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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Aug 2020

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At a glance

  • Drugs Methylthioninium chloride-Cosmo (Primary)
  • Indications Adenoma; Colorectal cancer
  • Focus Diagnostic use; Registrational
  • Sponsors Cosmo Pharmaceuticals; Cosmo Technologies

Most Recent Events

  • 21 Aug 2020 According to a Cosmo Pharmaceuticals media release, based on this study the European Commission (EC) has approved Methylthioninium Chloride Cosmo, prolonged release tablets (Methylene Blue MMX) for the visualization of colorectal lesions during colonoscopies. The Centralized European licence will be effective simultaneously in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
  • 12 Mar 2019 FDA Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER) denied Cosmo's last appeal while reiterating the need of a phase III confirmatory trial for approval of the drug.Company has no intention to peruse any additional appeal with the FDA. The company intends to conduct a phase III confirmatory trial and will present a new clinical protocol to the FDA with different endpoints.
  • 05 Jun 2018 Results presented at the Digestive Disease Week 2018

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