Methylthioninium chloride controlled-release tablet - Cosmo

Drug Profile

Methylthioninium chloride controlled-release tablet - Cosmo

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

Latest Information Update: 18 Oct 2017

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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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Colorectal cancer

Most Recent Events

  • 16 Oct 2017 FDA assigns PDUFA action date of 21/05/2018 for Methylene Blue MMX™ for Colorectal cancer
  • 24 Jul 2017 Preregistration for Colorectal cancer (Diagnosis, In the elderly, In adults) in USA (PO)
  • 24 Jul 2017 Adverse events and efficacy data from a phase III trial in Colorectal cancer released by Cosmo Pharmaceuticals
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