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Silevertinib - Black Diamond Therapeutics

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Drug Profile

Silevertinib - Black Diamond Therapeutics

Alternative Names: BDTX-1535

Latest Information Update: 08 Dec 2025

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At a glance

  • Originator Black Diamond Therapeutics
  • Developer Barrow Neurological Institute; Black Diamond Therapeutics; St Josephs Hospital and Medical Center; The Ivy Brain Tumor Center
  • Class 2 ring heterocyclic compounds; Amides; Amines; Aniline compounds; Antineoplastics; Halogenated hydrocarbons; Morpholines; Quinazolines; Small molecules
  • Mechanism of Action Protein tyrosine kinase inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes - Glioblastoma; Non-small cell lung cancer

Highest Development Phases

  • Phase I/II Glioblastoma; Non-small cell lung cancer
  • Phase 0 Glioma

Most Recent Events

  • 03 Dec 2025 Efficacy and adverse events data from a phase I/II trial in Non-small cell lung cancer released by Black Diamond Therapeutics
  • 03 Dec 2025 Black Diamond Therapeutics plans a phase II trial for Glioblastoma (First-line therapy, Combination therapy) in the first half of 2026
  • 07 Aug 2025 Silevertinib - Black Diamond Therapeutics is available for licensing as of 07 Aug 2025

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