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 chymotrypsin-like elastase family member 1 and lysosomal protective protein.
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Commercial
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
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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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| chronic hepatitis c | EFO_0004220 | D019698 | B18.2 |
| hepatitis c | — | D006526 | B19.2 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
87 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 6 | 10 | 14 | — | 3 | 33 |
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | — | 1 | 2 | — | 1 | 4 |
| Hiv | D006678 | O98.7 | 3 | — | 1 | — | — | 4 | |
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | 1 | |
| Hepacivirus | D016174 | — | — | 1 | — | — | 1 | ||
| Hepatitis b | D006509 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 2 | — | — | — | 3 |
| 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 | — | 3 | — | — | — | — | 3 | ||
| Hepatic insufficiency | D048550 | 2 | — | — | — | — | 2 | ||
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | — | — | — | — | 1 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | — | — | — | — | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
| Kidney diseases | D007674 | EFO_0003086 | N08 | 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 |
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 | 1102261 |
| ChEMBL ID | CHEMBL231813 |
| ChEBI ID | 68595 |
| PubChem CID | 3010818 |
| DrugBank | DB05521 |
| UNII ID | 655M5O3W0U (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CELA1
CELA1
CTSA
CTSA
Organism
Homo sapiens
Gene name
CELA1
Gene synonyms
ELA1
NCBI Gene ID
Protein name
chymotrypsin-like elastase family member 1
Protein synonyms
chymotrypsin like elastase family member 1, elastase 1, pancreatic, Elastase-1, Pancreatic elastase 1
Uniprot ID
Mouse ortholog
Cela1 (109901)
chymotrypsin-like elastase family member 1 (Q9Z1H1)
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000225949 | IFNL4, 151-152G>A | drug response | 2021-03-24 | 1A |
| VCV000226027 | IFNL3 | drug response | 2021-03-29 | 1B |
Financial
Incivek - Vertex Pharmaceuticals
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Trends
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Additional graphs summarizing 4,213 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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14,234 adverse events reported
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