Recent Updates
Recently added Catalysts

Clozapine

Phase 4FDA approved

Schizophrenia | Small molecule | Psychiatry |Novartis AG|Trials Updated: Sep 24, 2020

Clozapine development status

FDA approval on record Feb 10, 2004 as Fazaclo Odt
Approval holderJazz
ApplicationNDA021590
Highest phase Phase 4 (NCT00169039)
Phase scored for NVSPhase 3
Registered trials 9 across 6 sponsors since Sep 2005

Clozapine target and mechanism

Molecular targetDRD2, HTR2A
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL42

Also known as Clozaril

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment62

FDA Designations

No designations recorded

Clozapine clinical trials

Clozapine · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00250575A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant SchizophreniaSchizophrenia
COMPLETED43 Analytics
PHASE3COMPLETED
A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Values of hematological tests during the 24 week treatment
Incidence of hematological adverse events during the 24 week treatment
Compliance to Clozapine Patient Monitoring System during the 24 week treatment
Adverse events during the long term treatment (until NDA approval)
Baseline to 52 weeks
Vital signs at every 4 weeks
Baseline to 52 weeks
Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks)
Baseline to 52 weeks
ECG at every 12 weeks
Baseline to 52 weeks
Echo cardiogram at every 24 weeks
Baseline to 52 weeks

Secondary Endpoints

Changes in the symptoms of psychosis every 4 weeks up to week 24
Global change in severity of psychosis at baseline and week 12
Global impression of change in the condition of patients at week 12 and 24
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
ClozapineDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Diagnosed as schizophrenia * Not responded to at least two atypical antipshychotics launched in Japan * Inpatient Exclusion Criteria: * Low white blood cell count * Significant heart diseases * Diabetes mellitus Other protocol-defined exclusion criteria may apply.

Countries:Japan
Unlock Eligibility Criteria

Frequently asked questions about Clozapine

What is Clozapine used for?

Clozapine is used for schizophrenia, including treatment-resistant schizophrenia. It is a small molecule developed by Novartis AG under ticker NVS. The clinical program includes Phase 3 and Phase 2 studies in patients with treatment-resistant schizophrenia, with a minimum age of 18 years and both sexes eligible.

What does Clozapine target?

Clozapine targets DRD2 and HTR2A. It acts as an antagonist at these receptors, meaning it blocks dopamine D2 and serotonin 5-HT2A receptor activity. This target profile is the basis of its pharmacological action in schizophrenia.

Who makes Clozapine?

Clozapine is developed by Novartis AG, which trades under the ticker NVS. The company is responsible for the clinical development program in schizophrenia.

What phase is Clozapine in?

Clozapine is in Phase 3 development for schizophrenia. It is an investigational small molecule and has not been approved based on the data described here. The program includes two completed trials, one Phase 3 and one Phase 2, with no active trials currently listed.

What clinical trials is Clozapine in?

Clozapine has been studied in two completed trials: NCT00250575, a Phase 3 safety and efficacy study in treatment-resistant schizophrenia conducted in Japan with 43 patients, and NCT00154258, a Phase 2 long-term study in treatment-resistant schizophrenia with 19 patients. Both enrolled adults 18 years and older.