Calquence

(ACALABRUTINIB)

ApprovedSmall molecule

Acalabrutinib is used to treat certain types of blood cancers, particularly chronic lymphocytic leukemia and mantle cell lymphoma, by slowing or stopping the growth of cancer cells.[2] Calquence is currently approved and in use across 45 indications[4].[1]

Calquence is one of 627 small molecule programs targeting Lymphoma. It is currently in Approved.

Indications

133

Total Trials

Active Trials

626

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

LymphomaActive, not recruiting

CLLWithdrawn

Marginal Zone LymphomaActive, not recruiting

Waldenström Macroglobulinemia (WM)Active, not recruiting

Infectious DiseaseApproved

Non-Hodgkins LymphomaApproved

Food AllergyApproved

Marginal Zone B-Cell LymphomaApproved

Glioblastoma MultiformeApproved

Pancreatic CancerApproved

LymphomaPhase 2

Active, not recruiting

CLLPhase 2

Withdrawn

Marginal Zone LymphomaPhase 2

Active, not recruiting

Waldenström Macroglobulinemia (WM)Phase 2

Active, not recruiting

Infectious DiseaseApproved

Approved

Non-Hodgkins LymphomaApproved

Approved

Food AllergyApproved

Approved

Marginal Zone B-Cell LymphomaApproved

Approved

Glioblastoma MultiformeApproved

Approved

Pancreatic CancerApproved

Approved

Showing 10 of 45 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Calquence

AstraZeneca

Approved

8 2

Zofran

Novartis

Preclinical

2 3

Cabenuva

GSK

Preclinical

1 4

Norvir

AbbVie

Preclinical

1 5

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 6

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 7

Nuvigil

NNuvo Research GmbH

Preclinical

1 8

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

N/ARecruiting

CLL

NCT05950997

Phase 1/2Recruiting

B-Cell NHL

NCT03571568

Q4 2026

Phase 2Recruiting

Mantle Cell Lymphoma

NCT06054776

Phase 2Recruiting

Chronic Lymphocytic Leukemia

NCT05336812

Phase 2Active, not recruiting

Waldenström Macroglobulinemia (WM)

NCT02180724

Phase 2Active, not recruiting

Liver Lymphoma

NCT04115631

Clinical

Trials by Indication[1]

Chronic Lymphocytic Leukemia27 trials

Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial

Recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT04941716·20 enrolled

Study to Investigate the Use of Acalabrutinib in the Treatment of Patients With Chronic Lymphocytic Leukemia

Completed·PPETHEMA Foundation·Phase 3·NCT04178798·22 enrolled

Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax

Terminated·TTG Therapeutics, Inc.·Phase 2·NCT04016805·41 enrolled

Show 24 more trials

Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04505254·60 enrolled

Tafasitamab, Acalabrutinib, and Obinutuzumab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Recruiting·OOHSU Knight Cancer Institute·Phase 1·NCT05943496·27 enrolled

Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia

Active, not recruiting·—·Phase 2·NCT04657094·4 enrolled

Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Recruiting·MMayo Clinic·Phase 2·NCT05388006·27 enrolled

A Study to Investigate the Sequencing Strategy of Pirtobrutinib After Disease Progression on First-line Acalabrutinib Treatment for Adult Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 2·NCT06839872

ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia

Active, not recruiting·AAcerta Pharma BV·Phase 1/2·NCT02029443·306 enrolled

Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia

Recruiting·OOhio State University Comprehensive Cancer Center·Phase 2·NCT05336812·52 enrolled

Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT03932331·105 enrolled

A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT06428019·170 enrolled

Acalabrutinib and High Frequency Low Dose Subcutaneous Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma

Completed·UUniversity of Rochester·Phase 2·NCT03788291·39 enrolled

Acalabrutinib in Combination With ACP-319, for Treatment of Chronic Lymphocytic Leukemia

Active, not recruiting·AAcerta Pharma BV·Phase 1·NCT02157324·12 enrolled

A Randomized, Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Acalabrutinib Versus Chlorambucil Plus Rituximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04075292·155 enrolled

A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06136559·1,200 enrolled

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Recruiting·BBeOne Medicines·Phase 3·NCT07277231·500 enrolled

A Non-interventional, Observational Cohort Study of Chronic Lymphocytic Leukaemia Patients Treated With Acalabrutinib in the First-line Setting Through the UK Early Access Programme: Early Access Programme Outcomes In aCalabrutinib (EPIC).

