Ozmosi | Obinutuzumab Drug Profile

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 Indications: None

Known Adverse Events: None

Company: Hoffmann-La Roche
Company Location:
Company Founding Year: 1896
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Obinutuzumab

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: 87

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 1: Burkitt Lymphoma|Colorectal Cancer|Leukemia, Plasma Cell

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Probability of Success	Latest Trial Update Date	Data Updated
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	Waldenstrom Macroglobulinemia\|Mantle-Cell Lymphoma\|Lymphoma, Non-Hodgkin\|Marginal Zone Lymphoma\|Lymphoproliferative Disorders\|Follicular Lymphoma	2026-09-23	12%	2026-02-10	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
NCT02992522	OSU-16187	P1	Active, not recruiting	Burkitt Lymphoma\|B-Cell Marginal Zone Lymphoma\|Diffuse Large B-Cell Lymphoma\|Lymphoma, Non-Hodgkin\|Follicular Lymphoma	2026-08-15	12%	2025-09-10	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
NCT06186648	GLORIFY	P2	Recruiting	Lymphocytic Chronic B-Cell Leukemia\|Bone Marrow Diseases\|Diffuse Large B-Cell Lymphoma\|T-Cell Peripheral Lymphoma\|Aging, Premature\|Tumor Lysis Syndrome\|Chronic Lymphoid Leukemia\|HIV Infections\|COVID-19\|Obstetric Labor, Premature\|Pregnancy Outcomes\|Cytokine Release Syndrome\|T-Cell Leukemia	2026-03-01	12%	2024-04-20	Primary Completion Date\|Primary Endpoints\|Start Date\|Study Completion Date\|Treatments\|Trial Status
NCT05783596	NCT05783596	P2	Active, not recruiting	Follicular Lymphoma\|B-Cell Marginal Zone Lymphoma\|Lymphoma, Non-Hodgkin	2026-03-01	2%	2025-09-18	Patient Enrollment\|Primary Endpoints
NCT05050214	ORION	P2	Active, not recruiting	Kidney Diseases\|Glomerulonephritis, Membranous\|Membranous Nephropathy	2026-02-01	50%	2025-05-10	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
NCT04722172	NCT04722172	P2	Active, not recruiting	Lymphoma, B-Cell\|Lymphocytic Chronic B-Cell Leukemia\|Chronic Lymphoid Leukemia	2026-02-01	12%	2025-08-27	Primary Endpoints\|Treatments
NCT04963296	ALLEGORY	P3	Active, not recruiting	Lupus Erythematosus, Systemic	2025-09-15	53%	2025-10-09	Patient Enrollment\|Primary Endpoints\|Study Completion Date\|Treatments
NCT05627557	INShore	P3	Active, not recruiting	Nephrotic Syndrome	2025-09-04	47%	2025-09-13
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	Acute Respiratory Distress Syndrome\|Chronic Lymphoid Leukemia	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
NCT04826003	BP42675	P1	Completed	Colorectal Cancer	2024-11-11	23%	2025-07-15
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
NCT04578600	NCI-2020-05946	P1	Completed	Leukemia, Plasma Cell\|Lymphocytic Chronic B-Cell Leukemia\|Mantle-Cell Lymphoma\|Waldenstrom Macroglobulinemia\|Lymphoma, Non-Hodgkin\|B-Cell Marginal Zone Lymphoma\|Follicular Lymphoma\|Chronic Lymphoid Leukemia\|Hairy Cell Leukemia	2023-12-12	33%	2025-04-26	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments\|Trial Status
NCT02867384	NCT02867384	P2	Completed	Graft vs Host Disease	2023-11-29	50%	2025-03-13
jRCT2031210296	jRCT2031210296	P3	Completed	Follicular Lymphoma\|Marginal Zone Lymphoma	2032-08-25
NCT04702256	OBILUP	P3	Recruiting	Lupus Erythematosus, Systemic\|Lupus Nephritis	2031-12-01	63%	2021-12-11
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	Lymphoma, B-Cell\|Chronic Lymphoid Leukemia\|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
2023-503628-22-00	CA41705	P3	Active, not recruiting	Lupus Nephritis	2029-02-28	66%	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

Recent News Events

Date	Type	Title
01/29/2026	News Article	[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong 2025 results with 7% sales growth
01/29/2026	News Article	Enterome appoints leading hematologist and IFLI Executive Partner Mehrdad Mobasher, M.D., M.P.H., to its Board of Directors
01/26/2026	News Article	Health Canada authorizes Gazyva® (obinutuzumab) for adults with active lupus nephritis
01/23/2026	News Article	AstraZeneca's Tagrisso® and Calquence® Among First Oncology Treatments Granted Accelerated Access Through Ontario's FAST Program

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Obinutuzumab

Alternative Names: obinutuzumab, ga101, Gazyva, RG7159, RG 7159, RG-7159 Clinical Status: Inactive Latest Update: 2026-02-12 Latest Update Note: Clinical Trial Update