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← All drugs Report issue

acalabrutinib

Trade name: calquence

Small moleculeapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Oct 31, 2017

Acalabrutinib, also known as ACP-196, is a novel irreversible second-generation Bruton’s tyrosine kinase (BTK) inhibitor, which prevents the activation of the B-cell antigen receptor (BCR) signaling pathway and that, was rationally designed to be more potent and selective than ibrutinib. This drug in clinical trials phase III for treatment the treatment of relapsed chronic lymphocytic leukemia. Also in combination with others drugs, Acalabrutinib in phase II of clinical trials for the treatment Glioblastoma Multiforme, Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Rheumatoid Arthritis and some others. — NCATS

Clinical trial activity

144 trials · 83 clinical orgs · 4 marketing orgs

Phase 1
46
Phase 2
110
Phase 3
20
Phase 4
2

Earliest trial started Jan 1, 2014 (NCT02029443)

Timeline

2010s

  1. Jan 1, 2014

    Acerta Pharma — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2014

    Acerta Pharma — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2015

    Acerta Pharma — Earliest Phase 3 Sponsor(trial)

  4. May 13, 2015

    Orphan Drug Designation

  5. Oct 31, 2017

    Acerta Pharma — Earliest FDA Approval

  6. Oct 31, 2017

    Acerta Pharma — NDA Secondary Org

  7. Oct 31, 2017

    Acerta Pharma — NDA Organization

  8. Oct 31, 2017

    AstraZeneca — NDA Secondary Org

2020s

  1. Aug 3, 2022

    AstraZeneca — Marketing Organization

  2. Jan 18, 2023

    Alembic — Marketing Organization

  3. May 12, 2025

    MSN Laboratories — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedBreakthroughOct 31, 2017

Chemistry & pharmacology

Loading structure…

SMILES

CC#CC(=O)N1CCC[C@H]1C2=NC(=C3N2C=CN=C3N)C4=CC=C(C=C4)C(=O)NC5=NC=CC=C5
Mol. weight
465.5065 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • acalabrutinib
  • acalabrutinib
  • acalabrutinib
  • acalabrutinib
  • acalabrutinib
  • acalabrutinib
  • acalabrutinib
  • acp-196
  • acp-196
  • acp-196
  • acp-196

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07257055Phase 2May 12, 2026University of Texas at Houston
NCT07277231Phase 3Jan 31, 2026BeOne Medicines
NCT06958705Phase 2Dec 1, 2025AbbVie, Nanjing Medical University
NCT07052695Phase 1/Phase 2 (Phase 2)Nov 30, 2025Genentech, Harvard University
NCT07024706Phase 2Sep 30, 2025AbbVie, AstraZeneca, Genentech
NCT07029737Phase 2Sep 5, 2025Apices Soluciones S.L., AstraZeneca
NCT06839872Phase 2Jun 30, 2025AstraZeneca, Eli Lilly
NCT07014917Phase 2Jun 1, 2025University of Cincinnati
NCT06757647Phase 2Mar 15, 2025Acerta Pharma, AstraZeneca, Ohio State University
NCT06846489Phase 2Mar 1, 2025Sun Yat-Sen University
NCT06520098Phase 2Jan 1, 2025Department of Veteran Affairs
NCT06441097Phase 2Dec 31, 2024Jiao Tong University
NCT06651970Phase 4Nov 30, 2024AstraZeneca, Center for Information and Study on Clinical Research Participation (CISCRP), ERT Clinical, Fortrea
NCT06564038Phase 1/Phase 2 (Phase 2)Sep 13, 2024AstraZeneca
NCT06428019Phase 3Aug 5, 2024AbbVie
NCT06319456Phase 3Apr 7, 2024Ascentage Pharma Group Inc., Chinese Academy of Medical Sciences
NCT05952024Phase 2Mar 29, 2024AstraZeneca
NCT05971251Phase 1Dec 18, 2023ADC Therapeutics SARL, University of Alabama, Birmingham
NCT06136559Phase 3Dec 13, 2023Merck
NCT06054776Phase 2Dec 10, 2023City of Hope National Medical Center, National Cancer Institute (NCI)
Showing 20 of 144 trials
Page 1 / 8

Organizations

Research & Development (83)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Acerta PharmaFor profit544132014
AstraZenecaFor profit502152017
National Cancer Institute (NCI)Government14112018
University of Texas at HoustonAcademic/Hospital9922019
Harvard UniversityAcademic/Hospital7712018
MerckFor profit7122015
ParexelFor profit6032019
GenentechFor profit5012018
City of Hope National Medical CenterAcademic/Hospital4412021
University of WashingtonAcademic/Hospital4412018
AbbVieFor profit3122024
Chinese Academy of Medical SciencesAcademic/Hospital3022019
German CLL Study GroupAcademic/Hospital3322019
Ohio State UniversityAcademic/Hospital3322021
Cornell UniversityAcademic/Hospital2212019
HOVON - Dutch Haemato-Oncology AssociationAcademic/Hospital2122019
Mayo ClinicAcademic/Hospital2212018
Moorgreen Hospital, SouthamptonAcademic/Hospital2212017
Nanjing Medical UniversityAcademic/Hospital2222023
University of CologneAcademic/Hospital2022021
83 organizations
Page 1 / 5

Marketing (6)

OrganizationOrg typeRelationshipDate
Acerta PharmaFor profitNDA2Oct 31, 2017
Acerta PharmaFor profitNDAOct 31, 2017
AlembicFor profitMKTGJan 18, 2023
AstraZenecaFor profitMKTGAug 3, 2022
AstraZenecaFor profitNDA2Oct 31, 2017
MSN LaboratoriesFor profitMKTGMay 12, 2025