Recruiting· AstraZeneca logo

AstraZeneca··NCT05557695·287 enrolled

A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects With Chronic Lymphocytic Leukemia.

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT04008706·552 enrolled

A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia

Active, not recruiting·AAcerta Pharma BV·Phase 3·NCT02477696·533 enrolled

A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib (ACP-196) in Combination With Obinutuzumab, and Acalabrutinib Monotherapy in Subjects With Previously Untreated CLL

Active, not recruiting·AAcerta Pharma BV·Phase 3·NCT02475681·535 enrolled

A Prospective, Open-label, Multicentre, Randomized, Phase-3-trial of Acalabrutinib, Obinutuzumab and Venetoclax (GAVE) Compared to Obinutuzumab and Venetoclax (GVE) in Previously Untreated Patients With High Risk Chronic Lymphocytic Leukemia (CLL)

Recruiting·GGerman CLL Study Group·Phase 3·NCT05197192·202 enrolled

A Phase II Study of Venetoclax (ABT-199) Consolidation for Patients Currently Receiving Ibrutinib or Acalabrutinib for High-risk CLL

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03128879·59 enrolled

A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia

Active, not recruiting·AAcerta Pharma BV·Phase 3·NCT02970318·310 enrolled

A Phase II Study Using ACP-196 (Acalabrutinib) in Patients With Relapsed/Refractory and Treatment-naïve Deletion 17p CLL/SLL: Pharmacodynamic Assessment of BTK Inhibition and Antitumor Response.

Completed·AAcerta Pharma BV·Phase 2·NCT02337829·48 enrolled

A Phase 1 Proof-of-Concept Study Investigating AZD6738 Monotherapy and Acalabrutinib in Combination With AZD6738 (ATR Inhibitor) in Subjects With Relapsed or Refractory High-risk Chronic Lymphocytic Leukemia (CLL)

Active, not recruiting·AAcerta Pharma BV·Phase 1·NCT03328273·12 enrolled

Randomized Phase 2 Study Comparing Acalabrutinib to Acalabrutinib and Obinutuzumab in the Treatment of Patients With Early-Stage Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Who Are at High Risk of Disease Progression

Recruiting·MMayo Clinic·Phase 2·NCT03516617·120 enrolled

Mantle Cell Lymphoma17 trials

Acalabrutinib for the Treatment of Ibrutinib-Intolerant Mantle Cell Lymphoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04189757·9 enrolled

Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT04402138·15 enrolled

Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Recruiting·—·Phase 2·NCT06054776·40 enrolled

Show 14 more trials

Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04662255·500 enrolled

A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Recruiting·GGuangzhou Lupeng Pharmaceutical Company LTD.·Phase 3·NCT07377578·394 enrolled

Acalabrutinib and Rituximab in Elderly Patients With Untreated Mantle Cell Lymphoma

Active, not recruiting·NNordic Lymphoma Group·Phase 2·NCT05214183·81 enrolled

Acalabrutinib Study in Indian Patients With Chronic Lymphocytic Leukaemia & Relapsed and Refractory Mantle Cell Lymphoma

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT04930536·103 enrolled

Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma

Recruiting·SSun Yat-sen University·Phase 2·NCT06846489·50 enrolled

A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Withdrawn·AAcerta Pharma BV·Phase 3·NCT02735876

Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT04566887·105 enrolled

Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma

Completed·WWashington University School of Medicine·Phase 2·NCT03623373·13 enrolled

Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Recruiting·—·Phase 2·NCT04484012·36 enrolled

