Livtencity

(Maribavir)

ApprovedSmall molecule

Livtencity is a small molecule that works as a Phosphotransferase Pul97 Inhibitor; Serine/threonine-Protein Kinase BGLF4 Inhibitor.[2] It is being used across 4 indications, with its most advanced program in Approved.[1]

Livtencity is one of 130 small molecule programs targeting Viral Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

129

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Viral DiseaseActive, not recruiting

Liver TransplantActive, not recruiting

Cytomegalovirus InfectionActive, not recruiting

Kidney TransplantActive, not recruiting

Viral DiseaseApproved

Active, not recruiting

Liver TransplantPhase 3

Active, not recruiting

Cytomegalovirus InfectionPhase 3

Active, not recruiting

Kidney TransplantApproved

Active, not recruiting

Competition

Competitive Landscape

476 competitors in Kidney Transplant

#DrugCompanyPhaseTrials

Livtencity

Takeda

Approved

1 2

Nulojix

Bristol-Myers Squibb

Preclinical

16 3

Simulect

Novartis

Preclinical

15 4

Zinbryta

Roche

Preclinical

6 5

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

1 6

Radicava

Shionogi

Preclinical

1 7

Cysteine Hydrochloride

Novartis

Preclinical

1 8

Sensipar

Amgen

Preclinical

1 9

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

4 10

Jardiance

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Cytomegalovirus (CMV) Infection

NCT06439342

Q1 2027

Phase 3Recruiting

Hematopoietic Stem Cell Transplant (HSCT)

NCT05319353

Not yet recruiting

Cytomegalovirus Infection

NCT07141095

Q1 2028

Phase 2Recruiting

Malignancy

NCT07014319

Q3 2031

Recruiting

Cytomegalovirus Infection

NCT06577363

Clinical

Trials by Indication[1]

Cytomegalovirus Infection3 trials

A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection

Recruiting· Takeda logo

Takeda··NCT06577363·250 enrolled

A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants

Completed· Takeda logo

Takeda·Phase 3·NCT02927067·553 enrolled

A Prospective Single-Arm Observational Study of Maribavir for the Treatment of Post Hematopoietic Stem Cell Transplantation Cytomegalovirus Infection

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China··NCT07141095·17 enrolled

Cytomegalovirus (CMV) Infection3 trials

A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections

Recruiting· Takeda logo

Takeda·Phase 3·NCT06439342·20 enrolled

A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection

Completed· Takeda logo

Takeda·Phase 3·NCT05137717·41 enrolled

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

Completed· Takeda logo

Takeda·Phase 3·NCT02931539·352 enrolled

Cytomegalovirus (CMV)2 trials

The Safety and Effectiveness of Different Dose Levels of 1263W94 in the Treatment of Cytomegalovirus (CMV) of the Eyes in HIV-Infected Patients

Completed· GSK logo

GSK·Phase 1·NCT00002373·56 enrolled

Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients

Completed· Takeda logo

Takeda·Phase 3·NCT00411645·681 enrolled

Adult2 trials

Study of SHP620 (Maribavir) in Healthy Adults

Completed· Takeda logo

Takeda·Phase 1·NCT02775240·18 enrolled

Maribavir Food-Effect Study in Healthy Adults Participants

Completed· Takeda logo

Takeda·Phase 1·NCT05382104·31 enrolled

Pediatric1 trial

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

Terminated· Takeda logo

Takeda·Phase 1·NCT04131556·20 enrolled

7 more indications

Malignancy1 trial

Phase II Trial of Maribavir for CMV in Patients With Lymphoid Malignancy on Bispecific Antibodies

Recruiting·SSeoul National University Hospital·Phase 2·NCT07014319·20 enrolled

Kidney Transplant1 trial

Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients

Completed·MMedical University of South Carolina·Phase 4·NCT06034925·70 enrolled

Stem Cell Transplant1 trial

Maribavir for Prevention of CMV After Stem Cell Transplants

Completed· Takeda logo

Takeda·Phase 2·NCT00223925·111 enrolled

Hematopoietic Stem Cell Transplant (HSCT)1 trial

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)

Recruiting· Takeda logo

Takeda·Phase 3·NCT05319353·80 enrolled

Liver Transplant1 trial

Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients

Completed· Takeda logo

Takeda·Phase 3·NCT00497796·307 enrolled

Transplant Recipient1 trial

Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients

Completed· Takeda logo

Takeda·Phase 2·NCT01611974·120 enrolled

Oral1 trial

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Maribavir Administered in Healthy Japanese Participants Compared With Matched, Healthy, Non-Hispanic, Caucasian Participants and to Assess Dose-Proportionality of 3 Doses of Maribavir in Japanese Participants

Completed· Takeda logo

Takeda·Phase 1·NCT04497883·24 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 23, 2021

LIVTENCITY

NDA NDA215596

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Maribavir. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Maribavir compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Maribavir. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215596). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Livtencity. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Phosphotransferase Pul97 Inhibitor; Serine/threonine-Protein Kinase BGLF4 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Takeda

Patent Landscape[5]

Patent Cliff

Oct 27, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12447169Oct 27, 2031

11684632Jan 4, 2032

12447170Nov 18, 2042

12433907Nov 18, 2042

12213989Nov 18, 2042

2 more patents

12527771Oct 11, 2043

12295940Oct 11, 2043

Livtencity

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q1 2028

Q3 2031

Trials by Indication[1]

Cytomegalovirus Infection3 trials

Cytomegalovirus (CMV) Infection3 trials

Cytomegalovirus (CMV)2 trials

Adult2 trials

Pediatric1 trial

Malignancy1 trial

Kidney Transplant1 trial

Stem Cell Transplant1 trial

Hematopoietic Stem Cell Transplant (HSCT)1 trial

Liver Transplant1 trial

Transplant Recipient1 trial

Oral1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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