BRIUMVI (ublituximab-xiiy)
BRIUMVI is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting multiple sclerosis; Active secondary progressive multiple sclerosis.
How BRIUMVI Works
Ublituximab-xiiy binds to CD20, a cell surface antigen found on pre-B and mature B lymphocytes. Once the drug binds to these lymphocytes, it induces cell lysis, which is the breakdown and destruction of the cell. This therapeutic effect is achieved through biological mechanisms including antibody-dependent cellular cytolysis and complement-dependent cytolysis.
Details
- Status
- Prescription
- First Approved
- 2022-12-28
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
BRIUMVI Approval History
What BRIUMVI Treats
3 indicationsBRIUMVI is approved for 3 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Clinically isolated syndrome
- Relapsing-remitting multiple sclerosis
- Active secondary progressive multiple sclerosis
BRIUMVI Target & Pathway
ProTarget
A protein found on the surface of B-cells but not stem cells or plasma cells. Anti-CD20 antibodies deplete B-cells, making them effective in B-cell cancers and autoimmune diseases where B-cells drive pathology.
BRIUMVI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BRIUMVI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BRIUMVI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BRIUMVI
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BRIUMVI FDA Label Details
Indications & Usage
FDA Label (PDF)BRIUMVI is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting multiple sclerosis; Active secondary progressive multiple sclerosis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.