TRILEPTAL (oxcarbazepine)
TRILEPTAL is indicated for the treatment of Partial-Onset Seizures.
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
TRILEPTAL 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 TRILEPTAL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02219373 | P00008001 | Ph 3 | not yet recruiting | Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Clinical Effectiveness Study |
| NCT06849219 | NO.F.2-81/2024-GENL/77/JPMC | Ph 4 | active not recruiting | Comparison of Oxcarbazepine Versus Carbamazepine in the Management of Trigeminal Neuralgia |
| NCT03695094 results posted | UP0070 2018-001941-16 | Ph 1 | completed | A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil |
| NCT01051193 | CTRI476B1301E1 | Ph 2, Ph 3 | completed | Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures |
| NCT02456896 results posted | T/IM-NF/Pharm/14/19 | Ph 4 | completed | Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder |
| NCT02104661 PROXIMUS | 8722 2013-002419-87, 14-LO-0185 | Ph 2 | completed | Protective Role of Oxcarbazepine in Multiple Sclerosis |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01702623 | OXCA-S600-PVFS-2 | Ph 1 | completed | Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions |
| NCT01703468 | OXCA-S600-PVFD-2 | Ph 1 | completed | Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions |
| NCT01891890 COPE results posted | IRB00066541 PCORI 527 | Ph 3 | terminated | Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE) |
| NCT02705768 | T/IM -NF/Pharm/15/30 | Ph 4 | completed | Effect of Carbamazepine and Oxcarbazepine on Serum Neuron-specific Enolase and S100B in Focal Seizures |
| NCT02078089 | IUCRO-0453 | Ph 1 | terminated | Oxcarbazepine Plus Morphine in Patients With Refractory Cancer Pain |
| NCT01498822 OPTIMAL results posted | N01367 2014-002713-32 | Ph 4 | completed | Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy |
| NCT00900237 results posted | BIA-2093-127 | Ph 1 | completed | Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine |
| NCT01302275 IMIOXC | IMIOXC | Ph 4 | completed | Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain |
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
Indications & Usage
FDA Label (PDF)TRILEPTAL is indicated for the treatment of Partial-Onset Seizures.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.