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 34 indications[4].[1]

Calquence is one of 674 small molecule programs targeting Hepatic failure. It is currently in Approved.

Indications

133

Total Trials

Active Trials

673

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Hepatic FailureApproved

Non-Hodgkins LymphomaApproved

MacroglobulinemiaActive, not recruiting

AnaphylaxisActive, not recruiting

Central Nervous System LymphomaActive, not recruiting

LymphomaActive, not recruiting

LeukemiaActive, not recruiting

Infectious DiseaseApproved

Chronic Graft Versus Host DiseaseActive, not recruiting

Childhood LeukemiaActive, not recruiting

Hepatic FailureApproved

Approved

Non-Hodgkins LymphomaApproved

Approved

MacroglobulinemiaPhase 2

Active, not recruiting

AnaphylaxisPhase 2

Active, not recruiting

Central Nervous System LymphomaPhase 1

Active, not recruiting

LymphomaPhase 2

Active, not recruiting

LeukemiaPhase 1/Phase 2

Active, not recruiting

Infectious DiseaseApproved

Approved

Chronic Graft Versus Host DiseasePhase 2

Active, not recruiting

Childhood LeukemiaApproved

Active, not recruiting

Showing 10 of 34 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Calquence

AstraZeneca

Approved

4 2

Bnt162b2

BioNTech

Preclinical

29 3

COVID-19 Vaccine

Moderna

Preclinical

27 4

Aimovig

Amgen

Preclinical

1 5

Nexavar

Bayer

Preclinical

1 6

Nitrostat

VViatris Specialty LLC

Preclinical

1 7

Calcium

Eli Lilly

Preclinical

—8

HB-Admscs

HHope Biosciences Research Foundation

Preclinical

4 9

Interferon-Gamma

SSPP Pharmaclon Ltd.

Preclinical

1 10

MRNA COVID-19 Vaccine

Novartis

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 1Active, not recruiting

Chronic Lymphocytic Leukemia

NCT03328273

Phase 2Active, not recruiting

Mantle Cell Lymphoma

NCT04765111

Phase 2Recruiting

Mantle Cell Lymphoma

NCT04484012

Phase 1/2Recruiting

B-Cell NHL

NCT03571568

N/ARecruiting

CLL

NCT05950997

Q4 2026

Phase 2Recruiting

Mantle Cell Lymphoma

NCT06054776

Clinical

Trials by Indication[1]

Chronic Lymphocytic Leukemia23 trials

Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT04008706·552 enrolled

Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)

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

Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04075292·155 enrolled

Show 20 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 in Combination With ACP-319, for Treatment of Chronic Lymphocytic Leukemia

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

A Study 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

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 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

Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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

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

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

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

A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

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

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 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

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 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

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 Lymphoma22 trials

Acalabrutinib and Rituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma

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

Venetoclax and Acalabrutinib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

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

Show 19 more trials

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

Recruiting·—·Phase 2·NCT06054776·40 enrolled

A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma

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

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

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

Acalabrutinib and Rituximab in Elderly Patients With Untreated Mantle Cell Lymphoma

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

A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL

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

Acalabrutinib for the Treatment of Ibrutinib-Intolerant Mantle Cell Lymphoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04189757·9 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, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma

Active, not recruiting·—·Phase 2·NCT04783415·12 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

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

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 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

A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05951959·108 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

Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma

Recruiting·—·Phase 2·NCT04626791·45 enrolled

Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma

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

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

Lymphoma7 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

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

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

Show 4 more trials

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

Withdrawn·NNarendranath Epperla·Phase 1·NCT04836832

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

Terminated·UUniversity of Miami·Phase 2·NCT04189952·2 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 Maintenance for the Treatment of Patients With Large B-cell Lymphoma

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

Relapsed/Refractory5 trials

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

Acalabrutinib Plus RICE for Relapsed/Refractory DLBCL

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

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

Show 2 more trials

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

Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL

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

CLL5 trials

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

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

Copanlisib Plus Ibrutinib or Acalabrutinib in R/R CLL

Withdrawn·IInhye Ahn·Phase 2·NCT04685915

Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03128879·90 enrolled

Show 2 more trials

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

A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL

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

56 more indications

COVID-194 trials

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

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

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

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

Show 1 more trial

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

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

Follicular Lymphoma2 trials

Acalabrutinib, Lenalidomide, and Rituximab for the Treatment of CD20 Positive Stage III-IV, Grade 1-3a Follicular Lymphoma

