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Ofatumumab

Alternative Names: ofatumumab, arzerra, gsk1841157, humax-cd20, omb-157, omb157, omb 157, Kesimpta
Latest Update: 2024-06-11
Latest Update Note: Clinical Trial Update

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: None *

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: Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting

Known Adverse Events: Headache | Respiratory Tract Infections

Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Ofatumumab

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: 14

Highest Development Phases

Phase 3: Multiple Sclerosis

Phase 2: Chronic Lymphoid Leukemia|Lung Cancer|Lymphocytic Chronic B-Cell Leukemia|Mantle-Cell Lymphoma|Mesothelioma|Nephrotic Syndrome|Pleural Cancer

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

NEOS

P3

Active, not recruiting

Multiple Sclerosis

2029-10-19

2017-004703-51

P3

Active, not recruiting

Multiple Sclerosis

2029-06-10

ALITHIOS

P3

Recruiting

Multiple Sclerosis

2027-12-30

95%

NEOS

P3

Recruiting

Multiple Sclerosis

2027-03-02

95%

NEOS

P3

Recruiting

Multiple Sclerosis

2027-03-02

95%

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