Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate the pharmacological and pharmacokinetic profiles of acyclovir across completed, recruiting, and uninitiated protocols. Sponsored by public institutions, pharmaceutical companies, and university networks, these studies evaluate patient populations ranging from pediatric to pregnant subjects. Research primarily targets viral pathologies—including herpes simplex, herpes zoster, varicella, and cytomegalovirus—while also exploring indications in schizophrenia, obesity, and symptomatic apical periodontitis.

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
NCT05452928 NOT_YET_RECRUITING
Herpes Simplex 2; Meningitis, Viral
Jacob Bodilsen
 2026-06-01 PHASE4
NCT07014397 COMPLETED
Symptomatic Apical Periodontitis
Tehran University of Medical Sciences
 2024-11-01
NCT06757907 COMPLETED
Herpetic Keratitis
Al-Azhar University
 2024-10-01
NCT06228430 Not yet recruiting
Healthy Volunteer
International Bio service
 2024-02-12 Phase 1
NCT05589688 Not yet recruiting
Obesity
University Hospital Toulouse
 2024-01 Phase 1
NCT06058858 Not yet recruiting
Cytomegalovirus Infections|Acute Leukemia|B Cell Lymphoma
Assistance Publique - Hôpitaux de Paris
 2023-10-01 --
NCT05468619 Recruiting
Herpes Simplex
National Institute of Allergy and Infectious Diseases (NIAID)
 2022-09-23 Phase 1
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
NCT02152358 COMPLETED
Viral Pneumonia
Assistance Publique Hopitaux De Marseille
 2014-02-05 PHASE4
NCT01327144 COMPLETED
Herpes Zoster
EMS
 2012-06 PHASE3
NCT02205489 COMPLETED
Relapsing-remitting Multiple Sclerosis
Genzyme, a Sanofi Company
 2014-10 PHASE4
NCT01633476 UNKNOWN
ANCA Associated Vasculitis; CMV Infection
Professor Lorraine Harper
 2013-07 PHASE2
NCT01364792 COMPLETED
Schizophrenia; Psychosis
University Medical Center Groningen
 2011-04 PHASE2
NCT02711267 COMPLETED
Dermatologic Disorders
Medical University of Graz
 2014-01
NCT01959841 COMPLETED
Herpes Zoster
Maruho Co., Ltd.
 2013-08 PHASE3
NCT01281007 COMPLETED
GENITAL HERPES
EMS
 2012-07 PHASE3
NCT01503918 COMPLETED
Critical Illness
University Hospital Birmingham NHS Foundation Trust
 2012-01 PHASE2
NCT00652184 UNKNOWN
Herpes Zoster; Postherpetic Neuralgia
aRigen Pharmaceuticals, Inc.
 2008-03 PHASE2
NCT00711776 COMPLETED
Herpes Labialis
GlaxoSmithKline
 2008-04-10 PHASE1
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
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 Acyclovir (Aciclovir) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Acyclovir is a synthetic guanosine nucleoside analogue that undergoes selective phosphorylation by viral thymidine kinase to form acyclo-guanosine monophosphate, which subsequently terminates viral DNA elongation. This mechanism directly halts viral propagation within host cells, providing clinical efficacy in treating herpes simplex, herpes zoster, varicella, and cytomegalovirus infections evaluated across 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.