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CALQUENCE · pharmadog

pharmadog
drugs
CALQUENCE

drug · small molecule

patient view →

CALQUENCE

Marketedupdated 2mo ago

by $AZN ASTRAZENECA PLC🔗 ChEMBL

Approved

community read0 votes

Small 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

phase 1 2 completion · 1

view all 13 catalysts →

News(0)

no news has mentioned this drug yet

brand

CALQUENCE

generic

ACALABRUTINIB

MOA

12.1 Mechanism of Action Acalabrutinib is a small-molecule inhibitor of Bruton tyrosine kinase (BTK). Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B cell antigen receptor (BCR) and cytokine receptor pathways. In B cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, acalabrutinib inhibited BTK‑mediated activation of downstream signaling proteins CD86 and CD69 and inhibited malignant B-cell proliferation and tumor growth in mouse xenograft models.

phase

marketed

CALQUENCE (ACALABRUTINIB) — FDA approval

CALQUENCE (ACALABRUTINIB) — FDA approval

CALQUENCE (ACALABRUTINIB) — FDA approval

CALQUENCE (ACALABRUTINIB) — FDA approval

CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval

CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval

CALQUENCE (ACALABRUTINIB) — FDA approval

CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval

CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval

CALQUENCE (ACALABRUTINIB) — FDA approval

CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval

CALQUENCE (ACALABRUTINIB) — FDA approval

phase 1 2 completion

AstraZeneca Plc — Calquence (Phase I/II Trial Completion)

Data sources

openFDA · ClinicalTrials.gov · OpenTargets

last refreshed 1m ago

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Patent cliff

source: FDA Orange Book

first barrier falls

Nov 21, 2026

137 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 7459554140d
Nov 24, 2026compositionUS 7459554140d

FDA exclusivities (3)

Jan 16, 2028I-960Indication (3y)1.5y
Jan 16, 2028I-960Indication (3y)1.5y
Nov 21, 2026ODE-274Orphan Drug (7y)137d

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$AZN195.15+6.14%

$AZN195.15+6.14%

$AZN195.15+6.14%

$AZN195.15+6.14%

$AZN195.15+6.14%

$AZN195.15+6.14%

$AZN195.15+6.14%

$AZN195.15+6.14%

$AZN195.15+6.14%

$AZN195.15+6.14%

$AZN195.15+6.14%

$AZN195.15+6.14%

🐶 often sniffed alongside

top 7

tagApproval48 co-mentions · 12 sources
tagSmall Molecule24 co-mentions · 12 sources
tagNeurology3 co-mentions · 1 sources
tagPsychiatry & CNS3 co-mentions · 1 sources
company$AZNASTRAZENECA PLC1 co-mentions · 1 sources
tagOncology1 co-mentions · 1 sources
tagDLBCL1 co-mentions · 1 sources

$AZN195.15+6.14%

Trials studying CALQUENCE

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)recruitingn=1,200
phase2A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphomaactive not recruitingn=108
phase3A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLLactive not recruitingn=310
phase2ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemiaactive not recruitingn=306
—Acalabrutinib in Patients With Chronic Lymphocytic Leukemia With Direct Oral Anticoagulation (CICERO)completedn=45
phase2Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCLactive not recruitingn=37
—Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdomrecruitingn=350
—Acalabrutinib Real World Italian obSErvational Study -ARISEactive not recruitingn=151

more trials →