BANZEL (rufinamide)
Banzel (rufinamide) is an antiepileptic medication indicated for the adjunctive treatment of seizures. It is used specifically for patients diagnosed with Lennox-Gastaut Syndrome, a severe form of epilepsy. The medication is approved for use in adults as well as pediatric patients one year of age and older.
How BANZEL Works
The precise mechanism by which rufinamide exerts its antiepileptic effect is unknown. Research suggests the drug functions by modulating sodium channel activity, specifically by prolonging the inactive state of the channel. This action slows the recovery of sodium channels and limits the sustained repetitive firing of action potentials in the neurons.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2008-11-14
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, TABLET
BANZEL Approval History
What BANZEL Treats
2 indicationsBANZEL is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Lennox-Gastaut Syndrome
- Seizures
BANZEL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to BANZEL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06740825 | AC220-164 | Ph 1 | completed | Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects |
| NCT01405053 results posted | E2080-G000-303 | Ph 3 | completed | 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 |
| NCT01151540 results posted | E2080-J081-305 | Ph 3 | completed | A Long Term Extension Study of E2080 in Lennox-Gastaut Patients |
| NCT02095899 RUFPTPS | 2013-253 | Ph 2 | withdrawn | Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome |
| NCT02332174 | TJXH-Rufi | Ph 1 | completed | Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BANZEL FDA Label Details
Indications & Usage
FDA Label (PDF)BANZEL is indicated for the treatment of Lennox-Gastaut Syndrome; Seizures.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment