Provenge(sipuleucel-t)
Provenge (sipuleucel-t) is a cell pharmaceutical. Sipuleucel-t was first approved as Provenge on 2010-04-29. It is used to treat prostatic neoplasms in the USA. It has been approved in Europe to treat prostatic neoplasms.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Provenge
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)
Sipuleucel-t
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Provenge | sipuleucel-T | Dendreon Pharmaceuticals LLC | A-125197 RX | 2010-04-29 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| provenge | Biologic Licensing Application | 2021-12-09 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| Q2043 | Sipuleucel-t, minimum of 50 million autologous cd54+ cells activated with pap-gm-csf, including leukapheresis and all other preparatory procedures, per infusion |
Clinical
Clinical Trials
8 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | 1 | 2 | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 1 | — | 1 | — | — | 2 |
Indications Phases 2
No data
Indications Phases 1
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SIPULEUCEL-T |
| INN | — |
| Description | Sipuleucel-T, sold under the brand name Provenge, developed by Dendreon Pharmaceuticals, LLC, is a cell-based cancer immunotherapy for prostate cancer (CaP). It is an autologous cellular immunotherapy.
|
| Classification | Cell |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 917381-47-6 |
| RxCUI | 997261 |
| ChEMBL ID | CHEMBL1237024 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06688 |
| UNII ID | — |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,487 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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126 adverse events reported
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