Drug Profile

Acalabrutinib - Acerta Pharma/AstraZeneca

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

Latest Information Update: 20 Jun 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

17 Jun 2025 AstraZeneca plans a phase II MAVRiC trial for Chronic lymphocytic leukemia (Combination therapy, Second-line therapy or greater) in September 2025 (PO) (NCT07024706)
15 Jun 2025 AstraZeneca plans the phase II SOUND-MCL trial for Mantle cell lymphoma (Combination therapy, First-line therapy) in Spain (PO) in June 2025 (NCT07029737)
06 Jun 2025 European Commission approves fixed-duration Calquence-based regimens for Chronic lymphocytic leukaemia (First-line therapy, Combination therapy) in EU

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