Entyvio(vedolizumab)
Entyvio (vedolizumab) is an antibody pharmaceutical. Vedolizumab was first approved as Entyvio on 2014-05-20. It is used to treat crohn disease, enteritis, and ulcerative colitis in the USA. It has been approved in Europe to treat crohn disease and ulcerative colitis.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
digestive system diseases | D004066 |
Trade Name
FDA
EMA
Entyvio
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)
Vedolizumab
Tradename | Proper name | Company | Number | Date | Products |
---|---|---|---|---|---|
Entyvio | vedolizumab | Takeda | N-125476 RX | 2014-05-20 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
entyvio | Biologic Licensing Application | 2020-11-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
crohn disease | EFO_0000384 | D003424 | K50 |
enteritis | — | D004751 | K52.9 |
ulcerative colitis | EFO_0000729 | D003093 | K51 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
---|---|
J3380 | Injection, vedolizumab, 1 mg |
Clinical
Clinical Trials
97 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Ulcerative colitis | D003093 | EFO_0000729 | K51 | 3 | 6 | 12 | 12 | 10 | 43 |
Crohn disease | D003424 | EFO_0000384 | K50 | 3 | 7 | 11 | 12 | 6 | 39 |
Inflammatory bowel diseases | D015212 | EFO_0003767 | 1 | — | 1 | 2 | 6 | 10 | |
Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | 1 | — | 1 |
Pouchitis | D019449 | EFO_0003921 | K91.850 | — | — | — | 1 | — | 1 |
Self efficacy | D020377 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Sclerosing cholangitis | D015209 | EFO_0004268 | K83.01 | — | — | 1 | — | — | 1 |
Myelodysplastic syndromes | D009190 | D46 | — | — | 1 | — | — | 1 | |
Lymphoma | D008223 | C85.9 | — | — | 1 | — | — | 1 | |
Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | — | — | 1 | — | — | 1 | |
Biphenotypic leukemia acute | D015456 | C95.0 | — | — | 1 | — | — | 1 | |
Myelomonocytic leukemia juvenile | D054429 | C93.3 | — | — | 1 | — | — | 1 |
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 | 3 | — | — | — | 3 |
Non-small-cell lung carcinoma | D002289 | 2 | 2 | — | — | — | 2 | ||
Melanoma | D008545 | 2 | 1 | — | — | — | 2 | ||
Colitis | D003092 | EFO_0003872 | K52.9 | 2 | 2 | — | — | — | 2 |
Lung neoplasms | D008175 | C34.90 | 1 | 1 | — | — | — | 1 | |
Celiac disease | D002446 | EFO_0001060 | K90.0 | — | 1 | — | — | — | 1 |
Graft vs host disease | D006086 | D89.81 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 5 | — | — | — | — | 5 | ||
Diet therapy | D004035 | 1 | — | — | — | — | 1 | ||
Hiv | D006678 | O98.7 | 1 | — | — | — | — | 1 | |
Macular degeneration | D008268 | EFO_0001365 | H35.30 | 1 | — | — | — | — | 1 |
Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Therapeutics | D013812 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | VEDOLIZUMAB |
INN | vedolizumab |
Description | Vedolizumab (humanized mab) |
Classification | Antibody |
Drug class | monoclonal antibodies |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
PDB | — |
CAS-ID | 943609-66-3 |
RxCUI | 1538097 |
ChEMBL ID | CHEMBL1743087 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB09033 |
UNII ID | 9RV78Q2002 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Entyvio - Takeda
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,962 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,502 adverse events reported
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