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Acalabrutinib · Calquence, ACP-196

Small molecule · Inhibitor of Bruton tyrosine kinase (BTK) · developed by Astrazeneca

Approved FDA, Oct 2017

AZN Developer

1 Registered trials

What is Acalabrutinib?

Acalabrutinib is a small-molecule inhibitor of Bruton tyrosine kinase (BTK) that forms a covalent bond with a cysteine residue in the BTK active site. It inhibits BTK-mediated signaling in B cells, blocking pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Calquence, ACP-196
Drug type: Small molecule
Targets: Bruton tyrosine kinase (BTK)
Mechanism: Inhibitor of Bruton tyrosine kinase (BTK)
Pathways: B-cell proliferation, B-cell trafficking, B-cell chemotaxis, B-cell adhesion
Therapy area: Oncology
Developer: Astrazeneca (AZN)
FDA status: Approved as Calquence (October 31, 2017), NDA210259 · FDA label
UNII: I42748ELQW

✅ FDA-approved uses

Previously untreated mantle cell lymphoma (in combination with bendamustine and rituximab)
Previously treated mantle cell lymphoma
Chronic lymphocytic leukemia
Small lymphocytic lymphoma

From the indications section of the FDA label (version of Feb 19, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT02180711	Phase 1/2	Non Hodgkin Lymphoma	Active not recruiting	AZN

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Non Hodgkin Lymphoma

Other drugs acting on BTK

Pirtobrutinib FDA approved Zanubrutinib FDA approved APG-3288 Phase 1

More from Astrazeneca

Anifrolumab FDA approved Benralizumab FDA approved Camizestrant FDA approved Durvalumab FDA approved Olaparib FDA approved Tremelimumab FDA approved Actinium Ac 225 FPI-2068 Phase 1 Adavosertib Phase 2 AZD0240 Phase 1 AZD4144 Phase 1 AZD4916 Phase 1 AZD5492 Phase 1/2

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the AZN page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z