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.
33,115 reports in total, 14,618 marked serious.
- Fatigue5,537
- Headache4,634
- Pyrexia3,584
- Pain3,564
- Chills3,484
- Influenza like illness2,900
- Nausea1,817
- Multiple sclerosis relapse1,705
- Covid-191,519
- Asthenia1,507
Trials
Key trials
Large trials with a reported result on their main goal.
- ARTIOS
Completed · Phase 3 · Relapsing and progressive · Main goal met
- Ofatumumab, phase 3
Completed · Phase 3 · Relapsing and progressive · Main goal met
- Ofatumumab, phase 3
Completed · Phase 3 · Relapsing and progressive · Main goal met
Running now
- SOLI
Recruiting · Relapsing MS · ongoing
- Ofatumumab, early phase 1
Not yet recruiting · Early phase 1 · Relapsing and progressive · ongoing
- Ofatumumab
Running, not recruiting · Relapsing MS · ongoing
- Ofatumumab
Recruiting · Relapsing MS · ongoing
- Ofatumumab
Enrolling by invitation · Relapsing MS · ongoing
- Ofatumumab, phase 1 / phase 2
Recruiting · Phase 1 / Phase 2 · NMOSD · ongoing
- SOSTOS
Running, not recruiting · Phase 4 · Relapsing and progressive · ongoing
- NEOS
Running, not recruiting · Phase 3 · Relapsing MS · ongoing
- Alemtuzumab
Running, not recruiting · Relapsing MS · ongoing
- NEOS
Ongoing · Phase 3 · MS (type not specified)
Other trials (19)
Completed small trials, dose-finding studies and trials in other diseases.
- Ocrelizumab
Completed · Relapsing and progressive · no_result_found
- Ofatumumab
Status unknown · Relapsing MS · result_in_paper_unread
- Ofatumumab, phase 4
Completed · Phase 4 · Relapsing MS · results_posted_no_test
- Ofatumumab
Completed · Relapsing MS · no_result_found
- AGNOS
Completed · Phase 4 · Relapsing MS · results_posted_no_test
- STHENOS
Completed · Phase 3 · Relapsing MS · results_posted_no_test
- Interferon, phase 4
Terminated · Phase 4 · Relapsing MS · Stopped: safety
- KYRIOS
Completed · Phase 4 · Relapsing MS · results_posted_no_test
- TIMIOS
Completed · Relapsing MS · no_result_found
- Ofatumumab, phase 4
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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