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Drugs / Acalabrutinib
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Acalabrutinib

also known as ACP-196 · CALQUENCE · [14C]Acp-196 · ACA · ACALABRUTINIB MALEATE · Acalabrutinib maleate anhydrous · Acalabrutinib maleate monohydrate · Calquence (acalabrutinib) · +1 more

Small molecule targets BTK via inhibition

Developed for
chronic lymphocytic leukemia/small lymphocytic lymphoma · mantle cell lymphoma · B-cell chronic lymphocytic leukemia · diffuse large B-cell lymphoma · COVID-19 · Richter transformation · B-cell non-Hodgkin lymphoma · marginal zone lymphoma
+40 more · Waldenstrom macroglobulinemia · central nervous system non-hodgkin lymphoma · hematopoietic and lymphoid cell neoplasm · high grade B-cell lymphoma · plasma cell myeloma · primary mediastinal large B-cell lymphoma · chronic graft versus host disease · follicular lymphoma · indolent B-cell non-Hodgkin lymphoma · large B-cell lymphoma · malignant pancreatic neoplasm · non-Hodgkin lymphoma · primary central nervous system lymphoma · prolymphocytic leukemia · anti-HLA hyperimmunization · autoimmune hemolytic anemia, warm type · B-cell acute lymphoblastic leukemia · Burkitt lymphoma · diffuse large B-cell lymphoma activated B-cell type · food allergy · glioblastoma · hairy cell leukemia · head and neck squamous cell carcinoma · high-grade B-cell lymphoma double-hit/triple-hit · Hodgkins lymphoma · lymphoplasmacytic lymphoma · lymphoproliferative syndrome · monoclonal gammopathy of uncertain significance · neoplasm of mature B-cells · nodal marginal zone B-cell lymphoma · non-small cell lung carcinoma · ovarian cancer · peripheral neuropathy · platelet disorder, undefined · post-transplant lymphoproliferative disease · rheumatoid arthritis · splenic marginal zone lymphoma · T-cell/histiocyte rich large B cell lymphoma · urothelial carcinoma · refractory hematologic cancer
Investigated by
AstraZeneca · Acerta Pharma BV · National Cancer Institute (NCI) · M.D. Anderson Cancer Center · City of Hope Medical Center · Merck Sharp & Dohme LLC
+82 more · Genentech, Inc. · German CLL Study Group · Parexel · AbbVie · Dana-Farber Cancer Institute · Fred Hutchinson Cancer Center · HOVON Foundation · Mayo Clinic · National Institutes of Health (NIH) · University Hospital Southampton NHS Foundation Trust · Washington University School of Medicine · Weill Medical College of Cornell University · ADC Therapeutics S.A. · Academic Medical Center - University of Amsterdam · Academic and Community Cancer Research United · Apices Soluciones S.L. · Aprea Therapeutics · Ascentage Pharma Group Inc. · Austin I Kim · BioInvent International AB · Bloodwise · Celgene Corporation · Chang Gung Memorial Hospital · China Medical University Hospital · Deepa Jagadeesh · ECOG-ACRIN Cancer Research Group · Eli Lilly and Company · Emory University · French Innovative Leukemia Organisation · Imugene Limited · Incyte Corporation · International Extranodal Lymphoma Study Group (IELSG) · Jennifer R. Brown, MD, PhD · Johns Hopkins University · Jonsson Comprehensive Cancer Center · Karolinska Institutet · Kartos Therapeutics, Inc. · Kite, A Gilead Company · Massachusetts General Hospital · Memorial Sloan Kettering Cancer Center · Milton S. Hershey Medical Center · MingSight Pharmaceuticals, Inc · Narendranath Epperla · National Cheng-Kung University Hospital · National Health Research Institutes, Taiwan · National Taiwan University Hospital · Nordic Lymphoma Group · OHSU Knight Cancer Institute · Oregon Health and Science University · PETHEMA Foundation · Patrick C. Johnson, MD · Polish Lymphoma Research Group · Rigshospitalet, Denmark · Roche-Genentech · Ruijin Hospital · SCRI Development Innovations, LLC · Saarland University · Saarland University Medical Center · Seema Bhat · Seoul National University Hospital · Shayna Sarosiek, MD · Shin Mineishi · Sun Yat-sen University · Sunnybrook Health Sciences Centre · Swedish Medical Center · Swiss Cancer Institute · TG Therapeutics, Inc. · The First Affiliated Hospital of Soochow University · The First Affiliated Hospital with Nanjing Medical University · UNC Lineberger Comprehensive Cancer Center · University College, London · University Health Network, Toronto · University Hospital Giessen and Marburg · University Hospital Regensburg · all 88 on the full record

