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
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
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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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
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 | |
HCPCS
No data
Clinical
Clinical Trials
42 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatic encephalopathy | D006501 | K72.91 | — | 1 | 2 | — | — | 3 | |
| Covid-19 | D000086382 | U07.1 | 1 | 3 | 1 | — | — | 3 | |
| Tibial fractures | D013978 | EFO_0003944 | S82.20 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | 1 | 2 |
| Head and neck neoplasms | D006258 | — | 1 | — | — | 1 | 2 | ||
| Insulin resistance | D007333 | EFO_0002614 | — | 1 | — | — | — | 1 | |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | 1 | — | — | — | 1 |
| Wound infection | D014946 | 1 | 1 | — | — | — | 1 | ||
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | — | — | — | 4 | 4 |
| Anesthesia | D000758 | — | — | — | — | 1 | 1 | ||
| Delayed emergence from anesthesia | D055191 | — | — | — | — | 1 | 1 | ||
| Neuromuscular blockade | D019148 | — | — | — | — | 1 | 1 | ||
| Critical care | D003422 | — | — | — | — | 1 | 1 | ||
| Ingrown nails | D009263 | L60.0 | — | — | — | — | 1 | 1 | |
| Radiodermatitis | D011855 | L58 | — | — | — | — | 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 | 1482790 |
| ChEMBL ID | CHEMBL501849 |
| ChEBI ID | — |
| PubChem CID | 24873435 |
| DrugBank | DB06290 |
| UNII ID | 9WS5RD66HZ (ChemIDplus, GSRS) |
Target
Agency Approved
Organism
Hepacivirus C
Gene name
Gene synonyms
NCBI Gene ID
—
Protein name
Genome polyprotein
Protein synonyms
Uniprot ID
Mouse ortholog
—
—
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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160 adverse events reported
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