voxilaprevir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| Hepatitis Virus C (HVC) protease inhibitors | 5242 | 1535212-07-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 4 | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| 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:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.64 | acidic |
| pKa2 | 1.22 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Vosevi | HUMAN PRESCRIPTION DRUG LABEL | 3 | 61958-2401 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 34 sections |