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed mantle cell lymphoma 2 milestones
Filed US (FDA) Calquence mantle cell lymphoma 2024-10-03

“AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted” astrazeneca.com ↗
Filed US (FDA) — mantle cell lymphoma 2017-08-02

“the US Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for acalabrutinib” astrazeneca.com ↗
Approved Indication not stated 3 milestones
Label expansions (3) US (FDA) CALQUENCE — 2019-11-21 – 2026-02-19 fda.gov ↗
Approved EU (EMA) Calquence — 2020-11-05 europa.eu ↗
Approved US (FDA) CALQUENCE — 2017-10-31 fda.gov ↗

Trials 141 · started per year

today
US approved 2017
EU approved 2020
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201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05495464 Nov 2022 → Mar 2027 expected mantle cell lymphoma M.D. Anderson Cancer Center Active not recruiting No outcome recorded
Phase 129 trials
Phase 1 NCT06675123 Jun 2026 → Mar 2028 expected mantle cell lymphoma City of Hope Medical Center Recruiting No outcome recorded
Phase 1 NCT05971251 Dec 2023 → Dec 2026 expected chronic lymphocytic leukemia/small lymphocytic lymphoma University of Alabama at Birmingham Active not recruiting No outcome recorded
Phase 1 NCT05943496 Oct 2023 → Jan 2027 expected B-cell chronic lymphocytic leukemia OHSU Knight Cancer Institute Recruiting No outcome recorded
Phase 1 NCT04836832 Jul 2022 → Dec 2023 follicular lymphoma, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma Narendranath Epperla Withdrawn No outcome recorded
Phase 1 NCT04462328 Apr 2021 → Dec 2026 expected primary central nervous system lymphoma Washington University School of Medicine Active not recruiting No outcome recorded
Phase 1 NCT04688151 Feb 2021 → Dec 2025 primary central nervous system lymphoma National Health Research Institutes, Taiwan Completed No outcome recorded
Phase 1 NCT04564040 Oct → Dec 2020 COVID-19, mantle cell lymphoma AstraZeneca Completed No outcome recorded
Phase 1 NCT04497948 Sep → Nov 2020 COVID-19 Acerta Pharma BV Terminated No outcome recorded
Phase 1 NCT04489797 Jul → Aug 2020 infectious disease AstraZeneca Completed No outcome recorded
Phase 1 NCT04488016 Jun 2020 → Jan 2021 B-cell neoplasm AstraZeneca Completed No outcome recorded
Phase 1/219 trials
Phase 1/2 NCT06564038 Jan 2025 → Jun 2029 expected chronic lymphocytic leukemia/small lymphocytic lymphoma, large B-cell lymphoma, mantle cell lymphoma AstraZeneca Recruiting No outcome recorded
Phase 1/2 NCT05256641 Jan 2023 → Jan 2027 expected central nervous system non-hodgkin lymphoma, high grade B-cell lymphoma Jonsson Comprehensive Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT04961801 Mar 2022 → Jan 2026 leukemia, lymphoma Shin Mineishi Withdrawn No outcome recorded Stop: Business
Phase 1/2 NCT04906902 Aug 2021 → Nov 2025 overdue central nervous system non-hodgkin lymphoma Dana-Farber Cancer Institute Active not recruiting No outcome recorded
Phase 1/2 NCT04855695 Jul 2021 → Jun 2027 expected mantle cell lymphoma Austin I Kim Recruiting No outcome recorded
Phase 1/2 NCT04419389 Mar → Aug 2021 chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma Aprea Therapeutics Terminated No outcome recorded Stop: Business
Phase 1/2 NCT04502394 Feb 2021 → Oct 2022 B-cell chronic lymphocytic leukemia, diffuse large B-cell lymphoma Kartos Therapeutics, Inc. Unknown No outcome recorded
Phase 1/2 NCT04630756 Feb 2021 → Sep 2023 hematopoietic and lymphoid cell neoplasm AstraZeneca Completed No outcome recorded
Phase 1/2 NCT04257578 Dec 2020 → Aug 2025 overdue high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma University of Washington Active not recruiting No outcome recorded
Phase 1/2 NCT03932331 Apr 2020 → Dec 2022 overdue B-cell chronic lymphocytic leukemia AstraZeneca Active not recruiting No outcome recorded
Phase 272 trials · 4 met primary · 4 missed
Phase 2 NCT07582159 Dec 2026 → Apr 2029 expected chronic lymphocytic leukemia/small lymphocytic lymphoma City of Hope Medical Center Not yet recruiting No outcome recorded
Phase 2 NCT07024706 Jun 2026 → May 2029 expected chronic lymphocytic leukemia/small lymphocytic lymphoma AstraZeneca Recruiting No outcome recorded
