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Bezuclastinib - Cogent Biosciences

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Drug Profile

Bezuclastinib - Cogent Biosciences

Alternative Names: CGT 9486; PLX 9486

Latest Information Update: 05 Sep 2024

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At a glance

  • Originator Plexxikon
  • Developer Cogent Biosciences; Plexxikon
  • Class Antineoplastics; Small molecules
  • Mechanism of Action Proto-oncogene protein c-kit inhibitors
  • Orphan Drug Status

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

    Yes - Gastrointestinal stromal tumours; Systemic mastocytosis
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Gastrointestinal stromal tumours
  • Phase II Systemic mastocytosis
  • Phase I/II Solid tumours

Most Recent Events

  • 03 Sep 2024 Cogent Biosciences announces intention to submit NDA to regulatory body for Gastrointestinal stromal tumours and Systemic mastocytosis
  • 03 Sep 2024 Cogent Biosciences completes enrolment in its phase III PEAK trial for Gastrointestinal stromal tumours in Australia, Brazil, Canada, Denmark, France, Germany, Hong Kong, Hungary, Italy, South Korea, Netherlands, Norway, Spain, Sweden, Taiwan, the US, Argentina, Chile, Czech Republic, Mexico, Poland and the UK
  • 27 Jun 2024 Cogent Biosciences successfully discussed with the US FDA to integrate the Mastocytosis Symptom Severity Daily Diary (MS2D2) into the SUMMIT trial's second part

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