The safety and efficacy of Methylene Blue MMX modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.

Trial Profile

The safety and efficacy of Methylene Blue MMX modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.

Completed
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
  • Most Recent Events

    • 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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