Deutetrabenazine

Drug Profile

Deutetrabenazine

Alternative Names: Austedo; d6-tetrabenazine; Deuterium-substituted tetrabenazine; Dutetrabenazine; SD-809; SD-809 ER; SD-809 Extended Release

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Auspex Pharmaceuticals
  • Developer Auspex Pharmaceuticals; Teva Pharmaceutical Industries
  • Class Antipsychotics; Neuroprotectants; Organic deuterium compounds; Quinolizines; Small molecules
  • Mechanism of Action Vesicular monoamine transporter 2 inhibitors
  • Orphan Drug Status

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

    Yes - Huntington's disease; Gilles de la Tourette's syndrome
  • 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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Chorea
  • Phase III Drug-induced dyskinesia
  • No development reported Gilles de la Tourette's syndrome

Most Recent Events

  • 20 Oct 2016 FDA assigns PDUFA action date of 03/04/2017 for deutetrabenazine for Chorea
  • 20 Oct 2016 US FDA accepts resubmitted NDA for deutetrabenazine for Chorea for review
  • 22 Sep 2016 Top-line efficacy and adverse events data from the phase III AIM-TD study in Drug-induced dyskinesia released by Teva Pharmaceutical
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