Numerous clinical trials spanning Early Phase 1 through Phase 3 evaluate copanlisib across hematological malignancies and solid tumors, such as relapsed or refractory indolent non-Hodgkin lymphoma, endometrial, ovarian, and prostate cancers. Supported by industry leaders including Bayer and AbbVie alongside prominent academic centers, these protocols encompass active not recruiting, completed, suspended, terminated, and withdrawn statuses. Early- to mid-stage investigations focus on combination strategies targeting refractory B-cell lymphomas and advanced castration-resistant prostate cancer.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03474744 | ACTIVE_NOT_RECRUITING | Marginal Zone Lymphoma |
Christian Buske |
2019-12-15 | PHASE2 |
| NCT03502733 | ACTIVE_NOT_RECRUITING | Lymphoma; Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2018-08-14 | PHASE1 |
| NCT04939272 | ACTIVE_NOT_RECRUITING | Recurrent Mantle Cell Lymphoma; Refractory Mantle Cell Lymphoma |
City of Hope Medical Center |
2022-06-29 | PHASE1; PHASE2 |
| NCT04253262 | ACTIVE_NOT_RECRUITING | Metastatic Castration-resistant Prostate Cancer |
Brown University |
2020-04-03 | PHASE1; PHASE2 |
| NCT06218667 | WITHDRAWN | Prostate Cancer |
Memorial Sloan Kettering Cancer Center |
2024-01-11 | PHASE1; PHASE2 |
| NCT02465060 | ACTIVE_NOT_RECRUITING | Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Exocrine Pancreas Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Kidney Carcinoma; Liver Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Corpus Neoplasm; Malignant Uterine Neoplasm; Melanoma; Multiple Myeloma; Ovarian Carcinoma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Melanoma; Recurrent Multiple Myeloma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Prostate Carcinoma; Recurrent Rectal Carcinoma; Recurrent Skin Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma; Skin Carcinoma; Thyroid Gland Carcinoma |
National Cancer Institute (NCI) |
2015-08-17 | PHASE2 |
| NCT03884998 | ACTIVE_NOT_RECRUITING | Chronic Lymphocytic Leukemia; Diffuse Large B-Cell Lymphoma; Follicular Lymphoma; Indolent Non-Hodgkin Lymphoma; Lymphoplasmacytic Lymphoma; Marginal Zone Lymphoma; Richter Syndrome |
City of Hope Medical Center |
2019-07-10 | PHASE1 |
| NCT03586661 | COMPLETED | Deleterious BRCA1 Gene Mutation; Deleterious BRCA2 Gene Mutation; Endometrial Adenocarcinoma; High Grade Ovarian Serous Adenocarcinoma; Platinum-Resistant Ovarian Carcinoma; Primary Peritoneal High Grade Serous Adenocarcinoma; Progressive Disease; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma |
M.D. Anderson Cancer Center |
2019-04-29 | PHASE1 |
| NCT03581942 | COMPLETED | Refractory/Recurrent Primary Central Nervous System Lymphoma (PCNSL) |
Memorial Sloan Kettering Cancer Center |
2018-08-23 | PHASE1; PHASE2 |
| NCT04895579 | COMPLETED | Non Small Cell Lung Cancer |
Zhonglin Hao |
2021-05-12 | PHASE1 |
| NCT04317105 | ACTIVE_NOT_RECRUITING | Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2020-07-17 | PHASE1; PHASE2 |
| NCT03789240 | ACTIVE_NOT_RECRUITING | Follicular Lymphoma; Non-Hodgkin's Lymphoma; NHL |
National Cancer Institute (NCI) |
2019-08-22 | PHASE2 |
| NCT04572763 | ACTIVE_NOT_RECRUITING | Diffuse Large B Cell Lymphoma; Relapsed Diffuse Large B-Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma |
Dana-Farber Cancer Institute |
2021-09-08 | PHASE1; PHASE2 |
| NCT05687721 | WITHDRAWN | Advanced Urothelial Carcinoma |
VA Office of Research and Development |
2025-06-02 | PHASE1; PHASE2 |
| NCT04263584 | COMPLETED | Diffuse Large B Cell Lymphoma |
University Hospital Muenster |
2020-06-19 | PHASE2 |
| NCT04433182 | TERMINATED | Diffuse Large B-cell Lymphoma |
