CALQUENCE

PeakSM

acalabrutinib

NDAORALTABLET
Approved
Aug 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

Tyrosine Kinase Inhibitors

Pharmacologic Class:

Kinase Inhibitor

Clinical Trials (5)

NCT07024706Phase 2Not Yet Recruiting

Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab

Started Jan 2026
80 enrolled
Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)
NCT07277231Phase 3Recruiting

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
NCT07288515N/ARecruiting

Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus

Started Dec 2025
50 enrolled
Chronic Lymphocytic Leukemia
NCT07029737Phase 2Recruiting

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
NCT06839872Phase 2Withdrawn

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
0
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Loss of Exclusivity

LOE Date
Jul 1, 2036
125 months away
Patent Expiry
Jul 1, 2036
Exclusivity Expiry
Jan 16, 2028

Patent Records (5)

Patent #ExpiryTypeUse Code
7459554
Nov 24, 2026
Substance
9290504
Jul 11, 2032
SubstanceProduct
9758524
Jul 11, 2032
U-2145
10239883
Jul 11, 2032
U-2668
11771696
Jan 21, 2035
U-3710