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Cytomegalovirus Retinitis

9
Pipeline Programs
7
Companies
28
Clinical Trials
1
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Small Molecule
1785%
Monoclonal Antibody
315%
+ 10 programs with unclassified modality

On Market (1)

Approved therapies currently available

Roche
CYTOVENEApproved
ganciclovir
Roche
oral1994

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Roche
RocheSTAVANGER NORWAY, Norway
2 programs
1
GanciclovirN/ASmall Molecule
ZidovudineN/A
Genentech
GenentechCA - Oceanside
13 programs
2
1
3
GanciclovirPhase 3Small Molecule1 trial
ValganciclovirPhase 3Small Molecule4 trials
ValganciclovirPhase 3Small Molecule1 trial
GanciclovirPhase 2Small Molecule1 trial
Foscarnet sodiumPhase 11 trial
+8 more programs
Active Trials
NCT00002247Completed225
NCT00002135Completed
NCT00002257Completed150
+13 more trials
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
5 programs
1
SevirumabPhase 2Monoclonal Antibody1 trial
CidofovirN/ASmall Molecule
Foscarnet sodiumN/A4 trials
GanciclovirPHASE_1Small Molecule1 trial
GanciclovirPHASE_1Small Molecule
Active Trials
NCT00000964Completed6Est. Oct 1990
NCT00000729Completed10Est. Jun 1992
NCT00000665Completed240
+3 more trials
Kite Pharma
Kite PharmaCA - El Segundo
4 programs
1
CidofovirPhase 2Small Molecule
CidofovirN/ASmall Molecule
CidofovirN/ASmall Molecule
CidofovirN/ASmall Molecule
Ionis Pharmaceuticals
4 programs
Fomivirsen sodiumN/A1 trial
Fomivirsen sodiumN/A1 trial
Fomivirsen sodiumPHASE_21 trial
Fomivirsen sodiumPHASE_21 trial
Active Trials
NCT00002187Completed
NCT00002355Completed60
NCT00002156Completed194
+1 more trials
Sandoz
SandozAustria - Kundl
1 program
SevirumabPHASE_1Monoclonal Antibody
Novartis
NovartisBASEL, Switzerland
1 program
SevirumabPHASE_1Monoclonal Antibody2 trials
Active Trials
NCT00002016Completed
NCT00002268Completed

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
GenentechValganciclovir
Allergy TherapeuticsSevirumab
GenentechGanciclovir
GenentechValganciclovir
GenentechValganciclovir
GenentechGanciclovir
Allergy TherapeuticsGanciclovir
Allergy TherapeuticsFoscarnet sodium
Allergy TherapeuticsFoscarnet sodium
GenentechFoscarnet sodium
Allergy TherapeuticsFoscarnet sodium
GenentechValganciclovir
GenentechZidovudine

Clinical Trials (28)

Total enrollment: 3,444 patients across 28 trials

NCT00017784GenentechValganciclovir

Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection

500 patients
Phase 3Unknown

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

180 patients
Phase 3Completed
NCT00002377GenentechValganciclovir

A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes

Start: Jan 1997Est. completion: Dec 2002
Phase 3Completed

A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)

Est. completion: Aug 1998300 patients
Phase 2Completed

A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )

194 patients
Phase 2Completed

The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV

Est. completion: Aug 1995850 patients
Phase 2Completed

The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes

Phase 2Completed
NCT01335932GenentechValganciclovir

Ganciclovir/Valganciclovir for Prevention of CMV Reactivation in Acute Injury of the Lung and Respiratory Failure

Start: Mar 2011Est. completion: Oct 2016160 patients
Phase 2Completed
NCT00194467GenentechValganciclovir

Suppression of Oral HHV8 Shedding With Valganciclovir

Start: Dec 2002Est. completion: Mar 200532 patients
Phase 2Completed

A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir

Est. completion: Feb 199548 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

A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes

Est. completion: Jan 199825 patients
Phase 1Completed

The Effect of Stomach Acid on Foscarnet

Est. completion: Oct 19906 patients
Phase 1Completed

A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease

Est. completion: Jun 199210 patients
Phase 1Completed
NCT00000970GenentechFoscarnet sodium

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

Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome

Est. completion: Feb 199253 patients
Phase 1Completed

A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis

Phase 1Completed
NCT02871401GenentechValganciclovir

A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)

Start: Jan 2018Est. completion: Jan 202031 patients
Phase 1Completed
NCT00002222GenentechValganciclovir

A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS

200 patients
N/ACompleted

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

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

A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS

100 patients
N/ACompleted

An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access

N/ACompleted
NCT00002299GenentechInterferon beta-1b

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 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

A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes

60 patients
N/ACompleted

A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis

N/ACompleted

Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component

240 patients
N/ACompleted

Phase Legend

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

Key Insights

3 late-stage (Phase 3) programs, potential near-term approvals
Small Molecule is the dominant modality (85% of programs)
7 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.