OXTELLAR XR (oxcarbazepine)
OXTELLAR XR is indicated for the treatment of Partial-Onset Seizures.
How OXTELLAR XR Works
The pharmacological activity of this drug 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, which helps prevent the spread of synaptic impulses. Additionally, the drug may contribute to anticonvulsant effects by increasing potassium conductance and modulating high-voltage activated calcium channels.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-10-19
- Patent Cliff
- 2027
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
OXTELLAR XR Approval History
What OXTELLAR XR Treats
1 indicationsOXTELLAR XR is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Partial-Onset Seizures
OXTELLAR XR 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.
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 OXTELLAR XR
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.
OXTELLAR XR FDA Label Details
Indications & Usage
FDA Label (PDF)OXTELLAR XR is indicated for the treatment of Partial-Onset Seizures.
OXTELLAR XR Patents & Exclusivity
Patents (11 active)
Pro Intelligence Preview
Deep insights for OXTELLAR XR
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 99 active patents
Trial Analysis
- • 15 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment