LIVTENCITY (maribavir)
LIVTENCITY is indicated for the treatment of Cytomegalovirus Infection; Cytomegalovirus Disease.
How LIVTENCITY Works
Maribavir is a cytomegalovirus (CMV) pUL97 kinase inhibitor. It functions by inhibiting the adenosine triphosphate (ATP) binding site of the pUL97 protein kinase, thereby preventing viral DNA replication, encapsidation, and the egress of mature capsids from the nucleus of infected cells. This targeted mechanism allows for activity against CMV strains that have developed resistance to DNA polymerase inhibitors like ganciclovir or foscarnet.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-11-23
- Patent Cliff
- 2043
- Routes
- ORAL
- Dosage Forms
- TABLET
LIVTENCITY Approval History
What LIVTENCITY Treats
2 indicationsLIVTENCITY is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cytomegalovirus Infection
- Cytomegalovirus Disease
LIVTENCITY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LIVTENCITY
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06034925 results posted | Pro00125967 | Ph 4 | completed | Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients |
| NCT07511127 | RJBMT-2026CMV | Ph 3 | recruiting | Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Allo-HSCT |
| NCT06439342 | TAK-620-3002 | Ph 3 | recruiting | A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections |
| NCT07014319 MALMBA | 2505-076-1641 | Ph 2 | recruiting | Phase II Trial of Maribavir for CMV in Patients With Lymphoid Malignancy on Bispecific Antibodies |
| NCT04131556 results posted | TAK-620-1019 | Ph 1 | terminated | A Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral-Suspension Formulations of Maribavir to the Current Maribavir Tablet Formulation Administered in Healthy Adult Participants |
| NCT05319353 | TAK-620-2004 2021-004279-15, jRCT2031230753 | Ph 3 | recruiting | A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT) |
| NCT05137717 results posted | TAK-620-3001 jRCT2021210056 | Ph 3 | completed | A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection |
| NCT05382104 results posted | TAK-620-1025 | Ph 1 | completed | Maribavir Food-Effect Study in Healthy Adults Participants |
| NCT02927067 results posted | SHP620-302 2015-004726-34 | Ph 3 | completed | A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants |
| NCT02931539 results posted | SHP620-303 2015-004725-13 | Ph 3 | completed | Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir |
| NCT02775240 results posted | SHP620-115 | Ph 1 | completed | Study of SHP620 (Maribavir) in Healthy Adults |
| NCT01611974 results posted | 1263-202 SHP620-202 | Ph 2 | completed | Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LIVTENCITY FDA Label Details
Indications & Usage
FDA Label (PDF)LIVTENCITY is indicated for the treatment of Cytomegalovirus Infection; Cytomegalovirus Disease.
LIVTENCITY Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for LIVTENCITY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2043
- • 7 active patents
Trial Analysis
- • 12 total trials
- • Stage: Expansion
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment