Drugs / Copanlisib
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Copanlisib

Small molecule targets PIK3CA, PIK3CD via inhibition

Developed for
non-Hodgkin lymphoma · diffuse large B-cell lymphoma · follicular lymphoma · metastatic malignant neoplasm · neoplasm · female breast carcinoma · plasma cell myeloma · HER2 positive breast carcinoma
+61 more · invasive breast carcinoma · mantle cell lymphoma · adult lymphoma · B-cell chronic lymphocytic leukemia · cancer · chronic lymphocytic leukemia/small lymphocytic lymphoma · endometrial cancer · estrogen-receptor positive breast cancer · head and neck squamous cell carcinoma · Her2-receptor negative breast cancer · indolent B-cell non-Hodgkin lymphoma · marginal zone lymphoma · non-small cell lung carcinoma · ovarian serous adenocarcinoma · primary peritoneal serous adenocarcinoma · progesterone-receptor positive breast cancer · prostate carcinoma · refractory malignant neoplasm · adult acute lymphoblastic leukemia · bone cancer · breast adenocarcinoma · Burkitt lymphoma · cholangiocarcinoma · colorectal cancer · diffuse large B-cell lymphoma germinal center B-cell type · endometrial endometrioid adenocarcinoma · endometrial mixed adenocarcinoma · endometrial serous adenocarcinoma · endometrial undifferentiated carcinoma · endometrium adenocarcinoma · Ewing sarcoma · fallopian tube carcinoma · fallopian tube endometrioid adenocarcinoma · fallopian tube serous adenocarcinoma · gallbladder carcinoma · hepatocellular carcinoma · high grade B-cell lymphoma · high grade malignant neoplasm · Hodgkins lymphoma · hormone receptor-positive breast cancer · lymphoma · lymphoplasmacytic lymphoma · mycosis fungoides · neoplasm of mature T-cells or NK-cells · neuroblastoma · nodal marginal zone B-cell lymphoma · osteosarcoma · ovarian cancer · ovarian endometrioid adenocarcinoma · primary central nervous system lymphoma · primary mediastinal large B-cell lymphoma · prostate cancer · rhabdomyosarcoma · Richter transformation · T-cell non-Hodgkin lymphoma · T-cell/histiocyte rich large B cell lymphoma · thyroid gland follicular carcinoma · thyroid gland papillary carcinoma · triple-negative breast carcinoma · urothelial carcinoma · peripheral T-cell lymphoma, not otherwise specified
Investigated by
Bayer · National Cancer Institute (NCI) · Memorial Sloan Kettering Cancer Center · M.D. Anderson Cancer Center · Bristol-Myers Squibb · Cancer Trials Ireland
+38 more · City of Hope Medical Center · Columbia University · NRG Oncology · University of Washington · AbbVie · Big Ten Cancer Research Consortium · Brown University · Celltrion Healthcare Co., LTD · Chonnam National University Hospital · Christian Buske · Clovis Oncology, Inc. · Consortium for Improving Survival of Lymphoma · Dana-Farber Cancer Institute · Dorothy Sipkins, MD, PhD · Fondazione Italiana Linfomi - ETS · H. Lee Moffitt Cancer Center and Research Institute · Inhye Ahn · Jonsson Comprehensive Cancer Center · Ludwig-Maximilians - University of Munich · Mayo Clinic · OHSU Knight Cancer Institute · Optimapharm · Oregon Health and Science University · Rhode Island Hospital · Roche Pharma AG · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Swiss Cancer Institute · The Miriam Hospital · Translational Research in Oncology · UNICANCER · University Hospital Muenster · University of Michigan · University of Michigan Rogel Cancer Center · University of Ulm · VA Office of Research and Development · X-act Cologne Clinical Research GmbH · Zentrum für Klinische Studien Ulm · Zhonglin Hao

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) ALIQOPA 2017-09-14 fda.gov

