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.
3,894 reports in total, 932 marked serious.
- Infusion related reaction1,435
- Fatigue238
- Headache124
- Malaise116
- Pain109
- Urinary tract infection103
- Illness100
- Multiple sclerosis relapse99
- Asthenia94
- Gait disturbance90
Trials
Key trials
Large trials with a reported result on their main goal.
- Study to Assess the Efficacy and Safety of Ublituximab in Participants
Completed · Phase 3 · Relapsing MS · Met its main goal
- Study to Assess the Efficacy and Safety of Ublituximab in Participants
Completed · Phase 3 · Relapsing MS · Met its main goal
Running now
- Study to Assess Effects of Ublituximab in Pediatric Participants With
Recruiting · Phase 2 / Phase 3 · Relapsing MS · Still running
- Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatme
Recruiting · Not a drug-phase study · Relapsing and progressive · Still running
- A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (
Recruiting · Phase 2 · Relapsing MS · Still running
- Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis
Recruiting · Phase 4 · Relapsing MS · Still running
- Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
Recruiting · Phase 4 · Relapsing MS · Still running
- Effects of Ublituximab on Motor Functions in Multiple Sclerosis
Recruiting · Early phase 1 · Relapsing MS · Still running
- A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Ra
Running, not recruiting · Phase 3 · Relapsing MS · Still running
- A Single-Center Study to Characterize the Safety and Efficacy of Ublit
Recruiting · Relapsing MS · Still running
- Evaluation of intravenous or subcutaneous administration of ublituxima
Running, not recruiting · Phase 1 · Relapsing MS · Still running
- Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modi
Recruiting · Phase 3 · Relapsing MS · Still running
Other trials (3)
Completed small trials, dose-finding studies and trials in other diseases.
- An Extension of the TG1101-RMS201 Trial
Completed · Phase 2 · Relapsing MS · No results found
- Phase IIa Study of Ublituximab in Participants With Relapsing Forms of
Completed · Phase 2 · Relapsing MS · Main goal was not benefit
- Ublituximab for Acute Neuromyelitis Optica (NMO) Relapses
Completed · Phase 1 · NMOSD · Results posted, not judged
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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