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Cytomegalovirus Infections

25
Pipeline Programs
18
Companies
50
Clinical Trials
4 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
8
2
6
1
4
4
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
2392%
Monoclonal Antibody
14%
Vaccine
14%
+ 30 programs with unclassified modality

On Market (1)

Approved therapies currently available

Roche
CYTOVENEApproved
ganciclovir
Roche
oral1994

Competitive Landscape

18 companies ranked by most advanced pipeline stage

Genentech
GenentechCA - Oceanside
12 programs
2
1
2
2
GanciclovirPhase 4Small Molecule1 trial
ValganciclovirPhase 4Small Molecule1 trial
ValganciclovirPhase 3Small Molecule1 trial
Valganciclovir CMV ProphylaxisPhase 31 trial
valganciclovir [Valcyte]Phase 2/31 trial
+7 more programs
Active Trials
NCT00002024Completed
NCT00002025Completed
NCT00002251Completed20
+9 more trials
Roche
RocheSTAVANGER NORWAY, Norway
4 programs
1
GanciclovirN/ASmall Molecule3 trials
GanciclovirN/ASmall Molecule
GanciclovirN/ASmall Molecule
valganciclovirPHASE_3Small Molecule4 trials
Active Trials
NCT00002134Completed450
NCT00002015Completed20
NCT00002330Completed280
+4 more trials
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
1
CMV-Specific T-cell Guided Letermovir DiscontinuationPhase 41 trial
Active Trials
NCT07569653Recruiting120Est. Dec 2027
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
7 programs
2
2
1
LetermovirPhase 3Small Molecule1 trial
LetermovirPhase 2Small Molecule1 trial
Letermovir 480 MG [Prevymis]Phase 21 trial
V160Phase 11 trial
V160 Low Dose IMPhase 11 trial
+2 more programs
Active Trials
NCT04478474Completed100Est. Sep 2022
NCT06337955Active Not Recruiting204Est. Dec 2024
NCT03840174Completed18Est. Nov 2019
+4 more trials
MSD
MSDIreland - Ballydine
7 programs
2
2
1
LetermovirPhase 3Small Molecule
LetermovirPhase 2Small Molecule
Letermovir 480 MG [Prevymis]Phase 2
V160Phase 1
V160 Low Dose IMPhase 1
+2 more programs
MCM Vaccines
MCM VaccinesNetherlands - Leiden
1 program
1
CMV gB vaccinePhase 2Vaccine1 trial
Active Trials
NCT00125502Completed464Est. Jan 2010
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
1
viral specific cytotoxic t-lymphocytesPhase 21 trial
Active Trials
NCT03266640Recruiting20Est. Dec 2027
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
11 programs
1
1
SDZ MSL-109Phase 1/21 trial
CidofovirPhase 1Small Molecule1 trial
A Comparison of HIV-Infected Patients With and Without Opportunistic (AIDS-Related) InfectionN/A1 trial
CMV Infection in Adolescent MalesN/A1 trial
Cytomegalovirus Cell-Mediated ImmunityN/A1 trial
+6 more programs
Active Trials
NCT00005572Completed90
NCT00302029Terminated411Est. Dec 2008
NCT00815165Completed165Est. Aug 2011
+12 more trials
ViiV Healthcare
ViiV HealthcareNC - Durham
1 program
1
PentamerPhase 1/2
SpyBiotech
SpyBiotechUK - Oxford
1 program
1
SPYVAC01Phase 11 trial
Active Trials
NCT06145178Completed120Est. Jul 2025
Merck & Co.
Merck & Co.RAHWAY, NJ
2 programs
GanciclovirN/ASmall Molecule
Non Primary HCMV Infection: Natural History and Immune ResponseN/A
Moderna
ModernaCAMBRIDGE, MA
1 program
CMV PCR on salivaN/A1 trial
Active Trials
NCT06522880Recruiting100Est. Dec 2027
QIAGEN
QIAGENGermany - Hilden
1 program
Evaluation of the Artus® CMV PCR TestN/A1 trial
Active Trials
NCT01034709Completed111Est. Jun 2014
Nielsen BioSciences
Nielsen BioSciencesCA - San Diego
1 program
Herpesvirus Immunology in Solid Organ Transplant Recipients - Liver Transplant StudyN/A1 trial
Active Trials
NCT05532540Active Not Recruiting80Est. Jan 2033
Bristol Myers Squibb
1 program
LobucavirN/ASmall Molecule1 trial
Active Trials
NCT00002352Completed30
Sandoz
SandozAustria - Kundl
1 program
SevirumabPHASE_1Monoclonal Antibody1 trial
Active Trials
NCT00002268Completed
VBI Vaccines
VBI VaccinesMA - Cambridge
1 program
VBI-1501A 0.5 μgPHASE_11 trial
Active Trials
NCT02826798Completed128Est. Aug 2017
Biotest Pharmaceuticals
Biotest PharmaceuticalsGermany - Dreieich
1 program
Cytotect®CPPHASE_21 trial
Active Trials
NCT05370976Terminated2Est. Aug 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
UNION therapeuticsCMV-Specific T-cell Guided Letermovir Discontinuation
GenentechValganciclovir
GenentechGanciclovir
Rochevalganciclovir
Allergy Therapeuticsganciclovir
Allergy TherapeuticsGanciclovir
Sharp TherapeuticsLetermovir
Rochevalganciclovir
GenentechValganciclovir CMV Prophylaxis
GenentechValganciclovir
Rochevalganciclovir
Rochevalganciclovir
Allergy TherapeuticsValganciclovir
Allergy TherapeuticsGanciclovir
Genentechvalganciclovir [Valcyte]

