Wednesday, July 8, 2026
🇺🇸 FDA

Drug profile · INN

acalabrutinib maleate

CALQUENCE

acalabrutinib maleate (CALQUENCE) is a tyrosine-protein kinase btk inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 20
Pipeline programs 23
News articles 0
Drug details — acalabrutinib maleate
US status
approved
Class
—
Route
ORAL
Patents
20
Programs
23
Data quality
0.84
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Quick answer

acalabrutinib maleate (CALQUENCE) is a tyrosine-protein kinase btk inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN acalabrutinib maleate
Brand CALQUENCE
Mechanism Tyrosine-protein kinase BTK inhibitor
Target Tyrosine-protein kinase BTK
Route ORAL
Formulation TABLET

Mechanism of action

Tyrosine-protein kinase BTK inhibitor

Primary target: Tyrosine-protein kinase BTK

Approval history

Authority Status Date
FDA approved —

Pipeline programs

Search pipeline
  1. ACE-CL-006 Phase 3 · Anaxis Pharma · High Risk Chronic Lymphocytic Leukaemia
  2. ACE-CL-007 Phase 3 · Anaxis Pharma · Chronic Lymphocytic Leukemia
  3. ACE-LY-308 Phase 3 · Anaxis Pharma · Mantle Cell Lymphoma
  4. APG2575CG301 Phase 3 · Anaxis Pharma · Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  5. BGB-11417-304 Phase 3 · BEONE MEDICINES AUS · treatment-naive Chronic Lymphocytic Leukemia
  6. Calquence 100 mg hard capsules Phase 3 · AstraZeneca · Chronic lymphocytic leukemia
  7. Calquence 100 mg hard capsules Phase 3 · Anaxis Pharma · Relapsed or Refractory Chronic Lymphocytic Leukemia
  8. D8220C00027 Phase 3 · AstraZeneca · Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Related & competitor drugs

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  1. ibrutinib Antineoplastic and immunomodulating agents (L01)
  2. zanubrutinib Antineoplastic and immunomodulating agents (L01)
  3. acalabrutinib Antineoplastic and immunomodulating agents (L01)
  4. pirtobrutinib Antineoplastic and immunomodulating agents (L01)
  5. rilzabrutinib Nervous system (NOT)
  6. tolebrutinib Tyrosine-protein kinase BTK inhibitor

Related patents

Browse patents

  1. WO 2026093542

    TRAITEMENT D'ASSOCIATION D'UN AGONISTE DU GLP1R ET D'UN INHIBITEUR DU SGLT-2

    Expires Wed May 02 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  2. WO 2026093541

    SCHÉMAS POSOLOGIQUES POUR L'AZD5004

    Expires Wed May 02 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  3. WO 2026093543

    TRAITEMENT COMBINÉ PAR AGONISTE DU GLP1R ET INHIBITEUR DE PCSK9

    Expires Wed May 02 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  4. WO 2026093537

    MÉTHODES DE TRAITEMENT DU DIABÈTE

    Expires Wed May 02 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  5. WO 2026094002

    COMBINAISONS DE MOLÉCULES D'ACTIVATION DE LYMPHOCYTES T BISPÉCIFIQUES DESTINÉES À ÊTRE UTILISÉES DANS LE TRAITEMENT DE TUMEURS SOLIDES EXPRIMANT CLAUDINE 18.2

    Expires Wed May 02 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  6. WO 2026093539

    MÉTHODES DE TRAITEMENT OU DE GESTION DE L'OBÉSITÉ

    Expires Wed May 02 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  7. WO 2026078165

    CONJUGUÉS COMPRENANT DES LIANTS CLIVABLES

    Expires Wed Apr 11 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  8. WO 2026078163

    CONJUGUÉS COMPRENANT DES LIANTS

    Expires Wed Apr 11 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  9. WO 2026057740

    TRAITEMENT DU CANCER AVEC DES MOLÉCULES DE LIAISON THÉRAPEUTIQUES

    Expires Wed Mar 14 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  10. WO 2026057582

    COMBINAISONS THÉRAPEUTIQUES D'UN INHIBITEUR D'AKT, D'UN INHIBITEUR DE BCL-2 ET D'UN GLUCOCORTICOÏDE

    Expires Wed Mar 14 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  11. WO 2026017827

    COMPOSÉS DE CARBOXAMIDE UTILISÉS EN TANT QU'INHIBITEURS DE PKMYT1

    Expires Wed Jan 17 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  12. WO 2025257199

    THÉRAPIES POUR LE TRAITEMENT DE PLAIES

    Expires Wed Dec 13 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  13. WO 2025248119

    DÉRIVÉS DE 6-(CYCLO)ALCOXYPURINE UTILES EN TANT QU'INHIBITEURS DE POLQ

    Expires Wed Nov 29 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  14. WO 2025248117

    DÉRIVÉS DE 6-AMINOPURINE UTILES EN TANT QU'INHIBITEURS DE POLQ

    Expires Wed Nov 29 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  15. WO 2025242689

    MÉTHODES DE TRAITEMENT D'UNE MALADIE RÉNALE MÉDIÉE PAR APOL1

    Expires Wed Nov 22 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  16. WO 2025238159

    POLYTHÉRAPIE COMPRENANT DE L'AZD0780 ET DE L'ÉZÉTIMIBE

    Expires Wed Nov 15 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  17. WO 2025237912

    INHIBITEURS DE KEAP1 DESTINÉS À ÊTRE UTILISÉS DANS LE TRAITEMENT DE LA BRONCHECTASIE

    Expires Wed Nov 15 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  18. US 12090156

    Application of CB-839 in preparation of drug for inhibiting corneal neovascularization (CNV)

    Expires Mon Sep 12 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  19. US 12016950

    Devices and methods for treating ear pain

    Expires Mon Jun 20 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  20. US 11980602

    Cannabinoid prodrug compounds

    Expires Mon May 09 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is acalabrutinib maleate?

acalabrutinib maleate (CALQUENCE) is a tyrosine-protein kinase btk inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for acalabrutinib maleate?

CALQUENCE is a marketed brand name for acalabrutinib maleate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of acalabrutinib maleate?

acalabrutinib maleate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.

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