The SOUND-MCL Study: A Single-arm, Open-label, Multicenter, Phase II Study of Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT07029737·55 enrolled

A Phase II Study of Modified VR-CAP and Acalabrutinib as First Line Therapy for Transplant-Eligible Patients With Mantle Cell Lymphoma

Active, not recruiting·AAcademic and Community Cancer Research United·Phase 2·NCT04626791·41 enrolled

A Phase II Study of Acalabrutinib Plus Rituximab in Previously Untreated Elderly Patients With Mantle Cell Lymphoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04765111·53 enrolled

A Phase II Study of BTK Inhibitor Acalabrutinib and PI3Kδ Inhibitor Umbralisib in Combination With Ublituximab (AU2) in Patients With Previously Untreated Mantle Cell Lymphoma (MCL)

Active, not recruiting·CCity of Hope Medical Center·Phase 2·NCT04783415·12 enrolled

Phase II Study of Acalabrutinib and Rituximab for Elderly or Frail Patients With Previously Untreated Mantle Cell Lymphoma

Active, not recruiting·UUniversity College, London·Phase 2·NCT05004064·48 enrolled

Lymphoma8 trials

Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma

Recruiting·JJonsson Comprehensive Cancer Center·Phase 1/2·NCT05256641·24 enrolled

Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas

Active, not recruiting·PPatrick C. Johnson, MD·Phase 2·NCT05583149·28 enrolled

Acalabrutinib and Duvelisib for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

Withdrawn·NNarendranath Epperla·Phase 1·NCT04836832

Show 5 more trials

Platform Study for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma (PRISM Study)

Completed·AAcerta Pharma BV·Phase 1·NCT03527147·30 enrolled

Acalabrutinib With Rituximab and Lenalidomide in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Completed·SSeoul National University Hospital·Phase 2·NCT04094142·66 enrolled

A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas

Active, not recruiting·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT04548648·10 enrolled

Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma

Terminated·UUniversity of Miami·Phase 2·NCT04189952·2 enrolled

A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05495464·22 enrolled

Relapsed/Refractory4 trials

Acalabrutinib in Combination With Anti-CD20 and Venetoclax in Relapsed/Refractory or Untreated CLL/SLL/PLL

Completed·AAcerta Pharma BV·Phase 1·NCT02296918·69 enrolled

Efficacy of Acalabrutinib in Very Old or Frail Patients With Treatment-naïve or Relapsed/Refractory CLL

Completed·GGerman CLL Study Group·Phase 2·NCT04883749·53 enrolled

Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients with Relapsed/refractory CLL

Completed·GGerman CLL Study Group·Phase 2·NCT03787264·46 enrolled

Show 1 more trial

Acalabrutinib Plus RICE for Relapsed/Refractory DLBCL

Unknown status·SSwedish Medical Center·Phase 2·NCT03736616·47 enrolled

COVID-194 trials

Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT04346199·177 enrolled

Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19

Terminated·AAcerta Pharma BV·Phase 1·NCT04497948·9 enrolled

Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT04380688·62 enrolled

Show 1 more trial

World Health Organization (WHO) COVID-19 Solidarity Trial for COVID-19 Treatments

Unknown status·TThe University of The West Indies·Phase 3·NCT04647669·100 enrolled

60 more indications

Diffuse Large B-Cell Lymphoma4 trials

Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04978584·62 enrolled

Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

Completed·AAcerta Pharma BV·Phase 1·NCT02112526·21 enrolled

A Prospective, Open-Label, Single-Arm, Phase II Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With Diffuse Large B-Cell Lymphoma (ACRUE)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05952024·80 enrolled

Show 1 more trial

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL

Active, not recruiting·AAcerta Pharma BV·Phase 3·NCT04529772·611 enrolled

CLL3 trials

Copanlisib Plus Ibrutinib or Acalabrutinib in R/R CLL

Withdrawn·IInhye Ahn·Phase 2·NCT04685915

Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL

Recruiting·MMassachusetts General Hospital·Phase 2·NCT04560322·40 enrolled

A Single Arm Study of Acalabrutinib Conbimed With Obinutuzumab in Chinese Patients With Previously Untreated CLL

