NDAORALFILM
Approved
Nov 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
5/8 — Partial
SYMPAZAN (clobazam) by Teva is cytochrome p450 2d6 inhibitors [moa]. First approved in 2018.
Drug data last refreshed 3h ago · AI intelligence enriched 3h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYMPAZAN (clobazam) is an oral benzodiazepine film formulation that works as a cytochrome P450 2D6 inhibitor. It is indicated for adjunctive treatment of seizures, primarily in patients with Lennox-Gastaut syndrome and other refractory epilepsy conditions. The drug modulates GABAergic neurotransmission to reduce seizure frequency.
$0.003BPart D
Peak13.4 years to LOEProduct is at peak commercial maturity with modest Part D penetration, suggesting stable but specialized market reach with lean commercial infrastructure.
Mechanism of Action
Cytochrome P450 2D6 Inhibitors
Pharmacologic Class:
Benzodiazepine
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol
Started Mar 2016
18 enrolled
Epilepsy
A Randomized Controlled Trial to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol
Started Jan 2016
20 enrolled
Epilepsy
Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
Started Mar 2015
3 enrolled
Dravet Syndrome
Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
Started Mar 2015
0Dravet Syndrome
Clobazam Adjunctive Treatment of Adults With Refractory Focal Epilepsy
Started Feb 2015
20 enrolled
Epilepsy
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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.