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Deutetrabenazine - Teva Pharmaceutical

Drug Profile

Deutetrabenazine - Teva Pharmaceutical

Alternative Names: AUSTEDO; AUSTEDO XR; d6-tetrabenazine; Deuterium-substituted tetrabenazine; Dutetrabenazine; SD-809; SD-809 ER; SD-809 Extended Release; TEV-50717

Latest Information Update: 31 May 2024

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At a glance

  • Originator Auspex Pharmaceuticals
  • Developer Auspex Pharmaceuticals; Nuvelution Pharma; Teva Pharmaceutical Industries
  • Class Antipsychotics; Neuropsychotherapeutics; Organic deuterium compounds; Quinolizines; Small molecules
  • Mechanism of Action Dopamine receptor antagonists; Dopamine release inhibitors; 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
  • New Molecular Entity No

Highest Development Phases

  • Marketed Chorea; Drug-induced dyskinesia
  • Phase III Dyskinesias; Gilles de la Tourette's syndrome

Most Recent Events

  • 29 May 2024 US FDA approves deutetrabenazine extended-release tablets (AUSTEDO XR) with four new tablet strengths ,,, 48 mg) for Drug-induced dyskinesia in USA
  • 29 May 2024 US FDA approves deutetrabenazine extended-release tablets (AUSTEDO XR) with four new tablet strengths ,,, 48 mg) for Chorea associated with Huntington's disease in USA
  • 26 Feb 2024 Jiangsu Nhwa and Teva Pharmaceuticals enter into a marketing agreement for commercialization of deutetrabenazine in China for Chorea and Dyskinesias
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