maribavir

Trade name: Livtencity

Small moleculeapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Nov 23, 2021

Maribavir, sold under the brand name Livtencity, is an antiviral medication that is used to treat post-transplant cytomegalovirus (CMV). Maribavir is a cytomegalovirus pUL97 kinase inhibitor that works by preventing the activity of human cytomegalovirus enzyme pUL97, thus blocking virus replication. — Wikipedia

Clinical trial activity

17 trials · 6 clinical orgs · 1 marketing orgs

Phase 1
6
Phase 2
10
Phase 3
7
Phase 4
1

Earliest trial started Nov 2, 1999 (NCT00002373)

Timeline

1990s

  1. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jun 7, 2011

    Orphan Drug Designation

2020s

  1. Nov 23, 2021

    Takeda — Earliest FDA Approval

  2. Nov 23, 2021

    Takeda — Marketing Organization

  3. Nov 23, 2021

    Takeda — NDA Secondary Org

  4. Nov 23, 2021

    Takeda — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewBreakthroughNov 23, 2021

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)Nc1nc2cc(Cl)c(Cl)cc2n1[C@H]1O[C@@H](CO)[C@H](O)[C@@H]1O
Mol. weight
376.24 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • 1263w94
  • 1263w94
  • 1263w94
  • 5,6-dichloro-2-isopropylamino-1-b-l-ribofuranosyl-1h-benzimidazole
  • benzimidavir
  • bw 1263w94
  • bw-1263w94
  • gw 1263
  • gw-1263
  • gw257406x
  • gw 257406x
  • gw-257406x
  • maribavir
  • maribavir
  • maribavir
  • maribavir

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07014319Phase 2Sep 1, 2025Seoul National University
NCT06439342Phase 3Mar 14, 2025Takeda
NCT06034925Phase 4Nov 6, 2023Medical University of South Carolina, Takeda
NCT05918822Phase 1Aug 10, 2023Takeda
NCT05319353Phase 3Mar 31, 2023Takeda
NCT05382104Phase 1Jun 1, 2022Takeda
NCT05137717Phase 3Dec 1, 2021Takeda
NCT04497883Phase 1Aug 20, 2020Shire
NCT04131556Phase 1Oct 18, 2019Shire
NCT02927067Phase 3Apr 6, 2017Shire
NCT02931539Phase 3Dec 1, 2016Shire
NCT02775240Phase 1Aug 1, 2016Shire
NCT01611974Phase 2Jul 1, 2012Shire, ViroPharma
NCT00497796Phase 3Jul 1, 2007Shire, ViroPharma
NCT00411645Phase 3Dec 1, 2006Shire, ViroPharma
NCT00223925Phase 2Oct 1, 2004Shire
NCT00002373Phase 1Nov 2, 1999Glaxo Wellcome
Showing 17 of 17 trials
Page 1 / 1

Organizations

Research & Development (6)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ShireFor profit9932004
TakedaFor profit6532021
ViroPharmaFor profit3022006
Glaxo WellcomeFor profit1111999
Medical University of South CarolinaAcademic/Hospital1112023
Seoul National UniversityAcademic/Hospital1112025
6 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
TakedaFor profitMKTGNov 23, 2021
TakedaFor profitNDA2Nov 23, 2021
TakedaFor profitNDANov 23, 2021