Valganciclovir

Generic Name: Valganciclovir

Brand Names: Valcyte

Drug Type: Small Molecule

Chemical Formula: C_₁₄H_₂₂N_₆O_₅

CAS Number: 175865-60-8

Unique Ingredient Identifier: GCU97FKN3R

Background: Valganciclovir hydrochloride (Valcyte, manufactured by Roche) is an antiviral medication used to treat cytomegalovirus infections. As the L-valyl ester of ganciclovir, it is actually a prodrug for ganciclovir. After oral administration, it is rapidly converted to ganciclovir by intestinal and hepatic esterases.

Indication: Valganciclovir is an antiviral medication used for the treatment of cytomegalovirus infections.

Associated Conditions: Cytomegalovirus (CMV) Infections, Cytomegalovirus Retinitis

Associated Therapies: -

Clinical Trials

Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections

Phase 3

Not yet recruiting

Conditions: Cytomegalovirus Infection

Interventions: Drug: Letermovir
Drug: Letermovir placebo
Drug: Valganciclovir

First Posted Date: 2024-03-28

Last Posted Date: 2024-07-19

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 80

Registration Number: NCT06334497

Locations: 🇫🇷
Hôpital Necker Enfants Malades, Paris, France

Maribavir Vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients

Phase 4

Active, not recruiting

Conditions: CMV
Transplant Complication

Interventions: Drug: Valganciclovir
Drug: Maribavir

First Posted Date: 2023-09-13

Last Posted Date: 2024-10-11

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 70

Registration Number: NCT06034925

Locations: 🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States

CMV Immunity Monitoring in Lung Transplant Recipients

Phase 2

Not yet recruiting

Conditions: Lung Transplant; Complications

Interventions: Device: Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)
Diagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA) Assay
Drug: Valganciclovir

First Posted Date: 2023-02-01

Last Posted Date: 2023-11-14

Lead Sponsor: NYU Langone Health

Target Recruit Count: 50

Registration Number: NCT05708755

Locations: 🇺🇸
NYU Langone Health, New York, New York, United States

Utilization of the Viracor® Assay for Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients

Completed

Conditions: Kidney Transplant; Complications

Interventions: Drug: Valganciclovir

First Posted Date: 2022-02-14

Last Posted Date: 2024-11-12

Lead Sponsor: Piedmont Healthcare

Target Recruit Count: 37

Registration Number: NCT05238220

Locations: 🇺🇸
Piedmont Atlanta Hospital, Atlanta, Georgia, United States

Nanatinostat Plus Valganciclovir in Patients With Advanced EBV+ Solid Tumors, and in Combination With Pembrolizumab in EBV+ RM-NPC

Phase 1

Active, not recruiting

Conditions: Nasopharyngeal Carcinoma
EBV-Related Gastric Carcinoma
EBV-Related Leiomyosarcoma
EBV Related Carcinoma
EBV-Related Sarcoma

Interventions: Drug: Nanatinostat
Drug: Valganciclovir
Drug: Pembrolizumab

First Posted Date: 2021-12-22

Last Posted Date: 2024-11-21

Lead Sponsor: Viracta Therapeutics, Inc.

Target Recruit Count: 26

Registration Number: NCT05166577

Locations: 🇺🇸
Stanford Cancer Center, Stanford, California, United States
🇺🇸
University of Colorado Hospital, Aurora, Colorado, United States
🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

and more 10 locations

Letermovir for CMV Prevention After Lung Transplantation

Phase 2

Active, not recruiting

Conditions: Lung Transplant
CMV

Interventions: Drug: Valganciclovir
Drug: Letermovir

First Posted Date: 2021-09-13

Last Posted Date: 2024-12-20

Lead Sponsor: Fernanda P Silveira, MD, MS

Target Recruit Count: 16

Registration Number: NCT05041426

Locations: 🇺🇸
UPMC, Pittsburgh, Pennsylvania, United States

ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION

Phase 1

Recruiting

Conditions: Major Depressive Disorder

Interventions: Drug: Placebo
Drug: Valganciclovir

First Posted Date: 2021-01-26

Last Posted Date: 2024-01-22

Lead Sponsor: Laureate Institute for Brain Research, Inc.

Target Recruit Count: 24

Registration Number: NCT04724447

Locations: 🇺🇸
Laureate Institute for Brain Research, Tulsa, Oklahoma, United States

Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy

Phase 3

Terminated

Conditions: Ulcerative Colitis, Unspecified

Interventions: Drug: Valganciclovir

First Posted Date: 2019-08-22

Last Posted Date: 2024-04-10

Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Target Recruit Count: 6

Registration Number: NCT04064697

Locations: 🇫🇷
CHU de Montpellier, Montpellier, France
🇫🇷
CHU de Nice, Nice, France
🇫🇷
CHU de Lyon Sud, Lyon, France

and more 5 locations

(Val)Ganciclovir TDM in Transplant Recipients

Conditions: Cytomegalovirus Infections

Interventions: Drug: Ganciclovir
Drug: Valganciclovir

First Posted Date: 2018-10-09

Last Posted Date: 2019-10-10

Lead Sponsor: University Medical Center Groningen

Target Recruit Count: 100

Registration Number: NCT03698435

Locations: 🇳🇱
UMCG, Groningen, Netherlands

Clinical Trial of Efficacy and Safety of the Combination of Reduced Duration Prophylaxis Followed by Immuno-guided Prophylaxis in Lung Transplant Recipients.

Phase 3

Completed

Conditions: Transplantation Infection
Cytomegalovirus Infections

Interventions: Drug: Valganciclovir
Drug: Ganciclovir

First Posted Date: 2018-10-09

Last Posted Date: 2023-09-15

Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

Target Recruit Count: 150

Registration Number: NCT03699254

Locations: 🇪🇸
Hospital Universitario 12 de Octubre, Madrid, Spain
🇪🇸
Hospital Univesitario Reina Sofía, Córdoba, Spain
🇪🇸
Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain

and more 4 locations

Drug Development Updates

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