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Fenebrutinib - Genentech

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Drug Profile

Fenebrutinib - Genentech

Alternative Names: GDC-0853; RG-7845; RO-7010939

Latest Information Update: 16 Oct 2025

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At a glance

  • Originator Genentech
  • Developer Chugai Pharmaceutical; Genentech
  • Class Antineoplastics; Antirheumatics; Piperazines; Pyrazines; Pyridines; 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Multiple sclerosis
  • No development reported Autoimmune disorders
  • Discontinued Chronic lymphocytic leukaemia; Chronic urticaria; Non-Hodgkin's lymphoma; Rheumatoid arthritis; Systemic lupus erythematosus

Most Recent Events

  • 22 Sep 2025 Phase-II clinical trials in Multiple sclerosis (In children, In adolescents) in Ukraine, Brazil, Argentina (PO) (EUCT2024-519800-28-00) (NCT07161258)
  • 22 Aug 2025 Roche plans a phase II trial for Multiple sclerosis (In children, In Adolescents) in France, Poland, Portugal, Spain (PO, Tablet) (CTIS2024-519800-28-00)
  • 30 May 2025 Adverse events and efficacy data from phase III FENopta OLE trial in Multiple sclerosis released by Genentech

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