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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: 04 Sep 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

  • 04 Sep 2026 Efficacy data from the phase II SUMMIT trial in Systemic mastocytosis presented at the 2026 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2026)
  • 30 Jun 2026 Preregistration for Systemic mastocytosis (Late-stage disease) in USA (PO)
  • 16 Jun 2026 Phase-III clinical trials in Gastrointestinal stromal tumours (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in Hong Kong (PO)

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