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
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
Highest Development Phases
Phase 3: Multiple Sclerosis
Phase 2: Chronic Lymphoid Leukemia|Lymphocytic Chronic B-Cell Leukemia|Mantle-Cell Lymphoma|Nephrotic Syndrome
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 |
|
| CBAF312D2301 | P3 |
Unknown Status |
Multiple Sclerosis |
2029-06-01 |
|
| COMB157G2399 | P3 |
Unknown Status |
Multiple Sclerosis |
2028-09-07 |