drug · small molecule
CALQUENCE
Marketedupdated 5mo agoby $AZN ASTRAZENECA PLC🔗 ChEMBL
Approvedcommunity read0 votes
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top 7Small molecule drug with a maximum clinical stage of Approval (across all indications), with 4 approved and 20 investigational indications.
indications
investigational
DLBCL
targets
Tyrosine-protein kinase BTK
all catalysts(13)
approval · 12
Oct 31, 2017
approval
$AZN156.90-0.51%
CALQUENCE (ACALABRUTINIB) — FDA approval
CALQUENCE
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Nov 21, 2019
approval
$AZN156.90-0.51%
CALQUENCE (ACALABRUTINIB) — FDA approval
CALQUENCE
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Nov 21, 2019
approval
$AZN156.90-0.51%
CALQUENCE (ACALABRUTINIB) — FDA approval
CALQUENCE
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Mar 24, 2022
approval
$AZN156.90-0.51%
CALQUENCE (ACALABRUTINIB) — FDA approval
CALQUENCE
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Aug 3, 2022
approval
$AZN156.90-0.51%
CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval
CALQUENCE
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Aug 3, 2022
approval
$AZN156.90-0.51%
CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval
CALQUENCE
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Jun 5, 2024
approval
$AZN156.90-0.51%
CALQUENCE (ACALABRUTINIB) — FDA approval
CALQUENCE
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Jun 5, 2024
approval
$AZN156.90-0.51%
CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval
CALQUENCE
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Jan 16, 2025
approval
$AZN156.90-0.51%
CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval
CALQUENCE
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Jan 16, 2025
approval
$AZN156.90-0.51%
CALQUENCE (ACALABRUTINIB) — FDA approval
CALQUENCE
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Feb 19, 2026
approval
$AZN156.90-0.51%
CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval
CALQUENCE
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Feb 19, 2026
approval
$AZN156.90-0.51%
CALQUENCE (ACALABRUTINIB) — FDA approval
CALQUENCE
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Trials studying CALQUENCE
- phase2A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
- phase2A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain
- phase2Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
- phase3Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
- phase3A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
- phase3A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
- phase4Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure
- phase2Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab
Patent cliff
source: FDA Orange Bookfirst barrier falls
Nov 21, 2026
45 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (17)
- Jul 1, 2036formulationUS 10167291
- Jul 1, 2036compositionUS 11059829
- Jul 1, 2036compositionUS 9796721
- Aug 11, 2035method-of-use (U-4431)US 11166951
- Aug 11, 2035method-of-use (U-4427)US 11166951
- Jan 21, 2035method-of-use (U-4109)US 10272083
- Jan 21, 2035method-of-use (U-2687)US 10272083
- Jan 21, 2035method-of-use (U-3710)US 11771696
- Jan 21, 2035method-of-use (U-3710)US 11771696
- Jul 11, 2032method-of-use (U-2668)US 10239883
- Jul 11, 2032method-of-use (U-2666)US 10239883
- Jul 11, 2032compositionUS 9290504
- Jul 11, 2032compositionUS 9290504
- Jul 11, 2032method-of-use (U-2145)US 9758524
- Jul 11, 2032method-of-use (U-2145)US 9758524
- Nov 24, 2026compositionUS 745955448d
- Nov 24, 2026compositionUS 745955448d
FDA exclusivities (3)
- Jan 16, 2028I-960Indication (3y)1.3y
- Jan 16, 2028I-960Indication (3y)1.3y
- Nov 21, 2026ODE-274Orphan Drug (7y)45d
News(2)
- Dual-acting drug from AbbVie, Genmab scores in frontline lymphoma trialThe better-than-expected results could make Epkinly the new “undisputed” treatment standard in newly diagnosed DLBCL, according to one analyst.biopharma_dive · 2h ago
- Retrospective Data Show Potential Real-World TTNT and OS Improvements With Next-Generation BTK Inhibitors in R/R MCLRetrospective data showed zanubrutinib was associated with improved real-world overall survival vs ibrutinib in second- or third-line mantle cell lymphoma.onclive · 4mo ago
Data sources
last refreshed 3h ago
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