Valganciclovir

Summary

Valganciclovir (CHEMBL1201314) is an approved small-molecule prodrug (ATC J05AB14); indicated across 15 conditions including viral infectious disease and cytomegalovirus infection.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: J05AB14
• Indications: 15 conditions
• Clinical trials: 91
• Chemistry: 354.36 Da · C14H22N6O5

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1201314
Name	Valganciclovir
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	135413535
ChEBI	CHEBI:63635
ATC	J05AB14
Molecular formula	C14H22N6O5
Molecular weight	354.36
InChIKey	WPVFJKSGQUFQAP-GKAPJAKFSA-N

SMILES: CC(C)[C@@H](C(=O)OCC(CO)OCN1C=NC2=C1N=C(NC2=O)N)N

IUPAC name: [2-[(2-amino-6-oxo-1H-purin-9-yl)methoxy]-3-hydroxypropyl] (2S)-2-amino-3-methylbutanoate

ChEBI definition: The L-valinyl ester of ganciclovir, into which it is rapidly converted by intestinal and hepatic esterases. It is a synthetic analogue of 2’-deoxyguanosine.

Pharmacological roles (ChEBI): prodrug, antiviral drug.

Also known as: Valganciclovir, valganciclovir, VALGANCICLOVIR, VALGANCICLOVIR HYDROCHLORIDE

Parent form; salt/anhydrous children: CHEMBL1200454

Patent coverage: 5,903 distinct patent families (24,346 SureChEMBL compound mentions), from 4 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 1 (assay-derived). Sample: cGMP-inhibited 3’,5’-cyclic phosphodiesterase 3A.

Bioactivity

ChEMBL activities: 1 potent at pChembl ≥ 5 of 1 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
PDE3A	5.16	AC50	7000	nM	CHEMBL_ACT_25190603

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

15 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
viral infectious disease	4	MONDO:0005108	EFO:0000763
cytomegalovirus infection	3	MONDO:0005132	EFO:0001062
ulcerative colitis	3	MONDO:0005101	EFO:0000729
cytomegalovirus retinitis	3	MONDO:0000878	EFO:1001302
B-cell chronic lymphocytic leukemia	2	MONDO:0004948	EFO:0000095
lymphoma	2	MONDO:0005062	EFO:0000574
sensorineural hearing loss disorder	2	MONDO:0020678	EFO:1001176
Castleman disease	2	MONDO:0015564	MONDO:0015564
leukemia	2	MONDO:0005059	EFO:0000565
idiopathic pulmonary fibrosis	1	MONDO:0800504	EFO:0000768
kidney disorder	1	MONDO:0005240	EFO:0003086
myalgic encephalomeyelitis/chronic fatigue syndrome	1	MONDO:0005404	EFO:0004540
major depressive disorder	1	MONDO:0002009	MONDO:0002009
nasopharyngeal carcinoma	1	MONDO:0015459	MONDO:0015459

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 91.

Phase distribution

Phase	Trials
PHASE3	23
PHASE2	23
PHASE4	15
Not specified	12
PHASE1	8
PHASE2/PHASE3	5
PHASE1/PHASE2	5

Top trials by phase / activity

NCT	Phase	Status	Title
NCT07235683	PHASE4	RECRUITING	Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients
NCT07266467	PHASE4	RECRUITING	Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Disease in Chinese Kidney Transplant Recipients
NCT07430683	PHASE4	ACTIVE_NOT_RECRUITING	Valganciclovir Prophylaxis Versus Preemptive Therapy for Cytomegalovirus in Living Donor Kidney Transplant Recipients
NCT00034385	PHASE4	COMPLETED	Valganciclovir to Prevent Cytomegalovirus Infection in Kidney and Kidney/Pancreas Transplant Recipients
NCT00189150	PHASE4	COMPLETED	Pharmacokinetics of Mmf and Valganciclovir
NCT00264290	PHASE4	COMPLETED	Valganciclovir to Reduce T Cell Activation in HIV Infection
NCT00361933	PHASE4	WITHDRAWN	Valganciclovir to Treat HHV-8 Associated Multicentric Castleman’s Disease
NCT00431353	PHASE4	COMPLETED	VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients
NCT01255644	PHASE4	COMPLETED	Antiviral Treatment of Chronic Lymphocytic Leukemia
NCT01376804	PHASE4	COMPLETED	A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
NCT01509404	PHASE4	COMPLETED	Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection
NCT01552369	PHASE4	COMPLETED	CMV Antiviral Prevention Strategies in D+R-Liver Transplants (CAPSIL)
NCT01663740	PHASE4	COMPLETED	A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls
NCT02503982	PHASE4	COMPLETED	Valganciclovir Dosing in Pediatric Solid Organ Transplant Recipients
NCT06034925	PHASE4	COMPLETED	Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients
NCT06334497	PHASE3	RECRUITING	Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections
NCT07079735	PHASE2/PHASE3	RECRUITING	Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant
NCT00002377	PHASE3	COMPLETED	A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
NCT00006145	PHASE3	COMPLETED	Preventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV
NCT00016068	PHASE3	COMPLETED	Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation
NCT00017784	PHASE3	UNKNOWN	Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
NCT00090766	PHASE2/PHASE3	COMPLETED	A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients
NCT00227370	PHASE3	COMPLETED	Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation
NCT00237653	PHASE3	TERMINATED	MICI-CMV:Valganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus
NCT00241345	PHASE3	TERMINATED	Trial of Preemptive Treatment With Oral Valganciclovir Compared With Intravenous (IV) Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant
NCT00275314	PHASE3	TERMINATED	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
NCT00275665	PHASE3	COMPLETED	The Study is Being Done to See if Taking the Drug Valganciclovir Can Prevent CMV Infection.
NCT00294515	PHASE3	COMPLETED	IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
NCT00330018	PHASE3	COMPLETED	Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)
NCT00466817	PHASE3	COMPLETED	Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections
NCT01185223	PHASE3	TERMINATED	Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
NCT01655212	PHASE3	TERMINATED	Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial
NCT02005822	PHASE3	COMPLETED	Congenital Cytomegalovirus: Efficacy of Antiviral Treatment
NCT02439957	PHASE3	TERMINATED	A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus
NCT02439970	PHASE3	TERMINATED	A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease
NCT02606266	PHASE2/PHASE3	TERMINATED	Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance
NCT02927067	PHASE3	COMPLETED	A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants
NCT02931539	PHASE3	COMPLETED	Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
NCT03443869	PHASE3	COMPLETED	Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)
NCT03586284	PHASE2/PHASE3	TERMINATED	Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).