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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: 18 Jun 2026

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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; Mastocytosis
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Gastrointestinal stromal tumours; Systemic mastocytosis
  • Phase I/II Solid tumours

Most Recent Events

  • 12 Jun 2026 Updated efficacy and adverse events data from the phase II APEX Part 2 trial in Systemic mastocytosis released by Cogent Biosciences
  • 30 May 2026 Updated efficacy data from phase III PEAK trial in Gastrointestinal stromal tumours released by Cogent Biosciences
  • 28 May 2026 FDA assigns PDUFA action date of 30/11/2026 for Bezuclastinib for Gastrointestinal stromal tumours

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