A phase 3 pivotal study of XEN496, a Kv7 potassium channel modulator for the potential treatment of KCNQ2 epileptic encephalopathy
Phase of Trial: Phase III
Latest Information Update: 05 Nov 2019
Price : $35 *
At a glance
- Drugs Retigabine (Primary)
- Indications Epilepsy
- Focus Registrational; Therapeutic Use
- Sponsors Xenon Pharmaceuticals
- 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.
- 06 Mar 2019 According to a Xenon Pharmaceuticals media release, In response to Xenon's pre-IND briefing package submission, the FDA indicated that it was acceptable to study XEN496 in infants and children up to 4 years old, and that a single pivotal trial in approximately 20 patients may be considered adequate in order to demonstrate XEN496's efficacy in KCNQ2-EE.