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Drug

Clozapine

Established medicine
ClassSerotonin 2a (5-HT2a) receptor antagonistResearchActive indication expansion
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.

RxNorm2626ChEMBLCHEMBL42ATCN05AH02UNIIJ60AR2IKIC
2
Research papers
8
Active clinical trials
2
Protein targets
65
Regulatory events
Latest activity
beta

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

<![CDATA[Clozapine Remains Underused After REMS Elimination: A Conversation With Jose Rubio, MD, PhD]]>

Industry2026-10-08Psychiatric Times

Label change: CLOZAPINE (ANDA075417)

Regulatory2026-10-02FDA

Label change: CLOZAPINE (ANDA075417)

Regulatory2026-10-02FDA

Label change: CLOZAPINE (ANDA075417)

Regulatory2026-10-02FDA

Label change: CLOZAPINE (ANDA202873)

Regulatory2026-10-02FDA

Serious Neutropenia in Clozapine Use: Rare, Occurs Early

Industry2026-09-03Medscape Medical News

[Correspondence] New clozapine regulations, old inequalities?

Industry2026-09-01The Lancet Psychiatry

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

Clinical trial2026-08-25Results expected Q3 2027 · ClinicalTrials.gov

Biomarkers to Enhance Early Schizophrenia Treatment

Clinical trial2026-07-31Results expected Q3 2030 · ClinicalTrials.gov

[Comment] Clozapine and GLP-1 receptor agonists: an underrated gastrointestinal safety risk

Industry2026-07-23The Lancet Psychiatry

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

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
mhrafda

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

65 events

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.

Earliest approval on record (generic/biosimilar)
1999-05-27
Latest approval
2025-06-13
Authorities
FDA · MHRA
Total events
65
fdaU.S. Food and Drug Administration· 64 events
2026-10-02Label change
Label change: CLOZAPINE (ANDA075417)
Evidence ↗
2026-10-02Label change
Label change: CLOZAPINE (ANDA075417)
Evidence ↗
2026-10-02Label change
Label change: CLOZAPINE (ANDA075417)
Evidence ↗
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 ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

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
51
registered trials across all phases
LATEST COMPLETION 2022
8
Active studies
8
Recruiting
43
Late-stage (III+)
29
Completed
14
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

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.

RecruitingPH IVDr. Inge Wintern=4182028

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

RecruitingPH IVCentre for Addiction and Mental Healthn=302027

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
1999–2023
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
Recent papers

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
Major research themes3
Antipsychotic Agents1Bipolar Disorder1Clozapine1
Journals, researchers & institutions
Top journals
  • The British journal of psychiatry : the journal of mental science1
  • The Journal of clinical psychiatry1
Leading researchers
  • Kane JM1
  • Lähteenvuo M1
  • Paljärvi T1
  • Taipale H1
  • Tanskanen A1
  • Tiihonen J1
Leading institutions
free-text, unnormalised
  • Hillside Hospital1
  • University of Eastern Finland1

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.