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Valtrex

(Valacyclovir)

ApprovedSmall molecule

GGlaxo Dba Glaxosmithkline

Valacyclovir is used to treat infections caused by herpes viruses, including cold sores, genital herpes, and shingles. It works by stopping the virus from multiplying in your body.[2] Valtrex is currently approved and in use across 23 indications[4].[1]

Valtrex is one of 511 small molecule programs targeting HIV infection. It is currently in Approved.

23

Indications

76

Total Trials

13

Active Trials

510

Competitors

13

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionApproved

AbscessRecruiting

Herpes Simplex InfectionApproved

Viral DiseaseActive, not recruiting

Prostate AdenocarcinomaApproved

MacroglobulinemiaActive, not recruiting

Lung CancerApproved

Anaplastic AstrocytomaApproved

Long COVID-19Approved

Herpes LabialisActive, not recruiting

HIV InfectionApproved

Approved

AbscessApproved

Recruiting

Herpes Simplex InfectionApproved

Approved

Viral DiseaseApproved

Active, not recruiting

Prostate AdenocarcinomaApproved

Approved

MacroglobulinemiaPhase 2

Active, not recruiting

Lung CancerApproved

Approved

Anaplastic AstrocytomaApproved

Approved

Long COVID-19Approved

Approved

Herpes LabialisApproved

Active, not recruiting

Showing 10 of 23 indications

Competition

Competitive Landscape

199 competitors in Lung Cancer

#DrugCompanyPhaseTrials

Valtrex

GGlaxo Dba Glaxosmithkline

Keytruda

Imfinzi

Opdivo

Bristol-Myers Squibb

Yervoy

Bristol-Myers Squibb

Abraxane

Bristol-Myers Squibb

Alunbrig

Alecensa

Tarlatamab-Dznl

Lynparza

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Prostate Cancer

NCT02768363

Q3 2027

ApprovedRecruiting

Achalasia

NCT05550194

Q4 2027

Phase 2Not yet recruiting

HSV-2 Infection

NCT07912996

Q2 2028

Phase 2Recruiting

Chronic Lymphocytic Leukemia

NCT05536349

Phase 2Recruiting

COVID-19

NCT07597902

Clinical

Trials by Indication[1]

Genital Herpes4 trials

A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes

Completed· Astellas logo

Astellas·Phase 2·NCT00486200·695 enrolled

Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes

Completed· Novartis logo

Novartis·Phase 3·NCT00306787·1,179 enrolled

Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes

Terminated·AAiCuris Anti-infective Cures AG·Phase 2·NCT01658826·91 enrolled

Show 1 more trial

Randomised Controlled Trial Assessing the Impact of Genital Herpes Suppressive Therapy on HIV Shedding

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 2·NCT00158509·215 enrolled

Herpes Zoster4 trials

Randomized Study of Two Doses of Oral Valacyclovir in Immunocompromised Patients With Uncomplicated Herpes Zoster

Completed·NNational Center for Research Resources (NCRR)·N/A·NCT00006131·66 enrolled

A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster

Completed·SShanghai Institute Of Biological Products·Phase 2·NCT05492591·50 enrolled

A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00900783·350 enrolled

Show 1 more trial

A Phase 2b Trial of EPB-348 for the Treatment of Herpes Zoster

Completed·EEpiphany Biosciences·Phase 2·NCT00831103·373 enrolled

HIV-14 trials

HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1, HSV-2 Co-infected Men.

Completed·UUniversity of Washington·Phase 3·NCT00378976·20 enrolled

Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons

Completed·UUniversity of Washington·Phase 4·NCT01026454·32 enrolled

HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons

Completed·UUniversity of Washington·Phase 3·NCT00465205·20 enrolled

Show 1 more trial

An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons

Withdrawn·UUniversity of Washington·N/A·NCT01059084

Herpes Simplex Virus3 trials

Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV

Completed·UUniversity of Washington·Phase 4·NCT00527618·28 enrolled

Valacyclovir in Neonatal Herpes Simplex Virus Disease

Completed·UUniversity of Alabama at Birmingham·Phase 1·NCT04448392·7 enrolled

Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix

Completed·UUniversity of Toronto·N/A·NCT00946556·30 enrolled

Prostate Cancer2 trials

Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery

Unknown status·TThe Methodist Hospital Research Institute·Phase 2·NCT03541928·60 enrolled

A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer

Active, not recruiting·CCandel Therapeutics, Inc.·Phase 2·NCT02768363·187 enrolled

49 more indications

Chronic Hepatitis2 trials

Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C

Unknown status·—·Phase 1·NCT01037621·50 enrolled

Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)

Completed·VVA Office of Research and Development·Phase 1·NCT01453075·31 enrolled

Randomized2 trials

Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2

Completed·UUniversity of Washington·Phase 4·NCT01346475·50 enrolled

Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2

Completed·UUniversity of Washington·Phase 4·NCT00362297·31 enrolled

Cytomegalovirus Infection2 trials

Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation

Completed·FFred Hutchinson Cancer Center·Phase 3·NCT00045292

Prenatal Treatment of Congenital Cytomegalovirus Infection with Letermovir Versus Valaciclovir

