MedPath

Clozapine

Generic Name
Clozapine
Brand Names
Clozaril, Fazaclo, Versacloz
Drug Type
Small Molecule
Chemical Formula
C18H19ClN4
CAS Number
5786-21-0
Unique Ingredient Identifier
J60AR2IKIC

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

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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