Ublituximab
Briumvi (ublituximab) is an antibody pharmaceutical. Ublituximab was first approved as Briumvi on 2022-12-28. It is used to treat relapsing-remitting multiple sclerosis in the USA. It has been approved in Europe to treat multiple sclerosis and relapsing-remitting multiple sclerosis. The pharmaceutical is active against B-lymphocyte antigen CD20.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Briumvi
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Ublituximab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Briumvi | ublituximab-xiiy | TG Therapeutics | N-761238 RX | 2022-12-28 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| briumvi | Biologic Licensing Application | 2025-08-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| relapsing-remitting multiple sclerosis | EFO_0003929 | D020529 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
45 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 1 | 2 | 4 | 1 | 4 | 11 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 9 | 11 | 4 | — | — | 19 |
| Lymphoma | D008223 | — | C85.9 | 8 | 7 | 1 | — | — | 12 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | 2 | 3 | — | 4 | 10 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 6 | 4 | 1 | — | — | 8 |
| Lymphoid leukemia | D007945 | — | C91 | 3 | 3 | 3 | — | — | 8 |
| Leukemia | D007938 | — | C95 | 2 | 3 | 3 | — | — | 7 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 4 | 3 | 1 | — | — | 6 |
| Follicular lymphoma | D008224 | — | C82 | 3 | 4 | 1 | — | — | 6 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 4 | 4 | 1 | — | — | 6 |
| Sclerosis | D012598 | — | — | 1 | 2 | 2 | — | 1 | 6 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma | D016393 | — | — | 6 | 1 | — | — | — | 6 |
| Waldenstrom macroglobulinemia | D008258 | — | C88.0 | 3 | 1 | — | — | — | 3 |
| Disease progression | D018450 | — | — | — | 1 | — | — | — | 1 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | 1 | — | — | — | 1 |
| Muscular diseases | D009135 | EFO_0002970 | G72.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | 1 | — | — | — | — | 1 |
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | 1 | — | — | — | — | 1 |
| Optic neuritis | D009902 | EFO_0007405 | H46 | 1 | — | — | — | — | 1 |
| Reactive arthritis | D016918 | EFO_0007460 | M02.3 | 1 | — | — | — | — | 1 |
| Hodgkin disease | D006689 | — | C81 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ublituximab |
| INN | ublituximab |
| Description | Ublituximab, sold under the brand name Briumvi, is an immunomodulator used for the treatment of multiple sclerosis. It is a CD20-directed cytolytic monoclonal antibody.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108354 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB11850 |
| UNII ID | U59UGK3IPC (ChemIDplus, GSRS) |
Target
Agency Approved
MS4A1
MS4A1
Organism
Homo sapiens
Gene name
MS4A1
Gene synonyms
CD20
NCBI Gene ID
Protein name
B-lymphocyte antigen CD20
Protein synonyms
B-lymphocyte cell-surface antigen B1, B-lymphocyte surface antigen B1, Bp35, CD20, CD20 antigen, CD20 receptor, Leukocyte surface antigen Leu-16, Membrane-spanning 4-domains subfamily A member 1, membrane-spanning 4-domains, subfamily A, member 1
Uniprot ID
Mouse ortholog
Ms4a1 (12482)
B-lymphocyte antigen CD20 (P19437)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,036 adverse events reported
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