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

Clinical Trials

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

Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia

Phase 2

Active, not recruiting

Conditions: Cytomegalovirus Infections
Tuberculosis
Pneumonia
HIV/AIDS

Interventions: Drug: Valganciclovir Oral Solution [Valcyte]
Drug: Tuberculostatic Agents

First Posted Date: 2019-04-16

Last Posted Date: 2024-02-09

Lead Sponsor: Hospital Universitario 12 de Octubre

Target Recruit Count: 563

Registration Number: NCT03915366

Locations: 🇮🇹
PENTA Foundation, Padova, Italy
🇲🇿
Hospital Central Maputo, Maputo, Mozambique
🇳🇱
Stichting Katholieke Universiteit Radboudumc, Nimega, Netherlands

and more 10 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

Pharmacokinetic Parameters of Innovative Valganciclovir Versus Generic Valganciclovir

Not Applicable

Completed

Conditions: Kidney Transplantation
Cytomegalovirus Infections
Pharmacokinetics
Therapeutic Equivalency

Interventions: Drug: Innovative Valganciclovir
Drug: Generic Valganciclovir

First Posted Date: 2018-08-15

Last Posted Date: 2018-11-21

Lead Sponsor: Luis Eduardo Morales Buenrostro

Target Recruit Count: 8

Registration Number: NCT03631316

Locations: 🇲🇽
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico

Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes

Phase 2

Completed

Conditions: Cytomegalovirus Anterior Uveitis

Interventions: Drug: Valganciclovir Hydrochloride
Drug: Ganciclovir Sodium
Drug: Placebo Oral Tablet
Drug: Topical placebo

First Posted Date: 2018-07-13

Last Posted Date: 2024-12-06

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 51

Registration Number: NCT03586284

Locations: 🇺🇸
Proctor Foundation, UCSF, San Francisco, California, United States
🇹🇭
Chulalongkorn University, Bangkok, Thailand
🇹🇭
Chiang Mai University, Chiang Mai, Thailand

and more 1 locations

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting

Conditions: Breastfed Infants of Mothers on Select DOI
Lactating Women on Select DOI

First Posted Date: 2018-04-27

Last Posted Date: 2024-12-17

Lead Sponsor: Duke University

Target Recruit Count: 1600

Registration Number: NCT03511118

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
Ann and Robert H. Lurie Childrens Hospital of Chicago, Chicago, Illinois, United States
🇺🇸
Loma Linda University Health, Loma Linda, California, United States

and more 19 locations

Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)

Phase 3

Completed

Conditions: CMV Disease

Interventions: Drug: Letermovir
Drug: Valganciclovir
Drug: Acyclovir (ACV)
Drug: Placebo to ACV
Drug: Placebo to LET
Drug: Placebo to VGCV

First Posted Date: 2018-02-23

Last Posted Date: 2023-07-28

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 601

Registration Number: NCT03443869

Locations: 🇺🇸
University of Chicago ( Site 0251), Chicago, Illinois, United States
🇺🇸
Brigham & Women's Hospital ( Site 0244), Boston, Massachusetts, United States
🇺🇸
The Ohio State University Wexner Medical Center ( Site 0264), Columbus, Ohio, United States

and more 91 locations

Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies

Phase 1

Completed

Conditions: Epstein-Barr Virus-Associated Lymphoma
Lymphoproliferative Disorders

Interventions: Drug: VRx-3996
Drug: Valganciclovir

First Posted Date: 2018-01-12

Last Posted Date: 2025-03-20

Lead Sponsor: Viracta Therapeutics, Inc.

Target Recruit Count: 64

Registration Number: NCT03397706

Locations: 🇺🇸
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
🇺🇸
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
🇺🇸
University of California, Los Angeles, Los Angeles, California, United States

and more 25 locations

Asymptomatic Congenital CMV Treatment

Phase 2

Terminated

Conditions: Congenital Cytomegalovirus Infection

Interventions: Drug: Valganciclovir

First Posted Date: 2017-10-04

Last Posted Date: 2023-01-26

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 7

Registration Number: NCT03301415

Locations: 🇺🇸
University of Alabama - Children's of Alabama - Clinical Virology, Birmingham, Alabama, United States
🇺🇸
Arkansas Children's Hospital - Infectious Diseases, Little Rock, Arkansas, United States
🇺🇸
University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases, Louisville, Kentucky, United States

and more 6 locations

Drug Development Updates

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