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glecaprevir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| Hepatitis Virus C (HVC) protease inhibitors | 5243 | 1365970-03-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Glecaprevir is an inhibitor of the HCV 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 assay, glecaprevir inhibited the proteolytic activity of recombinant NS3/4A enzymes from clinical isolates of HCV genotypes 1a, 1b, 2a, 2b, 3a, 4a, 5a, and 6a with IC50 values ranging from 3.5 to 11.3 nM.
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 |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 1.876 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 31.623 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 7.145 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 7.047 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 4.950 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 7.370 | % | High | 1 |
| herg | hERG pIC50 | 4.454 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 1.127 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 15.596 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 4.260 | % | High | 1 |
| kinase-safety-class | PDK1,PDK2,PDK4 | 3 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 14.454 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 8.279 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 4 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 91.622 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 | |||
| pppb | Pig plasma protein binding (% unbound) | 5.830 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 6.683 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 50.860 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 5.210 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 746.449 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 26, 2017 | EMA | AbbVie Deutschland GmbH & Co. KG | |
| Aug. 3, 2017 | FDA | ABBVIE INC | |
| Sept. 27, 2017 | PMDA | AbbVie GK |
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 | J05AP57 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections |
| FDA MoA | N0000182138 | Cytochrome P450 1A2 Inhibitors |
| 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 |
| FDA MoA | N0000190114 | Cytochrome P450 3A Inhibitors |
| FDA MoA | N0000191272 | UGT1A1 Inhibitors |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:35469 | antidepressant |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Related Drugs by ATC class:
J05AP Antivirals for treatment of HCV infections 18 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chronic hepatitis C | indication | 128302006 | |
| Compensated cirrhosis | indication | 371139006 |
🐶 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 | 0.86 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 10028937 | June 10, 2030 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 3 YEARS AND OLDER WITH ACUTE HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 10028937 | June 10, 2030 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 10028937 | June 10, 2030 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 10039754 | June 10, 2030 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 3 YEARS AND OLDER WITH ACUTE HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 10039754 | June 10, 2030 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 10039754 | June 10, 2030 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG |
| 50MG/PACKET;20MG/PACKET | MAVYRET | ABBVIE | N215110 | June 10, 2021 | RX | PELLETS | ORAL | 10028937 | June 10, 2030 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 3 YEARS AND OLDER WITH ACUTE HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS |
| 50MG/PACKET;20MG/PACKET | MAVYRET | ABBVIE | N215110 | June 10, 2021 | RX | PELLETS | ORAL | 10028937 | June 10, 2030 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG |
| 50MG/PACKET;20MG/PACKET | MAVYRET | ABBVIE | N215110 | June 10, 2021 | RX | PELLETS | ORAL | 10039754 | June 10, 2030 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 3 YEARS AND OLDER WITH ACUTE HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS |
| 50MG/PACKET;20MG/PACKET | MAVYRET | ABBVIE | N215110 | June 10, 2021 | RX | PELLETS | ORAL | 10039754 | June 10, 2030 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 9586978 | Nov. 6, 2030 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 3 YEARS AND OLDER WITH ACUTE HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 9586978 | Nov. 6, 2030 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 9586978 | Nov. 6, 2030 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG |
| 50MG/PACKET;20MG/PACKET | MAVYRET | ABBVIE | N215110 | June 10, 2021 | RX | PELLETS | ORAL | 9586978 | Nov. 6, 2030 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 3 YEARS AND OLDER WITH ACUTE HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS |
| 50MG/PACKET;20MG/PACKET | MAVYRET | ABBVIE | N215110 | June 10, 2021 | RX | PELLETS | ORAL | 9586978 | Nov. 6, 2030 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 8648037 | Jan. 19, 2032 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 3 YEARS AND OLDER WITH ACUTE HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 8648037 | Jan. 19, 2032 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 8648037 | Jan. 19, 2032 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG |
| 50MG/PACKET;20MG/PACKET | MAVYRET | ABBVIE | N215110 | June 10, 2021 | RX | PELLETS | ORAL | 8648037 | Jan. 19, 2032 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 3 YEARS AND OLDER WITH ACUTE HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS |
| 50MG/PACKET;20MG/PACKET | MAVYRET | ABBVIE | N215110 | June 10, 2021 | RX | PELLETS | ORAL | 8648037 | Jan. 19, 2032 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 10286029 | March 14, 2034 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 3 YEARS AND OLDER WITH ACUTE HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 10286029 | March 14, 2034 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 11484534 | March 14, 2034 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 3 YEARS AND OLDER WITH ACUTE HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | 11484534 | March 14, 2034 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG |
| 50MG/PACKET;20MG/PACKET | MAVYRET | ABBVIE | N215110 | June 10, 2021 | RX | PELLETS | ORAL | 10286029 | March 14, 2034 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 3 YEARS AND OLDER WITH ACUTE HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS |
| 50MG/PACKET;20MG/PACKET | MAVYRET | ABBVIE | N215110 | June 10, 2021 | RX | PELLETS | ORAL | 10286029 | March 14, 2034 | TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 IN PEDIATRIC PATIENTS 3 TO LESS THAN 12 YEARS OF AGE OR WEIGHING LESS THAN 45 KG |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | April 30, 2026 | TREATMENT OF PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1,2,3,4,5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A) |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | April 30, 2026 | TREATMENT OF PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), BUT NOT BOTH |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | Oct. 30, 2026 | PEDIATRIC EXCLUSIVITY |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | June 10, 2028 | FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A); AND TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), B |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | June 10, 2028 | TREATMENT OF ACUTE HEPATITIS C VIRUS (HCV) INFECTION IN ADULTS AND PEDIATRIC PATIENTS AGES 3 TO LESS THAN 18 YEARS OF AGE |
| 50MG/PACKET;20MG/PACKET | MAVYRET | ABBVIE | N215110 | June 10, 2021 | RX | PELLETS | ORAL | June 10, 2028 | FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A); AND TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), B |
| 50MG/PACKET;20MG/PACKET | MAVYRET | ABBVIE | N215110 | June 10, 2021 | RX | PELLETS | ORAL | June 10, 2028 | TREATMENT OF ACUTE HEPATITIS C VIRUS (HCV) INFECTION IN ADULTS AND PEDIATRIC PATIENTS AGES 3 TO LESS THAN 18 YEARS OF AGE |
| 100MG;40MG | MAVYRET | ABBVIE | N209394 | Aug. 3, 2017 | RX | TABLET | ORAL | Dec. 10, 2028 | PEDIATRIC EXCLUSIVITY |
| 50MG/PACKET;20MG/PACKET | MAVYRET | ABBVIE | N215110 | June 10, 2021 | RX | PELLETS | ORAL | Dec. 10, 2028 | PEDIATRIC EXCLUSIVITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| NS5B protein | Enzyme | Ki | 10.28 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| K6BUU8J72P | UNII |
| 4036871 | VANDF |
| C4519536 | UMLSCUI |
| CHEBI:755595 | CHEBI |
| O31 | PDB_CHEM_ID |
| CHEMBL3545363 | ChEMBL_ID |
| 66828839 | PUBCHEM_CID |
| DB13879 | DRUGBANK_ID |
| D10814 | KEGG_DRUG |
| 10261 | INN_ID |
| C000612853 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11267 | IUPHAR_LIGAND_ID |
| 736837006 | SNOMEDCT_US |
| 816101006 | SNOMEDCT_US |
| 33000 | MMSL |
| d08633 | MMSL |
| 017295 | NDDF |
| 1940635 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Mavyret | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0074-2600 | PELLET | 50 mg | ORAL | NDA | 34 sections |
| Mavyret | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0074-2625 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 34 sections |