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Acalabrutinib (ACP-196)
Acalabrutinib is a selective inhibitor of Bruton's tyrosine kinase (BTK) that blocks B-cell proliferation and survival signaling.
Acalabrutinib is a selective inhibitor of Bruton's tyrosine kinase (BTK) that blocks B-cell proliferation and survival signaling. Used for Chronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma (SLL), Mantle cell lymphoma (MCL).
At a glance
| Generic name | Acalabrutinib (ACP-196) |
|---|---|
| Also known as | Acalabrutinib |
| Sponsor | Acerta Pharma BV |
| Drug class | BTK inhibitor |
| Target | BTK (Bruton's tyrosine kinase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Acalabrutinib covalently binds to BTK, a key enzyme in B-cell receptor signaling, preventing activation of downstream pathways critical for malignant B-cell survival and proliferation. By selectively targeting BTK with minimal off-target effects, it reduces tumor burden in B-cell malignancies while potentially sparing normal immune function compared to less selective BTK inhibitors.
Approved indications
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Mantle cell lymphoma (MCL)
Common side effects
- Diarrhea
- Headache
- Fatigue
- Infections
- Thrombocytopenia
- Anemia
- Nausea
Key clinical trials
- Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL) (PHASE3)
- Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (PHASE2)
- A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy (PHASE2)
- A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM) (PHASE1, PHASE2)
- A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma (PHASE2)
- An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia (PHASE2)
- Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma (PHASE1, PHASE2)
- Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (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 (ACP-196) CI brief — competitive landscape report
- Acalabrutinib (ACP-196) updates RSS · CI watch RSS
- Acerta Pharma BV portfolio CI