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Acalabrutinib capsule
Acalabrutinib is a selective inhibitor of Bruton's tyrosine kinase (BTK) that blocks B-cell proliferation and survival signaling in hematologic malignancies.
Acalabrutinib is a selective inhibitor of Bruton's tyrosine kinase (BTK) that blocks B-cell proliferation and survival signaling in hematologic malignancies. Used for Chronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma (SLL), Mantle cell lymphoma (MCL).
At a glance
| Generic name | Acalabrutinib capsule |
|---|---|
| Also known as | Calquence®, Calquence |
| Sponsor | AstraZeneca |
| Drug class | Bruton's tyrosine kinase (BTK) inhibitor |
| Target | BTK (Bruton's tyrosine kinase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Acalabrutinib covalently binds to BTK, a key enzyme in B-cell receptor signaling, preventing downstream activation of proliferation and survival pathways. This selective BTK inhibition leads to apoptosis of malignant B cells while sparing other immune cells, making it effective in BTK-dependent lymphoid cancers. The drug's selectivity for BTK over other kinases reduces off-target toxicity compared to earlier-generation BTK inhibitors.
Approved indications
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Mantle cell lymphoma (MCL)
- Marginal zone lymphoma (MZL)
Common side effects
- Diarrhea
- Headache
- Fatigue
- Bruising/bleeding
- Infection
- Nausea
- Rash
Key clinical trials
- A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (PHASE3)
- Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL (PHASE2)
- Bendamustine, Rituximab and Acalabrutinib in Waldenstrom's Macroglobulinemia (PHASE2)
- Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients (PHASE3)
- Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma (PHASE2)
- Copanlisib Plus Ibrutinib or Acalabrutinib in R/R CLL (PHASE2)
- Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma (PHASE2)
- AZD4573 in Novel Combinations With Anti-cancer Agents in Patients With Advanced Blood Cancer (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Acalabrutinib capsule CI brief — competitive landscape report
- Acalabrutinib capsule updates RSS · CI watch RSS
- AstraZeneca portfolio CI