voxilaprevir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
Hepatitis Virus C (HVC) protease inhibitors 5242 1535212-07-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • voxilaprevir
  • GS-9857
Voxilaprevir is a noncovalent, reversible inhibitor of the NS3/4A protease, which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication. In a biochemical inhibition assay, voxilaprevir inhibited the proteolytic activity of recombinant NS3/4A enzymes from clinical isolates of HCV genotypes 1b and 3a with Ki values of 38 and 66 pM, respectively.
  • Molecular weight: 868.94
  • Formula: C40H52F4N6O9S
  • CLOGP: 6.79
  • LIPINSKI: 3
  • HAC: 15
  • HDO: 3
  • TPSA: 195.22
  • ALOGS: -4.23
  • ROTB: 8

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
July 26, 2017 EMA GILEAD SCIENCES IRELAND UC
July 18, 2017 FDA GILEAD SCIENCES INC

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J05AP56 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HCV infections
FDA MoA N0000182638 HCV NS3/4A Protease Inhibitors
FDA EPC N0000182639 Hepatitis C Virus NS3/4A Protease Inhibitor
FDA MoA N0000185503 P-Glycoprotein Inhibitors
FDA MoA N0000190107 Organic Anion Transporting Polypeptide 1B1 Inhibitors
FDA MoA N0000190108 Organic Anion Transporting Polypeptide 1B3 Inhibitors
FDA MoA N0000190113 Breast Cancer Resistance Protein Inhibitors

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Chronic hepatitis C indication 128302006
Product containing ethinylestradiol contraindication 15432003
Pglycoprotein (Pgp) and/or strong cytochrome P450 (CYP) inducers contraindication 422728003
Dabigatran etexilate contraindication 700029008
Rosuvastatin contraindication 700067006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.64 acidic
pKa2 1.22 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8334270 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8334270 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8580765 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8580765 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8735372 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8735372 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8957046 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8957046 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9085573 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9085573 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9585906 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9585906 March 21, 2028 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 7964580 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 7964580 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8633309 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8633309 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8889159 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8889159 March 26, 2029 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9284342 Sept. 13, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 9284342 Sept. 13, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8618076 Dec. 11, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8618076 Dec. 11, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8575135 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8575135 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8921341 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8921341 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8940718 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 8940718 Nov. 16, 2032 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 11116783 Jan. 30, 2034 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 11116783 Jan. 30, 2034 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 11338007 June 1, 2037 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
400MG;100MG;100MG VOSEVI GILEAD SCIENCES INC N209195 July 18, 2017 RX TABLET ORAL 11338007 June 1, 2037 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Genome polyprotein Polyprotein INHIBITOR Ki 10.42 DRUG LABEL DRUG LABEL
Genome polyprotein Polyprotein INHIBITOR Ki 10.18 DRUG LABEL DRUG LABEL

External reference:

IDSource
0570F37359 UNII
4036863 VANDF
C4507236 UMLSCUI
L9P PDB_CHEM_ID
CHEMBL3707372 ChEMBL_ID
89921642 PUBCHEM_CID
DB12026 DRUGBANK_ID
D10899 KEGG_DRUG
10143 INN_ID
32914 MMSL
d08618 MMSL
017285 NDDF
736536005 SNOMEDCT_US
816106001 SNOMEDCT_US
1939323 RXNORM
C000619503 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Vosevi HUMAN PRESCRIPTION DRUG LABEL 3 61958-2401 TABLET, FILM COATED 100 mg ORAL NDA 34 sections