Drug

Clozapine

Regulatory activity · MHRA

ClassSerotonin 2a (5-HT2a) receptor antagonistEmerging researchLate-stage development

Also known as CLOZAPINE (GOLDEN STATE), CLOZAPINE (MAYNE), CLOZAPINE (SANDOZ), CLOZAPINE (SUN)+6 more

CLOZAPINE (GOLDEN STATE), CLOZAPINE (MAYNE), CLOZAPINE (SANDOZ), CLOZAPINE (SUN), Clozaril, FazaClo, Versacloz, Clozapin, Clozapina, Clozapinum.

RxNorm2626 ChEMBLCHEMBL42 ATCN05AH02UNIIJ60AR2IKIC

Research papers

Active clinical trials

Protein targets

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Biomarkers to Enhance Early Schizophrenia Treatment

Clinical trial2026-06-12Results expected Q3 2030 · ClinicalTrials.gov

Antipsychotic Response to Clozapine in B-SNIP Biotype-1 (Clozapine)

Clinical trial2026-05-11Results expected Q2 2027 · ClinicalTrials.gov

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

Clinical trial2026-05-04Results expected Q2 2028 · ClinicalTrials.gov

An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine Versus Non-Clozapine Antipsychotics in Individuals With Treatment-resistant Schizophrenia

Clinical trial2026-01-23Terminated · ClinicalTrials.gov

A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Clinical trial2026-01-22Results expected Q2 2028 · ClinicalTrials.gov

Biomarkers in Clozapine-responding Schizophrenia

Clinical trial2026-01-20Results expected Q4 2029 · ClinicalTrials.gov

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

Clinical trial2025-12-30Primary completion · ClinicalTrials.gov

A Randomised, Controlled Trial to Investigate 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.

Clinical trial2025-09-26Results expected Q2 2028 · ClinicalTrials.gov

A Randomized, Multicenter Clinical Trial to Assess the Efficacy and Safety of Clozapine vs Treatment as Usual for Treatment-resistant Psychosis in Adolescents and Young Adults With Intellectual Disability.

Clinical trial2025-01-30Primary completion · ClinicalTrials.gov

Real-world effectiveness of pharmacological treatments for bipolar disorder: register-based national cohort study.

Research2023-10-01The British journal of psychiatry : the journal of mental science

Drug Safety Update: Clozapine: reminder of potentially fatal risk of intestinal obstruction, faecal impaction, and paralytic ileus

Regulatory2017-10-26MHRA

Management strategies for the treatment of schizophrenia.

Research1999-01-01The Journal of clinical psychiatry

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Clozapine

Aliases & brands

CLOZAPINE (GOLDEN STATE)CLOZAPINE (MAYNE)CLOZAPINE (SANDOZ)CLOZAPINE (SUN)ClozarilFazaCloVersaclozClozapinClozapinaClozapinum

RxNorm CUI

2626

ChEMBL ID

CHEMBL42

ATC codes

N05AH02

UNII

J60AR2IKIC

Primary mechanism

Serotonin 2a (5-HT2a) receptor antagonist

Regulatory jurisdictions

mhra

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

5-hydroxytryptamine receptor 2A

HTR2A · P28223

ANTAGONISTSerotonin 2a (5-HT2a) receptor antagonist

D(2) dopamine receptor

DRD2 · P14416

ANTAGONISTDopamine D2 receptor antagonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities

MHRA

Total events

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2017-10-26Safety communicationSafety

Drug Safety Update: Clozapine: reminder of potentially fatal risk of intestinal obstruction, faecal impaction, and paralytic ileus

Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

51 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2022

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 51

Early Phase 11Phase 13Phase 1 / 21Phase 23Phase 39Phase 427Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Biomarkers to Enhance Early Schizophrenia Treatment

RecruitingPH IVNorthwell Healthn=1802030

Biomarkers in Clozapine-responding Schizophrenia

RecruitingPH IVJimmi Nielsenn=2002029

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

RecruitingPH IVNew York State Psychiatric Instituten=2802028

RecruitingPH IVDr. Inge Wintern=4182028

Antipsychotic Response to Clozapine in B-SNIP Biotype-1 (Clozapine)

RecruitingPH IVUniversity of Texas Southwestern Medical Centern=5242027

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Open Label, Multiple-dose, 2-way Crossover, Phase I Study to Compare the Safety and Pharmacokinetics Profile of WID-CLZ18 and Clozaril 100 mg Tablet (Clozapine) After Oral Administration in Schizophrenia Patients

CompletedPH IWhanin Pharmaceutical Companyn=332022

Pharmacokinetics of Clozapine and Norclozapine and the Effect of Pantoprazole

CompletedPH IUniversiti Sains Malaysian=332022

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

CompletedN/AUniversity of Maryland, Baltimoren=2742021

The Efficacy for Execution Function and Genetic Mechanism of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia

CompletedPH IVShanghai Mental Health Centern=1542021

Comparison of Maintenance ECT Versus Clozapine on Psychopathology and Cerebral Hemodynamics in Treatment-resistant Schizophrenia: A Randomized Controlled Trial

CompletedPH IVAll India Institute of Medical Sciences, Bhubaneswarn=602020

Clozapine for Cannabis Use Disorder in Schizophrenia

CompletedPH IVDartmouth-Hitchcock Medical Centern=492017

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

19992023

Most influential

Real-world effectiveness of pharmacological treatments for bipolar disorder: register-based national cohort study.

The British journal of psychiatry : the journal of mental science · 2023 · 24 cites

Management strategies for the treatment of schizophrenia.

The Journal of clinical psychiatry · 1999 · 18 cites

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Lithium

Studied across the same disease area as Clozapine in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.