Cytomegalovirus Infections

14
Pipeline Programs
8
Companies
34
Clinical Trials
1 recruiting
4
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Small Molecule
990%
Monoclonal Antibody
110%
+ 8 programs with unclassified modality

On Market (4)

Approved therapies currently available

Roche
CYTOVENEApproved
ganciclovir
Roche
oral1994
U
GANZYK-RTUApproved
ganciclovir
Unknown Company
intravenous2017
U
VALCYTEApproved
valganciclovir
Unknown Company
oral2001
U
VALGANCICLOVIR HYDROCHLORIDEApproved
valganciclovir
Unknown Company
oral2019

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Roche
RocheSTAVANGER NORWAY, Norway
4 programs
1
1
valganciclovirPhase 3Small Molecule5 trials
GanciclovirN/ASmall Molecule1 trial
GanciclovirN/ASmall Molecule1 trial
GanciclovirN/ASmall Molecule5 trials
Active Trials
NCT00002025Completed
NCT00002251Completed20
NCT00000768Completed24Est. Aug 1998
+9 more trials
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
7 programs
1
2
3
Valacyclovir hydrochloridePhase 31 trial
ValganciclovirPhase 3Small Molecule1 trial
ganciclovirPhase 3Small Molecule1 trial
FiacitabinePhase 21 trial
MF-59Phase 21 trial
+2 more programs
Active Trials
NCT00302029TerminatedEst. Dec 2008
NCT00000805CompletedEst. Mar 1998
NCT00000981CompletedEst. Feb 1993
+4 more trials
Biotest Pharmaceuticals
Biotest PharmaceuticalsGermany - Dreieich
1 program
1
Cytotect®CPPhase 21 trial
Active Trials
NCT05370976TerminatedEst. Aug 2023
Sandoz
SandozAustria - Kundl
1 program
1
SevirumabPhase 1Monoclonal Antibody1 trial
Active Trials
NCT00002268Completed
VBI Vaccines
VBI VaccinesMA - Cambridge
1 program
1
VBI-1501A 0.5 μgPhase 11 trial
Active Trials
NCT02826798CompletedEst. Aug 2017
M&
Merck & Co.RAHWAY, NJ
2 programs
GanciclovirN/ASmall Molecule1 trial
Non Primary HCMV Infection: Natural History and Immune ResponseN/A1 trial
Active Trials
NCT04478474Completed100Est. Sep 2022
NCT06337955Active Not Recruiting204Est. Dec 2024
Moderna
ModernaCAMBRIDGE, MA
1 program
CMV PCR on salivaN/A1 trial
Active Trials
NCT06522880Recruiting100Est. Dec 2027
Bristol Myers Squibb
1 program
LobucavirN/ASmall Molecule1 trial
Active Trials
NCT00002352Completed30

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Allergy Therapeuticsganciclovir
Rochevalganciclovir
Rochevalganciclovir
Allergy TherapeuticsValganciclovir
Rochevalganciclovir
Allergy TherapeuticsFiacitabine
Biotest PharmaceuticalsCytotect®CP
Allergy TherapeuticsMF-59
Rochevalganciclovir
RocheGanciclovir
RocheGanciclovir
Allergy TherapeuticsGanciclovir
VBI VaccinesVBI-1501A 0.5 μg
Rochevalganciclovir
Rochevalganciclovir

Showing 15 of 23 trials with date data

Clinical Trials (34)

Total enrollment: 2,170 patients across 34 trials

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 2005
Phase 3Completed
NCT00001038Allergy TherapeuticsValacyclovir hydrochloride

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

Phase 3Completed
NCT00275314Rochevalganciclovir

WP16302 A Bioequivalence Study Comparing Ganciclovir From the Valganciclovir Syrup Formulation and the Commercial Valganciclovir 450mg Tablet (Valcyte®) at a Dose of 900mg in Kidney Transplant Recipients

Start: Feb 2006Est. completion: Apr 20065 patients
Phase 3Terminated
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

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

Start: Aug 2000Est. completion: Feb 2006
Phase 3Completed
NCT00090766Rochevalganciclovir

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 1993
Phase 2Completed

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 2023
Phase 2Terminated

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

Start: Jun 2006Est. completion: Jun 2013
Phase 2Completed
NCT00141037Rochevalganciclovir

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

Start: Mar 2004Est. completion: Nov 2010130 patients
Phase 1/2Completed
NCT00000768RocheGanciclovir

A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients

Est. completion: Aug 199824 patients
Phase 1Completed

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
NCT00000970RocheGanciclovir

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 1998
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 2017
Phase 1Completed
NCT01165580Rochevalganciclovir

A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age

Start: May 2011Est. completion: Sep 201317 patients
Phase 1Completed
NCT00377741Rochevalganciclovir

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
NCT00002299RocheGanciclovir

The Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

N/ACompleted

A Study of Lobucavir in Patients With AIDS

30 patients
N/ACompleted
NCT00002251RocheGanciclovir

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

20 patients
N/ACompleted
NCT00002024RocheGanciclovir

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

N/ACompleted
NCT00000989RocheGanciclovir

The Safety and Effectiveness of Ganciclovir Used Alone or in Combination With Granulocyte-Macrophage Colony Stimulating Factor in the Treatment of Cytomegalovirus (CMV) of the Eye in Patients With AIDS

Est. completion: Jul 199250 patients
N/ACompleted
NCT00002247RocheGanciclovir

A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy

225 patients
N/ACompleted
NCT00002025RocheGanciclovir

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

N/ACompleted
NCT00002095RocheGanciclovir

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
NCT00002257RocheGanciclovir

A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS

150 patients
N/ACompleted
NCT00002273RocheGanciclovir

A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Large Intestine in Patients With AIDS

N/ACompleted
NCT06522880ModernaCMV PCR on saliva

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

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

Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients

Start: Sep 2020Est. completion: Sep 2022100 patients
N/ACompleted
NCT06337955Merck & Co.Non Primary HCMV Infection: Natural History and Immune Response

Non Primary HCMV Infection: Natural History and Immune Response

Start: Jun 2017Est. completion: Dec 2024204 patients
N/AActive Not Recruiting
NCT02062294Rochevalganciclovir

An Observational Study of Valcyte (Valganciclovir) in D+/R- Liver Transplant Recipients

Start: Jul 2010Est. completion: Sep 201114 patients
N/ACompleted
NCT00302029Allergy TherapeuticsCMV Infection in Adolescent Males

CMV Infection in Adolescent Males

Start: Jun 2006Est. completion: Dec 2008
N/ATerminated
NCT00374686Rochevalganciclovir

Study of Prophylactic Vs Preemptive Valganciclovir

Start: Mar 2003Est. completion: Sep 2005120 patients
N/ACompleted
NCT00566072RocheGanciclovir

The Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial

Start: May 2001Est. completion: May 200321 patients
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
1 actively recruiting trials targeting 2,170 patients
Small Molecule is the dominant modality (90% of programs)
8 companies competing in this space