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
196 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 | 10 | 20 | 20 | 49 | 102 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 3 | 7 | 16 | 20 | 44 | 90 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 3 | 16 | 20 | 19 | 34 | 89 |
| Ulcer | D014456 | MPATH_579 | — | 1 | 10 | 19 | 17 | 29 | 76 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | 1 | — | 2 | 6 | 35 | 44 |
| Intestinal diseases | D007410 | — | K63.9 | — | — | 2 | 5 | 15 | 22 |
| Healthy volunteers/patients | — | — | — | 7 | — | — | 1 | — | 8 |
| Herpes zoster | D006562 | EFO_0006510 | B02 | — | — | — | 1 | 1 | 2 |
| Pouchitis | D019449 | EFO_0003921 | K91.850 | — | — | 1 | 1 | — | 2 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Graft vs host disease | D006086 | — | D89.81 | — | 3 | 1 | — | — | 4 |
| Leukemia | D007938 | — | C95 | — | 3 | 3 | — | — | 4 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 3 | 3 | — | — | 4 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | — | 3 | 3 | — | — | 4 |
| Neoplasms | D009369 | — | C80 | 2 | 3 | 1 | — | — | 3 |
| Lymphoma | D008223 | — | C85.9 | — | 2 | 3 | — | — | 3 |
| Biphenotypic leukemia acute | D015456 | — | C95.0 | — | 2 | 3 | — | — | 3 |
| Myelomonocytic leukemia acute | D015479 | — | C92.5 | — | 1 | 2 | — | — | 2 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | — | 1 | 1 | — | — | 2 |
| Myeloid leukemia acute | D015470 | — | C92.0 | — | 2 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 4 | — | — | — | 5 |
| Infections | D007239 | EFO_0000544 | — | 1 | 3 | — | — | 1 | 4 |
| Melanoma | D008545 | — | — | 3 | 2 | — | — | — | 3 |
| Communicable diseases | D003141 | — | — | 1 | 3 | — | — | — | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 2 | — | — | — | 2 |
| Persistent infection | D000088562 | — | — | 1 | 2 | — | — | — | 2 |
| Hematopoietic stem cell transplantation | D018380 | — | — | 1 | 1 | — | — | — | 2 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | 1 | — | — | — | 1 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 1 | 1 | — | — | — | 1 |
| Cutaneous malignant melanoma | D000096142 | — | — | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diet therapy | D004035 | — | — | 1 | — | — | — | — | 1 |
| Hiv | D006678 | — | O98.7 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | — | — | 2 | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 2 | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 1 | 1 |
| Hepatitis b | D006509 | — | — | — | — | — | — | 1 | 1 |
| Pregnancy complications | D011248 | — | — | — | — | — | — | 1 | 1 |
| Therapeutics | D013812 | — | — | — | — | — | — | 1 | 1 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | — | 1 | 1 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | — | — | — | — | 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 7,248 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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73,836 adverse events reported
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