Ofatumumab
How it works: Removing B cells →
Kesimpta
EU: Approved in the EU since 2021US: FDA approved 2009
FDA dates refer to the first approval of the product's licence. For alemtuzumab and ofatumumab this was an earlier cancer approval.
- Molecule type
- Antibody
- Mechanism (ChEMBL)
- B-lymphocyte antigen CD20 binding agent
- Targets
- B-lymphocyte antigen CD20
- Availability
- Authorised in all EU and EEA countries. Reimbursement is decided by each country.
Approvals
Safety communications
None recorded.
Most-reported side effects (FDA reports)
Reports to the FDA's adverse event system (FAERS) show what people and doctors reported while taking the medicine. They do not prove the medicine caused it, and they are not rates.
33,718 reports in total, 15,042 marked serious.
- Fatigue5,594
- Headache4,671
- Pyrexia3,638
- Pain3,599
- Chills3,507
- Influenza like illness2,934
- Nausea1,834
- Multiple sclerosis relapse1,741
- Covid-191,523
- Asthenia1,521
Trials
Key trials
Large trials with a reported result on their main goal.
- An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and
Completed · Phase 3 · Relapsing and progressive · Met its main goal
- Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patient
Completed · Phase 3 · Relapsing and progressive · Met its main goal
- Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patient
Completed · Phase 3 · Relapsing and progressive · Met its main goal
Running now
- Switch to Ofatumumab and Level of Immunoglobulins
Recruiting · Relapsing MS · Still running
- An Open-Label, Single-Arm Clinical Study to Evaluate the Safety and Pr
Not yet recruiting · Early phase 1 · Relapsing and progressive · Still running
- ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatum
Running, not recruiting · Relapsing MS · Still running
- Exploring the Efficacy and Safety of Ofatumumab in Patients With Relap
Recruiting · Relapsing MS · Still running
- Retinal Atrophy and Neurofilament Light Chain in People With Multiple
Enrolling by invitation · Relapsing MS · Still running
- Ofatumumab in AQP4-IgG Seropositive NMOSD
Recruiting · Phase 1 / Phase 2 · NMOSD · Still running
- A Multicenter Study of Continued Current Therapy vs Transition to Ofat
Running, not recruiting · Phase 4 · Relapsing and progressive · Still running
- Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod
Running, not recruiting · Phase 3 · Relapsing MS · Still running
- A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY
Running, not recruiting · Relapsing MS · Still running
- Efficacy and safety of ofatumumab and siponimod compared to fingolimod
Ongoing · Phase 3 · MS (type not specified)
Other trials (19)
Completed small trials, dose-finding studies and trials in other diseases.
- WOE of Anti-CD20 Therapies
Completed · Relapsing and progressive · No results found
- Effects of Ofatumumab Treatment on Immune Cells and Meningeal Lymphati
Status unknown · Relapsing MS · Paper found, not read
- Study of Efficacy and Safety of Ofatumumab in Relapsing Multiple Scler
Completed · Phase 4 · Relapsing MS · Results posted, not judged
- Reduced Oligodendrocyte-specific Cytotoxicity and Ofatumumab Treatment
Completed · Relapsing MS · No results found
- Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Earl
Completed · Phase 4 · Relapsing MS · Results posted, not judged
- Open Label Randomized Multicenter to Assess Efficacy & Tolerability of
Completed · Phase 3 · Relapsing MS · Results posted, not judged
- A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple
Terminated · Phase 4 · Relapsing MS · Stopped: safety
- Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patie
Completed · Phase 4 · Relapsing MS · Results posted, not judged
- Time and Motion Study for Ocrelizumab and Ofatumumab Administration in
Completed · Relapsing MS · No results found
- Tracking the immune response to SARS-CoV-2 modRNA vaccines in an open-
Completed · Phase 4 · Relapsing MS
For information only, not medical advice. Talk to your neurologist before changing treatment.
Hypotheses involving this medicine
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Lab studies
Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.
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