maribavir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
June 7, 2013 EMA Takeda Pharmaceuticals International AG Ireland Branch
Nov. 23, 2021 FDA TAKEDA PHARMS USA

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
Hospitalisation 102.09 48.89 32 351 85049 63403590
Taste disorder 84.93 48.89 19 364 13643 63474996
Drug resistance 55.72 48.89 15 368 22918 63465721
Dysgeusia 53.35 48.89 17 366 46693 63441946

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 159.57 48.35 33 456 7122 34949320
Dysgeusia 89.89 48.35 27 462 26470 34929972
Hospitalisation 88.02 48.35 32 457 56870 34899572
Drug resistance 60.96 48.35 20 469 25907 34930535
Viral load increased 58.11 48.35 12 477 2515 34953927

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 82.12 58.75 21 284 42192 79701891
Cytomegalovirus viraemia 77.08 58.75 16 289 12805 79731278

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

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 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

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
Serine/threonine protein kinase UL97 Kinase INHIBITOR IC50 8.52 DRUG LABEL DRUG LABEL

External reference:

IDSource
CHEMBL515408 ChEMBL_ID
C400401 MESH_SUPPLEMENTAL_RECORD_UI
12049 IUPHAR_LIGAND_ID
DB06234 DRUGBANK_ID
018895 NDDF
4041017 VANDF
D04859 KEGG_DRUG
C1508759 UMLSCUI
7812 INN_ID
426042003 SNOMEDCT_US
426852000 SNOMEDCT_US
471161 PUBCHEM_CID
2586068 RXNORM
353741 MMSL
37579 MMSL
d09411 MMSL
PTB4X93HE1 UNII

Pharmaceutical products:

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