Cytomegalovirus Infection

12
Pipeline Programs
4
Companies
10
Clinical Trials
1 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
0
6
0
1
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

RNA Therapeutic
770%
Small Molecule
330%

On Market (2)

Approved therapies currently available

U
VALCYTEApproved
valganciclovir
Unknown Company
oral2001
U
VALGANCICLOVIR HYDROCHLORIDEApproved
valganciclovir
Unknown Company
oral2022

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
1
ValganciclovirPhase 4Small Molecule1 trial
Active Trials
NCT01552369CompletedEst. Jun 2018
Moderna
ModernaCAMBRIDGE, MA
7 programs
2
4
1
mRNA-1647Phase 3RNA Therapeutic1 trial
mRNA-1647Phase 2RNA Therapeutic1 trial
mRNA-1647Phase 2RNA Therapeutic1 trial
mRNA-1647Phase 2RNA Therapeutic1 trial
mRNA-1647Phase 2RNA Therapeutic1 trial
+2 more programs
Active Trials
NCT03382405Completed181Est. Oct 2020
NCT05105048Completed9Est. Aug 2023
NCT04232280Completed315Est. Jan 2023
+4 more trials
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
1 program
1
BrincidofovirPhase 2Small Molecule1 trial
Active Trials
NCT00942305Completed239Est. Jan 2012
Takeda
TakedaTOKYO, Japan
1 program
1
MaribavirPhase 2Small Molecule1 trial
Active Trials
NCT00223925Completed111Est. Apr 2006

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Allergy TherapeuticsValganciclovir
ModernamRNA-1647
ModernamRNA-1647
ModernamRNA-1647
ModernamRNA-1647
ModernamRNA-1647
Jazz PharmaceuticalsBrincidofovir
TakedaMaribavir
ModernamRNA-1647
ModernamRNA-1647

Clinical Trials (10)

Total enrollment: 8,668 patients across 10 trials

CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL")

Start: Oct 2012Est. completion: Jun 2018
Phase 4Completed

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age

Start: Oct 2021Est. completion: Nov 20257,454 patients
Phase 3Terminated

A Study of mRNA-1647 Cytomegalovirus Vaccine in Liver Transplant Candidates and Recipients

Start: Feb 2024Est. completion: Dec 20270
Phase 2Withdrawn

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.

Start: Apr 2023Est. completion: Aug 2026224 patients
Phase 2Recruiting

A Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus (CMV) mRNA-1647 Vaccine

Start: Jun 2021Est. completion: Jan 2026135 patients
Phase 2Completed

Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults

Start: Jan 2020Est. completion: Jan 2023315 patients
Phase 2Completed

Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients

Start: Oct 2009Est. completion: Jan 2012239 patients
Phase 2Completed

Maribavir for Prevention of CMV After Stem Cell Transplants

Start: Oct 2004Est. completion: Apr 2006111 patients
Phase 2Completed

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647

Start: Nov 2021Est. completion: Aug 20239 patients
Phase 1Completed

Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 in Healthy Adults

Start: Nov 2017Est. completion: Oct 2020181 patients
Phase 1Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 8,668 patients
RNA Therapeutic is the dominant modality (70% of programs)
4 companies competing in this space