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·N/A·NCT05950997·89 enrolled

Adult2 trials

A Study to Evaluate the Effect of [14C]Acp-196 (Acalabrutinib) in Healthy Adult Participants

Completed·AAcerta Pharma BV·Phase 1·NCT04898101·14 enrolled

A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and Its Active Metabolite (ACP-5862) When Administered Alone and With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole in Healthy Adult Participants

Completed·AAcerta Pharma BV·Phase 1·NCT05140096·30 enrolled

CLL/SLL2 trials

Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL

Recruiting·ZZulfa Omer·Phase 2·NCT07014917·62 enrolled

A Global Multicenter Open Label Randomized Phase III Confirmatory Study of Lisaftoclax (APG-2575) in Combination With Acalabrutinib vs Immunochemotherapy in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 3·NCT06319456·344 enrolled

Blood Cancer2 trials

A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.

Withdrawn·EEpizyme, Inc.·Phase 1/2·NCT05205252

AZD4573 in Novel Combinations With Anti-cancer Agents in Patients With Advanced Blood Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT04630756·40 enrolled

TED2 trials

Avo In R/R And Previously Untreated MCL

Recruiting·AAustin I Kim·Phase 1/2·NCT04855695·72 enrolled

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

Active, not recruiting·AAcerta Pharma BV·Phase 3·NCT02972840·635 enrolled

Chronic Lymphocytic Leukaemia2 trials

A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies

Recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT06564038·408 enrolled

A Multicentre, Open-label, Randomised Phase IV Study to Investigate Acalabrutinib Monotherapy Compared to Investigator's Choice of Treatment in Adults (> 18 Years) With Chronic Lymphocytic Leukaemia and Moderate to Severe Cardiac Impairment

Recruiting· AstraZeneca logo

AstraZeneca·Approved·NCT06651970·60 enrolled

Mantle Cell Lymphoma (MCL)2 trials

A Multicentre, Phase II, Open-label Study to Evaluate the Efficacy of Acalabrutinib in Combination With Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma (TrAVeRse)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05951959·108 enrolled

A Phase 1b, Multicenter, Open-label Study of Acalabrutinib in Combination With Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR) in Subjects With Mantle Cell Lymphoma

Active, not recruiting·AAcerta Pharma BV·Phase 1·NCT02717624·72 enrolled

Phase II1 trial

Assessing a ctDNA and PET-oriented Therapy in Patients With DLBCL A Multicenter, Open-label, Phase II Trial.

Active, not recruiting·SSwiss Cancer Institute·Phase 2·NCT04604067·260 enrolled

Immunotherapy1 trial

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

Active, not recruiting·AAcerta Pharma BV·Phase 3·NCT03836261·984 enrolled

Rheumatoid Arthritis1 trial

ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate

Completed·AAcerta Pharma BV·Phase 2·NCT02387762·31 enrolled

Chronic Graft Versus Host Disease1 trial

Acalabrutinib for the Treatment of Chronic Graft Versus Host Disease

Active, not recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT04198922·51 enrolled

B-cell Malignancies1 trial

Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies

Completed·AAcerta Pharma BV·Phase 1/2·NCT02328014·40 enrolled

Multiple Myeloma1 trial

An Open-Label, Phase 1b Study of Acalabrutinib With and Without Dexamethasone in Subjects With Multiple Myeloma

