Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XEN901 · 1 trial · 1 indication
To assess AEs as a criteria of safety and tolerability
To assess 12-lead ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability
To assess vital signs as a criteria of safety and tolerability
| Arm | Type | Description |
|---|---|---|
| XEN901 | EXPERIMENTAL | Single ascending dose: Single oral dose for each cohort; Multiple ascending dose: 7 days of single oral dose twice daily for each cohort |
| Placebo | PLACEBO_COMPARATOR | Single Ascending Dose: Single oral dose for each cohort; Multiple Ascending Dose: 7 days of single oral dose twice daily for each cohort |
| Name | Type | Description |
|---|---|---|
| XEN901 | DRUG | Capsule filled with XEN901 |
| Inert Ingredients Oral Product | DRUG | Placebo capsule |
Key Inclusion Criteria: * Healthy male or females aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.5 and 32.0 kg/m2 * Must agree to use effective methods of contraception, if applicable * Able to swallow capsules * Able to provide written, personally signed and dated I...
XEN901 is an investigational small molecule drug being developed by Xenon Pharmaceuticals Inc. (ticker: XENE). It is a sodium channel targeting compound that has completed a Phase 1 clinical trial in healthy volunteers. The specific therapeutic indications for XEN901 have not been disclosed.
XEN901 targets the Nav1.6 sodium channel. Nav1.6 is a voltage-gated sodium channel subtype that plays a key role in neuronal excitability. By targeting Nav1.6, XEN901 is designed to modulate sodium channel activity, though its exact clinical applications are still under investigation.
XEN901 is being developed by Xenon Pharmaceuticals Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol XENE. Xenon focuses on developing therapies for neurological disorders, and XEN901 is part of its pipeline of sodium channel targeting compounds.
XEN901 has completed a Phase 1 clinical trial. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Further clinical development may be ongoing or planned, but no later-phase trials have been registered.
XEN901 has been evaluated in one completed Phase 1 clinical trial, NCT03467100. This trial was a randomized, double-blind, placebo-controlled study of single and multiple ascending oral doses of XEN901 in 70 healthy volunteers in the United Kingdom. It assessed safety, tolerability, and pharmacokinetics.