Drug Profile

Acalabrutinib - Acerta Pharma/AstraZeneca

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

Latest Information Update: 19 Sep 2025

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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

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
No development reported Infections
Discontinued COVID 2019 infections; Haematological malignancies; Rheumatoid arthritis

19 Sep 2025 Launched for Chronic lymphocytic leukaemia (Combination therapy, First-line therapy) in Australia (PO)
19 Sep 2025 Launched for Chronic lymphocytic leukaemia (First-line therapy, Combination therapy) in Sweden (unspecified route)
19 Sep 2025 Launched for Chronic lymphocytic leukaemia (Monotherapy, First-line therapy) in Australia (PO)

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