Valacyclovir

Summary

Valacyclovir (CHEMBL1349) is an approved small-molecule antiviral drug (ATC J05AB11); indicated across 34 conditions including viral infectious disease and genital herpes.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: J05AB11
• Indications: 34 conditions
• Clinical trials: 120
• Chemistry: 324.34 Da · C13H20N6O4

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1349
Name	Valacyclovir
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	135398742
ChEBI	CHEBI:35854
ATC	J05AB11
Molecular formula	C13H20N6O4
Molecular weight	324.34
InChIKey	HDOVUKNUBWVHOX-QMMMGPOBSA-N

SMILES: CC(C)[C@@H](C(=O)OCCOCN1C=NC2=C1N=C(NC2=O)N)N

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

Pharmacological roles (ChEBI): antiviral drug.

Also known as: Valaciclovir, Valacv, Valacyclovir, valacyclovir, SID29215498, SID56422581, L-Valyl ester of Zidovudine, VALACICLOVIR, VALACYCLOVIR, VALACYCLOVIR HYDROCHLORIDE, valaciclovir

Parent form; salt/anhydrous children: CHEMBL1201110

Patent coverage: 10,676 distinct patent families (37,800 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 24,851 (66%) of the total. 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: 2 (assay-derived). Sample: Beta-lactamase, Menin/Histone-lysine N-methyltransferase MLL.

Bioactivity

ChEMBL activities: 1 potent at pChembl ≥ 5 of 2 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
P00811	5.55	Potency	2818	nM	CHEMBL_ACT_4697674

Target pathways

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

Indications & clinical

Indications

34 indications (5 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
genital herpes	4	MONDO:0005770	EFO:0007282
herpes zoster	4	MONDO:0005609	EFO:0006510
herpes labialis	4	MONDO:0043653	EFO:1001347
neoplasm	3	MONDO:0005070	EFO:0000616
encephalitis	3	MONDO:0019956	MONDO:0019956
herpes simplex infectious disease	3	MONDO:0004609	EFO:1002022
HIV infectious disease	3	MONDO:0005109	EFO:0000764
B-cell chronic lymphocytic leukemia	2	MONDO:0004948	EFO:0000095
cytomegalovirus infection	2	MONDO:0005132	EFO:0001062
chronic hepatitis C virus infection	2	MONDO:0005354	EFO:0004220
glioblastoma	2	MONDO:0018177	EFO:0000519
anaplastic astrocytoma	2	MONDO:0016684	EFO:0002499
herpes simplex virus gingivostomatitis	2	MONDO:0005792	EFO:0007307
chronic obstructive pulmonary disease	2	MONDO:0005002	EFO:0000341
Waldenstrom macroglobulinemia	2	MONDO:0100280	EFO:0009441
schizoaffective disorder	2	MONDO:0005487	EFO:0005411
glioma	2	MONDO:0021042	MONDO:0100342
leukemia	2	MONDO:0005059	EFO:0000565
bipolar disorder	2	MONDO:0004985	MONDO:0004985
long COVID-19	2	MONDO:0100233	MONDO:0100233
prostate adenocarcinoma	1	MONDO:0005082	EFO:0000673
infectious mononucleosis	1	MONDO:0005810	EFO:0007326
ependymoma	1	MONDO:0016698	EFO:1000028
lung neoplasm	1	MONDO:0021117	MONDO:0008903
exocrine pancreatic carcinoma	1	MONDO:0005192	EFO:0002618
paraganglioma	1	MONDO:0000448	EFO:1000453
periodontitis	0	MONDO:0005076	EFO:0000649

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

Clinical trials

Total trials: 120.

Phase distribution

Phase	Trials
PHASE2	35
PHASE1	27
Not specified	21
PHASE4	17
PHASE3	16
PHASE1/PHASE2	2
PHASE2/PHASE3	1
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05550194	PHASE4	RECRUITING	VZV in the Enteric Nervous System: Pathogenesis and Consequences
NCT00079911	PHASE4	TERMINATED	A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons
NCT00116844	PHASE4	COMPLETED	VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.
NCT00158860	PHASE4	COMPLETED	A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® Tablet is a Trademark of the GlaxoSmithKline Group of Companies.
NCT00161434	PHASE4	COMPLETED	A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons
NCT00306293	PHASE4	COMPLETED	VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2
NCT00362297	PHASE4	COMPLETED	Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
NCT00510263	PHASE4	COMPLETED	Scandinavian Bell’s Palsy Study
NCT00527618	PHASE4	COMPLETED	Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV
NCT01026454	PHASE4	COMPLETED	Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons
NCT01037712	PHASE4	TERMINATED	In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir
NCT01346475	PHASE4	COMPLETED	Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
NCT01651585	PHASE4	COMPLETED	In Utero Treatment of Cytomegalovirus congénitale Infection With Valacyclovir
NCT01682109	PHASE4	COMPLETED	Palatability Testing of a New Paediatric Formulation of Valacyclovir
NCT02152800	PHASE4	COMPLETED	A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster
NCT03134196	PHASE4	COMPLETED	Zoster Eye Disease Study
NCT06344195	PHASE4	UNKNOWN	Valacyclovir Monotherapy in Pain Management of Acute Periapical Abscesses After Emergency Chamber Opening
NCT01436968	PHASE3	ACTIVE_NOT_RECRUITING	Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer
NCT05446571	PHASE3	RECRUITING	Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir
NCT00001038	PHASE3	COMPLETED	A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
NCT00001649	PHASE3	COMPLETED	Valaciclovir to Prevent Transmission of Herpes Simplex Virus
NCT00005663	PHASE3	UNKNOWN	A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients
NCT00031486	PHASE3	COMPLETED	Long Term Treatment of Herpes Simplex Encephalitis (HSE) With Valacyclovir
NCT00045292	PHASE3	COMPLETED	Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
NCT00169416	PHASE3	COMPLETED	Evaluation Of Valaciclovir In Patients With Chickenpox
NCT00306787	PHASE3	COMPLETED	Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
NCT00378976	PHASE3	COMPLETED	HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1, HSV-2 Co-infected Men.
NCT00465205	PHASE3	COMPLETED	HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons
NCT00860977	PHASE3	COMPLETED	Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals?
NCT01176409	PHASE3	COMPLETED	Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2?
NCT01959841	PHASE3	COMPLETED	Phase III Study of ASP2151 in Herpes Zoster Patients
NCT02351102	PHASE2/PHASE3	COMPLETED	Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy
NCT02412917	PHASE3	TERMINATED	A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia
NCT07349680	PHASE3	COMPLETED	Ultrasound-Guided Thoracic Paravertebral Block With Steroid and Local Anesthetic for Acute Herpes Zoster: Effects on Pain Control and Prevention of Postherpetic Neuralgia
NCT00492050	PHASE2	ACTIVE_NOT_RECRUITING	Bortezomib and Rituximab for Patients With Waldenstrom’s Macroglobulinemia
NCT02768363	PHASE2	ACTIVE_NOT_RECRUITING	Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
NCT05266040	PHASE2	RECRUITING	Valacyclovir in Pain Management of Acute Apical Abscesses
NCT05536349	PHASE2	RECRUITING	Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)
NCT07332000	PHASE2	RECRUITING	A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
NCT07346144	PHASE1/PHASE2	RECRUITING	Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma

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).