Cytomegalovirus Infection

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule

850%

RNA Therapeutic

744%

Gene Therapy

16%

+ 6 programs with unclassified modality

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

MSDIreland - Ballydine

3 programs

LetermovirPhase 3Small Molecule

Letermovir tabletPhase 3

Sharp TherapeuticsPA - Pittsburgh

3 programs

LetermovirPhase 3Small Molecule

Letermovir tabletPhase 3

Medica CorpMA - Bedford

2 programs

Adoptive Cellular TherapyPhase 31 trial

CMV-specific T-cells, single infusion following single positive CMV PCR resultPhase 21 trial

Active Trials

NCT01220895Completed52Est. Jan 2014

NCT01077908Completed89Est. Oct 2014

Atara BiotherapeuticsCA - Thousand Oaks

1 program

CMV-pp65-specific cytotoxic T lymphocytesPhase 2

ModernaCAMBRIDGE, MA

7 programs

mRNA-1647PHASE_1RNA Therapeutic1 trial

mRNA-1647PHASE_2RNA Therapeutic1 trial

+2 more programs

Active Trials

NCT05105048Completed9Est. Aug 2023

NCT03382405Completed181Est. Oct 2020

NCT04975893Completed135Est. Jan 2026

+4 more trials

Allergy TherapeuticsUK - West Sussex

3 programs

Comparison of Two Test Methods-NASBA and Antigenemia-for Detecting Cytomegalovirus InfectionN/AGene Therapy1 trial

DBS Self-Collection KitN/A1 trial

ValganciclovirPHASE_4Small Molecule1 trial

Active Trials

NCT00001976Completed180Est. Feb 2003

NCT03910478Completed622Est. Jan 2024

NCT01552369Completed205Est. Jun 2018

GenentechCA - Oceanside

1 program

ValganciclovirN/ASmall Molecule

Jazz PharmaceuticalsCA - Palo Alto

1 program

BrincidofovirPHASE_2Small Molecule1 trial

Active Trials

NCT00942305Completed239Est. Jan 2012

TakedaTOKYO, Japan

1 program

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

Medica CorpAdoptive Cellular Therapy

ModernamRNA-1647

Medica CorpCMV-specific T-cells, single infusion following single positive CMV PCR result

Jazz PharmaceuticalsBrincidofovir

TakedaMaribavir

ModernamRNA-1647

Allergy TherapeuticsDBS Self-Collection Kit

Allergy TherapeuticsComparison of Two Test Methods-NASBA and Antigenemia-for Detecting Cytomegalovirus Infection

Clinical Trials (14)

Total enrollment: 9,676 patients across 14 trials

NCT01552369 Allergy TherapeuticsValganciclovir

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

Start: Oct 2012Est. completion: Jun 2018205 patients

Phase 4Completed

NCT05085366 ModernamRNA-1647

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

NCT01077908 Medica CorpAdoptive Cellular Therapy

Cytomegalovirus - Immunoprophylactic Adoptive Cellular Therapy Study

Start: Jul 2008Est. completion: Oct 201489 patients

Phase 3Completed

NCT06133010 ModernamRNA-1647

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

Start: Feb 2024Est. completion: Dec 20270

Phase 2Withdrawn

NCT05683457 ModernamRNA-1647

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 202684 patients

Phase 2Active Not Recruiting

NCT04975893 ModernamRNA-1647

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

NCT04232280 ModernamRNA-1647

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

NCT01220895 Medica CorpCMV-specific T-cells, single infusion following single positive CMV PCR result

Alternate Donor Study of Pre-Emptive Cellular Therapy

Start: Oct 2010Est. completion: Jan 201452 patients

Phase 2Completed

NCT00942305 Jazz PharmaceuticalsBrincidofovir

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

Start: Oct 2009Est. completion: Jan 2012239 patients

Phase 2Completed

NCT00223925 TakedaMaribavir

Maribavir for Prevention of CMV After Stem Cell Transplants

Start: Oct 2004Est. completion: Apr 2006111 patients

Phase 2Completed

NCT05105048 ModernamRNA-1647

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

Start: Nov 2021Est. completion: Aug 20239 patients

Phase 1Completed

NCT03382405 ModernamRNA-1647

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

Start: Nov 2017Est. completion: Oct 2020181 patients

Phase 1Completed

NCT03910478 Allergy TherapeuticsDBS Self-Collection Kit

Dried Blood Spot Testing of CMV Detection in HCT Recipients

Start: May 2019Est. completion: Jan 2024622 patients

N/ACompleted

NCT00001976 Allergy TherapeuticsComparison of Two Test Methods-NASBA and Antigenemia-for Detecting Cytomegalovirus Infection

Comparison of Two Test Methods-NASBA and Antigenemia-for Detecting Cytomegalovirus Infection

Start: Jan 2000Est. completion: Feb 2003180 patients

N/ACompleted

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & available

Key Insights

7 late-stage (Phase 3) programs, potential near-term approvals

Small Molecule is the dominant modality (50% of programs)

10 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.