Last reviewed · How we verify
Kesimpta (OFATUMUMAB)
Ofatumumab is a monoclonal antibody that binds to CD20 on B cells, leading to their depletion and reduction of autoimmune activity.
Ofatumumab is a monoclonal antibody that binds to CD20 on B cells, leading to their depletion and reduction of autoimmune activity. Used for Relapsing multiple sclerosis (RMS), Chronic lymphocytic leukemia (CLL).
At a glance
| Generic name | OFATUMUMAB |
|---|---|
| Sponsor | Novartis |
| Drug class | Anti-CD20 monoclonal antibody |
| Target | CD20 |
| Modality | Monoclonal antibody |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2009 |
Mechanism of action
Ofatumumab targets CD20, a surface antigen expressed on B lymphocytes. By binding to CD20, it triggers B cell destruction through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), thereby reducing the pathogenic B cell population responsible for autoimmune disease. This mechanism reduces relapse rates and disease progression in multiple sclerosis.
Approved indications
- Relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
Common side effects
- Infusion reactions
- Upper respiratory tract infections
- Headache
- Nasopharyngitis
- Fatigue
- Serious infections
Key clinical trials
- Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis (PHASE4)
- ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS (PHASE4)
- Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab (PHASE3)
- A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL (PHASE2)
- Characterizing the Use of Ofatumumab in a Real World Setting
- Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (PHASE3)
- A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis
- A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Kesimpta CI brief — competitive landscape report
- Kesimpta updates RSS · CI watch RSS
- Novartis portfolio CI