Phase 2 NCT07257055 Apr 2026 → Nov 2028 expected — M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT07029737 Sep 2025 → Dec 2027 expected mantle cell lymphoma AstraZeneca Recruiting No outcome recorded
Phase 2 NCT06839872 Jun 2025 → Jul 2028 chronic lymphocytic leukemia/small lymphocytic lymphoma AstraZeneca Withdrawn No outcome recorded
Phase 2 NCT06757647 May 2025 → Dec 2026 expected chronic lymphocytic leukemia/small lymphocytic lymphoma Seema Bhat Recruiting No outcome recorded
Phase 2 NCT06846489 Apr 2025 → Feb 2033 expected mantle cell lymphoma Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT06441097 Dec 2024 → Dec 2027 expected diffuse large B-cell lymphoma Ruijin Hospital Not yet recruiting No outcome recorded
Phase 2 NCT06054776 Dec 2024 → Oct 2026 expected mantle cell lymphoma City of Hope Medical Center Recruiting No outcome recorded
Phase 2 NCT05952024 Jul 2024 → Apr 2029 expected diffuse large B-cell lymphoma AstraZeneca Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03868722 Oct 2019 → Jul 2029 expected chronic lymphocytic leukemia/small lymphocytic lymphoma Rigshospitalet, Denmark Recruiting No outcome recorded
Phase 316 trials · 6 met primary
Phase 3 NCT07635511 Jun 2026 → Jan 2029 expected anti-HLA hyperimmunization, hematopoietic and lymphoid cell neoplasm, platelet disorder, undefined The First Affiliated Hospital of Soochow University Not yet recruiting No outcome recorded
Phase 3 NCT06428019 Aug 2024 → Mar 2028 expected B-cell chronic lymphocytic leukemia AbbVie Recruiting No outcome recorded
Phase 3 NCT06319456 Apr 2024 → Aug 2027 expected chronic lymphocytic leukemia/small lymphocytic lymphoma Ascentage Pharma Group Inc. Recruiting No outcome recorded
Phase 3 NCT05820841 Jun 2023 → Feb 2029 expected diffuse large B-cell lymphoma, large B-cell lymphoma Saarland University Recruiting No outcome recorded
Phase 3 NCT05057494 Sep 2022 → Jul 2027 expected chronic lymphocytic leukemia/small lymphocytic lymphoma AstraZeneca Active not recruiting No outcome recorded
Phase 3 NCT05197192 Apr 2022 → May 2028 expected B-cell chronic lymphocytic leukemia German CLL Study Group Recruiting No outcome recorded
Phase 3 NCT04529772 Oct 2020 → Feb 2027 expected diffuse large B-cell lymphoma Acerta Pharma BV Active not recruiting No outcome recorded
Phase 3 NCT04075292 Jan 2020 → Jan 2024 overdue chronic lymphocytic leukemia/small lymphocytic lymphoma AstraZeneca Active not recruiting Met primary
Phase 3 NCT04178798 Dec 2019 → Dec 2024 B-cell chronic lymphocytic leukemia PETHEMA Foundation Completed No outcome recorded
Phase 3 NCT04008706 Sep 2019 → Nov 2025 B-cell chronic lymphocytic leukemia AstraZeneca Completed No outcome recorded
Phase 41 trial
Phase 4 NCT04930536 Jul 2021 → May 2023 B-cell non-Hodgkin lymphoma AstraZeneca Completed No outcome recorded
Phase not applicable2 trials
— NCT05950997 Apr 2024 → May 2026 overdue chronic lymphocytic leukemia/small lymphocytic lymphoma The First Affiliated Hospital with Nanjing Medical University Recruiting No outcome recorded
— NCT05024006 Apr 2020 → Apr 2021 COVID-19 University of the Philippines Completed No outcome recorded
Comparator or background therapy16 trials
Phase 1/2 NCT07052695 Background Nov 2025 → Dec 2028 expected chronic lymphocytic leukemia/small lymphocytic lymphoma Inhye Ahn Recruiting No outcome recorded
Phase 1/2 NCT05205252 Comparator Dec 2021 → Jul 2023 refractory hematologic cancer Epizyme, Inc. Withdrawn No outcome recorded Stop: Business
Phase 2 NCT07014917 Background Dec 2025 → Jun 2028 expected chronic lymphocytic leukemia/small lymphocytic lymphoma Zulfa Omer Recruiting No outcome recorded
Phase 2 NCT06958705 Background Dec 2025 → Dec 2027 expected chronic lymphocytic leukemia/small lymphocytic lymphoma The First Affiliated Hospital with Nanjing Medical University Recruiting No outcome recorded
Phase 2 NCT06520098 Background Oct 2025 → Jun 2030 expected chronic lymphocytic leukemia/small lymphocytic lymphoma VA Office of Research and Development Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 72

