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ezogabine

Trade name: potiga

Small moleculeapproved

Approved

Jun 10, 2011

Ezogabine (U.S. adopted name) or retigabine (international nonproprietary name) is one of a family of aminopyrroles with anticonvulsant activity. It is used as an adjunctive treatment for partial epilepsies in treatment-experienced adult patients. The drug was approved by the European Medicines Agency under the trade name Trobalt and by the United States Food and Drug Administration (FDA), under the trade name Potiga. The mechanism by which ezogabine exerts its therapeutic effects has not been fully elucidated. In vitro studies indicate that ezogabine enhances transmembrane potassium currents mediated by the KCNQ (Kv7.2 to 7.5) family of ion channels. By activating KCNQ channels, ezogabine is thought to stabilize the resting membrane potential and reduce brain excitability. This mechanism of action is unique among antiepileptic drugs, and may hold promise for the treatment of other neurologic conditions, including migraine, tinnitus and neuropathic pain. In vitro studies suggest that ezogabine may also exert therapeutic effects through augmentation of GABA-mediated currents. — NCATS

Clinical trial activity

24 trials · 11 clinical orgs · 2 marketing orgs

Phase 1
5
Phase 2
17
Phase 3
12
Phase 4
2

Earliest trial started Sep 1, 2005 (NCT00232596)

Timeline

2000s

  1. Jan 1, 2005

    GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2007

    Bausch Health Companies — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2011

    GlaxoSmithKline — Earliest Phase 1 Sponsor(trial)

  2. Jun 10, 2011

    Bausch Health Companies — Earliest FDA Approval

  3. Jun 10, 2011

    GlaxoSmithKline — NDA Secondary Org

  4. Jun 10, 2011

    Bausch Health Companies — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 10, 2011

Chemistry & pharmacology

Loading structure…

SMILES

CCOC(=O)NC1=CC=C(NCC2=CC=C(F)C=C2)C=C1N
Mol. weight
303.3314 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Black box warningFirst in class

Sources

Also known as

  • awd-21360
  • awd-21360
  • d 20443
  • d-20443
  • d-20443
  • d-20443
  • d-20443
  • d-20443
  • d-20443
  • d 23129
  • d-23129
  • d-23129
  • d-23129
  • ethyl {2-amino-4-[(4-fluorobenzyl)amino]phenyl}carbamate
  • ethyl {2-amino-4-[(4-fluorobenzyl)amino]phenyl}carbamate
  • ethyl 2-amino-4-((p-fluorobenzyl)amino)carbanilate
  • ethyl 2-amino-4-((p-fluorobenzyl)amino)carbanilate
  • ethyl n-(2-amino-4-(4-fluorobenzylamino)phenyl)carbamate hydrochloride
  • ezg
  • ezg
  • ezogabine
  • ezogabine
  • ezogabine
  • ezogabine
  • ezogabine
  • ezogabine
  • ezogabine
  • ezogabine
  • gke-841
  • gke-841
  • gw582892x
  • gw582892x
  • gw 582892x
  • ke 841
  • n-(2-amino-4-(4-fluorobenzylamino)-phenyl) carbamic acid ethyl ester
  • n-(2-amino-4-(4-fluorobenzylamino)-phenyl) carbamic acid ethyl ester
  • n-(2-amino-4-(4-fluorobenzylamino)phenyl)carbamic acid ethyl ester
  • n-(2-amino-4-(4-fluorobenzylamino)phenyl)carbamic acid ethyl ester
  • n-(2-amino-4-(4-fluorobenzylamino)phenyl)carbamic acid ethyl ester
  • potiga
  • potiga
  • potiga
  • potiga
  • retigabine
  • retigabine
  • retigabine
  • retigabine
  • retigabine
  • retigabine
  • retigabine
  • retigabine
  • rtg
  • rtg
  • trobalt
  • trobalt
  • trobalt
  • trobalt
  • way 143841
  • way-143841
  • way-143841

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04912856Phase 3Aug 17, 2021Xenon Pharmaceuticals Inc.
NCT04639310Phase 3Dec 31, 2020Xenon Pharmaceuticals Inc.
NCT03043560Phase 2Jun 1, 2017Baylor University, Icahn School of Medicine at Mount Sinai, National Institute of Mental Health (NIMH)
NCT02450552Phase 2Jun 1, 2015ALS Association, GlaxoSmithKline, Harvard University
NCT02149836Phase 2Aug 1, 2014Icahn School of Medicine at Mount Sinai
NCT01777139Phase 3Apr 1, 2013GlaxoSmithKline
NCT01823159Phase 3Apr 1, 2013CHU Mont-Godinne, GlaxoSmithKline, Université catholique de Louvain
NCT01607346Phase 4Mar 27, 2013GlaxoSmithKline
NCT01721317Phase 4Dec 1, 2012Bausch Health Companies, GlaxoSmithKline
NCT01691872Phase 1Oct 1, 2012GlaxoSmithKline
NCT01668654Phase 3Sep 1, 2012Bausch Health Companies, GlaxoSmithKline
NCT01648101Phase 3Aug 1, 2012GlaxoSmithKline
NCT01494584Phase 2Jul 25, 2012Bausch Health Companies, GlaxoSmithKline
NCT01462669Phase 1Apr 10, 2012GlaxoSmithKline
NCT01583036Phase 1Jan 16, 2012GlaxoSmithKline
NCT01480609Phase 1Nov 1, 2011GlaxoSmithKline
NCT01336621Phase 3Feb 1, 2011GlaxoSmithKline
NCT01332513Phase 1Feb 1, 2011GlaxoSmithKline
NCT01227902Phase 3Jul 1, 2010GlaxoSmithKline
NCT00612105Phase 2Oct 1, 2007Bausch Health Companies, Sponsor GmbH
Showing 20 of 24 trials
Page 1 / 2

Organizations

Research & Development (11)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit191742005
Bausch Health CompaniesFor profit6132005
Icahn School of Medicine at Mount SinaiAcademic/Hospital2212014
Xenon Pharmaceuticals Inc.For profit2212020
ALS AssociationAcademic/Hospital1012015
Baylor UniversityAcademic/Hospital1012017
CHU Mont-GodinneAcademic/Hospital1112013
Harvard UniversityAcademic/Hospital1112015
National Institute of Mental Health (NIMH)Government1012017
Sponsor GmbHAcademic/Hospital1012007
Université catholique de LouvainAcademic/Hospital1012013
11 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
Bausch Health CompaniesFor profitNDAJun 10, 2011
GlaxoSmithKlineFor profitNDA2Jun 10, 2011