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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: 12 Dec 2025

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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

  • 08 Dec 2025 Cogent Biosciences announces intention to file a New Drug Application (NDA) to the US FDA for Systemic mastocytosis, in the first half of 2026
  • 08 Dec 2025 Updated efficacy and adverse events data from the phase II registration-directed APEX Part 2 trial in Systemic mastocytosis released by Cogent Biosciences
  • 06 Dec 2025 Updated adverse events and efficacy data from the phase-II SUMMIT trial in Systemic mastocytosis released by Cogent Biosciences

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