RUFINAMIDE
Rufinamide is an antiepileptic medication indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome. The drug is approved for use in adult patients and pediatric patients aged one year and older. It serves as a supplemental therapeutic option for managing the complex seizure patterns characteristic of this specific epilepsy syndrome.
How RUFINAMIDE Works
The exact mechanism by which rufinamide produces its antiepileptic effect is unknown, though research suggests it primarily modulates sodium channel activity. The drug works by prolonging the inactive state of these channels and slowing their recovery time. This process limits the sustained, repetitive firing of sodium-dependent action potentials in the brain, which helps control seizure activity.
Details
- Status
- Prescription
- First Approved
- 2016-05-16
- Routes
- ORAL
- Dosage Forms
- TABLET, SUSPENSION
Companies
RUFINAMIDE Approval History
What RUFINAMIDE Treats
2 indicationsRUFINAMIDE is approved for 2 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Lennox-Gastaut Syndrome
- Seizures
RUFINAMIDE 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 RUFINAMIDE
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.
RUFINAMIDE FDA Label Details
Indications & Usage
FDA Label (PDF)RUFINAMIDE is indicated for the treatment of Lennox-Gastaut Syndrome; Seizures.
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BANZEL
Full clinical data, patents, trials, and competitive landscape for rufinamide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.