NDAORALTABLETPriority Review
Approved
Sep 1989
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
CLOZARIL (clozapine) by Charter Medical is unknown. Approved for schizophrenia, schizoaffective disorder, psychotic disorder. First approved in 1989.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CLOZARIL (clozapine) is an oral atypical antipsychotic tablet approved in 1989 for treating severely ill patients with schizophrenia. It works primarily through antagonism of dopamine D2 and serotonin 5-HT2A receptors, with additional activity at adrenergic, cholinergic, and histaminergic receptors. As one of the earliest atypical antipsychotics, it remains a standard treatment option for treatment-resistant schizophrenia, though it has been largely superseded by newer long-acting formulations in the broader antipsychotic market.
$0.0BPart D
Mechanism of Action
unknown. However, it has been proposed that the therapeutic efficacy of clozapine in schizophrenia is mediated through antagonism of the dopamine type 2 (D 2 ) and the serotonin type 2A (5-HT 2A ) receptors. CLOZARIL also acts as an antagonist at adrenergic, cholinergic, histaminergic and other…
Pharmacologic Class:
Atypical Antipsychotic
Indications (3)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.