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  1. pharmadog
  2. ›drugs
  3. ›CALQUENCE
drug · small molecule
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CALQUENCE

Marketedupdated 3mo ago
by $AZN ASTRAZENECA PLC🔗 ChEMBL
Approved
community read0 votes

🐶 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

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
Oct 31, 2017
approval
$AZN164.95+3.03%
9y ago
CALQUENCE (ACALABRUTINIB) — FDA approval
CALQUENCE
→
Nov 21, 2019
approval
$AZN164.95+3.03%
7y ago
CALQUENCE (ACALABRUTINIB) — FDA approval
CALQUENCE
→
Nov 21, 2019
approval
$AZN164.95+3.03%
7y ago
CALQUENCE (ACALABRUTINIB) — FDA approval
CALQUENCE
→
Mar 24, 2022
approval
$AZN164.95+3.03%
4y ago
CALQUENCE (ACALABRUTINIB) — FDA approval
CALQUENCE
→
Aug 3, 2022
approval
$AZN164.95+3.03%
4y ago
CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval
CALQUENCE
→
Aug 3, 2022
approval
$AZN164.95+3.03%
4y ago
CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval
CALQUENCE
→
Jun 5, 2024
approval
$AZN164.95+3.03%
2y ago
CALQUENCE (ACALABRUTINIB) — FDA approval
CALQUENCE
→
Jun 5, 2024
approval
$AZN164.95+3.03%
2y ago
CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval
CALQUENCE
→
Jan 16, 2025
approval
$AZN164.95+3.03%
2y ago
CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval
CALQUENCE
→
Jan 16, 2025
approval
$AZN164.95+3.03%
2y ago
CALQUENCE (ACALABRUTINIB) — FDA approval
CALQUENCE
→
Feb 19, 2026
approval
$AZN164.95+3.03%
6mo ago
CALQUENCE (ACALABRUTINIB MALEATE) — FDA approval
CALQUENCE
→
Feb 19, 2026
approval
$AZN164.95+3.03%
6mo ago
CALQUENCE (ACALABRUTINIB) — FDA approval
CALQUENCE
→
phase 1 2 completion · 1
Apr 30, 2026
phase 1 2 completion
$AZN164.95+3.03%
4mo ago
AstraZeneca Plc — Calquence (Phase I/II Trial Completion)
CALQUENCE
→
view all 13 catalysts →

Trials studying CALQUENCE

  • phase4Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failurerecruitingn=60
  • 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
  • phase2Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumabrecruitingn=80
  • phase2An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphomaactive not recruitingn=124
  • phase3A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLLactive not recruitingn=310
  • phase2Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphomarecruitingn=168
  • phase2A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphomaactive not recruitingn=108
  • 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
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 21, 2026
93 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 745955496d
  • Nov 24, 2026compositionUS 745955496d

FDA exclusivities (3)

  • Jan 16, 2028I-960Indication (3y)1.4y
  • Jan 16, 2028I-960Indication (3y)1.4y
  • Nov 21, 2026ODE-274Orphan Drug (7y)93d

News(1)

  • Retrospective Data Show Potential Real-World TTNT and OS Improvements With Next-Generation BTK Inhibitors in R/R MCL
    Retrospective data showed zanubrutinib was associated with improved real-world overall survival vs ibrutinib in second- or third-line mantle cell lymphoma.
    onclive · 3mo ago
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
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 30m ago
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