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
2025/05/14
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
2020/10/08
Phase 4
Recruiting

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
Clozapine Tablets
国药准字H35020914
化学药品
片剂
4/7/2020
Clozapine Tablets
国药准字H32024027
化学药品
片剂
8/17/2020
Clozapine Tablets
国药准字H11020846
化学药品
片剂
6/1/2020
Clozapine Tablets
国药准字H50021493
化学药品
片剂
8/3/2020
Clozapine Tablets
国药准字H41025349
化学药品
片剂
8/4/2020
Clozapine Tablets
国药准字H44021538
化学药品
片剂
4/27/2020
Clozapine Tablets
国药准字H22022677
化学药品
片剂
3/18/2020
Clozapine Tablets
国药准字H33021307
化学药品
片剂
6/12/2020
Clozapine Tablets
国药准字H44021433
化学药品
片剂
10/10/2024
Clozapine Tablets
国药准字H44023042
化学药品
片剂
8/24/2020

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

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.