NDAORALTABLET, ORALLY DISINTEGRATING
Approved
Feb 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
FAZACLO ODT (clozapine) by Jazz Pharmaceuticals is unknown. First approved in 2004.
Drug data last refreshed 5h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FAZACLO ODT is an orally disintegrating tablet formulation of clozapine, a second-generation antipsychotic approved in 2004 for treatment-resistant schizophrenia. The drug works primarily through antagonism of dopamine D2 and serotonin 5-HT2A receptors, with additional activity at adrenergic, cholinergic, and histaminergic receptors. Clozapine remains one of the most efficacious antipsychotics for severe, treatment-resistant psychotic disorders.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team restructuring and shift toward managed care and market access roles.
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. Clozapine also acts as an antagonist at adrenergic, cholinergic, histaminergic and other…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
Started Apr 2024
50 enrolled
SchizophreniaSchizo Affective Disorder
Biomarkers in Clozapine-responding Schizophrenia
Started Feb 2021
200 enrolled
SchizophreniaPsychosis
An Adaptive Phase II/III, Two-Part, Double-Blind, Randomized, Placebo-controlled, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults
Started Mar 2017
287 enrolled
Refractory Schizophrenia
Augmenting Clozapine With Sertindole - SERCLOZ
Started Sep 2006
50 enrolled
Schizophrenia
Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia
Started Sep 2006
106 enrolled
Schizophrenia
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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.