Fondazione Italiana Linfomi - ETS |
2020-08-18 | PHASE2 |
| NCT03842228 | ACTIVE_NOT_RECRUITING | Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2019-11-21 | PHASE1 |
| NCT05082025 | TERMINATED | Endometrial Cancer; Ovarian Cancer |
M.D. Anderson Cancer Center |
2022-09-27 | PHASE2 |
| NCT04345913 | ACTIVE_NOT_RECRUITING | Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Triple-Negative Breast Carcinoma; Unresectable Triple-Negative Breast Carcinoma |
National Cancer Institute (NCI) |
2021-03-01 | PHASE1; PHASE2 |
| NCT04933617 | TERMINATED | Burkitt Lymphoma; High-grade B-cell Lymphoma; T-cell/Histocyte-rich Large B-cell Lymphoma; Diffuse Large B-Cell Lymphoma (DLBCL); Germinal Center B-cell Type (GCB) |
National Cancer Institute (NCI) |
2022-03-24 | PHASE1 |
| NCT04431635 | TERMINATED | Indolent Lymphoma |
University of Michigan Rogel Cancer Center |
2020-06-15 | PHASE1 |
| NCT04462471 | COMPLETED | Thyroid Carcinoma; Thyroid Cancer; Thyroid Cancer, Follicular; Thyroid Cancer (Follicular Cell); Thyroid Cancer, Papillary; BRAF V600E Mutation Positive |
Memorial Sloan Kettering Cancer Center |
2020-06-26 | PHASE1 |
| NCT05387616 | UNKNOWN | Follicular Lymphoma |
Ludwig-Maximilians - University of Munich |
2020-10-19 | PHASE2 |
| NCT02626455 | TERMINATED | Lymphoma, Non-Hodgkin |
Bayer |
2016-01-06 | PHASE3 |
| NCT03939897 | ACTIVE_NOT_RECRUITING | Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Metastatic HER2-Negative Breast Carcinoma; Metastatic Hormone Receptor-Positive Breast Carcinoma; Recurrent Breast Carcinoma |
National Cancer Institute (NCI) |
2020-06-17 | PHASE1 |
| NCT04750941 | TERMINATED | Follicular Lymphoma; Endometrial Cancer |
Columbia University |
2022-02-10 | PHASE2 |
| NCT04803123 | TERMINATED | Leukemia, Acute Lymphocytic |
Dorothy Sipkins, MD, PhD |
2021-06-21 | EARLY_PHASE1 |
| NCT05295589 | WITHDRAWN | Platinum-Refractory Fallopian Tube Carcinoma; Platinum-Refractory Ovarian Carcinoma; Platinum-Refractory Primary Peritoneal Carcinoma; Recurrent Fallopian Tube Endometrioid Adenocarcinoma; Recurrent Fallopian Tube High Grade Serous Adenocarcinoma; Recurrent Ovarian Endometrioid Adenocarcinoma; Recurrent Ovarian High Grade Serous Adenocarcinoma; Recurrent Platinum-Resistant Fallopian Tube Carcinoma; Recurrent Platinum-Resistant Ovarian Carcinoma; Recurrent Platinum-Resistant Primary Peritoneal Carcinoma; Recurrent Primary Peritoneal Endometrioid Adenocarcinoma; Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma |
National Cancer Institute (NCI) |
2022-06-30 | PHASE2 |
| NCT04685915 | WITHDRAWN | Chronic Lymphocytic Leukemia (CLL) |
Inhye Ahn |
2021-02-18 | PHASE2 |
| NCT03458728 | TERMINATED | Relapsed or Refractory Solid Tumors or Lymphoma in Children; Neuroblastoma; Osteosarcoma; Rhabdomyosarcoma; Ewing Sarcoma |
Bayer |
2018-04-30 | PHASE1; PHASE2 |
| NCT06400238 | ACTIVE_NOT_RECRUITING | Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma |
National Cancer Institute (NCI) |
2018-10-15 | PHASE2 |
| NCT06360588 | ACTIVE_NOT_RECRUITING | Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2018-10-08 | PHASE2 |
| NCT03484819 | COMPLETED | Recurrent Diffuse Large B-Cell Lymphoma; Recurrent Primary Mediastinal Large B-Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; Refractory Primary Mediastinal Large B-Cell Lymphoma |
National Cancer Institute (NCI) |
2019-12-13 | PHASE2 |
| NCT02369016 | COMPLETED | Lymphoma, Non-Hodgkin |
Bayer |
2015-09-22 | PHASE3 |
| NCT03735628 | COMPLETED | Non-small Cell Lung Cancer (NSCLC); Head and Neck Squamous Cell Carcinoma (HNSCC); Hepatocellular Carcinoma (HCC) |
Bayer |
2018-10-17 | PHASE1 |
| NCT03877055 | COMPLETED | Mantle Cell Lymphoma (MCL) |
Memorial Sloan Kettering Cancer Center |