DateIssuerRelease
2026-06-11 BioInvent International AB Results BioInvent’s BI-1206 Triplet Achieves 83% Response Rate in Refractory NHL with Improved Safety vs. SOC (EHA 2026) bioinvent.com ↗
Acalabrutinib (Calquence ® ) with BI-1206 + rituximab boosted efficacy without increasing toxicity
2026-04-19 Ascentage Pharma Group Inc. Results Ascentage Pharma to Present Four Promising Preclinical Studies Demonstrating the Potential of Combination Therapies at American Association for Cancer Research (AACR) 2026 Annual Meeting ascentage.com ↗
Multikinase inhibitor Olverembatinib (HQP1351) is efficacious and synergizes with BTK inhibitor acalabrutinib in mantle cell lymphoma (MCL) preclinical models
2026-03-17 Ascentage Pharma Group Inc. Results Ascentage Pharma to Present Data From Four Preclinical Studies In Its Innovative Pipeline at American Association of Cancer Research (AACR) Annual Meeting 2026 ascentage.com ↗
Multikinase inhibitor olverembatinib (HQP1351) is efficacious and synergizes with BTK inhibitor acalabrutinib in mantle cell lymph
2026-02-20 AstraZeneca Regulatory Calquence plus venetoclax approved in the US as first all-oral, fixed-duration combination for patients with chronic lymphocytic leukaemia in the 1st-line setting astrazeneca.com ↗
AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax has been approved in the US as the first all-oral, fixed-duration regimen for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
2026-02-20 AbbVie Regulatory U.S. Food and Drug Administration (FDA) Approves Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the combination regimen of VENCLEXTA® (venetoclax) and acalabrutinib for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL).
2026-02-19 Genentech, Inc. Regulatory FDA Approves Genentech’s Venclexta® Plus Acalabrutinib Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia gene.com ↗
FDA Approves Genentech’s Venclexta® Plus Acalabrutinib Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia
2025-12-08 BioInvent International AB Results BioInvent Presents Impressive Response Data from Ongoing Phase 2a Trial of Triple Combination BI-1206, Rituximab, and Calquence in r/r NHL at ASH 2025 bioinvent.com ↗
47% of patients exhibited complete responses (CR), with an overall response rate of 80%
2025-11-03 BioInvent International AB Results BioInvent to Present Early Phase 2a Data from Ongoing Trial with Triple Combination of BI-1206, Rituximab, and Calquence in r/r NHL, at ASH 2025 bioinvent.com ↗
Abstract data (as of August 4, 2025) published in the November supplemental issue of Blood demonstrates that the triple combination regimen is safe and well-tolerated, with encouraging efficacy data.
2025-07-29 AbbVie Regulatory AbbVie Submits for U.S. FDA Approval of Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗
2025-06-12 Janssen Research & Development, LLC Results Significant efficacy benefit of IMBRUVICA® (ibrutinib) plus venetoclax versus acalabrutinib plus venetoclax in frontline treatment of patients with chronic lymphocytic leukaemia suggested by indirect treatment comparison jnj.com ↗
The data were featured in a poster presentation at the 30thEuropean Hematology Association (EHA) Congress (Poster presentation #PF587) and reported that the I+V regimen yielded significantly better efficacy when compared to the A+V regimen.
2025-06-12 Janssen Research & Development, LLC Results Significant efficacy benefit of IMBRUVICA® (ibrutinib) plus venetoclax versus acalabrutinib plus venetoclax in frontline treatment of patients with chronic lymphocytic leukaemia suggested by indirect treatment comparison jnj.com ↗
The data were featured in a poster presentation at the 30th European Hematology Association (EHA) Congress (Poster presentation #PF587) and reported that the I+V regimen yielded significantly better efficacy when compared to the A+V regimen.
2025-06-06 AstraZeneca Regulatory Fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia in the 1st-line setting astrazeneca.com ↗
A fixed-duration regimen of AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, has been approved in the European Union (EU) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

All press releases naming this drug 77 releases

DateIssuerRelease

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 161 sources stand behind the page.

