Clinical Trials

Numerous clinical trials, spanning Phase 1 through Phase 4, evaluate valaciclovir hydrochloride across indications ranging from viral infections—such as herpes simplex, varicella, and prenatal cytomegalovirus—to exploratory conditions including schizophrenia, mild cognitive impairment, and symptomatic apical periodontitis. Sponsored by pharmaceutical corporations as well as academic and governmental institutions, these studies exhibit recruitment statuses ranging from completed trials to active Phase 3 evaluations for prenatal viral management.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07346144 RECRUITING
Glioblastoma (GBM); High Grade Gliomas; Recurrent Glioblastoma; Newly Diagnosed Glioblastoma
Trogenix ltd
 2026-04-21 PHASE1; PHASE2
NCT05446571 RECRUITING
Pregnant Women; CMV Infected Fetuses
Assistance Publique - Hôpitaux de Paris
 2023-10-20 PHASE3
NCT05902208 UNKNOWN
Periodontitis Chronic Generalized Severe
Centre Hospitalier Universitaire de Nice
 2024-02-05 PHASE3
NCT07014397 COMPLETED
Symptomatic Apical Periodontitis
Tehran University of Medical Sciences
 2024-11-01
NCT04732260 COMPLETED
Pregnant Women Undergoing TOP; TOP - Failed Attempted Termination of Pregnancy
Assistance Publique - Hôpitaux de Paris
 2021-06-11
NCT04165122 COMPLETED
Herpes Genitalis
Heidelberg ImmunoTherapeutics GmbH
 2019-11-15 PHASE2
NCT03699904 TERMINATED
COPD; EBV
Belfast Health and Social Care Trust
 2018-10-11 PHASE2
NCT02997982 COMPLETED
Alzheimer Disease; Mild Cognitive Impairment; Herpes Simplex
Hugo Lovheim
 2016-12 PHASE2
NCT01633476 UNKNOWN
ANCA Associated Vasculitis; CMV Infection
Professor Lorraine Harper
 2013-07 PHASE2
NCT01364792 COMPLETED
Schizophrenia; Psychosis
University Medical Center Groningen
 2011-04 PHASE2
NCT01959841 COMPLETED
Herpes Zoster
Maruho Co., Ltd.
 2013-08 PHASE3
NCT01503918 COMPLETED
Critical Illness
University Hospital Birmingham NHS Foundation Trust
 2012-01 PHASE2
NCT01602562 COMPLETED
Herpes Simplex
GlaxoSmithKline
 2012-05-07 PHASE3
NCT00652184 UNKNOWN
Herpes Zoster; Postherpetic Neuralgia
aRigen Pharmaceuticals, Inc.
 2008-03 PHASE2
NCT00510263 COMPLETED
Bell's Palsy
Uppsala University Hospital
 2001-05 PHASE4
NCT02226978 COMPLETED
Healthy
Boehringer Ingelheim
 2007-02 PHASE1
NCT00297206 COMPLETED
Herpes Simplex
GlaxoSmithKline
 2003-01-25 PHASE1
NCT00158860 COMPLETED
Herpes Genitalis
GlaxoSmithKline
 2004-06-21 PHASE4
NCT00116844 COMPLETED
Infections, Herpesviridae
GlaxoSmithKline
 2005-03-29 PHASE4
NCT00343278 COMPLETED
Virus Diseases
GlaxoSmithKline
 2005-07 PHASE4
NCT00169416 COMPLETED
Varicella
GlaxoSmithKline
 2005-03 PHASE3
NCT00169416 Completed
Varicella
GlaxoSmithKline
 2005-03 Phase 3
NCT00079911 TERMINATED
Herpes Genitalis
GlaxoSmithKline
 2004-03-12 PHASE4
NCT00001649 COMPLETED
Herpes Simplex
National Institute of Allergy and Infectious Diseases (NIAID)
 1997-08 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-06-12)

Check the Valaciclovir HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Valaciclovir HCl is a prodrug of aciclovir that undergoes intracellular conversion to aciclovir triphosphate, which competitively inhibits viral DNA polymerase and incorporates into viral DNA to cause premature chain termination. This disruption of viral DNA synthesis halts viral replication and cellular spread, providing therapeutic efficacy against herpes simplex, varicella-zoster, and cytomegalovirus infections evaluated in clinical studies.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.