2019-03-13 | PHASE1; PHASE2 |
| NCT05082025 | Active not recruiting | Endometrial Cancer|Ovarian Cancer |
M.D. Anderson Cancer Center|Bayer |
2022-09-27 | Phase 2 |
| NCT03432741 | TERMINATED | Breast Adenocarcinoma; Metastatic Breast Carcinoma; Recurrent Breast Carcinoma; Recurrent Hodgkin Lymphoma; Recurrent Mycosis Fungoides; Recurrent Non-Hodgkin Lymphoma; Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Refractory Breast Carcinoma; Refractory Hodgkin Lymphoma; Refractory Mycosis Fungoides; Refractory Nodal Marginal Zone Lymphoma; Refractory Non-Hodgkin Lymphoma; Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Stage IV Breast Cancer AJCC v6 and v7 |
Mayo Clinic |
2018-03-27 | PHASE1 |
| NCT04233697 | WITHDRAWN | Lymphoma, T-Cell |
Columbia University |
2020-02 | PHASE1 |
| NCT05217914 | Active not recruiting | Relapsed or Refractory Indolent Non-Hodgkin Lymphoma |
Bayer |
2022-07-01 | -- |
| NCT03711058 | COMPLETED | Unresectable or Metastatic Microsatellite Stable (MSS) Solid Tumor; Microsatellite Stable (MSS) Colon Cancer |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2019-01-17 | PHASE1; PHASE2 |
| NCT04939272 | Suspended | Recurrent Mantle Cell Lymphoma|Refractory Mantle Cell Lymphoma |
City of Hope Medical Center|National Cancer Institute (NCI) |
2022-06-29 | Phase 1|Phase 2 |
| NCT04108858 | TERMINATED | Anatomic Stage IV Breast Cancer AJCC v8; HER2-Positive Breast Carcinoma; Metastatic Breast Carcinoma |
National Cancer Institute (NCI) |
2021-05-20 | PHASE1; PHASE2 |
| NCT04156828 | TERMINATED | Grade 3b Follicular Lymphoma; Recurrent Diffuse Large B-Cell Lymphoma; Recurrent Follicular Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; Non-Hodgkin's Lymphoma |
University of Washington |
2020-03-31 | PHASE1 |
| NCT03128619 | TERMINATED | Estrogen Receptor Positive; HER2/Neu Negative; Invasive Breast Carcinoma; Multifocal Breast Carcinoma; Postmenopausal; Progesterone Receptor Positive; Stage I Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage III Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer |
Jonsson Comprehensive Cancer Center |
2017-08-02 | PHASE1 |
| NCT05010096 | WITHDRAWN | Locally Advanced Malignant Solid Neoplasm; Metastatic Malignant Neoplasm in the Bone; Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm |
M.D. Anderson Cancer Center |
2022-03-22 | PHASE1 |
| NCT03803761 | WITHDRAWN | Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Metastatic Malignant Neoplasm in the Brain; Prognostic Stage IV Breast Cancer AJCC v8 |
National Cancer Institute (NCI) |
2019-02-13 | PHASE1; PHASE2 |
| NCT04572763 | Active not recruiting | Diffuse Large B Cell Lymphoma|Relapsed Diffuse Large B-Cell Lymphoma|Refractory Diffuse Large B-Cell Lymphoma |
Dana-Farber Cancer Institute|AbbVie|Bayer |
2021-09-08 | Phase 1|Phase 2 |
| NCT03052933 | COMPLETED | Mature T-Cell and NK-Cell Neoplasm |
Chonnam National University Hospital |
2018-02-01 | PHASE1; PHASE2 |
| NCT04803123 | Terminated | Leukemia Acute Lymphocytic |
Dorothy Sipkins MD PhD|Bayer|Duke University |
2021-06-21 | Early Phase 1 |
| NCT03886649 | TERMINATED | Non-Hodgkin Lymphoma |
Swiss Cancer Institute |
2019-11-04 | PHASE1 |
| NCT04253223 | TERMINATED | Hyperglycemia Drug Induced |
Duke University |
2020-04-07 | PHASE1 |
| NCT02705859 | COMPLETED | HER2 Positive Breast Cancer |
Cancer Trials Ireland |
2016-04 | PHASE1 |
| NCT04155840 | TERMINATED | Lymphoid Leukemia; Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
University of Washington |
2020-01-31 | PHASE2 |
| NCT03517956 | COMPLETED | Advanced or Metastatic Solid Tumor |
Bayer |
2018-07-25 | PHASE1 |
| NCT05490771 | ACTIVE_NOT_RECRUITING | Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma |