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

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

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

Macroglobulinemia2 trials

Bendamustine, Rituximab and Acalabrutinib in Waldenstrom's Macroglobulinemia

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

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

High Risk CLL2 trials

Early Intervention With Acalabrutinib in Patients With High Risk CLL

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

A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL

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

Treatment2 trials

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL

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

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

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

Anaphylaxis1 trial

Preventing Anaphylaxis With Acalabrutinib

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

Elective1 trial

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

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

Chronic Lymphocytic Leukaemia1 trial

Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom

Recruiting· AstraZeneca logo

AstraZeneca··NCT05557695·350 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

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

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

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

Rheumatoid Arthritis1 trial

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

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

MRD1 trial

Mosunetuzumab for CLL MRD Clearance

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

CLL/SLL1 trial

Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL

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

Mature B-cell Malignancies1 trial

A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies

Recruiting· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT06564038·276 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

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

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

Richter's Syndrome1 trial

A Trial of CHOP-R Therapy, With or Without Acalabrutinib, in Patients With Newly Diagnosed Richter's Syndrome

Recruiting·UUniversity of Birmingham·Phase 2·NCT03899337·105 enrolled

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

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

Lenalidomide1 trial

Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL

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

Observational Study1 trial

Acalabrutinib Real World Italian obSErvational Study -ARISE

Active, not recruiting· AstraZeneca logo

AstraZeneca··NCT06205498·151 enrolled

Leukemia1 trial

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

Withdrawn·SShin Mineishi·Phase 1/2·NCT04961801

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

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

Neuropathy1 trial

ACALA-R In Predominantly Demyelinating IgM Mediated Neuropathy

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

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

Immunochemotherapy1 trial

A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.

Recruiting· Ascentage Pharma Group Inc. logo

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

Lymphoproliferative Disorder1 trial

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

Terminated·DDeepa Jagadeesh·Phase 2·NCT04337827·6 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

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

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

Central Nervous System Lymphoma1 trial

Acalabrutinib and Durvalumab in Primary and Secondary Central Nervous System Lymphoma

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

Trial1 trial

Public Health Emergency: SOLIDARITY TRIAL Philippines

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

Heart Failure1 trial

Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure

Recruiting· AstraZeneca logo

AstraZeneca·Phase 4·NCT06651970·60 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

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

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-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

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

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

Study of Acalabrutinib and Tafasitamab in MZL Patients

Active, not recruiting·IInternational Extranodal Lymphoma Study Group (IELSG)·Phase 2·NCT04646395·26 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 Leukemia23 trials

Mantle Cell Lymphoma22 trials

Lymphoma7 trials

Relapsed/Refractory5 trials

CLL5 trials

COVID-194 trials

Diffuse Large B-Cell Lymphoma4 trials

Follicular Lymphoma2 trials

Blood Cancer2 trials

Macroglobulinemia2 trials

High Risk CLL2 trials

TED2 trials

Treatment2 trials

Adult2 trials

Anaphylaxis1 trial

Multiple Myeloma1 trial

TIA1 trial

Elective1 trial

Chronic Lymphocytic Leukaemia1 trial

Phase II1 trial

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

B-cell Malignancies1 trial

Relapsed/Refractory B-cell Malignancies1 trial

Rheumatoid Arthritis1 trial

MRD1 trial

CLL/SLL1 trial

Mature B-cell Malignancies1 trial

Hematologic Malignancies1 trial

Chronic Graft Versus Host Disease1 trial

Newly Diagnosed Patients1 trial

Richter's Syndrome1 trial

Oral1 trial

Hepatic Impairment1 trial

Atrial Fibrillation1 trial

Lenalidomide1 trial

Observational Study1 trial

Leukemia1 trial

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

High Risk1 trial

Neuropathy1 trial

Gastric Acid1 trial

Ovarian Cancer1 trial

Immunochemotherapy1 trial

Lymphoproliferative Disorder1 trial

Immunotherapy1 trial

Safety and Efficacy1 trial

Efficacy1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Central Nervous System Lymphoma1 trial

Trial1 trial

B-cell NHL1 trial

Non-Small Cell Lung Cancer1 trial

Heart Failure1 trial

Gastric1 trial

Relapse1 trial

Non-Hodgkin Lymphoma1 trial

Chronic Lymphocytic Leukemia (CLL)1 trial

Non-Hodgkins 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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