Drugs / Acalabrutinib
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
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 140 · started per year
today
US approved 2017
EU approved 2020
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 128 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| follicular lymphoma, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma | Narendranath Epperla | Withdrawn | No outcome recorded |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 → Aug 2026 overdue | primary central nervous system lymphoma | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04688151 | Feb 2021 → Dec 2025 overdue | primary central nervous system lymphoma | National Health Research Institutes, Taiwan | Active not recruiting | 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 | NCT04435483 | May → Jun 2020 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05140096 | Jan → Apr 2020 | — | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT03968848 | Nov 2018 → Mar 2019 | liver disorder | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT03527147 | Jun 2018 → Mar 2021 | diffuse large B-cell lymphoma | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT03328273 | Jan 2018 → Sep 2021 overdue | B-cell chronic lymphocytic leukemia | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03198650 | Jun 2017 → Oct 2022 | B-cell chronic lymphocytic leukemia | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04905043 | Jun → Jul 2016 | — | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT02717624 | Apr 2016 → Jun 2022 overdue | mantle cell lymphoma | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04867980 | Apr → May 2016 | — | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT04898101 | Mar → Apr 2016 | — | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT04876807 | Jan → Mar 2016 | — | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT02211014 | Feb 2015 → Apr 2019 | plasma cell myeloma | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT02296918 | Dec 2014 → Aug 2021 | chronic lymphocytic leukemia/small lymphocytic lymphoma, prolymphocytic leukemia | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT04867941 | Oct 2014 → Feb 2015 | liver disorder | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT04914936 | Sep → Oct 2014 | — | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT02157324 | Aug 2014 → Jul 2020 overdue | B-cell chronic lymphocytic leukemia | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02112526 | Aug 2014 → Jun 2020 | diffuse large B-cell lymphoma activated B-cell type | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT04901923 | Mar → May 2014 | — | Acerta Pharma BV | 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 |
| 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 |
| 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 1/2 | NCT03492125 | May 2018 → Nov 2023 | chronic lymphocytic leukemia/small lymphocytic lymphoma | MingSight Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 1/2 | NCT03571568 | May 2018 → Sep 2026 expected | indolent B-cell non-Hodgkin lymphoma | BioInvent International AB | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03205046 | Jun 2017 → Nov 2019 | Richter transformation, diffuse large B-cell lymphoma | Acerta Pharma BV | Terminated | No outcome recorded |
| Phase 1/2 | NCT03571308 | Jun 2017 → Jan 2020 | non-Hodgkin lymphoma | University Hospital Southampton NHS Foundation Trust | Completed | No outcome recorded |
| Phase 1/2 | NCT02586857 | Jan 2016 → Jun 2020 overdue | glioblastoma | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02362035 | Feb 2015 → Jul 2020 | Burkitt lymphoma, Hodgkins lymphoma, Richter transformation, Waldenstrom macroglobulinemia +7 | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1/2 | NCT02180711 | Dec 2014 → Aug 2023 overdue | B-cell non-Hodgkin lymphoma | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02328014 | Dec 2014 → Jun 2020 | non-Hodgkin lymphoma, plasma cell myeloma | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1/2 | NCT02029443 | Jan 2014 → Jul 2021 overdue | Richter transformation, chronic lymphocytic leukemia/small lymphocytic lymphoma, prolymphocytic leukemia | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 272 trials | ||||||
