Drugs / Maribavir

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) LIVTENCITY 2025-11-21 fda.gov
Approved EU (EMA) Livtencity 2022-11-09 europa.eu
Approved US (FDA) LIVTENCITY 2021-11-23 fda.gov

Trials 18 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT05918822 Jul → Aug 2023 Takeda Completed No outcome recorded
Phase 1 NCT05382104 May → Jul 2022 Takeda Completed No outcome recorded
Phase 1 NCT04497883 Aug → Nov 2020 Shire Completed No outcome recorded
Phase 1 NCT04131556 Oct 2019 → Jan 2020 Shire Terminated No outcome recorded
Phase 1 NCT02775240 Jul → Sep 2016 cytomegalovirus infection Shire Completed No outcome recorded
Phase 1 NCT00002373 HIV infectious disease, cytomegalovirus infection Glaxo Wellcome Completed No outcome recorded
Phase 23 trials
Phase 2 NCT07014319 Nov 2025 → Oct 2027 expected cytomegalovirus infection Seoul National University Hospital Recruiting No outcome recorded
Phase 2 NCT01611974 Jul 2012 → Dec 2014 cytomegalovirus infection Shire Completed No outcome recorded
Phase 2 NCT00223925 Oct 2004 → Apr 2006 cytomegalovirus infection Shire Completed No outcome recorded
Phase 38 trials
Phase 3 NCT07511127 Feb 2026 → Dec 2027 expected hematopoietic and lymphoid cell neoplasm Ruijin Hospital Recruiting No outcome recorded
Phase 3 NCT06439342 Dec 2024 → Dec 2026 expected cytomegalovirus infection Takeda Recruiting No outcome recorded
Phase 3 NCT05319353 Nov 2023 → Jan 2027 expected cytomegalovirus infection Takeda Recruiting No outcome recorded
Phase 3 NCT05137717 Jan 2022 → Jun 2023 cytomegalovirus infection Takeda Completed No outcome recorded
Phase 3 NCT02927067 Apr 2017 → Jul 2022 cytomegalovirus infection Shire Completed No outcome recorded
Phase 3 NCT02931539 Dec 2016 → Aug 2020 cytomegalovirus infection Shire Completed No outcome recorded
Phase 3 NCT00497796 Jul 2007 → Sep 2009 cytomegalovirus infection Shire Completed No outcome recorded
Phase 3 NCT00411645 Dec 2006 → Nov 2008 cytomegalovirus infection Shire Completed No outcome recorded
Phase 41 trial
Phase 4 NCT06034925 Nov 2023 → Jun 2025 cytomegalovirus infection, disease related to solid organ transplantation Medical University of South Carolina Completed No outcome recorded

Press releases naming this drug 17 releases

DateIssuerRelease
2024-06-24 Takeda Takeda Announces Approval of LIVTENCITY® (maribavir) in Japan for Post-Transplant Cytomegalovirus (CMV) Infection/Disease That Is Refractory to Existing Anti-CMV Therapies takeda.com
2023-12-21 Takeda Takeda Announces China NMPA Approval of LIVTENCITY® (maribavir) for the Treatment of Adults With Post-transplant Cytomegalovirus (CMV) Refractory to Prior Therapies takeda.com
2022-12-19 Takeda Takeda’s Phase 3 AURORA Study Provides Evidence of Maribavir’s Clinically Meaningful and Durable Effect in Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Patients, Despite Missing Primary Endpoint takeda.com
2022-11-11 Takeda European Commission (EC) Approves LIVTENCITY TM▼ (maribavir) for the Treatment of Adults With Post-transplant Cytomegalovirus (CMV) Infection And/or Disease That Are Refractory (With or Without Resistance) to One or More Prior Therapies takeda.com
2022-09-16 Takeda Takeda Receives Positive CHMP Opinion for Maribavir for the Treatment of Adults with Post-transplant Cytomegalovirus (CMV) Refractory (With or Without Resistance) to Prior Therapies takeda.com
2022-04-22 Takeda Takeda Presents New Exploratory Analysis Showing Patients Treated With LIVTENCITY™ (Maribavir) Had Reductions in Hospitalization Rates and Length of Hospital Stay takeda.com
2021-12-08 Takeda Takeda Announces Publication of Data from SOLSTICE, a Pivotal Phase 3 Trial for LIVTENCITY™ (Maribavir) in Post-Transplant Recipients With Cytomegalovirus (CMV) Infection (Refractory, With or Without Resistance) takeda.com
2021-11-23 Takeda Takeda’s LIVTENCITY TM (maribavir) Approved by U.S. FDA as the First and Only Treatment for People Ages 12 and Older with Post-Transplant Cytomegalovirus (CMV), Refractory (With or Without Genotypic Resistance) to Conventional Antiviral Therapies takeda.com
2021-10-07 Takeda FDA Advisory Committee Recommends Use of Investigational Drug Maribavir (TAK-620) to Treat Post-Transplant Recipients with Cytomegalovirus (CMV) Infection and Disease Refractory to Treatment With or Without Resistance takeda.com
2021-06-07 Takeda Phase 3 Clinical Trial Subgroup Analysis Across Solid Organ Transplant (SOT) Types Supports Efficacy of Maribavir Over Conventional Therapies in Post-Transplant Recipients With Cytomegalovirus (CMV) Infection (Refractory, With or Without Resistance) takeda.com
2021-05-21 Takeda U.S. Food & Drug Administration Grants Priority Review of Maribavir for the Treatment of Post-Transplant Recipients With Cytomegalovirus Infection in Those Resistant and/or Refractory to Prior Anti-CMV Treatment takeda.com
2021-03-15 Takeda Subgroup Analysis from Phase 3 Clinical Trial Supports Efficacy of Maribavir Over Conventional Therapies in Transplant Recipients With Cytomegalovirus Infection (Refractory, With or Without Resistance) takeda.com

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 21 sources stand behind the page.

FieldValueCited text
Known as maribavir ClinicalTrials.gov intervention name — accepted as the source's own label NCT00411645
17

NCT07511127

NCT00223925

NCT04131556

NCT05918822

NCT00497796

NCT06439342

NCT02931539

NCT05382104

NCT07014319

NCT00002373

NCT05319353

NCT04497883

NCT06034925

NCT02927067

NCT02775240

NCT05137717

NCT01611974

Known as 1263W94 “multiple escalating doses of 1263W94 administered orally for 28 days in HIV infected patients with asymptomatic CMV shedding” NCT00002373
Known as BW-1263W94 ChEMBL registry synonym — accepted as the source's own label CHEMBL515408
Known as GW-257406X ChEMBL registry synonym — accepted as the source's own label CHEMBL515408
Known as Livtencity ChEMBL registry synonym — accepted as the source's own label CHEMBL515408
Known as MBV “Viral mutations conferring resistance against nucleotide and pyrophosphate analogs as well as maribavir (MBV) have evolved sequentially.” PMID 23870704 Jul 2013
Known as SHP620 “Study of SHP620 (Maribavir) in Healthy Adults” NCT02775240
Action Inhibit “maribavir, an inhibitor of the cytomegalovirus UL97 protein” PMID 23870704 Jul 2013
Modality Small molecule “Maribavir is an oral benzimidazole riboside” PMID 38071422 Jan 2024
Route Oral “administered orally” NCT00002373