elbasvir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antivirals, hepatitis C Virus (HCV) NS5A inhibitors | 5080 | 1370468-36-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
inhibits NS5A protein of hepatitis C virus
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 50 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 4 | Bocci G, Oprea TI, Benet LZ |
| BA (Bioavailability) | 0.32 % | Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 28, 2016 | FDA | MERCK SHARP DOHME |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Liver injury | 83.79 | 45.23 | 42 | 2302 | 60478 | 63426200 |
| Psoriatic arthropathy | 67.54 | 45.23 | 42 | 2302 | 91478 | 63395200 |
| Lupus vulgaris | 61.46 | 45.23 | 18 | 2326 | 5976 | 63480702 |
| Eye injury | 54.19 | 45.23 | 14 | 2330 | 2925 | 63483753 |
| Glossodynia | 52.19 | 45.23 | 47 | 2297 | 178829 | 63307849 |
| Pemphigus | 51.11 | 45.23 | 47 | 2297 | 183679 | 63302999 |
| Systemic lupus erythematosus | 45.98 | 45.23 | 47 | 2297 | 208871 | 63277807 |
| Ulcer haemorrhage | 45.71 | 45.23 | 14 | 2330 | 5408 | 63481270 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Pancreas transplant rejection | 47.76 | 30.82 | 7 | 685 | 318 | 79743378 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J05AP10 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections |
| ATC | J05AP54 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| FDA EPC | N0000191256 | Hepatitis C Virus NS5A Inhibitor |
| CHEBI has role | CHEBI:36044 | antiviral drugs |
| CHEBI has role | CHEBI:62868 | hepatoprotective agents |
| CHEBI has role | CHEBI:85185 | hepatitis C virus nonstructural protein 5A inhibitors |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chronic hepatitis C | indication | 128302006 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 12.46 | acidic |
| pKa2 | 12.98 | acidic |
| pKa3 | 13.06 | acidic |
| pKa4 | 13.59 | acidic |
| pKa5 | 5.64 | Basic |
| pKa6 | 5.03 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 50MG;100MG | ZEPATIER | MSD SUB MERCK | N208261 | Jan. 28, 2016 | RX | TABLET | ORAL | 7973040 | July 24, 2029 | TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS |
| 50MG;100MG | ZEPATIER | MSD SUB MERCK | N208261 | Jan. 28, 2016 | RX | TABLET | ORAL | 8871759 | May 4, 2031 | TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 50MG;100MG | ZEPATIER | MSD SUB MERCK | N208261 | Jan. 28, 2016 | RX | TABLET | ORAL | Dec. 9, 2024 | NEW PATIENT POPULATION |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Genome polyprotein | Polyprotein | INHIBITOR | EC50 | 11.52 | DRUG LABEL | DRUG LABEL | |||
| Genome polyprotein | Polyprotein | INHIBITOR | EC50 | 11.40 | DRUG LABEL | DRUG LABEL | |||
| Genome polyprotein | Polyprotein | INHIBITOR | EC50 | 12.52 | DRUG LABEL | DRUG LABEL | |||
| Nonstructural protein 5A | Unclassified | EC50 | 10.70 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 632L571YDK | UNII |
| D10625 | KEGG_DRUG |
| 4035373 | VANDF |
| C4080052 | UMLSCUI |
| CHEBI:132967 | CHEBI |
| CHEMBL3039514 | ChEMBL_ID |
| 71661251 | PUBCHEM_CID |
| DB11574 | DRUGBANK_ID |
| 9851 | INN_ID |
| C000589335 | MESH_SUPPLEMENTAL_RECORD_UI |
| 1734628 | RXNORM |
| 31482 | MMSL |
| d08416 | MMSL |
| 016673 | NDDF |
| 716042006 | SNOMEDCT_US |
| 816100007 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ZEPATIER | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0006-3074 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 31 sections |
| ZEPATIER | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0006-3074 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 31 sections |