The safety and efficacy of Methylene Blue MMX modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.
Phase of Trial: Phase III
Latest Information Update: 08 Nov 2017
At a glance
- Drugs Methylthioninium chloride-Cosmo (Primary)
- Indications Adenoma; Colon cancer
- Focus Diagnostic use; Registrational
- Sponsors Cosmo Pharmaceuticals
- 24 Oct 2017 According to a Cosmo Pharmaceuticals Media Release, New Drug Application (NDA) for LuMeBlue (methylene blue) has been submitted.
- 16 Oct 2017 Primary endpoint (Screening success rate) has been met, according to an Aries Pharmaceuticals media release.
- 16 Oct 2017 According to an Aries Pharmaceuticals media release, the US FDA has accepted the NDA for Methylene Blue MMX™ (MB MMX) and has set a PDUFA date of May 21, 2018. The NDA was based on this trial.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History