Drugs / Ezogabine
Ezogabine
also known as
retigabine · GW582892 · XEN496 · AWD-21360 · D-23129 · EZG · Ezogabine/retigabine · GKE-841 · +6 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Trobalt | — | 2018-07-19 | europa.eu ↗ |
| Approved | US (FDA) | POTIGA | — | 2011-06-10 | fda.gov ↗ |
| Approved | EU (EMA) | Trobalt | — | 2011-03-27 | europa.eu ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT01691872 | Oct 2012 | focal epilepsy | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT01462669 | Apr → Jun 2012 | epilepsy | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01583036 | Jan → Apr 2012 | epilepsy | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01332513 | Feb → May 2011 | epilepsy | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary · 2 missed | ||||||
| Phase 2 | NCT03043560 | Sep 2017 → Aug 2019 | atypical depressive disorder, depressive disorder | James Murrough | Completed | Missed primary |
| Phase 2 | NCT02450552 | Jun 2015 → Jan 2018 | amyotrophic lateral sclerosis | Brian Wainger | Completed | Met primary |
| Phase 2 | NCT02149836 | Aug 2014 → Dec 2016 | major depressive disorder | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 2 | NCT01494584 | Jul 2012 → Apr 2013 | epilepsy | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT00612105 | Oct 2007 → May 2009 | postherpetic neuralgia | Bausch Health Americas, Inc. | Completed | Missed primary |
| Phase 310 trials · 2 met primary | ||||||
| Phase 3 | NCT04912856 | Aug 2021 → Nov 2023 | epilepsy syndrome | Xenon Pharmaceuticals Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04639310 | Mar 2021 → May 2023 | epilepsy syndrome | Xenon Pharmaceuticals Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01777139 | Apr 2013 → Dec 2016 | epilepsy | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01668654 | Sep 2012 → Jun 2013 | epilepsy | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 3 | NCT01648101 | Aug 2012 → Dec 2013 | epilepsy | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 3 | NCT01227902 | Jul 2010 → Dec 2012 | epilepsy | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00310388 | Jul 2006 → Apr 2017 | epilepsy | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 3 | NCT00310375 | May 2006 → Nov 2016 | epilepsy | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00235755 | Dec 2005 → Apr 2008 | epilepsy | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00232596 | Sep 2005 → Jan 2008 | epilepsy | GlaxoSmithKline | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT01607346 | Mar 2013 → Nov 2016 | epilepsy | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 4 | NCT01721317 | Dec 2012 → Jun 2013 | epilepsy | GlaxoSmithKline | Terminated | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT01480609 Comparator | Nov 2011 → Apr 2012 | epilepsy | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01823159 Comparator | Apr → Dec 2013 | epilepsy | University Hospital of Mont-Godinne | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2020-10-08 | Xenon Pharmaceuticals Inc. | Regulatory Xenon Pharmaceuticals Receives FDA Feedback and is on Track to Initiate XEN496 Phase 3 Clinical Trial for the Treatment of KCNQ2-DEE Before Year-End xenon-pharma.com ↗
In addition, Xenon has received a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), which recommends the granting of an orphan medicinal product designation for XEN496 for the treatment of KCNQ2-DEE. |
| 2020-08-06 | Xenon Pharmaceuticals Inc. | Regulatory Xenon Pharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Corporate Update xenon-pharma.com ↗
XEN496 Phase 3 Protocol Submitted to FDA and Trial Initiation Anticipated in 2020 |
| 2011-06-13 | GlaxoSmithKline | Regulatory GlaxoSmithKline and Valeant announce US FDA approval of Potiga™ (ezogabine) gsk.com ↗
GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) announced today that the U.S. Food and Drug Administration (FDA) has approved Potiga™ (ezogabine) Tablets, a potassium channel opener, as adjunctive treatment of partial-onset seizures in patients aged 18 years and older. |
| 2011-04-18 | GlaxoSmithKline | Regulatory Regulatory update – GSK and Valeant respond to FDA on ezogabine gsk.com ↗
GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) submitted on 15 April 2011 the response to the U.S. Food and Drug Administration (FDA) Complete Response letter received on 30 November 2010 for the New Drug Application (NDA) for ezogabine*. |
| 2011-03-29 | GlaxoSmithKline | Regulatory GSK and Valeant receive European authorisation for Trobalt (retigabine) gsk.com ↗
This European authorisation represents the first licence for retigabine. |
| 2011-01-21 | GlaxoSmithKline | Regulatory Regulatory update - GSK and Valeant receive positive opinion in Europe from the CHMP for Trobalt (retigabine) gsk.com ↗ |
| 2010-11-30 | GlaxoSmithKline | Regulatory GSK and Valeant announce receipt of U.S. FDA Complete Response letter for ezogabine gsk.com ↗ |
| 2010-08-29 | GlaxoSmithKline | Regulatory GSK and Valeant announce new U.S. FDA PDUFA goal date for ezogabine gsk.com ↗
GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International (NYSE: VRX) announced today the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for ezogabine* to 30 November 2010. |
| 2009-11-02 | GlaxoSmithKline | Regulatory Retigabine Regulatory Update gsk.com ↗ |
All press releases naming this drug 11 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ezogabine | “We assessed the efficacy and tolerability of retigabine (RTG; international non-proprietary name)/ezogabine (EZG; US adopted name) as adjunctive therapy in adults with...” PMID 22512894 ↗ Apr 201211“Ezogabine MR1 at a dose strength of 300 mg will be orally administered with approximately 250 milliliter (mL) of water to group A subjects during the bioavailability phase.” NCT01332513 ↗ “retigabine/ezogabine will be administered three times a day (TID) as add-on therapy based on weight” NCT01668654 ↗ “Retigabine / Ezogabine will be available as immediate release tablets of 50 milligrams strength.” NCT01480609 ↗ “Retigabine (INN), Ezogabine (USAN)” NCT00310388 ↗ |
| Known as | AWD-21360 | ChEMBL registry synonym — accepted as the source's own label CHEMBL41355 ↗ |
| Known as | D-23129 | ChEMBL registry synonym — accepted as the source's own label CHEMBL41355 ↗ |
| Known as | EZG | “We assessed the efficacy and tolerability of retigabine (RTG; international non-proprietary name)/ezogabine (EZG; US adopted name) as adjunctive therapy in adults with...” PMID 22512894 ↗ Apr 2012 |
| Known as | Ezogabine/retigabine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01462669 ↗ |
| Known as | GKE-841 | ChEMBL registry synonym — accepted as the source's own label CHEMBL41355 ↗ |
| Known as | GW-582892X | ChEMBL registry synonym — accepted as the source's own label CHEMBL41355 ↗ |
| Known as | GW582892 | “This is a Phase IV adjunctive treatment dose-optimization study evaluating the efficacy, safety, and health outcomes of ezogabine/retigabine immediate release (IR) (GW582892)...” NCT01721317 ↗1“This is a Phase III study evaluating the efficacy, safety and tolerability, and health outcomes of 2 doses of retigabine immediate release (IR) (GW582892) compared with placebo...” NCT01648101 ↗ |
| Known as | Potiga | ChEMBL registry synonym — accepted as the source's own label CHEMBL41355 ↗ |
| Known as | Retigabina | ChEMBL registry synonym — accepted as the source's own label CHEMBL41355 ↗ |
| Known as | retigabine | “This is a multicentre, open label study to examine the effect of ezogabine/retigabine on the voiding function of adult subjects with drug-resistant partial onset seizures (POS).” NCT01607346 ↗15“Ezogabine: USAN Retigabine (International Nonproprietary Name)” NCT00310375 ↗ “Ezogabine/Retigabine IR” NCT01721317 ↗ “Ezogabine/Retigabine” NCT01494584 ↗ |
| Known as | RTG | “We assessed the efficacy and tolerability of retigabine (RTG; international non-proprietary name)/ezogabine (EZG; US adopted name) as adjunctive therapy in adults with...” PMID 22512894 ↗ Apr 2012 |
| Known as | Trobalt | ChEMBL registry synonym — accepted as the source's own label CHEMBL41355 ↗ |
| Known as | WAY-143841 | ChEMBL registry synonym — accepted as the source's own label CHEMBL41355 ↗ |
| Known as | XEN496 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04639310 ↗ |
| Action | Activate | “enhancement of GABA-A activity” NCT01823159 ↗ |
| Modality | Small molecule | — CHEMBL41355 ↗ |
| Route | Oral | “administered orally” NCT00232596 ↗ |