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 being developed by Xenon Pharmaceuticals Inc. It is currently in Phase 1 clinical development. The drug has been studied in a completed trial involving healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics.
XEN901 is being studied for use in healthy volunteers. The completed Phase 1 trial assessed the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of the drug. Its use in specific disease conditions has not been established.
XEN901 is being developed by Xenon Pharmaceuticals Inc., a company publicly traded under the ticker symbol XENE. The company conducted a Phase 1 clinical trial of XEN901 in healthy volunteers in the United Kingdom.
XEN901 is in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 70 healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
XEN901 has one completed clinical trial, identified as NCT03467100. This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of XEN901 in 70 healthy volunteers in the United Kingdom.
XEN901 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy volunteers. Further clinical development and regulatory review would be required before any approval could be considered.