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A phase 3 pivotal study of XEN496, a Kv7 potassium channel modulator for the potential treatment of KCNQ2 epileptic encephalopathy

Trial Profile

A phase 3 pivotal study of XEN496, a Kv7 potassium channel modulator for the potential treatment of KCNQ2 epileptic encephalopathy

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2020

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At a glance

  • Drugs Retigabine (Primary)
  • Indications Epilepsy
  • Focus Registrational; Therapeutic Use
  • Sponsors Xenon Pharmaceuticals
  • Most Recent Events

    • 13 Jan 2020 According to a Xenon Pharmaceuticals media release, after completion of the XEN496 PK study and discussions with the FDA on this Phase 3 clinical trial design in the first quarter of 2020, the company expects to initiate this study.
    • 05 Nov 2019 According to a Xenon Pharmaceuticals media release, the company expects to initiate this trial in 2020.
    • 06 Mar 2019 According to a Xenon Pharmaceuticals media release, the company expects to file an Investigational New Drug (IND) application in the third quarter of 2019, and, based on regulatory feedback, Xenon expects to initiate a Phase 3 clinical trial thereafter. The company is currently finalizing a pediatric-specific formulation to complete pre-clinical formulation testing with a final drug product expected in the second quarter of 2019.
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