MedPath

Valaciclovir

Generic Name
Valaciclovir
Brand Names
Valtrex
Drug Type
Small Molecule
Chemical Formula
C13H20N6O4
CAS Number
124832-26-4
Unique Ingredient Identifier
MZ1IW7Q79D
Background

Valaciclovir (valacyclovir), also known as Valtrex, is an antiviral drug that has been used to manage and treat various herpes infections for more than 2 decades. It was initially approved by the FDA in 1995 and marketed by GlaxoSmithKline . Valacyclovir is the L-valine ester of aciclovir. It is a member of the purine (guanine) nucleoside analog drug class . This class of drugs forms an important part of hepatitis, HIV, and cytomegalovirus drug regimens .

One major use of valacyclovir is the treatment of genital herpes episodes or outbreaks. Genital herpes is a frequently diagnosed sexually transmitted disease which currently affects more than 400 million individuals worldwide. It is caused by infection with the herpes simplex virus (HSV). Infection with this virus is lifelong with periodic episodes of reactivation .

Indication

Valacyclovir is a nucleoside analog DNA polymerase inhibitor indicated for :

Adults

• Cold Sores (Herpes Labialis)

• Genital Herpes

• Treatment of genital herpes lesions in immunocompetent patients (initial or recurrent episode)

• Suppression of genital herpes lesions in immunocompetent or HIV-infected patients

• Reduction of viral transmission

• Herpes Zoster

Pediatric Patients

• Cold Sores (Herpes Labialis)

• Chickenpox

Limitations of use

The efficacy and safety of valacyclovir have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.

Associated Conditions
Chickenpox, Genital Herpes, Genital herpes, initial episode, Herpes Labialis, Herpes Zoster, Recurrent Genital Herpes (RGH)
Associated Therapies
Suppression of Recurrent Genital Herpes (RGH)

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

Phase 1
Not yet recruiting
Conditions
Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant
Recurrent Malignant Brain Neoplasm
Resectable Brain Neoplasm
Interventions
Genetic: Ad-hCMV-Flt3L
Genetic: Ad-hCMV-TK
Procedure: Biospecimen Collection
Procedure: Magnetic Resonance Imaging
Other: Survey Administration
Procedure: Tumor Resection
First Posted Date
2025-04-06
Last Posted Date
2025-04-06
Lead Sponsor
University of Michigan Rogel Cancer Center
Target Recruit Count
11
Registration Number
NCT06914479
Locations
🇺🇸

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

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

Phase 4
Recruiting
Conditions
Acute Apical Abscess
Interventions
First Posted Date
2024-04-03
Last Posted Date
2024-04-10
Lead Sponsor
Dow University of Health Sciences
Target Recruit Count
82
Registration Number
NCT06344195
Locations
🇵🇰

Dr. Yumna Shaheen Ali, Karachi, Sindh, Pakistan

Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2

Phase 2
Completed
Conditions
Long COVID
PASC Post Acute Sequelae of COVID 19
Interventions
First Posted Date
2024-03-19
Last Posted Date
2025-01-22
Lead Sponsor
Bateman Horne Center
Target Recruit Count
59
Registration Number
NCT06316843
Locations
🇺🇸

Bateman Horne Center, Salt Lake City, Utah, United States

The Efficacy of Systemic Valacyclovir (Valtrex) on Periodontitis

Early Phase 1
Recruiting
Conditions
Severe Periodontitis
Interventions
Other: Control group
First Posted Date
2023-02-03
Last Posted Date
2023-07-12
Lead Sponsor
University of California, San Francisco
Target Recruit Count
40
Registration Number
NCT05712343
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

VZV in the Enteric Nervous System: Pathogenesis and Consequences

Phase 4
Recruiting
Conditions
Achalasia
Interventions
First Posted Date
2022-09-22
Last Posted Date
2025-05-16
Lead Sponsor
Vanderbilt University Medical Center
Target Recruit Count
40
Registration Number
NCT05550194
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

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

First Posted Date
2022-09-10
Last Posted Date
2025-04-08
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
60
Registration Number
NCT05536349
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster

Phase 2
Completed
Conditions
Herpes Zoster
Interventions
First Posted Date
2022-08-08
Last Posted Date
2023-12-29
Lead Sponsor
Shanghai Institute Of Biological Products
Target Recruit Count
50
Registration Number
NCT05492591
Locations
🇨🇳

Chinese Academy of Medical Sciences Dermatology Hospital, Nanjing, Jiangsu, China

Neonatal Phase 1 Valacyclovir Study

Phase 1
Recruiting
Conditions
Herpes Simplex
Interventions
First Posted Date
2022-07-21
Last Posted Date
2025-05-16
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
16
Registration Number
NCT05468619
Locations
🇺🇸

Nationwide Children's Hospital - Infectious Diseases, Columbus, Ohio, United States

🇺🇸

Children's of Alabama Child Health Research Unit (CHRU), Birmingham, Alabama, United States

🇺🇸

Emory University School of Medicine, Atlanta, Georgia, United States

and more 9 locations

Valacyclovir in Pain Management of Acute Apical Abscesses

Phase 2
Recruiting
Conditions
Acute Apical Abscess
Pain, Acute
Interventions
First Posted Date
2022-03-04
Last Posted Date
2023-07-12
Lead Sponsor
University of California, San Francisco
Target Recruit Count
250
Registration Number
NCT05266040
Locations
🇺🇸

UCSF Dental, San Francisco, California, United States

Using Oral Valacyclovir to Treat Patients With Refractory IC/BPS

Phase 1
Conditions
Overactive Bladder Syndrome
Pain, Chronic
Urge Incontinence
Quality of Life
First Posted Date
2021-10-26
Last Posted Date
2021-10-26
Lead Sponsor
Buddhist Tzu Chi General Hospital
Target Recruit Count
30
Registration Number
NCT05094414
Locations
🇨🇳

Hualien Tzu Chi Hospital, Hualien City, Taiwan

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