Padcev(enfortumab vedotin)
Padcev (enfortumab vedotin) is an antibody drug conjugate pharmaceutical. Enfortumab vedotin was first approved as Padcev on 2019-12-18. It is used to treat urinary bladder neoplasms in the USA. It has been approved in Europe to treat transitional cell carcinoma and urologic neoplasms. The pharmaceutical is active against nectin-4.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Padcev
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)
Enfortumab vedotin
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Padcev | enfortumab vedotin-ejfv | Astellas Pharma | N-761137 RX | 2019-12-18 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| padcev | Biologic Licensing Application | 2025-02-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| urinary bladder neoplasms | — | D001749 | C67 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9177 | Injection, enfortumab vedotin-ejfv, 0.25 mg |
Clinical
Clinical Trials
72 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Transitional cell carcinoma | D002295 | — | — | 12 | 18 | 3 | 1 | 5 | 32 |
| Urinary bladder neoplasms | D001749 | — | C67 | 11 | 13 | 6 | 1 | 2 | 25 |
| Urologic neoplasms | D014571 | — | C64-C68 | 10 | 14 | 1 | 1 | 2 | 22 |
| Ureteral neoplasms | D014516 | EFO_0003844 | C66 | 4 | 5 | 1 | 1 | — | 9 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 2 | 1 | — | — | 4 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 5 | 10 | — | — | 5 | 19 |
| Neoplasms | D009369 | — | C80 | 3 | 5 | — | — | 1 | 8 |
| Urethral neoplasms | D014523 | EFO_0003846 | — | 2 | 3 | — | — | — | 4 |
| Pelvic neoplasms | D010386 | — | — | 2 | 3 | — | — | — | 4 |
| Adenocarcinoma | D000230 | — | — | — | 3 | — | — | — | 3 |
| Squamous cell carcinoma | D002294 | — | — | — | 3 | — | — | — | 3 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | 1 | 1 | — | — | — | 2 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | 1 | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | — | — | — | 1 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | — | 1 | — | — | — | 1 |
Show 12 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Medical sociology | D012962 | — | — | 1 | — | — | — | — | 1 |
| Carcinoma in situ | D002278 | — | D09.9 | 1 | — | — | — | — | 1 |
| Non-muscle invasive bladder neoplasms | D000093284 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | — | C34.90 | — | — | — | — | 1 | 1 |
| Eye abnormalities | D005124 | — | Q15.9 | — | — | — | — | 1 | 1 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | — | 1 | 1 |
| Agranulocytosis | D000380 | HP_0012234 | D70 | — | — | — | — | 1 | 1 |
| Opportunistic infections | D009894 | — | — | — | — | — | — | 1 | 1 |
| Peripheral nervous system diseases | D010523 | — | G64 | — | — | — | — | 1 | 1 |
| Urogenital neoplasms | D014565 | EFO_0003863 | D07 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Enfortumab vedotin |
| INN | enfortumab vedotin |
| Description | Enfortumab vedotin (human mab) |
| Classification | Antibody |
| Drug class | synthetic analogs of the dolastatin series; monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3301589 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB13007 |
| UNII ID | DLE8519RWM (ChemIDplus, GSRS) |
Target
Agency Approved
NECTIN4
NECTIN4
Organism
Homo sapiens
Gene name
NECTIN4
Gene synonyms
LNIR, PRR4, PVRL4
NCBI Gene ID
Protein name
nectin-4
Protein synonyms
Ig superfamily receptor LNIR, nectin 4, Nectin cell adhesion molecule 4, poliovirus receptor-related 4, Poliovirus receptor-related protein 4
Uniprot ID
Mouse ortholog
Nectin4 (71740)
nectin-4 (Q8R007)
Alternate
No data
Variants
No data
Financial
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 1,785 documents
View more details
Safety
Black-box Warning
Black-box warning for: Padcev
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
5,152 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use