Ublituximab
How it works: Removing B cells →
Briumvi
EU: Approved in the EU since 2023US: FDA approved 2022
- 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.
3,781 reports in total, 835 marked serious.
- Infusion related reaction1,412
- Fatigue232
- Headache121
- Malaise114
- Pain108
- Urinary tract infection99
- Illness97
- Multiple sclerosis relapse94
- Asthenia91
- Inappropriate schedule of product administration88
Trials
Key trials
Large trials with a reported result on their main goal.
- ULTIMATE 1
Completed · Phase 3 · Relapsing MS · Main goal met
- Ublituximab, phase 3
Completed · Phase 3 · Relapsing MS · Main goal met
Running now
- Fingolimod, phase 2 / phase 3
Recruiting · Phase 2 / Phase 3 · Relapsing MS · ongoing
- Ublituximab, not applicable
Recruiting · Not a drug-phase study · Relapsing and progressive · ongoing
- Ublituximab, phase 2
Recruiting · Phase 2 · Relapsing MS · ongoing
- Ublituximab, phase 4
Recruiting · Phase 4 · Relapsing MS · ongoing
- Ublituximab, phase 4
Recruiting · Phase 4 · Relapsing MS · ongoing
- U-PACE
Recruiting · Early phase 1 · Relapsing MS · ongoing
- Ublituximab, phase 3
Running, not recruiting · Phase 3 · Relapsing MS · ongoing
- Ublituximab
Recruiting · Relapsing MS · ongoing
- Ublituximab, phase 1
Running, not recruiting · Phase 1 · Relapsing MS · ongoing
- ENHANCE
Recruiting · Phase 3 · Relapsing MS · ongoing
Other trials (3)
Completed small trials, dose-finding studies and trials in other diseases.
- Ublituximab, phase 2
Completed · Phase 2 · Relapsing MS · no_result_found
- Ublituximab, phase 2
Completed · Phase 2 · Relapsing MS · Not an efficacy test
- Ublituximab, phase 1
Completed · Phase 1 · NMOSD · results_posted_no_test
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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