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BRIUMVI (UBLITUXIMAB-XIIY)
BRIUMVI (generic name: UBLITUXIMAB-XIIY) is a CD20-directed Cytolytic Antibody [EPC] drug developed by TG THERAPEUTICS, INC. It is currently FDA-approved for Relapsing forms of multiple sclerosis.
BRIUMVI is a B-lymphocyte antigen CD20 binding agent, classified as a BINDING AGENT. It is used to treat conditions such as Multiple Sclerosis, Relapsing-Remitting, Relapsing Multiple Sclerosis, and Autoimmune Disorders.
At a glance
| Generic name | UBLITUXIMAB-XIIY |
|---|---|
| Sponsor | TG THERAPEUTICS, INC |
| Drug class | CD20-directed Cytolytic Antibody [EPC] |
| Target | B-lymphocyte antigen CD20 |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
Approved indications
- Relapsing forms of multiple sclerosis
Common side effects
- Infusion reactions
- Upper respiratory tract infections
- Lower respiratory tract infections
- Pyrexia
- Chills
- Headache
- Influenza-like illness
- Decreased neutrophil counts
- Decreased IgM levels
- Decreased IgA levels
- Decreased IgG levels
Serious adverse events
- Serious infusion reactions
- Progressive multifocal leukoencephalopathy
- Liver injury
- Infections
Key clinical trials
- Evaluating Safety, Efficacy and Pharmacokinetics of a Modified Regimen of Ublituximab (ENHANCE ) (Phase 3)
- Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosis (Phase 4)
- Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS) (Phase 2)
- A Post-marketing Study Evaluating the Presence and Concentration of BRIUMVI™ in Breast Milk (PROVIDE) (N/A)
- Study of Ublituximab in Early, Active, Autoantibody-Positive, IMMune-MedIated NecroTizing Myopathy (AIM01) (Phase 2)
- Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis (Phase 4)
- REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE) (N/A)
- BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI® (N/A)
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 |
|---|---|
| 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:
- BRIUMVI CI brief — competitive landscape report
- BRIUMVI updates RSS · CI watch RSS
- TG THERAPEUTICS, INC portfolio CI
Frequently asked questions about BRIUMVI
What is BRIUMVI?
What is BRIUMVI used for?
Who makes BRIUMVI?
What is the generic name of BRIUMVI?
What drug class is BRIUMVI in?
What development phase is BRIUMVI in?
What are the side effects of BRIUMVI?
What does BRIUMVI target?
Related
- Drug class: All CD20-directed Cytolytic Antibody [EPC] drugs
- Target: All drugs targeting B-lymphocyte antigen CD20
- Manufacturer: TG THERAPEUTICS, INC — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Relapsing forms of multiple sclerosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing