Product Description
Ofatumumab is an anti-CD20 IgG1? human monoclonal antibody that is being considered by the US Food and Drug Administration and the European Medicines Agency for marketing approval as a treatment for chronic lymphocytic leukemia. The mAb is also being studied as a treatment for lymphoma, rheumatoid arthritis and multiple sclerosis.
Mechanisms of Action: CD20 Antagonist
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous, Subcutaneous
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Jordan | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Venezuela
Approved Indications: None
Known Adverse Events: None
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States
Active Clinical Trial Count: 17
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Multiple Sclerosis|Multiple Sclerosis, Chronic Progressive|Multiple Sclerosis, Relapsing-Remitting
Phase 2: Chronic Lymphoid Leukemia|Lung Cancer|Lymphocytic Chronic B-Cell Leukemia|Mantle-Cell Lymphoma|Mesothelioma|Pleural Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04047628 |
BEAT-MS | P3 |
Recruiting |
Multiple Sclerosis, Chronic Progressive|Multiple Sclerosis, Relapsing-Remitting |
2026-10-01 |
41% |
2023-09-22 |
|
NCT04788615 |
STHENOS | P3 |
Active, not recruiting |
Multiple Sclerosis |
2025-11-11 |
52% |
2025-03-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT01243190 |
NCI-2011-00745 | P2 |
Completed |
Lymphocytic Chronic B-Cell Leukemia|Chronic Lymphoid Leukemia |
2023-03-28 |
58% |
2024-09-20 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT01437709 |
NCT01437709 | P2 |
Completed |
Mantle-Cell Lymphoma |
2023-09-12 |
65% |
2023-09-14 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
2023-507906-15-00 |
COMB157G2399 | P3 |
Active, not recruiting |
Multiple Sclerosis |
2028-09-07 |
2025-05-02 |
Treatments |
|
NCT03650114 |
ALITHIOS | P3 |
Active, not recruiting |
Multiple Sclerosis |
2027-12-30 |
66% |
2025-03-21 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
NCT04926818 |
NEOS | P3 |
Active, not recruiting |
Multiple Sclerosis |
2027-03-02 |
56% |
2025-01-15 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT06869785 |
FILIOS | P3 |
Recruiting |
Multiple Sclerosis |
2026-12-24 |
52% |
2025-03-29 |
Primary Endpoints|Start Date|Treatments|Trial Status |
2023-507431-37-00 |
COMB157G3301 | P3 |
Active, not recruiting |
Multiple Sclerosis |
2026-01-30 |
2025-05-02 |
Treatments |
|
NCT04353492 |
ARTIOS | P3 |
Completed |
Multiple Sclerosis |
2024-10-09 |
64% |
2025-03-29 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2023-507493-41-00 |
COMB157G23101 | P3 |
Completed |
Multiple Sclerosis |
2024-09-27 |
2025-05-02 |
Treatments |
|
2019-001341-40 |
2019-001341-40 | P3 |
Completed |
Multiple Sclerosis |
2024-04-12 |
64% |
2025-06-30 |
Treatments |
NCT04486716 |
OLIKOS | P3 |
Completed |
Multiple Sclerosis |
2023-11-20 |
53% |
2024-12-28 |
|
NCT04510220 |
2020P002078 | P3 |
Recruiting |
Multiple Sclerosis |
2021-12-31 |
13% |
2024-08-24 |
Primary Endpoints|Treatments|Trial Status |
2015-000684-13 |
LLC1215 | P2 |
Completed |
Chronic Lymphoid Leukemia |
2024-04-03 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
ACTRN12620001264976p |
2006-7041-83/hah | P2 |
Not yet recruiting |
Mesothelioma|Pleural Cancer|Lung Cancer |
None |
|||
2024-511686-11-00 |
CBAF312D2301 | P3 |
Active, not recruiting |
Multiple Sclerosis |
2029-06-01 |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/03/2025 |
News Article |
Positive phase III data for Roche's Gazyva/Gazyvaro show significant reduction in disease activity for systemic lupus erythematosus |
|
10/28/2025 |
News Article |
Positive phase III results for Roche's Gazyva/Gazyvaro in children and young adults with idiopathic nephrotic syndrome |
|
10/20/2025 |
News Article |
FDA approves Roche's Gazyva/Gazyvaro for the treatment of lupus nephritis |
|
10/17/2025 |
News Article |
CHMP recommends EU approval of Roche's Gazyva/Gazyvaro for lupus nephritis |