Vosevi(voxilaprevir)
Vosevi (voxilaprevir) is a small molecule pharmaceutical. Voxilaprevir was first approved as Vosevi on 2017-07-18. It is used to treat hepatitis c in the USA. It has been approved in Europe to treat chronic hepatitis c.
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Commercial
Trade Name
FDA
EMA
Combinations
Vosevi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sofosbuvir
+
Velpatasvir
+
Voxilaprevir
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
VOSEVI | Gilead Sciences | N-209195 RX | 2017-07-18 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
vosevi | New Drug Application | 2019-11-21 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Sofosbuvir / Velpatasvir / Voxilaprevir, Vosevi, Gilead Sciences Inc | |||
10912814 | 2037-06-01 | DP | |
11338007 | 2037-06-01 | DP | U-2039, U-2040 |
9296782 | 2034-07-17 | DS, DP | |
11116783 | 2034-01-30 | DP | U-2039, U-2040 |
8575135 | 2032-11-16 | DS, DP | U-2039, U-2040 |
8921341 | 2032-11-16 | DS, DP | U-2039, U-2040 |
8940718 | 2032-11-16 | DS, DP | U-2039, U-2040 |
9868745 | 2032-11-16 | DS, DP | |
8618076 | 2030-12-11 | DS, DP | U-2039, U-2040 |
9284342 | 2030-09-13 | DS, DP | U-2039, U-2040 |
7964580 | 2029-03-26 | DS, DP | U-2039, U-2040 |
8633309 | 2029-03-26 | DS, DP | U-2039, U-2040 |
8889159 | 2029-03-26 | DS, DP | U-2039, U-2040 |
8334270 | 2028-03-21 | DS, DP | U-2039, U-2040 |
8580765 | 2028-03-21 | DS, DP | U-2039, U-2040 |
8735372 | 2028-03-21 | DS, DP | U-2039, U-2040 |
8957046 | 2028-03-21 | U-2039, U-2040 | |
9085573 | 2028-03-21 | DS, DP | U-2039, U-2040 |
9585906 | 2028-03-21 | DS, DP | U-2039, U-2040 |
HCPCS
No data
Clinical
Clinical Trials
15 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | 3 | 3 | — | 7 |
Peripheral arterial disease | D058729 | EFO_0004265 | — | — | 1 | 3 | — | 4 | |
Coronary artery disease | D003324 | I25.1 | — | — | — | 1 | — | 1 | |
Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | — | — | 1 | — | 1 |
Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | 1 | — | 1 |
Healthy volunteers/patients | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | 3 | — | — | 4 |
Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 1 | 1 | — | — | 2 |
Stroke | D020521 | EFO_0000712 | I63.9 | — | — | 2 | — | — | 2 |
Ischemia | D007511 | EFO_0000556 | — | — | 2 | — | — | 2 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Acute coronary syndrome | D054058 | EFO_0005672 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | VOXILAPREVIR |
INN | voxilaprevir |
Description | Voxilaprevir is a hepatitis C virus (HCV) nonstructural (NS) protein 3/4A protease inhibitor (by Gilead) that is used in combination with sofosbuvir and velpatasvir. The combination has the trade name Vosevi and received a positive opinion from the European Committee for Medicinal Products for Human Use in June 2017.
|
Classification | Small molecule |
Drug class | antivirals: serine protease inhibitors |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CC[C@H]1[C@@H](C(=O)N[C@]2(C(=O)NS(=O)(=O)C3(C)CC3)C[C@H]2C(C)C)N2C[C@@H]1Oc1nc3cc(OC)ccc3nc1C(F)(F)CCCC[C@@H]1C[C@H]1OC(=O)N[C@@H](C(C)(C)C)C2=O |
Identifiers
PDB | — |
CAS-ID | 1535212-07-7 |
RxCUI | 1939323 |
ChEMBL ID | CHEMBL3707372 |
ChEBI ID | — |
PubChem CID | 89921642 |
DrugBank | DB12026 |
UNII ID | 0570F37359 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Vosevi - Gilead Sciences
$
€
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 683 documents
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Safety
Black-box Warning
Black-box warning for: Vosevi
Adverse Events
Top Adverse Reactions
Mock data
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188 adverse events reported
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