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: *
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: None
Known Adverse Events: None
Company: Hoffmann-La Roche
Company Location: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Peru, Poland, Puerto Rico, Romania, Russia, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 89
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Hoffmann-La Roche presented P3 Lupus Nephritis results on 2025-02-07 for Obinutuzumab
- Clinical Outcomes Reported - Hoffmann-La Roche presented P3 Chronic Lymphoid Leukemia results on 2024-12-08 for Obinutuzumab
- Clinical Outcomes Reported - Hoffmann-La Roche presented P3 Lupus Nephritis results on 2024-09-26 for Obinutuzumab
Highest Development Phases
Phase 3: Chronic Lymphoid Leukemia|Follicular Lymphoma|Glomerulonephritis, Membranous|Kidney Diseases|Lupus Erythematosus, Systemic|Lupus Nephritis|Lymphocytic Chronic B-Cell Leukemia|Marginal Zone Lymphoma|Membranous Nephropathy|Nephrosis, Lipoid|Nephrotic Syndrome
Phase 2: Acute Respiratory Distress Syndrome|Aging, Premature|B-Cell Marginal Zone Lymphoma|Bone Marrow Diseases|COVID-19|Colorectal Cancer|Cytokine Release Syndrome|Diffuse Large B-Cell Lymphoma|Glomerulosclerosis, Focal Segmental|Graft vs Host Disease|HIV Infections|Hairy Cell Leukemia|Lymphoma|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Lymphoproliferative Disorders|Mantle-Cell Lymphoma|Non-Small-Cell Lung Cancer|Obstetric Labor, Premature|Pregnancy Outcomes|T-Cell Leukemia|T-Cell Peripheral Lymphoma|Tumor Lysis Syndrome|Waldenstrom Macroglobulinemia
Phase 1: Burkitt Lymphoma|Leukemia, Plasma Cell
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| NCT06561360 | P2 |
Recruiting |
Hairy Cell Leukemia |
2027-09-09 |
62% |
2024-09-20 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
| POSTERITY | P2 |
Recruiting |
Lupus Nephritis |
2027-08-31 |
12% |
2025-01-03 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| GLORIFY | P2 |
Recruiting |
COVID-19|Bone Marrow Diseases|Tumor Lysis Syndrome|Diffuse Large B-Cell Lymphoma|Aging, Premature|T-Cell Peripheral Lymphoma|Lymphocytic Chronic B-Cell Leukemia|HIV Infections|T-Cell Leukemia|Obstetric Labor, Premature|Pregnancy Outcomes|Cytokine Release Syndrome|Chronic Lymphoid Leukemia |
2026-03-01 |
51% |
2024-04-20 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
| MAJESTY | P3 |
Active, not recruiting |
Glomerulonephritis, Membranous|Kidney Diseases|Membranous Nephropathy |
2025-12-29 |
52% |
2024-12-28 |
|
| STUDY00002247 | P2 |
Recruiting |
Marginal Zone Lymphoma|Follicular Lymphoma|Mantle-Cell Lymphoma|Lymphoproliferative Disorders|Lymphoma, Non-Hodgkin|Waldenstrom Macroglobulinemia |
2025-09-23 |
12% |
2025-03-28 |
Primary Completion Date|Primary Endpoints|Treatments |
| ALLEGORY | P3 |
Active, not recruiting |
Lupus Erythematosus, Systemic |
2025-09-16 |
83% |
2025-04-15 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| INShore | P3 |
Active, not recruiting |
Nephrotic Syndrome|Nephrosis, Lipoid |
2025-09-15 |
80% |
2025-04-04 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| OSU-16187 | P1 |
Active, not recruiting |
B-Cell Marginal Zone Lymphoma|Burkitt Lymphoma|Follicular Lymphoma|Diffuse Large B-Cell Lymphoma|Lymphoma, Non-Hodgkin |
2025-08-15 |
23% |
2025-03-07 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| NCT04983888 | P2 |
Active, not recruiting |
Glomerulosclerosis, Focal Segmental |
2025-06-01 |
50% |
2023-06-16 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| NCT04560322 | P2 |
Recruiting |
Chronic Lymphoid Leukemia|Lymphocytic Chronic B-Cell Leukemia|Lymphoma, B-Cell |
2025-03-01 |
45% |
2023-07-08 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| CLL2-BAG | P2 |
Completed |
Chronic Lymphoid Leukemia|Acute Respiratory Distress Syndrome |
2024-12-10 |
12% |
2025-06-11 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| 2016-000548-33 | P2 |
Completed |
Lymphoma |
2024-12-02 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
| BP42675 | P2 |
Completed |
Colorectal Cancer |
2024-11-11 |
23% |
2025-01-07 |
|
| NT-NAP-102-1 | P2 |
Completed |
Non-Small-Cell Lung Cancer |
2024-01-30 |
10% |
2024-02-23 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| NCI-2020-05946 | P1 |
Completed |
Chronic Lymphoid Leukemia|Leukemia, Plasma Cell|Lymphoma, Non-Hodgkin|B-Cell Marginal Zone Lymphoma|Mantle-Cell Lymphoma|Lymphocytic Chronic B-Cell Leukemia|Waldenstrom Macroglobulinemia|Follicular Lymphoma|Hairy Cell Leukemia |
2023-12-12 |
33% |
2025-04-26 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| NCT02867384 | P2 |
Completed |
Graft vs Host Disease |
2023-11-29 |
50% |
2025-03-13 |
|
| jRCT2031210296 | P3 |
Completed |
Marginal Zone Lymphoma|Follicular Lymphoma |
2032-08-25 |
|||
| OBILUP | P3 |
Recruiting |
Lupus Nephritis|Lupus Erythematosus, Systemic |
2031-12-01 |
63% |
2021-12-11 |
|
| NCI-2025-03338 | P2 |
Not yet recruiting |
Lymphocytic Chronic B-Cell Leukemia|Chronic Lymphoid Leukemia |
2031-06-01 |
12% |
2025-05-14 |
Primary Endpoints|Treatments |
| FIL_GAZEBO | P3 |
Recruiting |
Follicular Lymphoma |
2031-04-01 |
26% |
2024-02-24 |
|
| UCCC-HEM-24-02 | P2 |
Not yet recruiting |
Chronic Lymphoid Leukemia|Lymphoma, B-Cell|Lymphocytic Chronic B-Cell Leukemia |
2029-06-01 |
12% |
2025-05-20 |
Primary Endpoints|Treatments |
| REFRACT | P2 |
Recruiting |
Follicular Lymphoma |
2029-05-31 |
78% |
2024-11-27 |
|
| CA41705 | P3 |
Active, not recruiting |
Lupus Nephritis |
2029-02-28 |
52% |
2025-05-02 |
Treatments |
| jRCT2011210059 | P3 |
Recruiting |
Lupus Nephritis |
2028-08-31 |
|||
| WA41937 | P3 |
Active, not recruiting |
Membranous Nephropathy |
2028-06-01 |
52% |
2025-05-02 |
Treatments |
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