Gabapentin enacarbil

Drug Profile

Gabapentin enacarbil

Alternative Names: 1838262; ASP8825; Gabapentin-XP; GSK 1838262; Horizant; Regnite; Solzira; XP13512

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator XenoPort
  • Developer Astellas Pharma; GlaxoSmithKline; National Institute on Alcohol Abuse and Alcoholism; XenoPort
  • Class Acetic acids; Antiepileptic drugs; Carbamates; Cyclohexanecarboxylic acids; Small molecules
  • Mechanism of Action CACNA2D1 protein modulators; GABA receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity Yes
  • Available For Licensing Yes - Restless legs syndrome

Highest Development Phases

  • Marketed Postherpetic neuralgia; Restless legs syndrome
  • Phase II Alcoholism
  • Discontinued Diabetic neuropathies; Migraine

Most Recent Events

  • 22 Jan 2016 Phase-I clinical trials in Restless legs syndrome (In adolescents) in USA (PO)
  • 01 Jan 2016 Xenoport initiates enrolment in phase IV trials for Restless legs syndrome in USA (NCT02560766; NCT02633683)
  • 29 Dec 2015 XenoPort plans a pharmacokinetics phase I trial for Restless legs syndrome (In adolescents) in USA (PO) (NCT02633657)
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