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maribavir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antivirals | 5496 | 176161-24-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Livtencity is an antiviral drug against human cytomegalovirus. The antiviral activity of maribavir is mediated by competitive inhibition of the protein kinase activity of human CMV enzyme pUL97, which results in inhibition of the phosphorylation of proteins. Maribavir inhibited wildtype pUL97 protein kinase in a biochemical assay with an IC50 value of 0.003 microM.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.80 | g | O |
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAP3K21,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK,ZAP70 | 22 | |||
| kinase-selectivity-class | MAP2K6,PDK1 | 2 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 23, 2021 | FDA | TAKEDA PHARMS USA | |
| June 7, 2013 | EMA | Takeda Pharmaceuticals International AG Ireland Branch |
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 |
|---|---|---|---|---|---|---|
| Dysgeusia | 181.57 | 46.70 | 53 | 1080 | 52507 | 90574807 |
| Drug resistance | 156.70 | 46.70 | 42 | 1091 | 30407 | 90596907 |
| Taste disorder | 135.64 | 46.70 | 44 | 1089 | 61502 | 90565812 |
| Hospitalisation | 135.25 | 46.70 | 53 | 1080 | 128047 | 90499267 |
| Death | 88.19 | 46.70 | 60 | 1073 | 456491 | 90170823 |
| Viral load increased | 78.21 | 46.70 | 14 | 1119 | 1542 | 90625772 |
| Cytomegalovirus infection | 54.31 | 46.70 | 18 | 1115 | 26584 | 90600730 |
| Cytomegalovirus infection reactivation | 50.78 | 46.70 | 13 | 1120 | 7787 | 90619527 |
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 |
|---|---|---|---|---|---|---|
| Taste disorder | 318.10 | 36.45 | 75 | 1629 | 10132 | 42609499 |
| Dysgeusia | 216.27 | 36.45 | 72 | 1632 | 34117 | 42585514 |
| Drug resistance | 192.39 | 36.45 | 66 | 1638 | 34182 | 42585449 |
| Viral load increased | 158.50 | 36.45 | 34 | 1670 | 2963 | 42616668 |
| Cytomegalovirus infection reactivation | 131.70 | 36.45 | 38 | 1666 | 11140 | 42608491 |
| Hospitalisation | 109.28 | 36.45 | 55 | 1649 | 74275 | 42545356 |
| Cytomegalovirus viraemia | 82.19 | 36.45 | 26 | 1678 | 10351 | 42609280 |
| Product use issue | 63.60 | 36.45 | 39 | 1665 | 76712 | 42542919 |
| Death | 63.23 | 36.45 | 85 | 1619 | 471100 | 42148531 |
| Product distribution issue | 38.43 | 36.45 | 10 | 1694 | 1984 | 42617647 |
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 resistance | 340.31 | 48.34 | 90 | 1448 | 56284 | 110531477 |
| Dysgeusia | 152.70 | 48.34 | 51 | 1487 | 69934 | 110517827 |
| Taste disorder | 144.02 | 48.34 | 48 | 1490 | 65339 | 110522422 |
| Cytomegalovirus viraemia | 144.01 | 48.34 | 36 | 1502 | 17728 | 110570033 |
| Cytomegalovirus infection reactivation | 104.07 | 48.34 | 28 | 1510 | 18305 | 110569456 |
| Death | 85.24 | 48.34 | 73 | 1465 | 698796 | 109888965 |
| Viral load increased | 83.23 | 48.34 | 17 | 1521 | 3373 | 110584388 |
| Off label use | 62.52 | 48.34 | 89 | 1449 | 1500096 | 109087665 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J05AX10 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Other antivirals |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000998 | Antiviral Agents |
| FDA MoA | N0000182141 | Cytochrome P450 3A4 Inhibitors |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| FDA EPC | N0000193976 | Cytomegalovirus pUL97 Kinase Inhibitor |
| FDA MoA | N0000193977 | Cytomegalovirus pUL97 Kinase Inhibitors |
| CHEBI has role | CHEBI:22587 | antiviral agent |
