Drugs / Maribavir
Maribavir
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cytomegalovirus infection 2 milestones | |||||
| Filed | US (FDA) | — | cytomegalovirus infection | 2021-05-21 | “the U.S. Food & Drug Administration (FDA) has accepted a New Drug Application (NDA) for maribavir” takeda.com ↗ |
| Filed | EU (EMA) | — | cytomegalovirus infection | — | “Maribavir’s (TAK-620) filing and acceptance in the US and EU” takeda.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials · 1 missed | ||||||
| Phase 1 | NCT05918822 | Jul → Aug 2023 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT05382104 | May → Jul 2022 | — | Takeda | Completed | Mixed |
| Phase 1 | NCT04497883 | Aug → Nov 2020 | — | Shire | Completed | Missed primary |
| 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 · 1 met primary · 3 missed | ||||||
| Phase 3 | NCT07511127 | Feb 2026 → Dec 2027 expected | hematopoietic and lymphoid cell neoplasm | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT06439342 | Dec 2024 → Jul 2026 | cytomegalovirus infection | Takeda | Completed | 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 | Missed primary |
| Phase 3 | NCT02931539 | Dec 2016 → Aug 2020 | cytomegalovirus infection | Shire | Completed | Met primary |
| Phase 3 | NCT00497796 | Jul 2007 → Sep 2009 | cytomegalovirus infection | Shire | Completed | Missed primary |
| Phase 3 | NCT00411645 | Dec 2006 → Nov 2008 | cytomegalovirus infection | Shire | Completed | Missed primary |
| 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 |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2024-06-24 | Takeda | Regulatory 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 ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced that LIVTENCITY® (maribavir) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for post-transplant cytomegalovirus (CMV) infection/disease that is refractory to existing anti-CMV therapies. |
| 2023-12-21 | Takeda | Regulatory Takeda Announces China NMPA Approval of LIVTENCITY® (maribavir) for the Treatment of Adults With Post-transplant Cytomegalovirus (CMV) Refractory to Prior Therapies takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced that LIVTENCITY® (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet. |
| 2022-12-19 | Takeda | Results 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 ↗
At Week 8, 69.6% of Patients Treated With Maribavir Achieved CMV Clearance vs. 77.4% for Valganciclovir, but Did Not Demonstrate Non-inferiority Based on Prespecified Margin of 7% |
| 2022-11-11 | Takeda | Regulatory 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 | Regulatory 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 ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of maribavir 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 hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT). |
| 2022-04-22 | Takeda | Results Takeda Presents New Exploratory Analysis Showing Patients Treated With LIVTENCITY™ (Maribavir) Had Reductions in Hospitalization Rates and Length of Hospital Stay takeda.com ↗
Data Include Exploratory Analysis Showing LIVTENCITY Treated Patients With Post-Transplant Cytomegalovirus (CMV) Infections/Disease Had Reductions in Hospitalizations (34.8%; p=0.021) and Length of Hospital Stay (53.8%; p=0.029) Compared to Those Treated With Conventional Antiviral Therapies 1 |
| 2021-12-08 | Takeda | Results 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 ↗
The SOLSTICE study primary endpoint was met, with 55.7% (131/235) of adult patients on LIVTENCITY achieving confirmed CMV DNA level below the lower limit of quantification (<LLOQ, i.e. <137 IU/mL) at the end of Study Week 8 (end of treatment phase) |
| 2021-11-23 | Takeda | Regulatory 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 ↗
the U.S. Food and Drug Administration (FDA) has approved LIVTENCITY™ (maribavir) |
| 2021-10-07 | Takeda | Regulatory 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 ↗
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients. |
| 2021-06-07 | Takeda | Results 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 ↗
More than twice (55.6%, 79/142) as many SOT recipients with R/R CMV infection at baseline treated with maribavir achieved confirmed CMV viremia clearance at Study Week 8 (end of treatment phase) compared to those treated with conventional antiviral therapies (26.1%, 18/69) (investigator assigned treatment; IAT consists of one or a combination of ganciclovir, valganciclovir, foscarnet or cidofovir) (adjusted difference [95% CI]: 30.5% [17.3, 43.6]). |
| 2021-05-21 | Takeda | Regulatory 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 | Results 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 ↗ |
| 2021-02-12 | Takeda | Results Takeda's Maribavir Phase 3 Clinical Trial Met Primary Endpoint of Superiority to Conventional Antiviral Therapy in Transplant Recipients With Refractory, With or Without Resistance, Cytomegalovirus Infection/Disease takeda.com ↗
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today at the 2021 Transplantation & Cellular Therapy (TCT) Meetings Digital Experience announced new, late-breaking Phase 3 data from the TAK-620-303 (SOLSTICE) trial, for the investigational drug TAK-620 (maribavir) which met its primary endpoint of superiority compared to conventional antiviral therapies (investigator assigned treatment, [IAT], one or a combination of ganciclovir, valganciclovir, foscarnet or cidofovir) in transplant recipients with refractory, with or without resistance (R/R), cytomegalovirus (CMV) infection/disease. |
| 2020-12-04 | Takeda | Results New Phase 3 Data Show TAK-620 (maribavir), an Investigational Drug for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus (CMV) Infections, Meets Primary Endpoint takeda.com ↗
The SOLSTICE trial met its primary endpoint, defined as the proportion of patients who achieved confirmed CMV viremia clearance compared to IAT at the end of Study week 8. |
| 2019-09-25 | Takeda | Results New England Journal of Medicine Publishes Results of a Phase 2 Trial Evaluating Takeda’s TAK-620 (Maribavir) as a Potential Treatment of Cytomegalovirus (CMV) Infection takeda.com ↗
From the results of a Phase 2 study, maribavir, an investigational agent that targets a specific CMV protein, may result in the clearance of CMV infections, a condition with potentially fatal complications in transplant patients |
| 2018-01-04 | Takeda | Regulatory Shire Receives FDA Breakthrough Therapy Designation for Maribavir, an Investigational Treatment for Cytomegalovirus (CMV) Infection in Transplant Patients takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for maribavir (SHP620), a Phase 3 investigational treatment for cytomegalovirus (CMV) infection and disease in transplant patients resistant or refractory to prior therapy. |
| 2016-10-27 | Takeda | Results Results from Shire's Phase 2 Study of Maribavir Showed Activity Against CMV Infection in Patients Undergoing Transplant takeda.com ↗
In the study, 67% of patients treated with varying doses of maribavir (400 to 1200 mg twice daily) for up to 24 weeks had no detectable levels of the virus in their blood plasma within six weeks of starting treatment. |
All press releases naming this drug 17 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Maribavir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07511127 ↗ |
| 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 ↗ |