Trials 73 · started per year

today
US approved 2017
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201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT04803123 Jun 2021 → Apr 2023 adult acute lymphoblastic leukemia Dorothy Sipkins, MD, PhD Terminated No outcome recorded
Phase 131 trials
Phase 1 NCT04933617 Mar 2022 → Nov 2023 Burkitt lymphoma, T-cell/histiocyte rich large B cell lymphoma, diffuse large B-cell lymphoma germinal center B-cell type, high grade B-cell lymphoma National Cancer Institute (NCI) Terminated No outcome recorded
Phase 1 NCT05010096 Mar 2022 bone cancer, high grade malignant neoplasm, metastatic malignant neoplasm M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 1 NCT04895579 May 2021 → Nov 2025 non-small cell lung carcinoma Zhonglin Hao Completed No outcome recorded
Phase 1 NCT04462471 Jun 2020 → Sep 2023 thyroid gland follicular carcinoma, thyroid gland papillary carcinoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1 NCT03939897 Jun 2020 → Jun 2023 overdue female breast carcinoma, hormone receptor-positive breast cancer National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 1 NCT04431635 Jun 2020 → Nov 2023 indolent B-cell non-Hodgkin lymphoma University of Michigan Rogel Cancer Center Terminated No outcome recorded
Phase 1 NCT03878524 Apr → Dec 2020 acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 OHSU Knight Cancer Institute Terminated No outcome recorded
Phase 1 NCT04156828 Mar 2020 → Apr 2022 diffuse large B-cell lymphoma, follicular lymphoma University of Washington Terminated No outcome recorded
Phase 1 NCT04233697 Feb 2020 → Jul 2022 T-cell non-Hodgkin lymphoma Columbia University Withdrawn No outcome recorded
Phase 1 NCT03842228 Nov 2019 → Jul 2024 overdue metastatic malignant neoplasm National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 1/216 trials
Phase 1/2 NCT05687721 Jun 2025 urothelial carcinoma VA Office of Research and Development Withdrawn No outcome recorded
Phase 1/2 NCT06218667 Jan 2024 → Jan 2027 prostate cancer Memorial Sloan Kettering Cancer Center Withdrawn No outcome recorded
Phase 1/2 NCT04939272 Jun 2022 → Feb 2027 expected mantle cell lymphoma City of Hope Medical Center Active not recruiting No outcome recorded
Phase 1/2 NCT04572763 Sep 2021 → Jul 2025 overdue diffuse large B-cell lymphoma Dana-Farber Cancer Institute Active not recruiting No outcome recorded
Phase 1/2 NCT04108858 May 2021 → Apr 2022 HER2 positive breast carcinoma National Cancer Institute (NCI) Terminated No outcome recorded
Phase 1/2 NCT04345913 Mar 2021 → Mar 2024 overdue female breast carcinoma, triple-negative breast carcinoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 1/2 NCT04317105 Jul 2020 → Oct 2025 overdue metastatic malignant neoplasm National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 1/2 NCT04253262 Apr 2020 → Jan 2027 expected prostate carcinoma Brown University Active not recruiting No outcome recorded
Phase 1/2 NCT03877055 Mar 2019 → Oct 2022 mantle cell lymphoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1/2 NCT03803761 Feb 2019 → Feb 2022 female breast carcinoma, invasive breast carcinoma, metastatic malignant neoplasm in the brain National Cancer Institute (NCI) Withdrawn No outcome recorded
Phase 221 trials
Phase 2 NCT05082025 Sep 2022 → May 2024 endometrial cancer, ovarian cancer M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 2 NCT05295589 Jun 2022 → Mar 2023 fallopian tube endometrioid adenocarcinoma, fallopian tube serous adenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian serous adenocarcinoma +1 National Cancer Institute (NCI) Withdrawn No outcome recorded
Phase 2 NCT04750941 Feb 2022 → Jun 2023 endometrial cancer, follicular lymphoma Columbia University Terminated No outcome recorded
Phase 2 NCT04685915 Feb 2021 → Mar 2023 B-cell chronic lymphocytic leukemia Inhye Ahn Withdrawn No outcome recorded
Phase 2 NCT05387616 Oct 2020 → Sep 2023 follicular lymphoma Ludwig-Maximilians - University of Munich Unknown No outcome recorded
Phase 2 NCT04433182 Aug 2020 → Dec 2024 diffuse large B-cell lymphoma Fondazione Italiana Linfomi - ETS Terminated No outcome recorded
Phase 2 NCT04263584 Jun 2020 → Apr 2025 diffuse large B-cell lymphoma University Hospital Muenster Unknown No outcome recorded
Phase 2 NCT04155840 Jan 2020 → Mar 2021 chronic lymphocytic leukemia/small lymphocytic lymphoma University of Washington Terminated No outcome recorded
Phase 2 NCT03474744 Dec 2019 → Dec 2027 expected marginal zone lymphoma Christian Buske Active not recruiting No outcome recorded
Phase 2 NCT03484819 Dec 2019 → Nov 2022 primary mediastinal large B-cell lymphoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 33 trials
Phase 3 NCT02626455 Jan 2016 → Sep 2023 non-Hodgkin lymphoma Bayer Terminated No outcome recorded
Phase 3 NCT02369016 Sep 2015 → Oct 2022 non-Hodgkin lymphoma Bayer Completed No outcome recorded
Phase 3 NCT02367040 Aug 2015 → Aug 2020 non-Hodgkin lymphoma Bayer Completed No outcome recorded
Phase not stated1 trial
NCT06238583 cancer Bayer No longer available No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT02535247 Comparator Jan 2016 → Feb 2020 peripheral T-cell lymphoma, not otherwise specified Fox Chase Cancer Center Terminated No outcome recorded

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 76 sources stand behind the page.