| 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 → Jun 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 | NCT05951959 | Dec 2023 → Oct 2028 expected | mantle cell lymphoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05004064 | Nov 2023 → Jun 2026 overdue | mantle cell lymphoma | University College, London | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04941716 | May 2023 → Aug 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Fred Hutchinson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05583149 | Mar 2023 → Nov 2024 overdue | T-cell/histiocyte rich large B cell lymphoma, high grade B-cell lymphoma, high-grade B-cell lymphoma double-hit/triple-hit, indolent B-cell non-Hodgkin lymphoma +1 | Patrick C. Johnson, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05388006 | Jan 2023 → Feb 2027 expected | Richter transformation, chronic lymphocytic leukemia/small lymphocytic lymphoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT04660045 | May 2022 → Jan 2026 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Weill Medical College of Cornell University | Withdrawn | No outcome recorded |
| Phase 2 | NCT04978584 | Mar 2022 → Jan 2027 expected | diffuse large B-cell lymphoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05038904 | Dec 2021 → Dec 2022 | food allergy | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT05214183 | Dec 2021 → Jan 2027 expected | mantle cell lymphoma | Nordic Lymphoma Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05065554 | Nov 2021 → Dec 2026 expected | Waldenstrom macroglobulinemia, monoclonal gammopathy of uncertain significance, peripheral neuropathy | Shayna Sarosiek, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04646395 | Oct 2021 → Sep 2027 expected | marginal zone lymphoma | International Extranodal Lymphoma Study Group (IELSG) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04546620 | Oct 2021 → Nov 2027 expected | diffuse large B-cell lymphoma | University Hospital Southampton NHS Foundation Trust | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04963946 | Oct 2021 → Aug 2025 overdue | B-cell chronic lymphocytic leukemia | French Innovative Leukemia Organisation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04883437 | Sep 2021 → Sep 2026 expected | lymphoplasmacytic lymphoma, lymphoproliferative syndrome, mantle cell lymphoma, marginal zone lymphoma +1 | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT04626791 | Aug 2021 → Aug 2024 overdue | mantle cell lymphoma | Academic and Community Cancer Research United | Recruiting | No outcome recorded |
| Phase 2 | NCT04765111 | Jun 2021 → Aug 2026 overdue | mantle cell lymphoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04604067 | Jun 2021 → Jul 2026 overdue | diffuse large B-cell lymphoma | Swiss Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04883749 | Jun 2021 → May 2025 | chronic lymphocytic leukemia/small lymphocytic lymphoma | German CLL Study Group | Completed | No outcome recorded |
| Phase 2 | NCT04722172 | May 2021 → Feb 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04783415 | Mar 2021 → Jul 2022 overdue | mantle cell lymphoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04657094 | Mar 2021 → Apr 2023 overdue | autoimmune hemolytic anemia, warm type, chronic lymphocytic leukemia/small lymphocytic lymphoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04624906 | Mar 2021 → Dec 2025 overdue | Waldenstrom macroglobulinemia | Sunnybrook Health Sciences Centre | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04566887 | Mar 2021 → Sep 2028 expected | mantle cell lymphoma | University Health Network, Toronto | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04484012 | Dec 2020 → Sep 2026 expected | mantle cell lymphoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04523428 | Dec 2020 → Dec 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | HOVON Foundation | Recruiting | No outcome recorded |
| Phase 2 | NCT04624633 | Dec 2020 → Dec 2023 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | Jennifer R. Brown, MD, PhD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04198922 | Dec 2020 → Sep 2025 overdue | chronic graft versus host disease, hematopoietic and lymphoid cell neoplasm | Fred Hutchinson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04560322 | Oct 2020 → Mar 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04548648 | Oct 2020 → May 2025 overdue | central nervous system non-hodgkin lymphoma | UNC Lineberger Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04189952 | Sep 2020 → Jun 2021 | chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma, marginal zone lymphoma | University of Miami | Terminated | No outcome recorded |
| Phase 2 | NCT04337827 | Sep 2020 → Jun 2022 | post-transplant lymphoproliferative disease | Deepa Jagadeesh | Terminated | No outcome recorded |
