Trial Profile

An Open-Label, Long-Term Safety Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 21 Aug 2025

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At a glance

20 Jun 2025 According to European Medicines Agency media release, EMA's human medicines committee (CHMP) has recommended granting a marketing authorisation for Austedo (deutetrabenazine), for the treatment of adults with moderate-to-severe tardive dyskinesia.
23 Sep 2024 According to a Teva Pharmaceuticals media release, data were presented at the European College of Neuropsychopharmacology Congress (ECNP) in Milan 21-24 September 2024.
23 Sep 2024 Results of new analysis from the European cohort of the RIM-TD open-label extension (OLE) study presented in a Teva Pharmaceuticals media release.

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