Product Description
Obinutuzumab is a novel therapeutic anti-CD20 monoclonal antibody recently approved by the United States Food and Drug Administration (FDA) for use in combination with chlorambucil as first-line treatment of chronic lymphocytic leukemia (CLL). (Sourced from: https://pubmed.ncbi.nlm.nih.gov/24983589/)
Mechanisms of Action: CD20 Antagonist
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Lebanon | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Spain | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Chronic Leukemia | Chronic Lymphoid Leukemia | Leukemia | Lymphoid Leukemia
Known Adverse Events: Anemia | Thrombocytopenia | Neutropenia
Company: Hoffmann-La Roche
Company Location: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Active Clinical Trial Count: 117
Highest Development Phases
Phase 3: Chronic Lymphoid Leukemia|Diffuse Large B-Cell Lymphoma|Follicular Lymphoma|Glomerulonephritis, Membranous|Kidney Diseases|Lupus Erythematosus, Systemic|Lupus Nephritis|Lymphocytic Chronic B-Cell Leukemia|Lymphoma, Non-Hodgkin|Marginal Zone Lymphoma|Membranous Nephropathy|Nephrosis, Lipoid|Nephrotic Syndrome
Phase 2: Acute Respiratory Distress Syndrome|Aging, Premature|Anemia, Refractory|B-Cell Marginal Zone Lymphoma|Bone Marrow Diseases|COVID-19|Colorectal Cancer|Cytokine Release Syndrome|Glomerulosclerosis, Focal Segmental|Graft vs Host Disease|HIV Infections|Hairy Cell Leukemia|Leukemia, Plasma Cell|Lymphoma|Lymphoma, B-Cell|Lymphoproliferative Disorders|Mantle-Cell Lymphoma|Non-Small-Cell Lung Cancer|Obstetric Labor, Premature|Pregnancy Outcomes|Prolymphocytic B-Cell Leukemia|Prolymphocytic Leukemia|T-Cell Leukemia|T-Cell Peripheral Lymphoma|Tumor Lysis Syndrome|Waldenstrom Macroglobulinemia
Phase 1: Adenocarcinoma|Burkitt Lymphoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2031210296 | P3 |
Completed |
Marginal Zone Lymphoma|Follicular Lymphoma |
2032-08-25 |
|
| OBILUP | P3 |
Recruiting |
Lupus Erythematosus, Systemic|Lupus Nephritis |
2031-12-01 |
|
| 2019-004034-42 | P3 |
Active, not recruiting |
Lupus Nephritis |
2031-08-31 |
|
| FIL_GAZEBO | P3 |
Recruiting |
Follicular Lymphoma |
2031-04-01 |