Drug Profile


Alternative Names: ACP-196

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Acerta Pharma
  • Developer Acerta Pharma; AstraZeneca; Merck Sharp & Dohme; University Hospital Southampton NHS Foundation Trust
  • Class Antineoplastics; Benzamides; Heavy metals; Imidazoles; Pyrazines; Pyridines; Pyrrolidines; 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 - Mantle-cell lymphoma; Waldenstrom's macroglobulinaemia; Chronic lymphocytic leukaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Chronic lymphocytic leukaemia; Mantle-cell lymphoma
  • Phase II Bladder cancer; Head and neck cancer; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Rheumatoid arthritis
  • Phase I/II B cell lymphoma; B cell prolymphocytic leukaemia; Diffuse large B cell lymphoma; Glioblastoma; Multiple myeloma; Waldenstrom's macroglobulinaemia
  • Phase I Follicular lymphoma

Most Recent Events

  • 01 Aug 2017 Acalabrutinib receives Breakthrough Therapy status for Mantle cell lymphoma (Second-line therapy or greater) in USA
  • 07 Jul 2017 AstraZenenca plans regulatory submissions in Chronic lymphocytic leukaemia as a first-line therapy as well as second line therapy for relapsed or refractory disease, in USA and European Union in 2020 (AstraZeneca pipeline, July 2017)
  • 29 Jun 2017 AstraZeneca plans a phase I trial for B-cell lymphoma (Late-stage disease) in Japan, in June 2017 (NCT03198650)
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