Completed·AAcerta Pharma BV·Phase 1·NCT02211014·27 enrolled

TIA1 trial

Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL

Active, not recruiting·—·Phase 2·NCT03580928·72 enrolled

Lymphoproliferative Disorder1 trial

Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder

Terminated·DDeepa Jagadeesh·Phase 2·NCT04337827·6 enrolled

Elective1 trial

A Study Of The Selective PKC-β Inhibitor MS- 553

Terminated·MMingSight Pharmaceuticals, Inc·Phase 1/2·NCT03492125·60 enrolled

Newly Diagnosed Patients1 trial

Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection or Early Treatment

Recruiting·RRigshospitalet, Denmark·Phase 2/3·NCT03868722·212 enrolled

Atrial Fibrillation1 trial

Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies

Not yet recruiting·UUniversity Hospital, Caen··NCT07283965·15,000 enrolled

Follicular Lymphoma1 trial

Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas

Recruiting·EEmory University·Phase 2·NCT04883437·49 enrolled

Relapsed/Refractory B-cell Malignancies1 trial

A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies

Terminated·AAcerta Pharma BV·Phase 1/2·NCT03205046·25 enrolled

MRD1 trial

Mosunetuzumab for CLL MRD Clearance

Recruiting·IInhye Ahn·Phase 1/2·NCT07052695·40 enrolled

Hematologic Malignancies1 trial

ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies

Completed·AAcerta Pharma BV·Phase 1/2·NCT02362035·161 enrolled

Ovarian Cancer1 trial

Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191)

Completed·AAcerta Pharma BV·Phase 2·NCT02537444·78 enrolled

Efficacy1 trial

Efficacy of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL

Not yet recruiting·RRuijin Hospital·Phase 2·NCT06441097·152 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma

Completed·AAcerta Pharma BV·Phase 2·NCT02454179·78 enrolled

B-cell NHL1 trial

A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL

Recruiting·BBioInvent International AB·Phase 1/2·NCT03571568·140 enrolled

Non-Small Cell Lung Cancer1 trial

Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer

Completed·AAcerta Pharma BV·Phase 2·NCT02448303·74 enrolled

High Risk1 trial

Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WINDOW-4 Study

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07257055·30 enrolled

Gastric Acid1 trial

A Study in Healthy Subjects to Assess Bioavailability (Proportion of a Drug Which Enters the Circulation to Have an Active Effect) of Acalabrutinib Tablet and Protonpump Inhibitor Effect (Members of a Class of Medications That Inhibits in Gastric Acid Production) for Rabeprazole

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04564040·20 enrolled

Leukemia1 trial

Acalabrutinib for GVHD Prophylaxis in Allogeneic Hematopoietic Stem Cell Transplantation in Lymphomas and Leukemia

Withdrawn·SShin Mineishi·Phase 1/2·NCT04961801

Oral1 trial

A Study to Evaluate Effects of Proton-pump Inhibitor on Acalabrutinib Capsule When Administered Orally With COCA-COLA in Healthy Participants

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04489797·35 enrolled

Hepatic Impairment1 trial

Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite

Completed·AAcerta Pharma BV·Phase 1·NCT03968848·16 enrolled

Lenalidomide1 trial

Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL

Active, not recruiting·WWeill Medical College of Cornell University·Phase 2·NCT03863184·37 enrolled

High Risk CLL1 trial

Early Intervention With Acalabrutinib in Patients With High Risk CLL

Withdrawn·WWeill Medical College of Cornell University·Phase 2·NCT04660045

Observational Study1 trial

Acalabrutinib Real World Italian obSErvational Study -ARISE

Active, not recruiting· AstraZeneca logo

AstraZeneca··NCT06205498·151 enrolled

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Recruiting·SSeema Bhat·Phase 2·NCT06757647·61 enrolled

Anaphylaxis1 trial

Preventing Anaphylaxis With Acalabrutinib

Completed·JJohns Hopkins University·Phase 2·NCT05038904·10 enrolled

Gastric1 trial

A Study to Evaluate the Effect of Gastric pH on Acalabrutinib Pharmacokinetics (PK) in Healthy Adult Participants

Completed·AAcerta Pharma BV·Phase 1·NCT04905043·12 enrolled

Relapse1 trial

Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL

Active, not recruiting·—·Phase 2·NCT04624633·29 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT)

Completed·PPolish Lymphoma Research Group·Phase 2·NCT04716075·29 enrolled

Trial1 trial

Public Health Emergency: SOLIDARITY TRIAL Philippines

Completed·UUniversity of the Philippines·N/A·NCT05024006·1,314 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL

Unknown status·KKartos Therapeutics, Inc.·Phase 1/2·NCT04502394·84 enrolled

Treatment1 trial

A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04722172·55 enrolled

Neuropathy1 trial

ACALA-R In Predominantly Demyelinating IgM Mediated Neuropathy

Active, not recruiting·—·Phase 2·NCT05065554·12 enrolled

Primary Central Nervous System Lymphoma1 trial

Phase I Study With Dose Expansion of Acalabrutinib and Durvalumab (MEDI 4736) in Primary and Secondary Central Nervous System Lymphoma

Active, not recruiting·WWashington University School of Medicine·Phase 1·NCT04462328·25 enrolled

Non-Hodgkins Lymphoma1 trial

A Phase 2 Study of Acalabrutinib With DA-EPOCH-R or R-CHOP for Patients With Untreated Diffuse Large B-cell Lymphoma

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04002947·132 enrolled

Waldenström Macroglobulinemia (WM)1 trial

An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia

Active, not recruiting·AAcerta Pharma BV·Phase 2·NCT02180724·107 enrolled

Liver Lymphoma1 trial

A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients </= 70 Years Old With Untreated Mantle Cell Lymphoma

Active, not recruiting·EECOG-ACRIN Cancer Research Group·Phase 2·NCT04115631·360 enrolled

Recurrent Chronic Lymphocytic Leukemia1 trial

A Randomized Phase II Study of Acalabrutinib (ACA) + Venetoclax (VEN) +/- Early Obinutuzumab (OBIN) for Patients With Chronic Lymphocytic Leukemia (CLL)

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04169737·168 enrolled

Waldenstrom macroglobulinemia1 trial

A Multi-Center, Open-Label, Single-Arm Phase II Trial of Bendamustine, Rituximab and the Second Generation BTK Inhibitor Acalabrutinib in Previously Untreated Waldenstrom's Macroglobulinemia

Active, not recruiting·SSunnybrook Health Sciences Centre·Phase 2·NCT04624906·63 enrolled

Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma1 trial

A Phase III Prospective, Multicenter, Randomized, Open-Label Trial of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05057494·607 enrolled

Ann Arbor Stage III Grade 1 Follicular Lymphoma1 trial

A Phase II Study of Acalabrutinib, Lenalidomide, and Rituximab (aR2) in Patients With Previously Untreated Follicular Lymphoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04404088·60 enrolled

Blastoid Variant Mantle Cell Lymphoma1 trial

An Open Label, Phase II Investigator Initiated Study of Venetoclax and Acalabrutinib in Previously Treated Relapsed/Refractory Patients With Mantle Cell Lymphoma (MCL)

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03946878·32 enrolled

Richter syndrome1 trial

A Phase II, Randomised Study of CHOP-R in Combination With Acalabrutinib Compared to CHOP-R in Patients With Newly Diagnosed Richter's Syndrome and a Platform for Initial Investigations Into Activity of Novel Treatments in Relapsed/Refractory and Newly Diagnosed Richter's Syndrome.

Active, not recruiting·UUniversity of Birmingham·Phase 2·NCT03899337·72 enrolled

Chronic Lymphocytic Leukemia (CLL)1 trial

The MAVRiC Study: A Phase II Study of Disease Risk Mutation Guided Finite Duration Acalabrutinib Plus Venetoclax for Relapse in CLL/SLL After First-line Finite Covalent BTKi Plus BCL2i Combination, With or Without Obinutuzumab

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT07024706·80 enrolled

Non-Hodgkin Lymphoma1 trial

An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma

Active, not recruiting·AAcerta Pharma BV·Preclinical·NCT02180711·113 enrolled

Part1: Advanced B-cell Malignancies1 trial

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Acalabrutinib, a Selective and Irreversible Bruton's Tyrosine Kinase Inhibitor, in Japanese Adult Patients With Advanced B-cell Malignancies

