 trial

Genetic Polymorphism1 trial

Neutropenia1 trial

Parkinson's Disease1 trial

Panic Disorder1 trial

Developmental Delay1 trial

Drug Monitoring1 trial

Antipsychotics1 trial

Inflammatory Response1 trial

Psychosis1 trial

Drug1 trial

Treatment1 trial

Major Depressive Disorder1 trial

Schizophenia Disorder1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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