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Banzel (RUFINAMIDE)
Banzel works by stabilizing inactivated sodium channels in the brain, reducing the frequency of seizures.
Banzel (Rufinamide) is a small molecule drug developed by Eisai Inc, targeting carbonic anhydrase 5A, mitochondrial. It is a rufinamide class medication, FDA-approved in 2008 for the treatment of Lennox-Gastaut syndrome. Banzel is available as a generic medication, with 11 generic manufacturers, and is no longer under patent protection. As a commercial product, it is widely available in the market. Key safety considerations include its bioavailability of 85%.
At a glance
| Generic name | RUFINAMIDE |
|---|---|
| Sponsor | Eisai |
| Drug class | rufinamide |
| Target | Carbonic anhydrase 5A, mitochondrial |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2008 |
Mechanism of action
The precise mechanism(s) by which rufinamide exerts its antiepileptic effect is unknown.The results of in vitro studies suggest that the principal mechanism of action of rufinamide is modulation of the activity of sodium channels and, in particular, prolongation of the inactive state of the channel. Rufinamide (>= uM) significantly slowed sodium channel recovery from inactivation after prolonged prepulse in cultured cortical neurons, and limited sustained repetitive firing of sodium-dependent action potentials (EC 50 of 3.8 uM).
Approved indications
- Seizures associated with Lennox-Gastaut Syndrome
Common side effects
- Somnolence
- Convulsion
- Fatigue
- Dizziness
- Headache
- Nausea
- Vomiting
- Diplopia
- Vision Blurred
- Ataxia
- Tremor
- Nystagmus
Drug interactions
- desogestrel
- valproic acid
Key clinical trials
- Population Pharmacokinetics of Antiepileptic in Pediatrics
- An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303
- Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects (PHASE1)
- Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome
- Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures (PHASE3)
- Safety Study of Rufinamide Given as an add-on Therapy to Treat Patients With Seizures (PHASE3)
- Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures (PHASE3)
- 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 (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Banzel CI brief — competitive landscape report
- Banzel updates RSS · CI watch RSS
- Eisai portfolio CI