Ozmosi | Obinutuzumab Drug Profile
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Obinutuzumab

Alternative Names: obinutuzumab, ga101, Gazyva, RG7159, RG 7159, RG-7159
Clinical Status: Inactive
Latest Update: 2026-01-13
Latest Update Note: News Article

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:
Company CEO: Severin Schwan
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 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|Graft vs Host Disease|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|Waldenstrom Macroglobulinemia

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

NCT02992522

OSU-16187

P1

Active, not recruiting

B-Cell Marginal Zone Lymphoma|Burkitt Lymphoma|Lymphoma, Non-Hodgkin|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

NCT04578600

NCI-2020-05946

P1

Completed

Lymphoma, Non-Hodgkin|Hairy Cell Leukemia|Chronic Lymphoid Leukemia|B-Cell Marginal Zone Lymphoma|Lymphocytic Chronic B-Cell Leukemia|Follicular Lymphoma|Waldenstrom Macroglobulinemia|Mantle-Cell Lymphoma|Leukemia, Plasma Cell

2023-12-12

33%

2025-04-26

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status

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

NCT05039619

POSTERITY

P2

Recruiting

Lupus Nephritis

2027-08-31

12%

2025-01-03

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments

NCT05783596

NCT05783596

P2

Active, not recruiting

Lymphoma, Non-Hodgkin|B-Cell Marginal Zone Lymphoma|Follicular Lymphoma

2026-03-01

2%

2025-09-18

Patient Enrollment|Primary Endpoints

NCT06186648

GLORIFY

P2

Recruiting

Lymphocytic Chronic B-Cell Leukemia|Bone Marrow Diseases|Aging, Premature|T-Cell Peripheral Lymphoma|Diffuse Large B-Cell Lymphoma|T-Cell Leukemia|HIV Infections|Chronic Lymphoid Leukemia|Pregnancy Outcomes|Cytokine Release Syndrome|Tumor Lysis Syndrome|Obstetric Labor, Premature|COVID-19

2026-03-01

12%

2024-04-20

Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status

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

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

NCT04855695

NCT04855695

P2

Recruiting

Mantle-Cell Lymphoma

2025-12-31

12%

2025-01-30

Primary Completion Date|Primary Endpoints|Treatments

NCT04883437

STUDY00002247

P2

Recruiting

Mantle-Cell Lymphoma|Lymphoma, Non-Hodgkin|Lymphoproliferative Disorders|Marginal Zone Lymphoma|Waldenstrom Macroglobulinemia|Follicular Lymphoma

2025-09-23

12%

2025-03-28

Primary Completion Date|Primary Endpoints|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

NCT02867384

NCT02867384

P2

Completed

Graft vs Host Disease

2023-11-29

50%

2025-03-13

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

NCT04963296

ALLEGORY

P3

Active, not recruiting

Lupus Erythematosus, Systemic

2025-09-15

39%

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

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

61%

2025-05-02

Treatments

jRCT2011210059

jRCT2011210059

P3

Recruiting

Lupus Nephritis

2028-08-31

jRCT2031210296

jRCT2031210296

P3

Completed

Marginal Zone Lymphoma|Follicular Lymphoma

2032-08-25

NCT04702256

OBILUP

P3

Recruiting

Lupus Nephritis|Lupus Erythematosus, Systemic

2031-12-01

63%

2021-12-11

NCT06967610

NCI-2025-03338

P2

Recruiting

Lymphocytic Chronic B-Cell Leukemia|Chronic Lymphoid 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