TRILEPTAL
Trileptal (oxcarbazepine) is an anti-epileptic agent indicated for the treatment of partial-onset seizures. It is approved for use in adults as both a monotherapy and an adjunctive therapy. In pediatric populations, the drug is utilized as monotherapy for patients aged 4 to 16 years and as adjunctive therapy for patients aged 2 to 16 years.
How TRILEPTAL Works
The pharmacological activity of Trileptal is primarily exerted through its 10-monohydroxy metabolite (MHD), which blocks voltage-sensitive sodium channels. This action stabilizes hyperexcited neural membranes and inhibits repetitive neuronal firing, thereby reducing the propagation of synaptic impulses and preventing the spread of seizures. The drug may also contribute to anticonvulsant effects by increasing potassium conductance and modulating high-voltage activated calcium channels.
Details
- Status
- Prescription
- First Approved
- 2000-01-14
- Routes
- ORAL
- Dosage Forms
- TABLET, SUSPENSION
TRILEPTAL Approval History
What TRILEPTAL Treats
1 indicationsTRILEPTAL is approved for 1 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Partial-Onset Seizures
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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.
TRILEPTAL FDA Label Details
ProIndications & Usage
FDA Label (PDF)TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. TRILEPTAL is indicated for: Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4-16 years - Adjunctive therapy in the treatment of partial-onset seizures in...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.