| Phase 2 | NCT04505254 | Aug 2020 → Jun 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04402138 | Aug 2020 → Apr 2024 | mantle cell lymphoma | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04189757 | Aug 2020 → Jun 2027 expected | mantle cell lymphoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04169737 | Jul 2020 → Jul 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04404088 | Jul 2020 → Mar 2028 expected | B-cell non-Hodgkin lymphoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04380688 | Jun → Nov 2020 | COVID-19 | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT04346199 | Jun → Nov 2020 | COVID-19 | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT04115631 | Dec 2019 → Dec 2026 expected | liver lymphoma, mantle cell lymphoma | ECOG-ACRIN Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03863184 | Oct 2019 → Apr 2024 overdue | mantle cell lymphoma | Weill Medical College of Cornell University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04716075 | Aug 2019 → Jun 2024 | B-cell chronic lymphocytic leukemia, chronic graft versus host disease, mantle cell lymphoma | Polish Lymphoma Research Group | Completed | No outcome recorded |
| Phase 2 | NCT03736616 | Aug 2019 → Sep 2023 | diffuse large B-cell lymphoma | Swedish Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT03946878 | Aug 2019 → Feb 2028 expected | mantle cell lymphoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04002947 | Aug 2019 → May 2027 expected | diffuse large B-cell lymphoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT03899337 | Jul 2019 → Oct 2025 overdue | Richter transformation | University of Birmingham | Recruiting | No outcome recorded |
| Phase 2 | NCT04094142 | Jul 2019 → May 2022 | B-cell non-Hodgkin lymphoma | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03788291 | Mar 2019 → May 2023 | chronic lymphocytic leukemia/small lymphocytic lymphoma | University of Rochester | Completed | No outcome recorded |
| Phase 2 | NCT03787264 | Jan 2019 → Feb 2021 | chronic lymphocytic leukemia/small lymphocytic lymphoma | German CLL Study Group | Completed | No outcome recorded |
| Phase 2 | NCT03623373 | Nov 2018 → Feb 2020 | mantle cell lymphoma | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT03516617 | Sep 2018 → Mar 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT03580928 | Aug 2018 → Apr 2024 overdue | B-cell chronic lymphocytic leukemia | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02717611 | Mar 2016 → Oct 2020 overdue | B-cell chronic lymphocytic leukemia | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02537444 | Nov 2015 → Jul 2018 | ovarian cancer | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 2 | NCT02570711 | Oct 2015 → Apr 2016 | malignant pancreatic neoplasm | Acerta Pharma BV | Terminated | No outcome recorded |
| Phase 2 | NCT02448303 | May 2015 → Mar 2018 | non-small cell lung carcinoma | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 2 | NCT02454179 | May 2015 → May 2018 | head and neck squamous cell carcinoma | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 2 | NCT02362048 | May 2015 → Mar 2017 | malignant pancreatic neoplasm | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 2 | NCT02387762 | Apr 2015 → May 2016 | rheumatoid arthritis | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 2 | NCT02351739 | Apr 2015 → Feb 2018 | urothelial carcinoma | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 2 | NCT02213926 | Mar 2015 → Dec 2020 overdue | mantle cell lymphoma | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02337829 | Jan 2015 → Jun 2020 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 2 | NCT02180724 | Sep 2014 → Oct 2019 overdue | Waldenstrom macroglobulinemia | Acerta Pharma BV | Active not 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 | ||||||
| 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 | No outcome recorded |
| 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 3 | NCT03836261 | Feb 2019 → Jan 2027 expected | B-cell chronic lymphocytic leukemia | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02972840 | Apr 2017 → Feb 2027 expected | mantle cell lymphoma | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02970318 | Feb 2017 → Sep 2021 overdue | B-cell chronic lymphocytic leukemia | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02735876 | May 2016 → Jun 2020 | mantle cell lymphoma | Acerta Pharma BV | Withdrawn | No outcome recorded |
