Overview
Clozapine is a tricyclic dibenzodiazepine, classified as an atypical antipsychotic agent. Clozapine displays affinity to various neuroreceptors with a particularly low affinity to the dopamine receptors, thus breaking the mold of first-generation antipsychotics and deeming it "atypical".. This low affinity to dopamine receptors results in fewer extrapyramidal side effects, especially tardive dyskinesia. However, its promiscuity toward the muscarinic and adrenergic receptors can result in other side effects, notably gastrointestinal hypomotility and orthostatic hypotension. . Despite its effectiveness in treating both positive and negative symptoms of schizophrenia, clozapine was briefly removed from the market in various jurisdictions in 1970 due to severe agranulocytosis. However, continued evidence of its effectiveness led to clozapine's eventual reintroduction, although with a reluctance to prescribe it. Clozapine was approved by the FDA in 1989 for treatment-resistant schizophrenia under the brand CLOZARIL. Due to its severe adverse effects profile, clozapine is only available through a restricted program under a Risk Evaluation Mitigation Strategy (REMS) called the Clozapine REMS Program.
Indication
Clozapine is indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine should be used only in patients who have failed to respond adequately to standard antipsychotic treatment. Clozapine is also indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. Suicidal behavior refers to actions by a patient that put him/herself at risk for death.
Associated Conditions
- Suicidal Behaviour
- Treatment Resistant Schizophrenia
- Advanced dopaminomimetic psychosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/25 | Not Applicable | Not yet recruiting | |||
2025/05/14 | Phase 4 | Not yet recruiting | |||
2023/12/06 | N/A | Recruiting | The Royal Ottawa Mental Health Centre | ||
2023/08/25 | N/A | ENROLLING_BY_INVITATION | |||
2023/07/25 | Phase 4 | Recruiting | Dr. Inge Winter | ||
2023/02/23 | Phase 4 | Recruiting | |||
2022/11/02 | Phase 3 | Recruiting | Dr. Inge Winter | ||
2022/04/07 | Phase 4 | Recruiting | Mental Health Services in the Capital Region, Denmark | ||
2022/01/26 | Phase 4 | Recruiting | |||
2021/04/19 | Phase 1 | Completed | Whanin Pharmaceutical Company |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Mylan Pharmaceuticals Inc. | 0378-3815 | ORAL | 100 mg in 1 1 | 4/28/2023 | |
Aurobindo Pharma Limited | 65862-846 | ORAL | 100 mg in 1 1 | 1/18/2024 | |
Mylan Pharmaceuticals Inc. | 0378-0972 | ORAL | 50 mg in 1 1 | 7/15/2023 | |
Mylan Institutional Inc. | 51079-749 | ORAL | 200 mg in 1 1 | 12/27/2023 | |
Major Pharmaceuticals | 0904-7088 | ORAL | 200 mg in 1 1 | 1/4/2024 | |
Mylan Institutional Inc. | 51079-922 | ORAL | 100 mg in 1 1 | 12/27/2023 | |
HLS Therapeutics (USA), Inc. | 69809-0127 | ORAL | 100 mg in 1 1 | 2/11/2021 | |
Mayne Pharma Commercial LLC | 51862-901 | ORAL | 50 mg in 1 1 | 2/28/2024 | |
Mylan Institutional Inc. | 51079-921 | ORAL | 25 mg in 1 1 | 12/27/2023 | |
Aurobindo Pharma Limited | 65862-845 | ORAL | 50 mg in 1 1 | 1/18/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
CLOZAPINE TABLET 100 mg | SIN11384P | TABLET | 100 mg | 8/4/2000 | |
CLOZARIL TABLET 100 mg | MADAUS GmbH | SIN07235P | TABLET, FILM COATED | 100 mg | 11/6/1992 |
