Trial Profile
A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study With Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys With Duchenne Muscular Dystrophy (DMD)
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 28 Mar 2024
Price :
$35
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At a glance
- Drugs Vamorolone (Primary) ; Prednisone
- Indications Duchenne muscular dystrophy
- Focus Registrational; Therapeutic Use
- Acronyms VISION DMD
- Sponsors ReveraGen BioPharma
- 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.
- 21 Feb 2024 Results published in the Santhera Pharmaceuticals Media Release.
- 14 Feb 2024 According to a Santhera Pharmaceuticals media release, data from this study were published in the Neurology.