| Phase 3 | NCT02477696 | Jul 2015 → Sep 2020 overdue | B-cell chronic lymphocytic leukemia | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02475681 | Jun 2015 → Feb 2019 overdue | B-cell chronic lymphocytic leukemia | Acerta Pharma BV | Active not recruiting | 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 |
Also used as a comparator or background therapy in 16 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 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 |
| Phase 28 trials | ||||||
| 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 |
| Phase 2 | NCT06524375 Background | Aug 2024 → Oct 2026 expected | B-cell chronic lymphocytic leukemia | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05336812 Background | Sep 2022 → Oct 2026 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Ohio State University Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04685915 Background | Feb 2021 → Mar 2023 | B-cell chronic lymphocytic leukemia | Inhye Ahn | Withdrawn | No outcome recorded |
| Phase 2 | NCT04016805 Background | Aug 2019 → May 2022 | chronic lymphocytic leukemia/small lymphocytic lymphoma | TG Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03128879 Background | Jun 2017 → May 2027 expected | B-cell chronic lymphocytic leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07377578 Comparator | Feb 2026 → May 2031 expected | mantle cell lymphoma | Guangzhou Lupeng Pharmaceutical Company LTD. | Recruiting | No outcome recorded |
| Phase 3 | NCT07277231 Comparator | Jan 2026 → Feb 2031 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 3 | NCT06136559 Comparator | Dec 2023 → Sep 2032 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT04647669 Comparator | Jun → Nov 2021 | COVID-19 | The University of The West Indies | Unknown | No outcome recorded |
| Phase 3 | NCT04662255 Comparator | Apr 2021 → Jan 2027 expected | mantle cell lymphoma | Loxo Oncology, Inc. | Active not recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06651970 Comparator | Feb 2025 → Aug 2030 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma, heart failure | AstraZeneca | Recruiting | No outcome recorded |
Press releases naming this drug 13 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-20 | AstraZeneca | 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 ↗ |
| 2026-02-20 | AbbVie | 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 ↗ |
| 2025-07-29 | AbbVie | 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 ↗ |
| 2025-06-06 | AstraZeneca | Fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia in the 1st-line setting astrazeneca.com ↗ |
| 2025-05-06 | AstraZeneca | Calquence plus chemoimmunotherapy approved in the EU as first and only BTK inhibitor for 1st-line mantle cell lymphoma astrazeneca.com ↗ |
| 2025-04-29 | AstraZeneca | Fixed-duration Calquence-based regimens recommended for approval in the EU by CHMP for 1st-line chronic lymphocytic leukaemia astrazeneca.com ↗ |
| 2025-03-31 | AstraZeneca | Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for 1st-line mantle cell lymphoma astrazeneca.com ↗ |
| 2025-01-17 | AstraZeneca | Calquence plus chemoimmunotherapy approved in the US for patients with previously untreated mantle cell lymphoma astrazeneca.com ↗ |
| 2024-12-08 | AstraZeneca | Fixed-duration Calquence plus venetoclax demonstrated superior progression-free survival vs. standard of care in previously untreated chronic lymphocytic leukaemia, with 77% of patients progression free at three years in AMPLIFY Phase III trial astrazeneca.com ↗ |
| 2024-10-03 | AstraZeneca | Calquence granted Priority Review in the US for patients with untreated mantle cell lymphoma astrazeneca.com ↗ |
| 2024-07-29 | AstraZeneca | Fixed-duration Calquence plus venetoclax, with or without obinutuzumab, significantly improved progression-free survival in 1st-line chronic lymphocytic leukaemia in AMPLIFY Phase III trial astrazeneca.com ↗ |
| 2024-06-16 | AstraZeneca | Calquence plus chemoimmunotherapy reduced the risk of disease progression or death by 27% vs. standard of care in patients with untreated mantle cell lymphoma in ECHO Phase III trial astrazeneca.com ↗ |
| 2024-05-02 | AstraZeneca | Calquence combination regimen demonstrated statistically significant and clinically meaningful improvement in progression-free survival in 1st-line mantle cell lymphoma in ECHO Phase III trial astrazeneca.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 160 sources stand behind the page.
| Field | Value | Cited 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 ↗145“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 ↗ |
| 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 ↗ |
| 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 |