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT03198650·35 enrolled

B-cell Non Hodgkin Lymphoma1 trial

Acalabrutinib in Combination With Anti-CD19 Chimeric Antigen Receptor T-Cells (CART) in B-Cell Lymphoma

Active, not recruiting·UUniversity of Washington·Preclinical·NCT04257578·23 enrolled

Unspecified3 trials

Study of Acalabrutinib and Tafasitamab in MZL Patients

Active, not recruiting·IInternational Extranodal Lymphoma Study Group (IELSG)·Phase 2·NCT04646395·26 enrolled

Acalabrutinib in CNSL

Active, not recruiting·—·Phase 1/2·NCT04906902·49 enrolled

A Study of Acalabrutinib Suspension to Evaluate Relative Bioavailability and Proton-pump Inhibitor Effect in Healthy Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04435483·39 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 31, 2017

CALQUENCE

NDA NDA210259

Aug 3, 2022

CALQUENCE

NDA NDA216387

Sources

References

[1]
ClinicalTrials.gov — 133 trial records for ACALABRUTINIB. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Calquence drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — ACALABRUTINIB compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for ACALABRUTINIB. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216387). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Calquence. U.S. Food & Drug Administration.
[7]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tyrosine-Protein Kinase BTK Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AstraZeneca

Patent Landscape[6]

Patent Cliff

Nov 24, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7459554Nov 24, 2026

9290504Jul 11, 2032

10239883Jul 11, 2032

9758524Jul 11, 2032

11771696Jan 21, 2035

5 more patents

10272083Jan 21, 2035

11166951Aug 11, 2035

11059829Jul 1, 2036

10167291Jul 1, 2036

9796721Jul 1, 2036

Calquence

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Chronic Lymphocytic Leukemia27 trials

Mantle Cell Lymphoma17 trials

Lymphoma8 trials

Relapsed/Refractory4 trials

COVID-194 trials

Diffuse Large B-Cell Lymphoma4 trials

CLL3 trials

Adult2 trials

CLL/SLL2 trials

Blood Cancer2 trials

TED2 trials

Chronic Lymphocytic Leukaemia2 trials

Mantle Cell Lymphoma (MCL)2 trials

Phase II1 trial

Immunotherapy1 trial

Rheumatoid Arthritis1 trial

Chronic Graft Versus Host Disease1 trial

B-cell Malignancies1 trial

Multiple Myeloma1 trial

TIA1 trial

Lymphoproliferative Disorder1 trial

Elective1 trial

Newly Diagnosed Patients1 trial

Atrial Fibrillation1 trial

Follicular Lymphoma1 trial

Relapsed/Refractory B-cell Malignancies1 trial

MRD1 trial

Hematologic Malignancies1 trial

Ovarian Cancer1 trial

Efficacy1 trial

Head and Neck Squamous Cell Carcinoma1 trial

B-cell NHL1 trial

Non-Small Cell Lung Cancer1 trial

High Risk1 trial

Gastric Acid1 trial

Leukemia1 trial

Oral1 trial

Hepatic Impairment1 trial

Lenalidomide1 trial

High Risk CLL1 trial

Observational Study1 trial

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

Anaphylaxis1 trial

Gastric1 trial

Relapse1 trial

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Trial1 trial

Safety and Efficacy1 trial

Treatment1 trial

Neuropathy1 trial

Primary Central Nervous System Lymphoma1 trial

Non-Hodgkins Lymphoma1 trial

Waldenström Macroglobulinemia (WM)1 trial

Liver Lymphoma1 trial

Recurrent Chronic Lymphocytic Leukemia1 trial

Waldenstrom macroglobulinemia1 trial

Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma1 trial

Ann Arbor Stage III Grade 1 Follicular Lymphoma1 trial

Blastoid Variant Mantle Cell Lymphoma1 trial

Richter syndrome1 trial

Chronic Lymphocytic Leukemia (CLL)1 trial

Non-Hodgkin Lymphoma1 trial

Part1: Advanced B-cell Malignancies1 trial

B-cell Non Hodgkin Lymphoma1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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