maribavir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antivirals 5496 176161-24-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • maribavir
  • livtencity
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.
  • Molecular weight: 376.23
  • Formula: C15H19Cl2N3O4
  • CLOGP: 2.54
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 4
  • TPSA: 99.77
  • ALOGS: -2.72
  • ROTB: 4
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.80 g O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
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:

DateAgencyCompanyOrphan
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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
amenamevirbaloxavir marboxilbulevirtideenfuvirtidefavipiravirfostemsaviribalizumabinosine pranobexlenacapavirletermovirmaravirocmoroxydine show all 15 →

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA 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:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Livtencity HUMAN PRESCRIPTION DRUG LABEL 1 64764-800 TABLET, COATED 200 mg ORAL NDA 33 sections