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Methylthioninium chloride controlled-release tablet - Cosmo Pharmaceuticals

Drug Profile

Methylthioninium chloride controlled-release tablet - Cosmo Pharmaceuticals

Alternative Names: CB-17-01; LuMeBlue; Methylene blue delayed-release - Cosmo; Methylene Blue MMX; Methylene blue MMX®; Methylene blue tablet - Cosmo

Latest Information Update: 09 May 2019

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At a glance

  • Originator Cosmo Pharmaceuticals
  • Class Diagnostic agents; Dimethylamines; Phenothiazines; Small molecules
  • Mechanism of Action Undefined mechanism
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Colorectal cancer

Most Recent Events

  • 12 Mar 2019 The FDA Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER) denies the last appeal for Methylene Blue MMX™ for Colorectal cancer and recommends a phase III confirmatory trial for Colorectal cancer
  • 12 Mar 2019 Cosmo Pharmaceuticals plans a phase III confirmatory trial for Colorectal cancer (Diagnosis)
  • 12 Feb 2019 Preregistration for Colorectal cancer (Diagnosis, In the elderly, In adults) in European Union (PO)
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