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Cytomegalovirus Infections

24
Pipeline Programs
17
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
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
2392%
Monoclonal Antibody
14%
Vaccine
14%
+ 29 programs with unclassified modality

On Market (1)

Approved therapies currently available

Roche
CYTOVENEApproved
ganciclovir
Roche
oral1994

Competitive Landscape

17 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
NCT00002025Completed
NCT00002251Completed20
NCT00002095Completed700
+9 more trials
Roche
RocheSTAVANGER NORWAY, Norway
4 programs
1
GanciclovirN/ASmall Molecule
GanciclovirN/ASmall Molecule3 trials
GanciclovirN/ASmall Molecule
valganciclovirPHASE_3Small Molecule4 trials
Active Trials
NCT00002134Completed450
NCT00002330Completed280
NCT00002015Completed20
+4 more trials
MSD
MSDIreland - Ballydine
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
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
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 Antibody
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
GenentechValganciclovir
GenentechGanciclovir
Rochevalganciclovir
Allergy TherapeuticsGanciclovir
Allergy Therapeuticsganciclovir
MSDLetermovir
Rochevalganciclovir
GenentechValganciclovir CMV Prophylaxis
GenentechValganciclovir
Rochevalganciclovir
Rochevalganciclovir
Allergy TherapeuticsValganciclovir
Allergy TherapeuticsGanciclovir
Genentechvalganciclovir [Valcyte]
Allergy TherapeuticsFiacitabine

Showing 15 of 34 trials with date data

Clinical Trials (50)

Total enrollment: 7,647 patients across 50 trials

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

300 patients
Phase 4Completed
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

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

Est. completion: Aug 2007
Phase 3Completed
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
NCT06407232MSDLetermovir

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

Start: Aug 2024Est. completion: Sep 202690 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

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

Est. completion: Feb 199378 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

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

Est. completion: Mar 1998167 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
NCT06066957MSDLetermovir 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
NCT03728426MSDLetermovir

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

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

0
Phase 1Withdrawn

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 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 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
NCT01986010MSDV160 Low Dose IM

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
NCT00002015RocheGanciclovir

An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children

20 patients
N/ACompleted

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

N/ACompleted
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
NCT00002330RocheGanciclovir

A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

280 patients
N/ACompleted

A Study of Lobucavir in Patients With AIDS

30 patients
N/ACompleted

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

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

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

20 patients
N/ACompleted
NCT00002134RocheGanciclovir

A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis

450 patients
N/ACompleted
NCT06522880ModernaCMV PCR on saliva

Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study

Start: Aug 2023Est. completion: Dec 2027100 patients
N/ARecruiting

Related Jobs

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 7,647 patients
17 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.