Showing 15 of 36 trials with date data

Clinical Trials (50)

Total enrollment: 7,227 patients across 50 trials

Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients With AIDS Who Have CMV Retinitis

300 patients
Phase 4Completed
NCT07569653UNION therapeuticsCMV-Specific T-cell Guided Letermovir Discontinuation

Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.

Start: Oct 2025Est. completion: Dec 2027120 patients
Phase 4Recruiting
NCT01663740GenentechValganciclovir

A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls

Start: Jan 2012Est. completion: Dec 201659 patients
Phase 4Completed

VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients

Start: Apr 2004Est. completion: Aug 2008325 patients
Phase 4Completed
NCT00730769Rochevalganciclovir

Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients

Start: Mar 2004Est. completion: Jul 200821 patients
Phase 4Completed
NCT00001038Allergy TherapeuticsValacyclovir hydrochloride

A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients

1,200 patients
Phase 3Completed

A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.

Est. completion: Nov 2005130 patients
Phase 3Completed

A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

180 patients
Phase 3Completed

A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis

Est. completion: Aug 2007
Phase 3Completed

Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients

Start: Aug 2024Est. completion: Aug 202790 patients
Phase 3Recruiting
NCT01185223Rochevalganciclovir

Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation

Start: Sep 2010212 patients
Phase 3Terminated
NCT00372229GenentechValganciclovir CMV Prophylaxis

A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation

Start: May 2006Est. completion: Oct 2015299 patients
Phase 3Completed
NCT00294515GenentechValganciclovir

IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients

Start: Mar 2006Est. completion: Aug 2009326 patients
Phase 3Completed
NCT00227370Rochevalganciclovir

Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation

Start: Jul 2003Est. completion: Dec 2008136 patients
Phase 3Completed
NCT00275665Rochevalganciclovir

The Study is Being Done to See if Taking the Drug Valganciclovir Can Prevent CMV Infection.

