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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| entyvio | Biologic Licensing Application | 2022-10-24 |
| entyvio entyvio pen | Biologic Licensing Application | 2024-06-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| ulcerative colitis | EFO_0000729 | D003093 | K51 |
| crohn disease | EFO_0000384 | D003424 | K50 |
| enteritis | — | D004751 | K52.9 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J3380 | Injection, vedolizumab, 1 mg |
Clinical
Clinical Trials
204 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn disease | D003424 | EFO_0000384 | K50 | 2 | 4 | 13 | 13 | 25 | 57 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | 3 | 12 | 10 | 24 | 50 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 4 | 8 | 8 | 13 | 33 |
| Ulcer | D014456 | MPATH_579 | — | — | 3 | 8 | 8 | 12 | 31 |
| Pouchitis | D019449 | EFO_0003921 | K91.850 | — | — | 1 | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | 1 | — | 14 | 15 |
| Intestinal diseases | D007410 | — | K63.9 | — | — | 1 | — | 4 | 5 |
| Sclerosing cholangitis | D015209 | EFO_0004268 | K83.01 | — | — | 1 | — | — | 1 |
| Cholangitis | D002761 | HP_0030151 | K83.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Celiac disease | D002446 | EFO_0001060 | K90.0 | — | 1 | — | — | — | 1 |
| Enteritis | D004751 | — | K52.9 | — | 1 | — | — | — | 1 |
| Gastritis | D005756 | EFO_0000217 | K29.7 | — | 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 |
| Hematopoietic stem cell transplantation | D018380 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 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 | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1743087 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09033 |
| UNII ID | 9RV78Q2002 (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
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Entyvio – Takeda
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,237 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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85,769 adverse events reported
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