Ireland
--:--IST
Priya Life Science Compound trial record
Compound · clinical trials

Valacyclovir clinical trials

Also listed in trial records as Valtrex
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 7 trials in our USA, Mexico, France, Brazil and Taiwan registers that name Valacyclovir as an intervention. Synced 9 Nov 2026
7Current trials
4Recruiting now
4Lead sponsors
5Country registers
At a glance

Valacyclovir is named as an intervention in 7 current clinical trials in our USA, Mexico, France, Brazil and Taiwan registers. 4 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Candel Therapeutics, Inc (4). The most-studied condition is Prostate Cancer.

Valacyclovir also has an approved-drug profile on this site (FDA label data): Valtrex (Valacyclovir) →

Where Valacyclovir is approved

All regulators →

Of the three regulators tracked here, the first to approve Valacyclovir was the US, on 23 Jun 1995. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
23 Jun 1995
Valtrex
NDA020487 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
1 May 1996
Valtrex
Notice of Compliance 4721
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

What health systems spend on Valacyclovir

All medicines →
ENNHS England
Not dispensed in the community in England in the last 12 months under this name
Net ingredient cost, community prescriptions
USUS Medicaid
$34.4m
1,934,099 prescriptions in 2025 · Valacyclovir, Valacyclovir Hydrochloride, Valtrex
-1% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Valacyclovir works

All drug targets →
  • Human herpesvirus 1 DNA polymerase inhibitor Inhibitor
    ChEMBL only
Diseases it has been tested for in clinical trials, by furthest phase
  • HIV infectious diseasePhase 3
  • Herpes simplex encephalitisPhase 3
  • PeriodontitisPhase 3
  • Prostate cancerPhase 3
  • Alzheimer diseasePhase 2
  • COVID-19Phase 2
  • Cognitive impairmentPhase 2
  • Anaplastic astrocytomaPhase 2
  • Bipolar disorderPhase 2
  • Breast cancerPhase 2
32 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1349, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 4824, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Valacyclovir

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Valacyclovir

ATC code
J05AB11
ChEMBL
CHEMBL1349
DrugBank
DB00577
PubChem CID
135398742
CAS number
124832-26-4
FDA UNII
MZ1IW7Q79D
Wikidata
Q418594
Wikipedia
Valaciclovir

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting457%
  • Active, closed229%
  • By invitation114%

Trials by phase

  • Phase 3343%
  • Phase 2343%
  • Not applicable114%
01

Clinical trials of Valacyclovir

7 trials
StudyPhaseStatusLead sponsorRegisters
Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir
NCT05446571 · ClinicalTrials.gov ↗ · Pregnant Women, CMV Infected Fetuses
Phase 3 Recruiting Assistance Publique - Hôpitaux de Paris France
Aglatimagene Besadenovec + Prodrug and Pembrolizumab vs Docetaxel for Stage IV Non-Squamous NSCLC Progressing on Pembrolizumab (AURORA)
NCT07660094 · ClinicalTrials.gov ↗ · Non-squamous, Non-Small Cell Lung Cancer
Phase 3 Recruiting Candel Therapeutics, Inc USA
A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
NCT07332000 · ClinicalTrials.gov ↗ · Prostate Cancer Patients Treated by Radiotherapy, Prostate Cancer (Adenocarcinoma)
Phase 2 Recruiting Candel Therapeutics, Inc USA
Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study
NCT07294547 · ClinicalTrials.gov ↗ · Kidney Transplantation, Cytomegalovirus Infections, EBV Infection, Antiviral Prophylaxis
Not applicable Recruiting National Taiwan University Hospital Taiwan
Oral Herpesviruses and Oral Mucositis in Patients Receiving Head and Neck Radiotherapy
NCT07363031 · ClinicalTrials.gov ↗ · Oral Mucositis, Head and Neck Cancer (H&N), Radiotherapy Side Effects
Phase 2 By invitation Instituto Oncoclinicas Brazil
Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer
NCT01436968 · Prostate Cancer
Phase 3 Active, closed Candel Therapeutics, Inc USA, Mexico
Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
NCT02768363 · Prostate Cancer
Phase 2 Active, closed Candel Therapeutics, Inc USA, Mexico

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Valacyclovir

12 conditions
Prostate Cancer2Non-squamous, Non-Small Cell Lung Cancer1Prostate Cancer Patients Treated by Radiotherapy1Prostate Cancer (Adenocarcinoma)1Pregnant Women1CMV Infected Fetuses1Oral Mucositis1Head and Neck Cancer (H&N)1Radiotherapy Side Effects1Kidney Transplantation, Cytomegalovirus Infections1EBV Infection1Antiviral Prophylaxis1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Candel Therapeutics, Inc4
Assistance Publique - Hôpitaux de Paris1
Instituto Oncoclinicas1
National Taiwan University Hospital1
04

By country register

RegisterTrialsRecruiting
Clinical trials in USA42
Clinical trials in Mexico20
Clinical trials in France11
Clinical trials in Brazil10
Clinical trials in Taiwan11

A trial with sites in more than one country appears in each of those registers.

05

Related compounds

06

Questions about Valacyclovir trials

How many clinical trials are testing Valacyclovir?

7 current trials in our USA, Mexico, France, Brazil and Taiwan registers name Valacyclovir as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Valacyclovir trials recruiting patients?

Yes. 4 of the 7 trials are recruiting: 2 with sites in USA, 1 with sites in France and 1 with sites in Taiwan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Valacyclovir clinical trials?

Candel Therapeutics, Inc (4), Assistance Publique - Hôpitaux de Paris (1), Instituto Oncoclinicas (1) and National Taiwan University Hospital (1). The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Valacyclovir works or whether it is effective, and it is not medical advice.

Approvals, shortages and trials, every Friday

One email a week with new EMA and FDA approvals, EU and US medicine shortages, how many trials are recruiting in Ireland, and the week's Irish pharma news.

Free. Unsubscribe from any email with one click. See our privacy policy.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Valacyclovir works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Valacyclovir (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.