Start: Nov 2001Est. completion: Jul 200720 patients
Phase 3Completed

Preventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV

Start: Aug 2000Est. completion: Feb 2006350 patients
Phase 3Completed

Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection

Start: Dec 1991130 patients
Phase 3Completed
NCT00090766Genentechvalganciclovir [Valcyte]

A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients

Start: May 2004Est. completion: May 200563 patients
Phase 2/3Completed

Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS

Est. completion: Mar 1998167 patients
Phase 2Completed

A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure

Est. completion: Aug 1992156 patients
Phase 2Completed

A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Cannot Use Ganciclovir

0
Phase 2Withdrawn

CMV Retinitis Retreatment Trial

300 patients
Phase 2Completed

The Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus (CMV) in Patients With AIDS

Est. completion: Feb 199378 patients
Phase 2Completed
NCT06066957Sharp TherapeuticsLetermovir 480 MG [Prevymis]

Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients

Start: Apr 2024Est. completion: Aug 202680 patients
Phase 2Recruiting

Efficacy and Safety of Cytotect®CP, Hyperimmune Anti-CMV IVIg as CMV Prophylaxis in Patients Developing Acute Grade II-IV GVHD After Allogeneic Hematopoietic Cell Transplantation.

Start: Sep 2022Est. completion: Aug 20232 patients
Phase 2Terminated

Asymptomatic Congenital CMV Treatment

Start: Aug 2019Est. completion: Nov 20207 patients
Phase 2Terminated

Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection

Start: Jan 2019Est. completion: Mar 202210 patients
Phase 2Completed
NCT03266640Angeles Therapeuticsviral specific cytotoxic t-lymphocytes

Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)

Start: Nov 2018Est. completion: Dec 202720 patients
Phase 2Recruiting

gB/MF59 Vaccine in Preventing Cytomegalovirus Infection in Healthy Adolescent Females

Start: Jun 2006Est. completion: Jun 2013409 patients
Phase 2Completed

Islet Transplantation for Type 1 Diabetes

Start: Apr 2001Est. completion: Aug 201036 patients
Phase 2Completed

Recombinant CMV gB Vaccine in Postpartum Women

Start: Aug 1999Est. completion: Jan 2010464 patients
Phase 2Completed

Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation

Start: Mar 2004Est. completion: Nov 2010130 patients
Phase 1/2Completed

Valganciclovir in Congenital CMV Infants

Start: Jul 2002Est. completion: Jul 200724 patients
Phase 1/2Completed

Phase I/II Study of Human Anti-Cytomegalovirus (CMV) Monoclonal Antibody MSL-109 in Newborns With Symptomatic Congenital CMV Infection Without Central Nervous System Disease

Start: Feb 1995
Phase 1/2Completed

A Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria

Phase 1Completed

A Study of Cidofovir in HIV-Infected Children With Cytomegalovirus (CMV) Disease

0
Phase 1Withdrawn

A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine

24 patients
Phase 1Completed

A Phase I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease.

0
Phase 1Withdrawn

A Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients With AIDS Who Have Already Been Treated With Ganciclovir

Est. completion: Jun 199330 patients
Phase 1Completed

A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease

Est. completion: Mar 199832 patients
Phase 1Completed

A Study of Human Cytomegalovirus (HCMV) Vaccine SPYVLP01 With and Without Adjuvants

Start: Nov 2023Est. completion: Jul 2025120 patients
Phase 1Completed

Safety and Immunogenicity of the Human Cytomegalovirus (CMV) Vaccine (V160) in Healthy Japanese Men (V160-003)

Start: Mar 2019Est. completion: Nov 201918 patients
Phase 1Completed
NCT02826798VBI VaccinesVBI-1501A 0.5 μg

Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults

Start: Jun 2016Est. completion: Aug 2017128 patients
Phase 1Completed

Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)

Start: Nov 2013Est. completion: Mar 2017190 patients
Phase 1Completed
NCT00377741Genentechvalganciclovir [Valcyte]

A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.

Start: Dec 2004Est. completion: Jun 200631 patients
Phase 1Completed
NCT00005572Allergy TherapeuticsA Comparison of HIV-Infected Patients With and Without Opportunistic (AIDS-Related) Infection

A Comparison of HIV-Infected Patients With and Without Opportunistic (AIDS-Related) Infection

90 patients
N/ACompleted

Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient

N/ACompleted

A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir

20 patients
N/ACompleted

A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

700 patients
N/ACompleted

Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections

N/ACompleted

Phase Legend

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

Key Insights

4 late-stage (Phase 3) programs, potential near-term approvals
4 actively recruiting trials targeting 7,227 patients
18 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.