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT05446571·46 enrolled

Pregnancy2 trials

Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy

Completed·RRabin Medical Center·Phase 2/3·NCT02351102·100 enrolled

HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding

Completed·UUniversity of Washington·Phase 2·NCT00530777·148 enrolled

Kidney Transplant2 trials

ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation

Completed·UUniversity of Minnesota·Phase 2·NCT01972035·137 enrolled

Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study

Recruiting·NNational Taiwan University Hospital·N/A·NCT07294547·80 enrolled

Treatment2 trials

In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT01037712·6 enrolled

Early Non-Ablative Fractional Laser Resurfacing for Acne Scars After Treatment With Oral Isotretinoin

Completed·DDavid Smart·N/A·NCT03514771·15 enrolled

Abscess2 trials

Valacyclovir Monotherapy in Pain Management of Acute Periapical Abscesses After Emergency Chamber Opening

Recruiting·—·Phase 4·NCT06344195·82 enrolled

Valacyclovir in Pain Management of Acute Apical Abscesses

Recruiting·UUniversity of California, San Francisco·Phase 2·NCT05266040·60 enrolled

Malignant Glioma2 trials

Phase 1b Study of AdV-tk + Valacyclovir Combined With Radiation Therapy for Malignant Gliomas

Completed·CCandel Therapeutics, Inc.·Phase 1·NCT00751270·15 enrolled

Phase 2a Study of CAN-2409 With Standard Radiation Therapy for Malignant Glioma

Completed·CCandel Therapeutics, Inc.·Phase 2·NCT00589875·52 enrolled

Non-Small Cell Lung Carcinoma2 trials

Trial of Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma and Uveal Melanoma

Terminated·EEric Bernicker, MD·Phase 2·NCT02831933·11 enrolled

A Phase 3, Multicenter, Randomized, Controlled, Open-Label Clinical Trial of Aglatimagene Besadenovec (CAN-2409) Plus Prodrug and Pembrolizumab Versus Docetaxel for Stage IV Non-Squamous Non-Small Cell Lung Cancer Progressing on Pembrolizumab-based Treatment

Recruiting·CCandel Therapeutics, Inc.·Phase 3·NCT07660094·500 enrolled

Schizophrenia1 trial

Systematic Evaluation of Antiviral Medication in Schizophrenia

Completed·KKonasale Prasad·Phase 2·NCT00514449·31 enrolled

HIV1 trial

A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons

Completed·UUniversity of Washington·Phase 4·NCT00161434·60 enrolled

Fed1 trial

Valacyclovir 1000 mg Tablet Under Fed Conditions

Completed· Teva logo

Teva·Phase 1·NCT01149460·36 enrolled

Mood1 trial

Research Study of Bipolar Mood Symptoms and Cognitive Problems

Completed·JJohns Hopkins University·Phase 2·NCT00428298·60 enrolled

Chronic Lymphocytic Leukemia1 trial

Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05536349·60 enrolled

Alzheimer's Disease1 trial

Anti-viral Therapy in Alzheimer's Disease

Completed·—·Phase 2·NCT03282916·120 enrolled

Fasting Conditions1 trial

Valacyclovir 1000 mg Tablet Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT01149499·60 enrolled

Oncolytic Virus1 trial

SBRT and Oncolytic Virus Therapy Before Pembrolizumab for Metastatic TNBC and NSCLC

Completed·TThe Methodist Hospital Research Institute·Phase 2·NCT03004183·57 enrolled

Oncology Patients1 trial

A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

Completed·—·Phase 2·NCT00042328·30 enrolled

Efficacy and Safety1 trial

Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection by Valacyclovir and Interferon Inducer Kagocel

Completed·NNearmedic Plus LLC··NCT04664127·45 enrolled

Women1 trial

Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women

Withdrawn·UUniversity of Pittsburgh·N/A·NCT00682721

Macroglobulinemia1 trial

Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT00492050·46 enrolled

MPA1 trial

Study Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy Volunteers

Terminated· Astellas logo

Astellas·Phase 1·NCT00870441·442 enrolled

Children1 trial

Pharmacokinetics of Valacyclovir Oral Solution in Children

Terminated·RRadboud University Medical Center·N/A·NCT04081480·7 enrolled

Glioma1 trial

GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas

Completed·CCandel Therapeutics, Inc.·Phase 1·NCT03576612·41 enrolled

Neuralgia1 trial

A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia

Terminated·CContraVir Pharmaceuticals, Inc.·Phase 3·NCT02412917·237 enrolled

Infectious Mononucleosis1 trial

Controlled Trial of Valacyclovir in Infectious Mononucleosis

Completed·UUniversity of Minnesota·Phase 1/2·NCT00274404·20 enrolled

Newly Diagnosed1 trial

VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2

Completed· GSK logo

GSK·Phase 4·NCT00306293·70 enrolled

Recurrence1 trial

Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding

Completed·UUniversity of Alabama at Birmingham·N/A·NCT00803543·103 enrolled

Hepatitis C1 trial

Herpes Simplex Type 1 Suppression in Hepatitis C

Completed·VVA Office of Research and Development·Phase 2·NCT01580995·19 enrolled

Stomatitis1 trial

Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children?

