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Tirabrutinib - Gilead Sciences/Ono Pharmaceutical

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Drug Profile

Tirabrutinib - Gilead Sciences/Ono Pharmaceutical

Alternative Names: GS-4059; ONO-4059; Tirabutinib hydrochloride - Gilead Sciences/Ono Pharmaceutical; Velexbru

Latest Information Update: 19 Feb 2026

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At a glance

  • Originator Ono Pharmaceutical
  • Developer Gilead Sciences; Ono Pharmaceutical
  • Class Alkynes; Amines; Antineoplastics; Antirheumatics; Ketones; Phenyl ethers; Purines; Pyrrolidines; Skin disorder therapies; Small molecules
  • Mechanism of Action Agammaglobulinaemia tyrosine kinase inhibitors
  • Orphan Drug Status

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

    Yes - Waldenstrom's macroglobulinaemia; Lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Lymphoma; Waldenstrom's macroglobulinaemia
  • Phase III Non-Hodgkin's lymphoma; Pemphigus
  • Phase II B-cell lymphoma; Chronic lymphocytic leukaemia
  • No development reported Scleroderma
  • Discontinued Chronic urticaria; Rheumatoid arthritis; Sjogren's syndrome

Most Recent Events

  • 17 Feb 2026 Preregistration for Lymphoma (Second-line therapy or greater) in USA (PO)
  • 17 Feb 2026 US FDA assigns PDUFA action date of (18/12/2026) for Tirabrutinib for Lymphoma
  • 04 Feb 2026 Phase-III clinical trials in Non-Hodgkin's lymphoma (Second-line therapy or greater, Combination therapy) in USA (PO) (NCT07104032)

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