FieldValueCited text
Known as Copanlisib “A Phase I study of intravenous PI3K inhibitor copanlisib in Japanese patients with advanced or refractory solid tumors.” PMID 27915408 Dec 2016
73

“PI3 (Phosphatidylinositol-3)-Kinase Inhibitor CopanlisibNCT01460537

NCT01660451

NCT03789240

NCT03502733

NCT04431635

NCT06360588

NCT04433182

NCT03474744

NCT02367040

NCT04108858

NCT02626455

NCT04462471

NCT03586661

NCT04233697

NCT03735628

NCT03432741

NCT03842228

NCT02822482

NCT02728258

NCT04939272

NCT03878524

NCT03172884

NCT05687721

NCT04750941

NCT01411410

NCT02391116

NCT04685915

NCT01392521

NCT04572763

NCT03128619

NCT03711058

NCT03884998

NCT04803123

NCT06238583

NCT03052933

NCT02369016

NCT04317105

NCT03939897

NCT03517956

NCT02465060

NCT03886649

NCT03484819

NCT02253420

NCT05295589

NCT05490771

NCT04933617

NCT03877055

NCT06400238

NCT03458728

NCT06218667

NCT02705859

NCT04345913

NCT03581942

NCT02535247

NCT02342665

NCT02631590

NCT00962611

NCT04042051

NCT02119221

NCT05082025

NCT03803761

NCT02155582

NCT05387616

NCT02455297

NCT04895579

NCT03498430

NCT05010096

NCT04253262

NCT03377101

NCT04263584

NCT04156828

NCT04155840

NCT03655301

Known as Aliqopa “Copanlisib (Aliqopa, BAY80-6946) solution for IV infusion (test drug/investigational medicinal product)” NCT02391116
7

“Copanlisib (Aliqopa, BAY80-6946)” NCT06238583

“Copanlisib (ALIQOPA, BAY80-6946)” NCT03172884

“Copanlisib (Aliqopa, BAY80-6946)” NCT03655301

“Copanlisib (Aliqopa, BAY80-6946)” NCT02367040

“Copanlisib (Aliqopa, BAY80-6946)” NCT01660451

“Copanlisib (Aliqopa, BAY80-6946)” NCT00962611

“Copanlisib (Aliqopa, BAY80-6946)” NCT03498430

Known as BAY 80-6946 DIHYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL3218576
Known as BAY 84-1236 ChEMBL registry synonym — accepted as the source's own label CHEMBL3218576
Known as BAY80-6946 “Copanlisib (BAY 80-6946), a highly selective and potent class-1 PI3K inhibitor with sub-nanomolar IC50s against PI3Kα and PI3Kδ, has demonstrated activity in...” NCT03052933
19

“Copanlisib (Aliqopa, BAY80-6946) solution for IV infusion (test drug/investigational medicinal product)” NCT02391116

“effect of Rifampin on the pharmacokinetics of Copanlisib (BAY 80-6946) and safety” NCT02253420

“First-in-human phase I study of copanlisib (BAY 80-6946), an intravenous” PMID 27672108 Oct 2016

“Copanlisib (Aliqopa, BAY80-6946)” NCT03498430

“Copanlisib (Aliqopa, BAY80-6946)” NCT02367040

“Copanlisib (ALIQOPA, BAY80-6946)” NCT03172884

“Copanlisib (Aliqopa, BAY80-6946)” NCT01660451

“Copanlisib (Aliqopa, BAY80-6946)” NCT03655301

“Copanlisib (Aliqopa, BAY80-6946)” NCT00962611

“Copanlisib (Aliqopa, BAY80-6946)” NCT06238583

“Copanlisib (BAY 80-6946)” NCT02369016

“Copanlisib (BAY80-6946)” NCT01411410

“Copanlisib (BAY80-6946)” NCT03517956

“Copanlisib (BAY80-6946)” NCT02626455

“Copanlisib (BAY80-6946)” NCT02455297

“Copanlisib (BAY80-6946)” NCT02155582

“Copanlisib (BAY80-6946)” NCT02342665

“Copanlisib (BAY80-6946)” NCT02119221

“Copanlisib (BAY806946)” NCT03458728

Known as Copa Copanlisib (Copa): 60 mg/day i.v. on days 1,8,15” NCT04433182
Known as Copanlisib dihydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL3218576
Known as Copanlisib Hydrochloride “Drug: Copanlisib HydrochlorideNCT04939272
1

“Drug: Copanlisib HydrochlorideNCT03939897

Known as Copanlisib hydrochloride hydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL3218576
Action Inhibit “a phosphatidylinositol 3-kinase inhibitor” PMID 27672108 Oct 2016
2

“PI3-kinase p110-alpha subunit inhibitor” CHEMBL3218576

“PI3-kinase p110-delta subunit inhibitor” CHEMBL3218576

Modality Small molecule “Copanlisib is a small molecule pan-class 1 PI3K inhibitor” NCT04263584
Route Intravenous “Patients received three weekly intravenous infusions of copanlisib” PMID 27672108 Oct 2016
Target PIK3CA “PI3-kinase p110-alpha subunit inhibitor” CHEMBL3218576
Target PIK3CD “PI3-kinase p110-delta subunit inhibitor” CHEMBL3218576