Drug Profile

Acalabrutinib - Acerta Pharma/AstraZeneca

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

Latest Information Update: 24 Feb 2026

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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; Chronic lymphocytic leukaemia; Waldenstrom's macroglobulinaemia
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

20 Feb 2026 Registered for Chronic lymphocytic leukaemia (Combination therapy, First-line therapy) in USA (PO)
06 Dec 2025 Adverse events and efficacy data from a phase III trial in Mantle cell lymphoma presented at the 67th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2025)
31 Oct 2025 Acerta Pharma completes a phase II trial in Chronic lymphocytic leukemia (Second line therapy or greater, First-line therapy) in USA (PO) (NCT02337829)

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