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Methylthioninium chloride controlled-release tablet - Cosmo Pharmaceuticals

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Drug Profile

Methylthioninium chloride controlled-release tablet - Cosmo Pharmaceuticals

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

Latest Information Update: 04 Dec 2025

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At a glance

  • Originator Cosmo Pharmaceuticals
  • Developer Alfasigma; China Medical System; Cosmo Pharmaceuticals
  • Class Antineoplastics; Diagnostic agents; Dimethylamines; Phenothiazines; Small molecules
  • Mechanism of Action Diagnostic imaging enhancers
  • 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

  • Marketed Colorectal cancer

Most Recent Events

  • 04 Dec 2025 Methylthioninium chloride controlled-release tablet is still in registered phase for Colorectal cancer in Switzerland, Russia, United Kingdom and Mexico
  • 30 Mar 2023 Methylthioninium chloride licensed to China Medical system in Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Uzbekistan, Republic of Korea, Mongolia, Brunei Darussalam, Cambodia, Indonesia, Lao People’s Democratic Republic, Malaysia, Myanmar, Philippines, Singapore, Thailand, Timor-Leste, Vietnam, Afghanistan, Bangladesh, Bhutan, Iran, Maldives, Nepal, Pakistan and Sri Lanka
  • 14 Dec 2022 Efficacy data from a phase III trial in Colorectal cancer released by Cosmo Pharmaceuticals

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