Olysio(simeprevir)
Olysio (simeprevir) is a small molecule pharmaceutical. Simeprevir was first approved as Olysio on 2013-11-22. 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. The pharmaceutical is active against Genome polyprotein.
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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)
Simeprevir sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OLYSIO | Johnson & Johnson | N-205123 DISCN | 2013-11-22 | 1 products, RLD |
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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
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Simeprevir Sodium, Olysio, Janssen Prods | |||
| 8148399 | 2029-09-05 | DS, DP | U-1467 |
| 8349869 | 2026-07-28 | DS, DP | U-1467 |
| 8741926 | 2026-07-28 | DP | U-1467 |
| 8754106 | 2026-07-28 | DP | U-1467 |
| 9040562 | 2026-07-28 | DS, DP | U-1467 |
| 9353103 | 2026-07-28 | U-1467 | |
| 9623022 | 2026-07-28 | U-1467 | |
| 9856265 | 2026-07-28 | DS, DP | U-1467 |
| 7671032 | 2025-05-19 | DS, DP | |
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Clinical Trials
111 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 | 27 | 27 | 21 | 8 | 12 | 93 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 22 | 21 | 19 | 6 | 12 | 80 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 2 | 18 | 18 | 4 | 8 | 50 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 5 | 21 | 10 | 4 | 9 | 48 |
| Chronic hepatitis | D006521 | — | K73.9 | — | 5 | 1 | 1 | — | 7 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | 1 | 3 | 4 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | 3 | 4 | — | 2 | 9 |
| Virus diseases | D014777 | — | B34 | — | 2 | 3 | — | 1 | 6 |
| Communicable diseases | D003141 | — | — | — | — | 3 | — | 1 | 4 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 1 | — | 2 | 3 |
| Fibrosis | D005355 | — | — | — | — | 2 | — | 1 | 3 |
| Hepatitis b | D006509 | — | — | — | — | 2 | — | 1 | 3 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | 1 | — | 1 | 2 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | — | — | 1 | — | — | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | 1 | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepacivirus | D016174 | — | — | 12 | 2 | — | — | 1 | 15 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 2 | 5 | — | — | 1 | 7 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | 1 | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 14 | — | — | — | — | 14 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Viruses | D014780 | NCBITaxon_10239 | — | 1 | — | — | — | — | 1 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv | D006678 | — | — | — | — | — | — | 2 | 2 |
| Hemoglobinopathies | D006453 | — | D58.2 | — | — | — | — | 1 | 1 |
| Coinfection | D060085 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Simeprevir |
| INN | simeprevir |
| Description | Simeprevir is an azamacrocycle and a lactam. |
| Classification | Small molecule |
| Drug class | antivirals: serine protease inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1ccc2c(O[C@@H]3C[C@H]4C(=O)N[C@]5(C(=O)NS(=O)(=O)C6CC6)C[C@H]5/C=C\CCCCN(C)C(=O)[C@@H]4C3)cc(-c3nc(C(C)C)cs3)nc2c1C |
Identifiers
| PDB | — |
| CAS-ID | 923604-59-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL501849 |
| ChEBI ID | — |
| PubChem CID | 24873435 |
| DrugBank | DB06290 |
| UNII ID | 9WS5RD66HZ (ChemIDplus, GSRS) |
Target
Agency Approved
Organism
Hepacivirus hominis
Gene name
Gene synonyms
NCBI Gene ID
—
Protein name
Genome polyprotein
Protein synonyms
Uniprot ID
Mouse ortholog
—
—
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Safety
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6,349 adverse events reported
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