Maribavir

Highest phase reached
Approved
www.ebi.ac.uk
Drug type
Small molecule
www.ebi.ac.uk
First approval year
2021
www.ebi.ac.uk

First approval year
2021
www.ebi.ac.uk
Listing at source
Listed
Highest phase reached
Approved
www.ebi.ac.uk

Drug type
Small molecule
www.ebi.ac.uk
Drug name
Maribavir
www.ebi.ac.uk
Molecular weight
376.24
www.ebi.ac.uk
Structure (SMILES)
CC(C)Nc1nc2cc(Cl)c(Cl)cc2n1[C@H]1O[C@@H](CO)[C@H](O)[C@@H]1O
www.ebi.ac.uk

  • livtencity
  • Livtencity

  • 1263 w 94
  • 1263-W-94
  • 1263w94
  • 1263W94
  • bw 1263w94
  • BW-1263W94
  • gw 257406x
  • GW-257406X
  • livtencity
  • Livtencity
  • LIVTENCITY
  • maribavir
  • Maribavir
  • Maribavir (200 mg)
  • Maribavir (400 mg)
  • Maribavir (800 mg)
  • Maribavir [INN]
  • Maribavir [MI]
  • Maribavir [USAN]
  • Maribavir [WHO-DD]
  • maribavir inn
  • maribavir mi
  • maribavir usan
  • maribavir who dd

ATC classification codes
  • J05AX10
Sources for recorded values
www.ebi.ac.uk
CAS registry numbers
  • 176161-24-3
ChEMBL ID
CHEMBL515408
www.ebi.ac.uk
InChIKey
KJFBVJALEQWJBS-XUXIUFHCSA-N
www.ebi.ac.uk
PubChem compound IDs
  • 471161
RxNorm IDs (RxCUI)
  • 2586068
FDA ingredient codes (UNII)
  • PTB4X93HE1

Applicant
TAKEDA PHARMS USA
Approval date
23 Nov 2021
Application number
NDA215596

Status
Authorised
Status date
9 Nov 2022
Authorisation date
9 Nov 2022
Approved indications
LIVTENCITY is indicated for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT). Consideration should be given to official guidance on the appropriate use of antiviral agents.
Product number
EMEA/H/C/005787
Authorisation holder
Takeda Pharmaceuticals International AG Ireland Branch
Priority medicines scheme
No
Generic
No
Biosimilar
No
Generic medicines
0
Biosimilar medicines
0
Advanced therapy
No
Conditional approval
No
Additional monitoring
Yes
Accelerated assessment
No
Exceptional circumstances
No

Therapeutic areas

  • Cytomegalovirus Infections
European medicines record
www.ema.europa.eu

Patents
7
Designations
5
Earliest recorded loss of exclusivity
11 Oct 2043
First in class
Yes
Fast track
No
Breakthrough designation
Yes
Orphan designation
Yes
Priority review
Yes
Orphan exclusivity
No
Accelerated approval
No
Availability
Prescription only

Pharmacology name
maribavir
Type
Synthetic organic
Drug name stem
-vir
Approval recorded by Guide to Pharmacology
Yes

Administration routes

  • Oral

  • Mechanism
    Phosphotransferase pUL97 inhibitor
    Action type
    Inhibitor
    Target
    Serine/threonine protein kinase UL97
    Protein identifier
    P16788
  • Mechanism
    Serine/threonine-protein kinase BGLF4 inhibitor
    Action type
    Inhibitor
    Target
    Serine/threonine-protein kinase BGLF4
    Protein identifier
    P0C731

  • Mechanism
    Phosphotransferase pUL97 inhibitor
    Action type
    Inhibitor
    Target
    Serine/threonine protein kinase UL97
  • Mechanism
    Serine/threonine-protein kinase BGLF4 inhibitor
    Action type
    Inhibitor
    Target
    Serine/threonine-protein kinase BGLF4

  • Condition
    Virus Diseases
    Highest recorded phase
    4
    Condition identifier
    EFO:0000763
    Subject identifier
    D014777
  • Condition
    Cytomegalovirus Infections
    Highest recorded phase
    4
    Condition identifier
    EFO:0001062
    Subject identifier
    D003586

  • Condition identifier
    EFO_0000763
  • Condition identifier
    EFO_0001062
  • Condition identifier
    MONDO_0005062
    Highest recorded phase
    2
  • Condition identifier
    MONDO_0005108
    Highest recorded phase
    4
  • Condition identifier
    MONDO_0005132
    Highest recorded phase
    4
  • Condition identifier
    MONDO_0009693
    Highest recorded phase
    2

  • Event
    bronchopulmonary aspergillosis
    Reports
    3
    Reporting signal score
    13.133
  • Event
    cytomegalovirus chorioretinitis
    Reports
    3
    Reporting signal score
    16.1511
  • Event
    cytomegalovirus infection
    Reports
    6
    Reporting signal score
    24.2266
  • Event
    cytomegalovirus infection reactivation
    Reports
    5
    Reporting signal score
    28.8859
  • Event
    drug resistance
    Reports
    9
    Reporting signal score
    36.1918
  • Event
    escherichia sepsis
    Reports
    3
    Reporting signal score
    15.3096
  • Event
    febrile neutropenia
    Reports
    6
    Reporting signal score
    15.9496
  • Event
    infectious pleural effusion
    Reports
    3
    Reporting signal score
    17.1949
  • Event
    neurological decompensation
    Reports
    3
    Reporting signal score
    16.4449
  • Event
    pathogen resistance
    Reports
    4
    Reporting signal score
    16.6424

Dose
400 mg
Route
Oral
How often
Twice daily

Conditions of use

  • Take with or without food

Hydrogen bond acceptors
7
Hydrogen bond donors
4
Polar surface area
99.77
Calculated partition coefficient (ALogP)
1.77
Calculated partition coefficient (XLogP)
2.2
Prodrug
No
Chirality
Single enantiomer
Inorganic
No
Rule-of-five violations
0
Rotatable bonds
4
Heavy atoms
24
Molecular formula
C15H19Cl2N3O4
Monoisotopic mass
375.0752615
Natural product
Yes

  • 64764-800

Recorded assays
275
Active assays
16

Active assay types

  • Confirmatory

Related records

Trials (188)

Approved for (2)