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Trileptal®
Oxcarbazepine blocks voltage-gated sodium channels in neuronal membranes, reducing repetitive neuronal firing and stabilizing hyperexcited neural tissue.
Oxcarbazepine blocks voltage-gated sodium channels in neuronal membranes, reducing repetitive neuronal firing and stabilizing hyperexcited neural tissue. Used for Partial-onset seizures (monotherapy and adjunctive therapy in adults and children), Generalized tonic-clonic seizures (adjunctive therapy), Bipolar disorder (off-label use).
At a glance
| Generic name | Trileptal® |
|---|---|
| Sponsor | Teva Pharmaceuticals USA |
| Drug class | Anticonvulsant; sodium channel blocker |
| Target | Voltage-gated sodium channels |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | FDA-approved |
Mechanism of action
Oxcarbazepine is a prodrug that is rapidly metabolized to its active metabolite, 10-monohydroxy derivative (MHD), which inhibits voltage-dependent sodium channels and modulates high-voltage-activated calcium channels. This reduces the propagation of sodium-dependent action potentials in neurons, thereby decreasing seizure activity and abnormal electrical discharges in the brain.
Approved indications
- Partial-onset seizures (monotherapy and adjunctive therapy in adults and children)
- Generalized tonic-clonic seizures (adjunctive therapy)
- Bipolar disorder (off-label use)
Common side effects
- Dizziness
- Somnolence
- Diplopia (double vision)
- Ataxia
- Nausea
- Hyponatremia
- Rash
Key clinical trials
- Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers (PHASE1)
- Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions (PHASE1)
- Oxcarbazepine 600 mg Tablets Under Fasting Conditions (PHASE1)
- Comparison of Two Forms of Oxcarbazepine for the Treatment of Bipolar Depression (PHASE4)
- Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers (PHASE1)
- Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database
- Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5mL Under Fed Condition (NA)
- Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5 mL Under Fasting Conditions (NA)
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 |
|---|---|
| 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:
- Trileptal® CI brief — competitive landscape report
- Trileptal® updates RSS · CI watch RSS
- Teva Pharmaceuticals USA portfolio CI