Trial Profile

A pharmacokinetic trial which investigated the pharmacokinetic parameters of vamorolone in healthy adult Chinese volunteers

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 28 Mar 2024

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At a glance

28 Mar 2024 New trial record
27 Mar 2024 According to a Santhera Pharmaceuticals media release, the Center for Drug Evaluation (CDE) of NMPA accepted the filing and granted priority review for vamorolone in DMD for patients aged 4 years and older which could, subject to a positive outcome, lead to approval by Q1 2025. Filing is supported by VISION-DMD in addition, the filing included data from three open-label studies and pharmacokinetic study in Chinese healthy volunteers.

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