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
Company: Hoffmann-La Roche
Company Location:
Company Founding Year: 1896
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, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 79
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Hoffmann-La Roche presented P3 Lupus Erythematosus, Systemic results on 2025-11-03 for Obinutuzumab
- Clinical Outcomes Reported - Hoffmann-La Roche presented P3 Kidney Diseases results on 2025-10-28 for Obinutuzumab
- Clinical Outcomes Reported - Hoffmann-La Roche presented P3 Lupus Nephritis results on 2025-02-07 for Obinutuzumab
Highest Development Phases
Phase 3: Chronic Lymphoid Leukemia|Follicular Lymphoma|Glomerulonephritis, Membranous|Lupus Erythematosus, Systemic|Lupus Nephritis|Lymphocytic Chronic B-Cell Leukemia|Marginal Zone Lymphoma|Membranous Nephropathy|Nephrotic Syndrome
Phase 2: Acute Respiratory Distress Syndrome|Aging, Premature|B-Cell Marginal Zone Lymphoma|Bone Marrow Diseases|COVID-19|Cytokine Release Syndrome|Diffuse Large B-Cell Lymphoma|Glomerulosclerosis, Focal Segmental|HIV Infections|Hairy Cell Leukemia|Kidney Diseases|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
Phase 1: Burkitt Lymphoma|Colorectal Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT02992522 |
OSU-16187 | P1 |
Active, not recruiting |
Lymphoma, Non-Hodgkin|B-Cell Marginal Zone Lymphoma|Burkitt Lymphoma|Follicular Lymphoma|Diffuse Large B-Cell Lymphoma |
2026-08-15 |
12% |
2025-09-10 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04826003 |
BP42675 | P1 |
Completed |
Colorectal Cancer |
2024-11-11 |
23% |
2025-07-15 |
|
NCT06561360 |
NCT06561360 | P2 |
Recruiting |
Hairy Cell Leukemia |
2027-09-09 |
12% |
2024-09-20 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT04883437 |
STUDY00002247 | P2 |
Recruiting |
Lymphoproliferative Disorders|Follicular Lymphoma|B-Cell Marginal Zone Lymphoma|Lymphoma, Non-Hodgkin|Mantle-Cell Lymphoma |
2026-09-23 |
12% |
2026-02-10 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2021-000097-29 |
2021-000097-29 | P2 |
Active, not recruiting |
Lupus Nephritis |
2026-08-10 |
12% |
2025-05-06 |
Treatments |
NCT05783596 |
NCT05783596 | P2 |
Active, not recruiting |
Lymphoma, Non-Hodgkin|B-Cell Marginal Zone Lymphoma|Follicular Lymphoma |
2026-08-01 |
12% |
2026-03-17 |
|
NCT04450173 |
UCDCC#275 | P2 |
Recruiting |
Follicular Lymphoma |
2026-04-01 |
12% |
2025-04-26 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05896163 |
MAPtivate-6 | P2 |
Active, not recruiting |
Diffuse Large B-Cell Lymphoma |
2026-03-31 |
12% |
2025-10-23 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04560322 |
NCT04560322 | P2 |
Recruiting |
Lymphoma, B-Cell|Lymphocytic Chronic B-Cell Leukemia|Chronic Lymphoid Leukemia |
2026-03-01 |
12% |
2025-09-26 |
|
NCT06186648 |
GLORIFY | P2 |
Recruiting |
Lymphocytic Chronic B-Cell Leukemia|Bone Marrow Diseases|T-Cell Peripheral Lymphoma|Tumor Lysis Syndrome|Obstetric Labor, Premature|T-Cell Leukemia|HIV Infections|Aging, Premature|Diffuse Large B-Cell Lymphoma|Pregnancy Outcomes|COVID-19|Cytokine Release Syndrome|Chronic Lymphoid Leukemia |
2026-03-01 |
12% |
2024-04-20 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT05050214 |
ORION | P2 |
Active, not recruiting |
Glomerulonephritis, Membranous|Kidney Diseases|Membranous Nephropathy |
2026-02-01 |
50% |
2025-05-10 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04983888 |
NCT04983888 | P2 |
Completed |
Glomerulosclerosis, Focal Segmental |
2025-06-16 |
50% |
2025-09-12 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT02401503 |
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 |
2016-000548-33 | P2 |
Completed |
Lymphoma |
2024-12-02 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
NCT04880863 |
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 |
jRCT2031210296 |
jRCT2031210296 | P3 |
Completed |
Marginal Zone Lymphoma|Follicular Lymphoma |
2032-08-25 |
|||
NCT04702256 |
OBILUP | P3 |
Recruiting |
Lupus Erythematosus, Systemic|Lupus Nephritis |
2031-12-01 |
63% |
2021-12-11 |
|
jRCT2011220036 |
jRCT2011220036 | P3 |
Recruiting |
Nephrotic Syndrome |
2026-04-30 |
|||
NCT05039619 |
POSTERITY | P2 |
Recruiting |
Lupus Nephritis |
2028-06-15 |
12% |
2026-03-07 |
|
2023-503628-22-00 |
CA41705 | P3 |
Active, not recruiting |
Lupus Nephritis |
2029-02-28 |
50% |
2025-05-02 |
Treatments |
jRCT2011210059 |
jRCT2011210059 | P3 |
Recruiting |
Lupus Nephritis |
2028-08-31 |
|||
2023-506525-11-00 |
WA41937 | P3 |
Active, not recruiting |
Membranous Nephropathy |
2028-06-01 |
54% |
2025-05-02 |
Treatments |
NCT06967610 |
NCI-2025-03338 | P2 |
Recruiting |
Chronic Lymphoid Leukemia|Lymphocytic Chronic B-Cell Leukemia |
2031-06-01 |
2% |
2025-09-20 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT06978088 |
UCCC-HEM-24-02 | P2 |
Recruiting |
Chronic Lymphoid Leukemia|Lymphoma, B-Cell|Lymphocytic Chronic B-Cell Leukemia |
2029-06-01 |
12% |
2025-08-15 |
Primary Endpoints|Treatments|Trial Status |
NCT05848765 |
REFRACT | P2 |
Recruiting |
Follicular Lymphoma |
2029-05-31 |
78% |
2024-11-27 |