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| Stem definition | Drug id | CAS RN |
|---|---|---|
| monoclonal antibodies (chimeric origin); tumor | 5697 | 1174014-05-1 |
| Molecule | Description |
|---|---|
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Synonyms:
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The precise mechanism by which ublituximab-xiiy exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ublituximab-xiiy results in cell lysis through mechanisms including antibody-dependent cellular cytolysis and complement-dependent cytolysis.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 28, 2022 | FDA | TG THERAPEUTICS, INC | |
| May 31, 2023 | EMA | PROPHARMA GROUP THE NETHERLANDS B.V. |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infusion related reaction | 318.93 | 46.44 | 85 | 120 | 416695 | 90211547 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infusion related reaction | 137.12 | 61.43 | 33 | 118 | 60773 | 42560411 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infusion related reaction | 474.73 | 42.19 | 137 | 395 | 381025 | 110207742 |
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| Source | Code | Description |
|---|---|---|
| ATC | L04AG14 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Monoclonal antibodies |
| MeSH PA | D000091369 | Immunomodulating Agents |
| MeSH PA | D007155 | Immunologic Factors |
| FDA MoA | N0000175078 | CD20-directed Antibody Interactions |
| FDA EPC | N0000175657 | CD20-directed Cytolytic Antibody |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Relapsing forms of multiple sclerosis | indication | 426373005 | DOID:2378 |
| Viral hepatitis type B | contraindication | 66071002 | DOID:2043 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| B-lymphocyte antigen CD20 | Surface antigen | BINDING AGENT | UNKNOWN | DRUG LABEL |
| ID | Source |
|---|---|
| CHEBI:753332 | CHEBI |
| CHEMBL2108354 | ChEMBL_ID |
| C000619007 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8920 | IUPHAR_LIGAND_ID |
| DB11850 | DRUGBANK_ID |
| 1351582007 | SNOMEDCT_US |
| 4041960 | VANDF |
| 4041961 | VANDF |
| C4083151 | UMLSCUI |
| CHEMBL2109348 | ChEMBL_ID |
| 9334 | INN_ID |
| D11243 | KEGG_DRUG |
| 364480 | MMSL |
| 41161 | MMSL |
| d09959 | MMSL |
| 019257 | NDDF |
| U59UGK3IPC | UNII |
| 2626348 | RXNORM |
| C549677 | MESH_SUPPLEMENTAL_RECORD_UI |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| BRIUMVI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73150-150 | INJECTION, SOLUTION, CONCENTRATE | 150 mg | INTRAVENOUS | BLA | 31 sections |