CLOZAPINE TABLET 25 mg | SIN11497P | TABLET | 25 mg | 4/26/2001 | |
CLOZARIL TABLET 25 mg | MADAUS GmbH | SIN07234P | TABLET, FILM COATED | 25 mg | 11/6/1992 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
CLOZAREM 25 TAB 25MG | N/A | N/A | N/A | 12/30/2009 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
CLOZAPINE 100mg tablet bulk (AF) | 81087 | Medicine | A | 11/28/2001 | |
CLOZAPINE MYLAN clozapine 100 mg tablet blister pack | 311904 | Medicine | A | 1/10/2020 | |
AKM CLOZAPINE clozapine 25 mg tablet bottle pack | 311144 | Medicine | A | 9/17/2021 | |
CLOPINE 200 clozapine 200 mg tablet bottle | 95561 | Medicine | A | 10/10/2003 | |
PHARMACOR CLOZAPINE clozapine 25 mg tablet bottle pack | 310800 | Medicine | A | 9/17/2021 | |
CLOPINE 25 clozapine 25 mg tablet blister pack | 67947 | Medicine | A | 10/4/2000 | |
CLOPINE 50 clozapine 50 mg tablet bottle | 95559 | Medicine | A | 10/10/2003 | |
CLOPINE 25 clozapine 25 mg tablet bottle | 93972 | Medicine | A | 4/14/2003 | |
AKM CLOZAPINE clozapine 200 mg tablet blister pack | 311165 | Medicine | A | 9/17/2021 | |
CLOZITOR clozapine 100 mg tablet blister pack | 311161 | Medicine | A | 9/17/2021 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
AA-CLOZAPINE | aa pharma inc | 02458748 | Tablet - Oral | 50 MG | 2/27/2017 |
GEN-CLOZAPINE | Mylan Pharmaceuticals ULC | 02554631 | Tablet (Orally Disintegrating) - Oral | 12.5 MG | 5/29/2025 |
PMS-CLOZAPINE | 02240668 | Tablet - Oral | 25 MG | 3/5/2003 | |
AA-CLOZAPINE | aa pharma inc | 02458756 | Tablet - Oral | 200 MG | 2/27/2017 |
GEN-CLOZAPINE | Mylan Pharmaceuticals ULC | 02305003 | Tablet - Oral | 50 MG | 2/5/2008 |
AURO-CLOZAPINE | auro pharma inc | 02455218 | Tablet - Oral | 200 MG | N/A |
AA-CLOZAPINE | aa pharma inc | 02248035 | Tablet - Oral | 100 MG | 1/27/2004 |
GEN-CLOZAPINE | Mylan Pharmaceuticals ULC | 02305011 | Tablet - Oral | 200 MG | 2/5/2008 |
GEN-CLOZAPINE | Mylan Pharmaceuticals ULC | 02554658 | Tablet (Orally Disintegrating) - Oral | 25 MG | 5/29/2025 |
GEN-CLOZAPINE | Mylan Pharmaceuticals ULC | 02554682 | Tablet (Orally Disintegrating) - Oral | 200 MG | 5/29/2025 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
CLOZAPINA STADA 25 MG COMPRIMIDOS EFG | Laboratorio Stada S.L. | 88017 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
CLOZAPINA STADA 200 MG COMPRIMIDOS | Laboratorio Stada S.L. | 88020 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
LEPONEX 200 MG COMPRIMIDOS | 90232 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
NEMEA 25 MG COMPRIMIDOS BUCODISPERSABLES EFG | Adamed Laboratorios S.L.U. | 83970 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
LEPONEX 25 mg COMPRIMIDOS | 59548 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
ZOLKAR 100 MG COMPRIMIDOS EFG | 85552 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
NEMEA 100 mg COMPRIMIDOS EFG | Adamed Laboratorios S.L.U. | 71566 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
ZOLKAR 25 MG COMPRIMIDOS EFG | 85554 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
CLOZAPINA STADA 50 MG COMPRIMIDOS EFG | Laboratorio Stada S.L. | 88018 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
ZOLKAR 200 MG COMPRIMIDOS | 85553 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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