NDAORALSUSPENSION4 Generics Approved
Approved
Mar 2011
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
7
Data completeness
4/8 — Partial
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BANZEL (rufinamide) is an oral anticonvulsant small molecule approved in 2011 for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, a severe childhood epilepsy. The mechanism of action stabilizes the inactivated state of sodium channels, reducing repetitive neuronal firing. It is formulated as a suspension for pediatric administration.
$22MPart D
LOE ApproachingProduct is approaching loss of exclusivity with modest Part D spending of $22M and only 4,446 annual claims, indicating a niche indication with stable but limited commercial opportunity.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects
Started Oct 2024
32 enrolled
Healthy Subjects
Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects
Started Mar 2014
40 enrolled
Seizures
Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs
Started Jun 2011
37 enrolled
Lennox-Gastaut Syndrome
Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)
Started Mar 2008
239 enrolled
Generalized Anxiety Disorder
Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
Started Mar 2007
286 enrolled
Refractory Partial Onset Seizures
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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.