Clozapine: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Clozapine appears in the FDA drug-label database. Marketed as Clozapine.
- Drug class
- Atypical Antipsychotic (FDA established pharmacologic class)
- Boxed warning
- The FDA label for Clozapine carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 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 ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment ( 1.1 ) 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 ( 1.2 ) 1.1 Treatment-resistant Schizophrenia Clozapine Orally Disintegrating Tablets (Clozapine ODT) are 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 their use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment [see Warnings and Precautions (5.1 , 5.4) ]. The effectiveness of Clozapine ODT in treatment-resistant schizophrenia was demonstrated…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg. — Aurobindo Pharma USA Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2020-06-12 |
| Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing. — Teva Pharmaceuticals USA | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2018-09-21 |
Phase breakdown
Conditions being studied
Recruiting trials involving Clozapine
- Biomarkers in Clozapine-responding Schizophrenia
- Biomarkers to Enhance Early Schizophrenia Treatment
- CLOZAPINE Response in Biotype-1
- Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
- Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
- Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia
- 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.
Common questions
Is Clozapine FDA-approved?
Yes, marketed as Clozapine. Its FDA label carries a boxed warning.
How many recruiting trials involve Clozapine?
7 recruiting trials across 11 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.