Product Description
Kesimpta is a disease modifying drug (DMD) for active relapsing remitting and very active relapsing remitting MS. You have fewer relapses than you might have had without treatment and any relapses you do have should be less severe. Disease progression is slowed. Kesimpta is a highly effective (category 2.0) DMD; in clinical trials, people taking Kesimpta had 50-59% fewer relapses than people taking Aubagio. In clinical trials, MRI scans showed that people taking Kesimpta had fewer, smaller or no new areas of active MS (lesions). Kesimpta also slowed down the build-up of disability associated with MS. (Sourced from: https://mstrust.org.uk/a-z/kesimpta-ofatumumab)
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: Europe
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, Relapsing-Remitting|Multiple Sclerosis, Secondary Progressive
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, Relapsing-Remitting|Multiple Sclerosis, Secondary Progressive |
2026-10-01 |
30% |
2023-09-22 |
|
NCT04788615 |
STHENOS | P3 |
Completed |
Multiple Sclerosis |
2025-11-04 |
48% |
2025-11-27 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT01243190 |
NCI-2011-00745 | P2 |
Completed |
Chronic Lymphoid Leukemia|Lymphocytic Chronic B-Cell 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 |
64% |
2025-03-21 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
NCT04926818 |
NEOS | P3 |
Active, not recruiting |
Multiple Sclerosis |
2027-03-02 |
60% |
2025-01-15 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT06869785 |
FILIOS | P3 |
Recruiting |
Multiple Sclerosis |
2026-12-24 |
36% |
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 |
67% |
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 |
67% |
2025-06-30 |
Treatments |
NCT04486716 |
OLIKOS | P3 |
Completed |
Multiple Sclerosis |
2023-11-20 |
28% |
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 |
Pleural Cancer|Mesothelioma|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 |
|---|---|---|
|
12/09/2025 |
News Article |
European Commission approves Roche's Gazyva/Gazyvaro for adults with active lupus nephritis |
|
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 |