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Obinutuzumab

Alternative Names: obinutuzumab, ga101, Gazyva
Latest Update: 2024-04-04
Latest Update Note: Clinical Trial Update

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

Map of Global Clinical Trials for Obinutuzumab

Countries in Clinic: Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, 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: 7

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: ANCA Vasculitis|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|Granulomatosis with Polyangiitis|HIV Infections|Hairy Cell Leukemia|Leukemia, Plasma Cell|Lymphoma|Lymphoma, B-Cell|Lymphoproliferative Disorders|Mantle-Cell Lymphoma|Microscopic Polyangiitis|Non-Small-Cell Lung Cancer|Obstetric Labor, Premature|Pregnancy Outcomes|Prolymphocytic B-Cell Leukemia|Prolymphocytic Leukemia|Systemic Vasculitis|T-Cell Leukemia|T-Cell Peripheral Lymphoma|Tumor Lysis Syndrome|Waldenstrom Macroglobulinemia

Phase 1: Adenocarcinoma|Burkitt Lymphoma|Transitional Cell Carcinoma

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 Nephritis|Lupus Erythematosus, Systemic

2031-12-01

2019-004034-42

P3

Active, not recruiting

Lupus Nephritis

2031-08-31

REFRACT

P2

Recruiting

Follicular Lymphoma

2029-05-31

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