Ezogabine

Overview

Ezogabine (D23129) is a close structural analog of the centrally acting analgesic flupitrine. It is a neuronal potassium channel opener being developed as a first-in-class antiepileptic drug (AED) and is currently being studied in Phase 3 trials as an adjunctive treatment for partial-onset seizures in adult patients with refractory epilepsy. FDA approved in June 10, 2011 under the name of ezogabine.

Indication

Adjuvant treatment of partial-onset seizures.

Associated Conditions

Refractory Partial Onset Seizures

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE	2021/06/03	NCT04912856	Phase 3	Terminated	Xenon Pharmaceuticals Inc.
XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy	2020/11/20	NCT04639310	Phase 3	Terminated	Xenon Pharmaceuticals Inc.
Study to Treat Major Depressive Disorder With a New Medication	2017/02/06	NCT03043560	Phase 2	Completed	James Murrough
Clinical Trial of Ezogabine (Retigabine) in ALS Subjects	2015/05/21	NCT02450552	Phase 2	Completed	Brian Wainger
Study to Treat Major Depressive Disorder (MDD) With a New Medication	2014/05/29	NCT02149836	Phase 2	Completed	Icahn School of Medicine at Mount Sinai
Cortical Excitability Changes Induced by Retigabine: a Transcranial Magnetic Stimulation Study	2013/04/04	NCT01823159	Phase 3	Completed	University Hospital of Mont-Godinne
A Long-term, Safety, Tolerability, and Efficacy Study of Retigabine Immediate-release (IR) in Asian Adults With Partial Onset Seizures	2013/01/28	NCT01777139	Phase 3	Completed	GlaxoSmithKline
Pharmacokinetic Study of Retigabine Extended Release (XR) Formulation in Healthy Adult Japanese and Caucasian Subjects	2012/09/25	NCT01691872	Phase 1	Withdrawn	GlaxoSmithKline
Assessment of the Efficacy and Safety of 2 Doses of Retigabine Immediate Release (900 mg/Day and 600 mg/Day) Used as Adjunctive Therapy in Adult Asian Subjects With Drug-resistant Partial-onset Seizures	2012/07/24	NCT01648101	Phase 3	Terminated	GlaxoSmithKline
Effect of Haemodialysis on the Pharmacokinetics of Ezogabine/Retigabine and Its N-acetyl Metabolite	2011/11/29	NCT01480609	Phase 1	Completed	GlaxoSmithKline

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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