NDAORALTABLET
Approved
Aug 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
CALQUENCE (acalabrutinib) by AstraZeneca is tyrosine kinase inhibitors [moa]. First approved in 2022.
Drug data last refreshed 6h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CALQUENCE (acalabrutinib) is an oral tyrosine kinase inhibitor that selectively targets Bruton's tyrosine kinase (BTK), used primarily in hematologic malignancies including chronic lymphocytic leukemia and mantle cell lymphoma. It works by blocking BTK-dependent B-cell signaling pathways critical for tumor cell survival and proliferation. The drug represents a second-generation BTK inhibitor with improved selectivity profile compared to earlier agents.
$1.3BPart D
Peak9.7 years to LOEThe product is at peak commercial maturity with substantial Medicare utilization ($1.3B Part D spending in 2023), indicating a mature, well-established commercial infrastructure requiring experienced brand and commercial operations teams.
Mechanism of Action
Tyrosine Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Polatuzumab Vedotin, Mosunetuzumab, and Acalabrutinib for the Treatment of Mantle Cell Lymphoma, PAcMan Trial
Started Mar 2027
27 enrolled
Mantle Cell Lymphoma
A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Started Jan 2026
500 enrolled
Chronic Lymphocytic Leukemia
Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus
Started Dec 2025
50 enrolled
Chronic Lymphocytic Leukemia
A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain
Started Sep 2025
55 enrolled
Mantle-cell Lymphoma
A Study to Investigate the Sequencing Strategy of Pirtobrutinib After Disease Progression on First-line Acalabrutinib Treatment for Adult Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Started Jun 2025
0Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.