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Acalabrutinib - Acerta Pharma/AstraZeneca

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Drug Profile

Acalabrutinib - Acerta Pharma/AstraZeneca

Alternative Names: Acalabrutinib maleate; ACP-196; CALQUENCE; Calquence

Latest Information Update: 17 Jan 2024

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At a glance

  • Originator Acerta Pharma
  • Developer Acerta Pharma; AstraZeneca; Biologics Inc; National Institutes of Health (USA)
  • Class Anti-infectives; Antineoplastics; Antirheumatics; 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

  • Marketed Chronic lymphocytic leukaemia; Mantle-cell lymphoma
  • Phase III Diffuse large B cell lymphoma
  • Phase II B-cell lymphoma; Bladder cancer; Head and neck cancer; Non-Hodgkin's lymphoma; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Richter's syndrome; Waldenstrom's macroglobulinaemia
  • Phase I/II B-cell prolymphocytic leukaemia; Follicular lymphoma; Glioblastoma; Multiple myeloma
  • Phase I Infections
  • Discontinued COVID 2019 infections; Haematological malignancies; Rheumatoid arthritis

Most Recent Events

  • 13 Dec 2023 Phase-II clinical trials in Mantle-cell lymphoma (Combination therapy, First-line therapy) in United Kingdom (PO) (NCT05951959)
  • 13 Dec 2023 AstraZeneca initiates enrolment in a phase II TrAVeRse trial for Mantle cell lymphoma (Combination therapy, First-line therapy) in Australia and United Kingdom (PO) (NCT05951959)
  • 09 Dec 2023 Efficacy data from the phase II WAMM trial in Mantle-cell lymphoma presented at the 65th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2023)
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