Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XEN1101 · 6 trials · 5 indications
To assess the safety and tolerability of XEN1101
Median percent change (MPC) in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo.
Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo
| Arm | Type | Description |
|---|---|---|
| XEN1101 25 mg/day | EXPERIMENTAL | XEN1101 25 mg/day |
| XEN1101 15 mg/day | EXPERIMENTAL | XEN1101 15 mg/day |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| XEN1101 15 or 25 mg/day | EXPERIMENTAL | XEN1101 15 or 25 mg/day |
| XEN1101 10 mg | EXPERIMENTAL | During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 10 mg, orally with food, per day |
| XEN1101 20 mg | EXPERIMENTAL | During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 20 mg, orally with food, per day |
| 25 mg XEN1101 | EXPERIMENTAL | Capsule filled with 25 mg XEN1101 |
| 20 mg XEN1101 | EXPERIMENTAL | Capsule filled with 20 mg XEN1101 |
| 10 mg XEN1101 | EXPERIMENTAL | Capsule filled with 10 mg XEN1101 |
| Name | Type | Description |
|---|---|---|
| XEN1101 | DRUG | XEN1101 Capsules |
| Placebo | DRUG | Placebo Capsules |
| XEN1101 10 mg | DRUG | XEN1101 oral capsule |
| XEN1101 20 mg | DRUG | XEN1101 oral capsule |
Inclusion Criteria: * Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study * Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must ha...
XEN1101 is an investigational small molecule being developed for focal epilepsy, focal onset seizures, primary generalized tonic-clonic seizures, and major depressive disorder. It is in Phase 3 clinical development and is not yet approved for any indication.
XEN1101 targets Kv7 potassium channels. By modulating these channels, it is designed to regulate neuronal excitability, which is the basis for its development in seizure disorders and major depressive disorder.
XEN1101 is being developed by Xenon Pharmaceuticals Inc., which trades on the Nasdaq under the ticker XENE. The company is running multiple Phase 3 trials of XEN1101 in epilepsy indications.
XEN1101 is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 program includes completed and ongoing trials in focal onset seizures and primary generalized tonic-clonic seizures.
XEN1101 is being studied in several Phase 3 trials, including NCT05718817 (open-label epilepsy study), NCT05716100 (X-TOLE3 in focal-onset seizures), NCT05667142 (adjunctive therapy in primary generalized tonic-clonic seizures), and NCT05614063 (completed focal-onset seizures study). Total enrollment across these trials is approximately 1,205 participants.