Completed·SSt. Justine's Hospital·Phase 2·NCT02738229·80 enrolled

Postherpetic Neuralgia1 trial

Reduction of Postherpetic Neuralgia in Herpes Zoster

Completed·CCenter for Clinical Studies, Texas·N/A·NCT01250561·133 enrolled

Oral1 trial

Oral Valganciclovir Versus Valacyclovir

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00562770·46 enrolled

Immunodeficiency1 trial

Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals?

Completed·UUniversity Health Network, Toronto·Phase 3·NCT00860977·202 enrolled

Pancreas Cancer1 trial

AdV-tk Therapy With Surgery and Chemoradiation for Pancreas Cancer (PaTK01)

Completed·CCandel Therapeutics, Inc.·Phase 1·NCT00638612·27 enrolled

Psychosis1 trial

V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis

Completed·UUniversity of British Columbia·Phase 2·NCT00175513·100 enrolled

Malignant Brain Tumors1 trial

Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and Young Adult Patients With Resectable, Recurrent Primary Malignant Brain Tumors

Recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 1·NCT06914479·11 enrolled

Vaccine1 trial

HSV529 Vaccine in HSV-2 Seropositive Adults

Completed·FFred Hutchinson Cancer Center·Phase 1·NCT02571166·10 enrolled

Oral Mucositis1 trial

Oral Herpesviruses and Oral Mucositis in Patients Receiving Head and Neck Radiotherapy

Enrolling by invitation·IInstituto Oncoclinicas·Phase 2·NCT07363031·84 enrolled

HIV-Infected Individuals1 trial

Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2?

Completed·UUniversity Health Network, Toronto·Phase 3·NCT01176409·60 enrolled

Immunocompromised1 trial

Valacyclovir in Immunocompromised Children

Completed·—·Phase 1·NCT00059592·37 enrolled

Endodontic Treatment1 trial

Effect of Valaciclovir on Inter-Appointment Pain in Endodontic Treatment of Necrotic Teeth

Completed·TTehran University of Medical Sciences·N/A·NCT07014397·38 enrolled

Encephalitis1 trial

Long Term Treatment of Herpes Simplex Encephalitis (HSE) With Valacyclovir

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00031486·91 enrolled

Pediatric Brain Tumor1 trial

A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors

Completed·CCandel Therapeutics, Inc.·Phase 1·NCT00634231·8 enrolled

Refractory1 trial

Using Oral Valacyclovir to Treat Patients With Refractory IC/BPS

Unknown status·—·Phase 1·NCT05094414·30 enrolled

HSV-2 Infection1 trial

A Phase 2b, Randomized, Double-Blind, Active-Control, Parallel-Group Study to Evaluate the Safety and Efficacy of GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes

Not yet recruiting· Gilead logo

Gilead·Phase 2·NCT07912996·300 enrolled

COVID-191 trial

SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction (SHIELD)

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT07597902·150 enrolled

Achalasia1 trial

VZV in the Enteric Nervous System: Pathogenesis and Consequences

Recruiting·VVanderbilt University Medical Center·Approved·NCT05550194·40 enrolled

Herpes Simplex1 trial

A Phase I Adaptive, Multiple Dose Pharmacokinetic and Safety Assessment of Valacyclovir in Infants at Risk of Acquiring Neonatal Herpes Simplex Virus Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT05468619·17 enrolled

Unspecified2 trials

Palatability Testing of a New Paediatric Formulation of Valacyclovir

Completed·RRadboud University Medical Center·Phase 4·NCT01682109·41 enrolled

Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir

Completed·RRadboud University Medical Center·Phase 1·NCT01689285·16 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 23, 1995

VALTREX

NDA NDA020487

Jun 23, 1995

VALTREX

NDA NDA020487

Sep 8, 1995

VALTREX

NDA NDA020487

Aug 9, 1996

VALTREX

NDA NDA020487

Jan 13, 1997

VALTREX

NDA NDA020487

Dec 3, 2004

VALTREX

NDA NDA020487

Nov 23, 2005

VALTREX

NDA NDA020487

Dec 11, 2007

VALTREX

NDA NDA020487

Sep 2, 2008

VALTREX

NDA NDA020487

Apr 19, 2010

VALTREX

NDA NDA020487

Dec 10, 2019

VALTREX

NDA NDA020487

Jun 14, 2021

VALTREX

NDA NDA020487

Nov 12, 2025

VALTREX

NDA NDA020487

Sources

References

[1]
ClinicalTrials.gov — 76 trial records for Valacyclovir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Valtrex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Valacyclovir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Valacyclovir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020487). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Herpesvirus 1 DNA Polymerase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: GGlaxo Dba Glaxosmithkline

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