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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: 03 Jul 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

  • 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)
  • 16 Jun 2026 Phase-III clinical trials in Gastrointestinal stromal tumours (First-line therapy, Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in Australia, USA, Argentina, Brazil, Canada, Chile, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, Italy, Mexico, Netherlands, Norway, Poland, South Korea, Spain, Sweden, Taiwan, United Kingdom (PO) (NCT05208047)

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