Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Oxcarbazepine · 1 trial · 1 indication
Measured as change from baseline to end of study
| Arm | Type | Description |
|---|---|---|
| Oxcarbazepine XR | OTHER | Open Label Study |
| Name | Type | Description |
|---|---|---|
| Oxcarbazepine XR | DRUG | Open Label Study |
Inclusion Criteria 1. Able to provide written informed consent and agree to comply with study procedures. 2. Male or female aged 18 to 66 years, inclusive. 3. Successful completion of the 804P301 study. 4. Sexually active women, unless surgically sterile (at least 6 months prior to Study Medication...
Oxcarbazepine is an investigational small molecule being developed as an adjunctive therapy for patients with refractory partial epilepsy. It is designed for use in adults aged 18 years and older. The drug is currently in Phase 3 clinical development and has not been approved by the FDA.
Oxcarbazepine is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SUPN. The company is conducting clinical trials to evaluate the safety and tolerability of this drug as an add-on treatment for partial epilepsy.
Oxcarbazepine is in Phase 3 clinical development. A Phase 3 trial has been completed to assess its safety and tolerability as adjunctive therapy in subjects with refractory partial epilepsy. The drug remains investigational and is not yet approved for commercial use.
Oxcarbazepine has one completed Phase 3 clinical trial, registered as NCT00908349. The study evaluated the safety and tolerability of OXC XR as adjunctive therapy in 214 subjects with refractory partial epilepsy. The trial was conducted across multiple countries, including the United States, Bulgaria, Canada, Croatia, Mexico, Poland, Romania, and Russia.
Oxcarbazepine is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the treatment of partial epilepsy. A completed Phase 3 trial has evaluated its safety and tolerability, but the drug has not yet received regulatory approval.