Related Drugs by ATC class:
J05AX Other antivirals 15 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Post-transplant cytomegalovirus infection | indication | 28944009 | |
| Valganciclovir | contraindication | 129476000 | |
| Ganciclovir | contraindication | 372848001 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 200MG | LIVTENCITY | TAKEDA PHARMS USA | N215596 | Nov. 23, 2021 | RX | TABLET | ORAL | 12447169 | Oct. 27, 2031 | TREATMENT OF PATIENTS WITH POST-TRANSPLANT CYTOMEGALOVIRUS (CMV) INFECTION/DISEASE THAT IS REFRACTORY TO TREATMENT WITH GANCICLOVIR, VALGANCICLOVIR, CIDOFOVIR, OR FOSCARNET, BY ADMINISTERING 400 MG OF MARIBAVIR ORALLY TWICE DAILY |
| 200MG | LIVTENCITY | TAKEDA PHARMS USA | N215596 | Nov. 23, 2021 | RX | TABLET | ORAL | 11684632 | Jan. 4, 2032 | TREATMENT OF PATIENTS WITH POST-TRANSPLANT CYTOMEGALOVIRUS (CMV) INFECTION/DISEASE REFRACTORY TO TREATMENT WITH GANCICLOVIR, VALGANCICLOVIR, CIDOFOVIR, OR FOSCARNET, WHERE THE PATIENT IS A STEM CELL, KIDNEY, OR LIVER TRANSPLANT RECIPIENT |
| 200MG | LIVTENCITY | TAKEDA PHARMS USA | N215596 | Nov. 23, 2021 | RX | TABLET | ORAL | 12213989 | Nov. 18, 2042 | TREATING POST-TRANSPLANT CMV INFECTION/DISEASE REFRACTORY TO GANCICLOVIR, VALGANCICLOVIR, CIDOFOVIR OR FOSCARNET BY ADMINISTERING 1200 MG MARIBAVIR TWICE DAILY, WHERE THE PATIENT IS CONCOMITANTLY EXPOSED TO OR RECEIVING PHENYTOIN OR PHENOBARBITAL |
| 200MG | LIVTENCITY | TAKEDA PHARMS USA | N215596 | Nov. 23, 2021 | RX | TABLET | ORAL | 12433907 | Nov. 18, 2042 | TREATING POST-TRANSPLANT CMV INFECTION/DISEASE REFRACTORY TO GANCICLOVIR, VALGANCICLOVIR, CIDOFOVIR OR FOSCARNET BY ADMINISTERING 1200 MG MARIBAVIR TWICE DAILY, WHERE PATIENT IS EXPOSED TO/RECEIVING AN IMMUNOSUPPRESSANT AND PHENYTOIN OR PHENOBARBITAL |
| 200MG | LIVTENCITY | TAKEDA PHARMS USA | N215596 | Nov. 23, 2021 | RX | TABLET | ORAL | 12447170 | Nov. 18, 2042 | TREATING POST-TRANSPLANT CMV INFECTION/DISEASE REFRACTORY TO GANCICLOVIR, VALGANCICLOVIR, CIDOFOVIR OR FOSCARNET BY ADMINISTERING 800 OR 1200 MG MARIBAVIR 2X DAILY WHERE PATIENT IS CONCOMITANTLY EXPOSED TO/RECEIVING ANTICONVULSANT, IMMUNOSUPPRESSANT |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 200MG | LIVTENCITY | TAKEDA PHARMS USA | N215596 | Nov. 23, 2021 | RX | TABLET | ORAL | Nov. 23, 2026 | NEW CHEMICAL ENTITY |
| 200MG | LIVTENCITY | TAKEDA PHARMS USA | N215596 | Nov. 23, 2021 | RX | TABLET | ORAL | Nov. 23, 2028 | FOR THE TREATMENT OF ADULTS AND PEDIATRIC PATIENTS (12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG) WITH POST-TRANSPLANT CYTOMEGALOVIRUS (CMV) INFECTION/DISEASE THAT IS REFRACTORY TO TREATMENT (WITH OR WITHOUT GENOTYPIC RESISTANCE) WITH GANCICLOVIR, VALGANCICLOVIR, CIDOFOVIR OR FOSCARNET |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Histone deacetylase 6 | Enzyme | IC50 | 6.17 | CHEMBL | |||||
| Serine/threonine protein kinase UL97 | Kinase | INHIBITOR | IC50 | 8.52 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEBI:749006 | CHEBI |
| CHEMBL515408 | ChEMBL_ID |
| C400401 | MESH_SUPPLEMENTAL_RECORD_UI |
| 12049 | IUPHAR_LIGAND_ID |
| DB06234 | DRUGBANK_ID |
| 426042003 | SNOMEDCT_US |
| 426852000 | SNOMEDCT_US |
| 4041017 | VANDF |
| C1508759 | UMLSCUI |
| D04859 | KEGG_DRUG |
| 7812 | INN_ID |
| 471161 | PUBCHEM_CID |
| 353741 | MMSL |
| 37579 | MMSL |
| d09411 | MMSL |
| 018895 | NDDF |
| PTB4X93HE1 | UNII |
| 2586068 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Livtencity | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64764-800 | TABLET, COATED | 200 mg | ORAL | NDA | 33 sections |