FieldValueCited text
Known as acalabrutinib “This study will be a 2-part, open-label, single-center relative bioavailability, PPI effect, food-effect and particle size effect randomized crossover study of acalabrutinib...” NCT04488016 ↗
146

“The irreversible Bruton's Tyrosine Kinase (BTK) inhibitor acalabrutinib (ACA) has potent clinical activity as a single agent in patients with treatment naive and...” NCT04963946 ↗

“Dose level 1 Rituximab 375mg/m2 infusion once every 4 weeks for 8 cycles Acalabrutinib 100mg PO once every day Durvalumab 1500mg infusion once every 4 weeks” NCT04688151 ↗

“Commercially available cBTKi (ibrutinib or acalabrutinib, or zanubrutinib) will be administered in accordance with its prescribing label.” NCT06524375 ↗

“Acalabrutinib (ACP-196) is a highly selective, potent Bruton tyrosine kinase inhibitor developed to minimise off-target activity.” PMID 29241979 ↗ Dec 2017

“a covalent BTK inhibitor (e.g., ibrutinib, acalabrutinib, zanubrutinib)” NCT06675123 ↗

NCT04604067 ↗

NCT04462328 ↗

NCT03516617 ↗

NCT02735876 ↗

NCT04630756 ↗

Show 136 more sources
Known as [14C]Acp-196 “Participants in Cohort 2 will receive a single 100 mL dose of acalabrutinib 1 mg/mL oral solution containing a microtracer dose (\<10 μg; ≤1 μCi) of \[14C\]ACP-196 on Day 1.” NCT04898101 ↗
Known as ACA “The irreversible Bruton's Tyrosine Kinase (BTK) inhibitor acalabrutinib (ACA) has potent clinical activity as a single agent in patients with treatment naive and...” NCT04963946 ↗
Known as ACALABRUTINIB MALEATE ChEMBL registry synonym — accepted as the source's own label CHEMBL3707348 ↗
Known as Acalabrutinib maleate anhydrous ChEMBL registry synonym — accepted as the source's own label CHEMBL3707348 ↗
Known as Acalabrutinib maleate monohydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL3707348 ↗
Known as ACP-196 “A Randomized, Multicenter, Open Label, Phase 3 Study of Acalabrutinib (ACP-196) in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib Alone in Subjects With...” NCT02735876 ↗
17

“Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL” NCT03836261 ↗

“The names of the study drugs involved in this study are/is: * Acalabrutinib (CALQUENCE®, ACP-196)” NCT04624633 ↗

“100 mg Acalabrutinib (ACP-196) oral capsules twice daily for 1 year” NCT04624906 ↗

“Acalabrutinib, or ACP-196, is a next generation BTK inhibitor” NCT05214183 ↗

“Acalabrutinib (ACP-196) Monotherapy” NCT02970318 ↗

“Acalabrutinib (ACP-196)” NCT02180724 ↗

NCT02362048 ↗

NCT02351739 ↗

NCT04876807 ↗

NCT04914936 ↗

Show 7 more sources
Known as CALQUENCE “The names of the study drugs involved in this study are/is: * Acalabrutinib (CALQUENCE®, ACP-196)” NCT04624633 ↗
1

“Acalabrutinib (CALQUENCE®) is a covalent BTK inhibitor” NCT04497948 ↗
Known as Calquence (acalabrutinib) “Calquence (acalabrutinib)” NCT03836261 ↗
Known as Calquence maleate ChEMBL registry synonym — accepted as the source's own label CHEMBL3707348 ↗
Action Inhibit “Acalabrutinib is an oral, highly selective BTK inhibitor” PMID 31876911 ↗ Apr 2020
Modality Small molecule “an oral, small-molecule BTK inhibitor” NCT02180724 ↗
Route Oral “Patients received 100 mg oral acalabrutinib twice per day” PMID 31866281 ↗ Dec 2019
Target BTK “Acalabrutinib is an oral, highly selective BTK inhibitor” PMID 31876911 ↗ Apr 2020