MedPath

Valaciclovir

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

Overview

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 .

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)

FDA Approved Products

Valacyclovir Hydrochloride
Manufacturer:Physicians Total Care, Inc.
Route:ORAL
Strength:1 g in 1 1
Approved: 2012/01/03
NDC:54868-6089
Valacyclovir Hydrochloride
Manufacturer:Physicians Total Care, Inc.
Route:ORAL
Strength:500 mg in 1 1
Approved: 2012/01/03
NDC:54868-6090
Valacyclovir Hydrochloride
Manufacturer:A-S Medication Solutions
Route:ORAL
Strength:1 g in 1 1
Approved: 2023/03/28
NDC:50090-2223
Valacyclovir
Manufacturer:Yiling Pharmaceutical, Inc.
Route:ORAL
Strength:1 g in 1 1
Approved: 2023/12/29
NDC:69117-0011
Valacyclovir Hydrochloride
Manufacturer:NuCare Pharmaceuticals,Inc.
Route:ORAL
Strength:500 mg in 1 1
Approved: 2021/02/16
NDC:68071-4474

Singapore Approved Products

VALACICLOVIR PHARMATHEN INTERNATIONAL FILM-COATED TABLETS 500MG
Manufacturer:PHARMATHEN S.A.
Form:TABLET
Strength:500mg
Online:Yes
Approved: 2015/08/24
Approval:SIN14832P
VALOVIR 500 VALACYCLOVIR TABLETS 500 mg
Manufacturer:Hetero Labs Limited
Form:TABLET
Strength:500.00 mg
Online:Yes
Approved: 2015/10/23
Approval:SIN14878P
VALTREX TABLET 500 mg
Manufacturer:GLAXO WELLCOME SA
Form:TABLET, FILM COATED
Strength:500 mg
Online:Yes
Approved: 1995/06/29
Approval:SIN08229P
Vaciclor Tablet 500 mg
Manufacturer:BALKANPHARMA - DUPNITSA AD
Form:TABLET, FILM COATED
Strength:500 mg
Online:Yes
Approved: 2012/08/10
Approval:SIN14207P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath