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ombitasvir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antivirals, hepatitis C Virus (HCV) NS5A inhibitors | 4912 | 1258226-87-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
inhibits HCV NS5A protein
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 | Hosey CM, Chan R, Benet LZ |
| Vd (Volume of distribution) | 2.32 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 1.68 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.00 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 28.49 hours | Lombardo F, Berellini G, Obach RS |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 4.917 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 67.920 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 0.119 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 8.690 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 0.160 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 0.330 | % | High | 1 |
| herg | hERG pIC50 | 4.653 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 4.498 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 15.885 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 0.300 | % | High | 1 |
| kinase-safety-class | EIF2AK3,GRK2,ITK,PDK1,PDK2,PDK4 | 6 | |||
| kinase-selectivity-class | GRK2,PDK1 | 2 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 18.239 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 10.304 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 0.140 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 56.624 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 0.100 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 4.667 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 0.440 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 0.210 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 2.729 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 19, 2014 | FDA | ABBVIE INC | |
| Nov. 20, 2014 | EMA | AbbVie Ltd |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Drug interaction | 101.71 | 58.95 | 50 | 378 | 266949 | 42353958 |
| Erosive duodenitis | 59.75 | 58.95 | 11 | 417 | 1778 | 42619129 |
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 |
|---|---|---|---|---|---|---|
| Drug interaction | 163.09 | 56.55 | 71 | 567 | 500112 | 110088549 |
| Drug level increased | 66.30 | 56.55 | 20 | 618 | 47699 | 110540962 |
| Erosive duodenitis | 63.07 | 56.55 | 11 | 627 | 2280 | 110586381 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J05AP52 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections |
| ATC | J05AP53 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections |
| FDA EPC | N0000191256 | Hepatitis C Virus NS5A Inhibitor |
| FDA MoA | N0000191272 | UGT1A1 Inhibitors |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:36044 | antiviral drug |
| CHEBI has role | CHEBI:64951 | anti-HBV agent |
| CHEBI has role | CHEBI:85185 | hepatitis C virus nonstructural protein 5A inhibitor |
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 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.81 | acidic |
| pKa2 | 4.5 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VIEKIRA XR | ABBVIE | N208624 | July 22, 2016 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8501238 | Sept. 17, 2028 | USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION. |
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VIEKIRA XR | ABBVIE | N208624 | July 22, 2016 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 9139536 | Nov. 9, 2028 | TREATMENT OF HCV INFECTION USING DASABUVIR |
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VIEKIRA XR | ABBVIE | N208624 | July 22, 2016 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8188104 | May 17, 2029 | USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION. |
| 12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TECHNIVIE | ABBVIE | N207931 | July 24, 2015 | DISCN | TABLET | ORAL | 8642538 | Sept. 10, 2029 | TREATMENT OF HCV INFECTION USING PARITAPREVIR |
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VIEKIRA XR | ABBVIE | N208624 | July 22, 2016 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8642538 | Sept. 10, 2029 | TREATMENT OF HCV INFECTION USING PARITAPREVIR |
| 12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TECHNIVIE | ABBVIE | N207931 | July 24, 2015 | DISCN | TABLET | ORAL | 9006387 | June 10, 2030 | TREATMENT OF HCV INFECTION USING OMBITASVIR |
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VIEKIRA XR | ABBVIE | N208624 | July 22, 2016 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 9006387 | June 10, 2030 | TREATMENT OF HCV INFECTION USING OMBITASVIR |
| 12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TECHNIVIE | ABBVIE | N207931 | July 24, 2015 | DISCN | TABLET | ORAL | 9044480 | April 10, 2031 | TREATMENT OF HCV INFECTION USING PARITAPREVIR |
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VIEKIRA XR | ABBVIE | N208624 | July 22, 2016 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 9044480 | April 10, 2031 | TREATMENT OF HCV INFECTION USING PARITAPREVIR |
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VIEKIRA XR | ABBVIE | N208624 | July 22, 2016 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 10201584 | May 17, 2032 | TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION |
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VIEKIRA XR | ABBVIE | N208624 | July 22, 2016 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8466159 | Sept. 4, 2032 | TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN. |
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VIEKIRA XR | ABBVIE | N208624 | July 22, 2016 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8492386 | Sept. 4, 2032 | TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN |
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VIEKIRA XR | ABBVIE | N208624 | July 22, 2016 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8680106 | Sept. 4, 2032 | TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN. |
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VIEKIRA XR | ABBVIE | N208624 | July 22, 2016 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8685984 | Sept. 4, 2032 | TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN |
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VIEKIRA XR | ABBVIE | N208624 | July 22, 2016 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 10105365 | Jan. 2, 2035 | TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION |
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VIEKIRA XR | ABBVIE | N208624 | July 22, 2016 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 9333204 | Jan. 2, 2035 | TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION |
| EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VIEKIRA XR | ABBVIE | N208624 | July 22, 2016 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 9744170 | Jan. 2, 2035 | TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION |
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 | EC50 | 11.30 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Genome polyprotein | Polyprotein | INHIBITOR | EC50 | 10.85 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Nonstructural protein 5A | Unclassified | EC50 | 10.85 | CHEMBL | |||||
| Genome polyprotein [Cleaved into: Core protein p21 | Enzyme | EC50 | 10.92 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D10576 | KEGG_DRUG |
| 1456607-70-7 | SECONDARY_CAS_RN |
| 4034026 | VANDF |
| CHEBI:85183 | CHEBI |
| CHEMBL3127326 | ChEMBL_ID |
| C586094 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11272 | IUPHAR_LIGAND_ID |
| DB09296 | DRUGBANK_ID |
| 1597371 | RXNORM |
| 30776 | MMSL |
| d08320 | MMSL |
| 015825 | NDDF |
| 713479007 | SNOMEDCT_US |
| 714429000 | SNOMEDCT_US |
| C3852670 | UMLSCUI |
| 9740 | INN_ID |
| 54767916 | PUBCHEM_CID |
| 2302768XJ8 | UNII |
Pharmaceutical products:
None