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Drug ReportsVoxilaprevir
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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Drug
Target
Variants
Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
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
VOSEVIGilead SciencesN-209195 RX2017-07-18
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
voseviNew Drug Application2024-03-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hepatitis c—D006526B19.2
chronic hepatitis cEFO_0004220D019698B18.2
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Sofosbuvir / Velpatasvir / Voxilaprevir, Vosevi, Gilead Sciences Inc
109128142037-06-01DP
113380072037-06-01DPU-2039, U-2040
92967822034-07-17DS, DP
111167832034-01-30DPU-2039, U-2040
85751352032-11-16DS, DPU-2039, U-2040
89213412032-11-16DS, DPU-2039, U-2040
89407182032-11-16DS, DPU-2039, U-2040
98687452032-11-16DS, DP
86180762030-12-11DS, DPU-2039, U-2040
92843422030-09-13DS, DPU-2039, U-2040
79645802029-03-26DS, DPU-2039, U-2040
86333092029-03-26DS, DPU-2039, U-2040
88891592029-03-26DS, DPU-2039, U-2040
83342702028-03-21DS, DPU-2039, U-2040
85807652028-03-21DS, DPU-2039, U-2040
87353722028-03-21DS, DPU-2039, U-2040
89570462028-03-21U-2039, U-2040
90855732028-03-21DS, DPU-2039, U-2040
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AP: Antivirals for treatment of hcv infections
— J05AP56: Sofosbuvir, velpatasvir and voxilaprevir
HCPCS
No data
Clinical
Clinical Trials
32 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 cD006526—B19.24667831
HepatitisD006505HP_0012115K75.91234717
Hepatitis aD006506EFO_0007305B151114714
Chronic hepatitis cD019698EFO_0004220B18.212—3612
Virus diseasesD014777—B341——113
Chronic hepatitisD006521—K73.9———112
HivD006678—————2—2
Liver cirrhosisD008103EFO_0001422K74.0———112
FibrosisD005355—————112
Opioid-related disordersD009293EFO_0005611F11———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—145—313
Hepatitis bD006509——144—312
Communicable diseasesD003141——143—311
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N191————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008——————11
Patient complianceD010349——————11
Treatment adherence and complianceD000074822——————11
Drug-related side effects and adverse reactionsD064420—T88.7————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVoxilaprevir
INNvoxilaprevir
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 classantivirals: serine protease inhibitors
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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-ID1535212-07-7
RxCUI—
ChEMBL IDCHEMBL3707372
ChEBI ID—
PubChem CID89921642
DrugBank—
UNII ID0570F37359 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Vosevi – Gilead Sciences
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 842 documents
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Safety
Black-box Warning
Black-box warning for: Vosevi
Adverse Events
Top Adverse Reactions
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1,163 adverse events reported
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