Incivek, Incivo(telaprevir)
Incivek, Incivo (telaprevir) is a protein pharmaceutical. Telaprevir was first approved as Incivek on 2011-05-23. It is used to treat chronic hepatitis c and hepatitis c in the USA. It has been approved in Europe to treat chronic hepatitis c. It is known to target lysosomal protective protein and chymotrypsin-like elastase family member 1.
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Commercial
Therapeutic Areas
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Drug Products
FDA
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Telaprevir
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| INCIVEK | Vertex Pharmaceuticals | N-201917 DISCN | 2011-05-23 | 1 products |
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FDA
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hepatitis c | — | D006526 | B19.2 |
| chronic hepatitis c | EFO_0004220 | D019698 | B18.2 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
105 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis c | D006526 | — | B19.2 | 20 | 26 | 27 | 6 | 17 | 94 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 12 | 26 | 27 | 5 | 15 | 83 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 6 | 22 | 21 | 5 | 10 | 62 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 6 | 14 | 18 | 2 | 13 | 53 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis | D006521 | — | K73.9 | 1 | 5 | 7 | — | 2 | 15 |
| Infections | D007239 | EFO_0000544 | — | 1 | 2 | 4 | — | 1 | 8 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | 2 | 1 | — | 1 | 6 |
| Hiv | D006678 | — | — | 3 | — | 1 | — | 1 | 5 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | 1 | 2 | — | 1 | 4 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 2 | — | 1 | — | 1 | 4 |
| Communicable diseases | D003141 | — | — | — | — | 3 | — | — | 3 |
| Virus diseases | D014777 | — | B34 | — | 1 | 2 | — | — | 3 |
| Coinfection | D060085 | — | — | — | — | 1 | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | 1 | 1 | — | — | — | 2 |
| Depression | D003863 | — | F33.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Hepatic insufficiency | D048550 | — | — | 2 | — | — | — | — | 2 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | — | — | — | — | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | — | — | — | 1 |
| Liver failure | D017093 | HP_0001399 | K72.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 2 | 2 |
| Anemia | D000740 | HP_0001903 | D64.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Telaprevir |
| INN | telaprevir |
| Description | Telaprevir is an oligopeptide consisting of N-(pyrazin-2-ylcarbonyl)cyclohexylalanyl, 3-methylvalyl, octahydrocyclopenta[c]pyrrole-1-carboxy, and 3-amino-N-cyclopropyl-2-oxohexanamide residues joined in sequence. Used for treatment of chronic hepatitis C virus genotype 1 infection. It has a role as a peptidomimetic, a hepatitis C protease inhibitor and an antiviral drug. It is an oligopeptide, a member of pyrazines, a cyclopentapyrrole and a member of cyclopropanes. |
| Classification | Protein |
| Drug class | antivirals: serine protease inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC[C@H](NC(=O)[C@@H]1[C@H]2CCC[C@H]2CN1C(=O)[C@@H](NC(=O)[C@@H](NC(=O)c1cnccn1)C1CCCCC1)C(C)(C)C)C(=O)C(=O)NC1CC1 |
Identifiers
| PDB | — |
| CAS-ID | 402957-28-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL231813 |
| ChEBI ID | 68595 |
| PubChem CID | 3010818 |
| DrugBank | DB05521 |
| UNII ID | 655M5O3W0U (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
CTSA
CTSA
CELA1
CELA1
Organism
Homo sapiens
Gene name
CTSA
Gene synonyms
PPGB
NCBI Gene ID
Protein name
lysosomal protective protein
Protein synonyms
beta-galactosidase 2, beta-galactosidase protective protein, Carboxypeptidase C, Carboxypeptidase L, carboxypeptidase Y-like kininase, carboxypeptidase-L, Cathepsin A, deamidase, lysosomal carboxypeptidase A, PPCA, Protective protein cathepsin A, Protective protein for beta-galactosidase, urinary kininase
Uniprot ID
Mouse ortholog
Ctsa (19025)
lysosomal protective protein (Q8VEF6)
Variants
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Financial
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Incivek – Vertex Pharmaceuticals
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Telaprevir
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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37,102 adverse events reported
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