Rituxan, Mabthera(rituximab)
Blitzima, MabThera, Riabni, Rituxan, Rixathon, Riximyo, Ruxience, Truxima (rituximab) is an antibody pharmaceutical. Rituximab was first approved as Rituxan on 1997-11-26. It is used to treat b-cell lymphoma, granulomatosis with polyangiitis, lymphoid leukemia, mantle-cell lymphoma, and microscopic polyangiitis amongst others in the USA. It has been approved in Europe to treat b-cell chronic lymphocytic leukemia, microscopic polyangiitis, non-hodgkin lymphoma, pemphigus, and rheumatoid arthritis. The pharmaceutical is active against B-lymphocyte antigen CD20.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Riabni, Rituxan, Ruxience, Truxima (discontinued: Rituxan)
CombinationsRituxan hycela
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| riabni | Biologic Licensing Application | 2024-02-26 |
| rituxan | Biologic Licensing Application | 2025-01-06 |
| rituxan hycela | Biologic Licensing Application | 2024-11-20 |
| ruxience | Biologic Licensing Application | 2024-10-10 |
| truxima | Biologic Licensing Application | 2024-12-20 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
rituximab, Rituxan, Genentech, Inc. | |||
| 2026-09-27 | Orphan excl. | ||
rituximab / hyaluronidase human, Rituxan Hycela, Genentech, Inc. | |||
| 2024-06-22 | Orphan excl. | ||
Patent Expiration
No data
Clinical
Clinical Trials
2568 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 19 | 48 | 30 | 1 | 13 | 99 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 6 | 14 | 10 | 15 | 45 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | — | 6 | 14 | 10 | 15 | 45 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 8 | 17 | 10 | 1 | 4 | 35 |
| Leukemia | D007938 | — | C95 | 4 | 9 | 12 | 3 | 8 | 34 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 3 | 9 | 12 | 3 | 8 | 33 |
| Lymphoid leukemia | D007945 | — | C91 | 3 | 9 | 12 | 3 | 8 | 33 |
| Granulomatosis with polyangiitis | D014890 | EFO_0005297 | M31.3 | — | 1 | 1 | 2 | — | 4 |
| Microscopic polyangiitis | D055953 | EFO_1000784 | M31.7 | — | 1 | 1 | 1 | — | 3 |
| Systemic vasculitis | D056647 | — | — | — | 1 | 1 | 1 | — | 3 |
Show 3 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 11 | 20 | 13 | — | 4 | 40 |
| B-cell lymphoma | D016393 | — | — | 11 | 15 | 12 | — | 5 | 37 |
| Follicular lymphoma | D008224 | — | C82 | 7 | 12 | 7 | — | 7 | 27 |
| Mantle-cell lymphoma | D020522 | — | — | 1 | 5 | 1 | — | — | 6 |
| Thrombocytopenic purpura | D011696 | — | — | — | 3 | 1 | — | 1 | 5 |
| Purpura | D011693 | HP_0000979 | D69.2 | — | 3 | 1 | — | 1 | 5 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | 2 | 1 | — | 1 | 4 |
| Syndrome | D013577 | — | — | 1 | 4 | 1 | — | — | 4 |
| Vasculitis | D014657 | HP_0002633 | — | — | 1 | 2 | — | — | 3 |
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | D056648 | — | I77.82 | — | 1 | 2 | — | — | 3 |
Show 14 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 2 | — | — | — | 2 |
| Aids-related lymphoma | D016483 | EFO_1001365 | — | — | 2 | — | — | — | 2 |
| Aggression | D000374 | EFO_0003015 | — | — | 2 | — | — | — | 2 |
| Graft vs host disease | D006086 | — | D89.81 | — | 2 | — | — | — | 2 |
| Bronchiolitis obliterans syndrome | D000092122 | — | — | — | 2 | — | — | — | 2 |
| Waldenstrom macroglobulinemia | D008258 | HP_0005508 | C88.0 | — | 1 | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | 1 | — | — | — | 1 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | — | 1 | — | — | — | 1 |
| Recurrence | D012008 | — | — | 1 | 1 | — | — | — | 1 |
| Stem cell transplantation | D033581 | — | — | — | 1 | — | — | — | 1 |
Show 18 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | — | — | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Off-label use | D056687 | — | — | — | — | — | — | 1 | 1 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | — | — | — | 1 | 1 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | — | — | 1 | 1 |
| Eczema | D004485 | HP_0000964 | L30.9 | — | — | — | — | 1 | 1 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Rituximab |
| INN | rituximab |
| Description | Rituximab, sold under the brand name Rituxan among others, is a medication used to treat certain autoimmune diseases and types of cancer. It is used for non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, idiopathic thrombocytopenic purpura, pemphigus vulgaris, myasthenia gravis and Epstein–Barr virus-positive mucocutaneous ulcers. It is given by slow injection into a vein.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies: chimeric, tumors as target |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >1L6X:A|IMMUNOGLOBULIN GAMMA-1 HEAVY CHAIN CONSTANT REGION
GPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNG
KEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPP
VLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSL
>1L6X:B|Minimized B-domain of Protein A Z34C
FNMQCQRRFYEALHDPNLNEEQRNAKIKSIRDDC |
Identifiers
| PDB | 1L6X, 2OSL, 4KAQ, 6VJA, 6Y90 |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201576 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00073 |
| UNII ID | 4F4X42SYQ6 (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
Estimated US medical usage
Rituximab
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 82,138 documents
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Safety
Black-box Warning
Black-box warning for: Riabni, Rituxan, Rituxan hycela, Ruxience, Truxima
Adverse Events
Top Adverse Reactions
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203,127 adverse events reported
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