This page provides a reference hub for authoritative information concerning acalabrutinib and the established reference product CALQUENCE.
Regulatory sources
U.S. Food and Drug Administration — CALQUENCE
The FDA prescribing information provides U.S. indications, dosage, warnings, adverse reactions, drug interactions and clinical pharmacology.
DailyMed — CALQUENCE
DailyMed provides the current U.S. labeling record for CALQUENCE capsules, including its February 2026 revision.
European Medicines Agency — Calquence EPAR
The EMA EPAR provides European authorization information, indications, treatment combinations and safety information.
Originator and development history
AstraZeneca reports that its 2015 investment in Acerta Pharma provided access to acalabrutinib, then in Phase III development for B-cell malignancies. AstraZeneca completed the majority-stake transaction in 2016.
Clinical information
FDA clinical pharmacology information describes BTK occupancy, absorption, protein binding, metabolism, elimination and pharmacokinetic characteristics.
Acaluxen-specific documentation
The manufacturer, regulatory authorization and product-specific official documentation for Acaluxen are Everest Pharmaceuticals Ltd.