National Cancer Institute (NCI) |
2018-06-20 | PHASE2 |
| NCT03878524 | TERMINATED | Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Anatomic Stage IV Breast Cancer AJCC v8; Anemia; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Castration-Resistant Prostate Carcinoma; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Primary Myelofibrosis; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Recurrent Myeloproliferative Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Small Lymphocytic Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelomonocytic Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic/Myeloproliferative Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Refractory Primary Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma |
OHSU Knight Cancer Institute |
2020-04-01 | PHASE1 |
| NCT04042051 | TERMINATED | HER2-positive Breast Cancer; Metastatic Breast Cancer; Locally Advanced Breast Cancer; Unresectable Breast Cancer |
Cancer Trials Ireland |
2019-11-12 | PHASE1 |
| NCT02367040 | COMPLETED | Lymphoma,Non-Hodgkin |
Bayer |
2015-08-03 | PHASE3 |
| NCT03172884 | COMPLETED | Hepatic Insufficiency, Renal Insufficiency |
Bayer |
2017-06-14 | PHASE1 |
| NCT02535247 | TERMINATED | Lymphoma, T-Cell, Peripheral |
Fox Chase Cancer Center |
2016-01-05 | PHASE1; PHASE2 |
| NCT02631590 | COMPLETED | Biliary Carcinoma; Gall Bladder Carcinoma; Cholangiocarcinoma; Gastrointestinal Tumor |
H. Lee Moffitt Cancer Center and Research Institute |
2016-07-05 | PHASE2 |
| NCT02822482 | TERMINATED | Carcinoma, Squamous Cell of Head and Neck |
UNICANCER |
2016-06 | PHASE1; PHASE2 |
| NCT03498430 | COMPLETED | Lymphoma, Non-Hodgkin |
Bayer |
2018-04-27 | PHASE1 |
| NCT03655301 | COMPLETED | Healthy Volunteers |
Bayer |
2018-09-11 | PHASE1 |
| NCT02342665 | COMPLETED | Lymphoma Non-Hodgkin |
Bayer |
2015-04-21 | PHASE1; PHASE2 |
| NCT02728258 | COMPLETED | Endometrial Endometrioid Adenocarcinoma; Endometrial Mixed Cell Adenocarcinoma; Endometrial Serous Adenocarcinoma; Endometrial Undifferentiated Carcinoma; Metastatic Endometrioid Adenocarcinoma; Recurrent Uterine Corpus Cancer |
NRG Oncology |
2016-09-16 | PHASE2 |
| NCT03377101 | WITHDRAWN | Estrogen Receptor Positive; HER2/Neu Negative; Progesterone Receptor Positive; Stage IV Breast Cancer AJCC v6 and v7 |
National Cancer Institute (NCI) |
2018-08-07 | PHASE2 |
| NCT02253420 | COMPLETED | Medical Oncology |
Bayer |
2014-10-08 | PHASE1 |
| NCT02155582 | COMPLETED | Non Hodgkin Lymphoma |
Bayer |
2014-08-12 | PHASE1 |
| NCT02391116 | COMPLETED | Diffuse, Large B-Cell, Lymphoma |
Bayer |
2015-05-08 | PHASE2 |
| NCT01660451 | COMPLETED | Lymphoma, Non-Hodgkin |
Bayer |
2012-11-19 | PHASE2 |
| NCT02455297 | TERMINATED | Lymphoma, Mantle-Cell |
Bayer |
2015-08-24 | PHASE2 |
| NCT00962611 | COMPLETED | Neoplasms |
Bayer |
2009-11-19 | PHASE1 |
| NCT01460537 | COMPLETED | Neoplasms |
Bayer |
2011-11-18 | PHASE1 |
| NCT01411410 | COMPLETED | Neoplasms |
Bayer |
2011-08-24 | PHASE1 |
| NCT02119221 | COMPLETED | Healthy Volunteers |
Bayer |
2014-02 | PHASE1 |
| NCT01392521 | COMPLETED | Neoplasms |
Bayer |
2011-07 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-05-06)
Check the
Copanlisib (BAY 80-6946)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Copanlisib (BAY 80-6946) Solubility in DMSO
- Copanlisib (BAY 80-6946) Stock Solution
- Copanlisib (BAY 80-6946) Storage
- Copanlisib (BAY 80-6946) Stability
- Copanlisib (BAY 80-6946) Molecular Weight
- Copanlisib (BAY 80-6946) SMILES
- Copanlisib (BAY 80-6946) CAS Number
- Copanlisib (BAY 80-6946) Chemical Structure (2D and 3D)
- Copanlisib (BAY 80-6946) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.