drug
as of 2026-07-01Clozapine
Clozaril 100 mg (Clozapine)ClozarilPhase 2: ClozapinePhase 3A: Clozapine extended treatment or Combined clozapine-MECT therapyPhase 3B: Clozapine or another SGAsFazaClo (clozapine, USP) ODTclozapineclozapine+haloperidol
MeSH D003024UNII J60AR2IKICRxCUI 104775, 104776, 197535, 197536FDA_ApplNo NDA019758SPL_set_id 90876802-0e3a-44c9-9ff7-1754dfbe736aFDA_sponsor HERITAGE LIFEOrangeBook_Appl A074546, A074949, A075162, A075417, A075713, A076809, A090308, A201824
at a glance
small molecule · Atypical Antipsychotic [EPC]
US-approved (1989) as Clozaril
Developed by Shanghai Mental Health Center
Orange Book protection to 2028
55 trials in the graph
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
FDA class
Atypical Antipsychotic [EPC]
Mechanism of action
12.1 Mechanism of Action The mechanism of action of clozapine is unknown. However, it has been proposed that the therapeutic efficacy of clozapine in schizophrenia is mediated through antagonism of the dopamine type 2 (D 2 ) and the serotonin type 2A (5-HT 2A ) receptors. CLOZARIL also acts as an antagonist at adrenergic, cholinergic, histaminergic and other dopaminergic and serotonergic receptors.
Indications
Labeled
TouretteSchizophrenia
Patents & exclusivity
Orange Book
patent 80578112028-05-01
Adverse-event signal
FAERS spontaneous · within-drug share
Hematologic17.6%
top term: NEUTROPENIA
Mortality6.3%
top term: DEATH
Qt Cardiac3.3%
top term: TACHYCARDIA
Sedation2.8%
top term: SEDATION
Gi2.2%
top term: VOMITING
Weight Metabolic1.8%
top term: WEIGHT INCREASED
Eps Akathisia1.5%
top term: DYSKINESIA
Orthostatic1.1%
top term: HYPOTENSION
Anticholinergic1.1%
top term: CONSTIPATION
Nms0.6%
top term: NEUROLEPTIC MALIGNANT SYNDROME
Spontaneous reports — a signal of reporting share, not incidence.
Trials
55
Biomarkers to Enhance Early Schizophrenia Treatment
NCT06969755Phase 4Recruiting
Biomarkers in Clozapine-responding Schizophrenia
NCT05316883Phase 4Recruiting
Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
NCT05208190Phase 4Recruiting
Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
NCT05603104Phase 3Recruiting
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.
NCT05958875Phase 4Recruiting
CLOZAPINE Response in Biotype-1
NCT04580134Phase 4Recruiting
Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia
NCT02639702Phase 4Recruiting
An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine
NCT05741502Phase 4Terminated
Study to Compare Clozapine vs Treatment as Usual in People With Intellectual Disability & Treatment-resistant Psychosis
NCT04529226Phase 2Unknown
Characterizing Response to Antipsychotics in Schizophrenia
NCT06159322—Unknown
Effects of Buspirone Combined With Clozapine
NCT06906224Early Phase 1Completed
Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments(SMART-CAT)
NCT03510325Phase 3Completed
SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia
NCT04528095Phase 3Unknown
Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18
NCT04849026Phase 1Completed
Response to Clozapine in Treatment Resistant Schizophrenia: A Longitudinal Magnetic Resonance Spectroscopy Study
NCT02714894—Unknown
Biomarker and Safety Study of Clozapine in Patients With Benign Ethnic Neutropenia (BEN)
NCT02404155—Completed
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
NCT03652974Phase 4Completed
Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder
NCT03857581Phase 4Unknown
The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia
NCT03772951Phase 4Completed
Therapeutic Drug Monitoring for Individualized Clozapine Therapy
NCT03523741—Unknown
Comparison of Maintenance ECT Versus Clozapine in Treatment-resistant Schizophrenia
NCT03807882Phase 4Completed
Clinical and Genetic Influencing Factors on Clozapine Pharmacokinetics
NCT04240496—Completed
The Optimal Treatment for Treatment-resistant Schizophrenia
NCT02926976—Unknown
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)
NCT02600741—Completed
KOLs & investigators
12
Christoph U. Correll, MDKOL score 96
Gary Remington, MD PhD FRCPCKOL score 12
Dengtang Liu, MDKOL score 12
René Kahn, Prof. Dr.KOL score 11
Xiaoduo Fan, MD, MPH, MSKOL score 9
Jeffrey A. Lieberman, MDKOL score 9
Donald C. Goff, MDKOL score 8
Boaz Bloch, MDKOL score 5
Alasdair M Barr, Ph.D.KOL score 5
Deanna L. Kelly, Pharm.D., BCPPKOL score 5
Anders Fink-Jensen, MD, professor, DMSci.KOL score 5
Alan I. Green, MDKOL score 5
Facts & assertions
28 sourced
Anda Generic Count
48
Boxed Warning
present
Dosing Frequency
once daily
Faers Share Anticholinergic
0.011
Faers Share Eps Akathisia
0.015
Faers Share Gi
0.022
Faers Share Hematologic
0.176
Faers Share Mortality
0.063
Faers Share Nms
0.006
Faers Share Orthostatic
0.011
Faers Share Qt Cardiac
0.033
Faers Share Sedation
0.028
Faers Share Weight Metabolic
0.018
Fda Pharm Class Epc
Atypical Antipsychotic [EPC]
Has Generic Competition
yes
Latest Patent Expiry
2028-05-01
Latest Protection Date
2028-05-01
Mechanism Of Action
12.1 Mechanism of Action The mechanism of action of clozapine is unknown. However, it has been proposed that the therapeutic efficacy of clozapine in schizophrenia is mediated through antagonism of the dopamine type 2 (D 2 ) and the serotonin type 2A (5-HT 2A ) receptors. CLOZARIL also acts as an an
Originator Company
Heritage Life
Safety Eps Akathisia
present in label
Safety Nms
present in label
Safety Orthostatic
present in label
Safety Prolactin
present in label
Safety Qt Prolongation
present in label
Safety Sedation Somnolence
present in label
Safety Weight Metabolic
present in label
Us Approved
yes
Us Original Approval Date
1989-09-26
relationships
The graph out of here
developer
trial
indication
indication
indication
indication
indication
KOL
Christoph U. Correll, MD
personKOL score 96
Gary Remington, MD PhD FRCPC
personKOL score 12
Dengtang Liu, MD
personKOL score 12
René Kahn, Prof. Dr.
personKOL score 11