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valaciclovir

Trade name: Valtrex

Small moleculeapproved

Approved

Jun 23, 1995

Valaciclovir, also spelled valacyclovir, is an antiviral medication used to treat outbreaks of herpes simplex or herpes zoster (shingles). It is also used to prevent cytomegalovirus following a kidney transplant in high risk cases. It is taken by mouth. — Wikipedia

Clinical trial activity

124 trials · 118 clinical orgs · 27 marketing orgs

Phase 1
30
Phase 2
55
Phase 3
18
Phase 4
21

Earliest trial started Jan 1, 1997 (NCT00006131)

Timeline

1990s

  1. Jun 23, 1995

    Earliest FDA Approval

  2. Jun 23, 1995

    GlaxoSmithKline — NDA Secondary Org

  3. Jan 1, 1997

    Earliest Phase 3 Sponsor(trial)

  4. Jan 1, 1998

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  2. Jan 31, 2007

    Sun Pharmaceuticals — Marketing Organization

2010s

  1. May 24, 2010

    Atlantide Pharmaceuticals — Marketing Organization

  2. May 24, 2010

    Hikma — Marketing Organization

  3. May 24, 2010

    Chartwell Pharmaceuticals — Marketing Organization

  4. May 24, 2010

    Aurobindo Pharma — Marketing Organization

  5. May 24, 2010

    Cipla — Marketing Organization

  6. May 24, 2010

    Mylan — Marketing Organization

  7. May 24, 2010

    Sandoz — Marketing Organization

  8. May 24, 2010

    Teva — Marketing Organization

  9. May 24, 2010

    Time-Cap Labs Inc — Marketing Organization

  10. May 24, 2010

    West-Ward Pharmaceutical — Marketing Organization

  11. May 24, 2010

    Wockhardt — Marketing Organization

  12. May 24, 2010

    Novartis — Marketing Organization

  13. May 24, 2010

    Adaptis Pharma — Marketing Organization

  14. May 24, 2010

    Graviti Pharmaceuticals — Marketing Organization

  15. May 24, 2010

    AiPing Pharm Inc — Marketing Organization

  16. May 24, 2010

    PHARMOBEDIENT — Marketing Organization

  17. May 24, 2010

    Rising Pharmaceuticals — Marketing Organization

  18. Mar 16, 2011

    Watson Pharmaceuticals — Marketing Organization

  19. Apr 3, 2012

    Jubilant Innovation Ltd. — Marketing Organization

  20. Apr 4, 2014

    Apotex — Marketing Organization

  21. Apr 8, 2015

    Hetero Labs Ltd — Marketing Organization

  22. Dec 29, 2017

    Zydus Discovery DMCC — Marketing Organization

  23. Dec 29, 2017

    Cadila Healthcare — Marketing Organization

2020s

  1. Mar 18, 2020

    Yiling Pharmaceutical Inc. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 23, 1995

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)[C@H](N)C(=O)OCCOCn1cnc2c(=O)nc(N)[nH]c21
Mol. weight
324.34 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Prodrug

Sources

Also known as

  • 2-((2-amino-1,6-dihydro-6-oxo-9h-purin-9-yl)methoxy)ethyl l-valinate
  • 256u
  • 256u87
  • 256u87 hcl
  • 256u87 hcl
  • acyclovir, l-valyl ester
  • bw256u87
  • l-valine, 2-((2-amino-1,6-dihydro-6-oxo-9h-purin-9-yl)methoxy)ethyl ester
  • l-valine, 2-((2-amino-1,6-dihydro-6-oxo-9h-purin-9-yl)methoxy)ethyl ester
  • l-valine ester with 9-((2-hydroxyethoxy)methyl)guanine
  • l-valine ester with 9-((2-hydroxyethoxy)methyl)guanine
  • l-valylacyclovir
  • valaciclovir
  • valaciclovir
  • valaciclovir
  • valaciclovir
  • valaciclovir
  • valaciclovir
  • valaciclovir
  • valaciclovir
  • valaciclovirum
  • valaciclovirum
  • valacyclovir
  • valacyclovir
  • valacyclovir
  • valacyclovir
  • valacyclovir
  • valacyclovir
  • valacyclovir
  • valacyclovir
  • valacyclovir, (d)-isomer
  • valacyclovir, (dl)-isomer
  • valacyclovir hcl
  • valacyclovir hcl
  • valacyclovir hcl
  • valacyclovir hydrochloride
  • valacyclovir hydrochloride
  • valacyclovir hydrochloride
  • valacyclovir hydrochloride
  • valacyclovir hydrochloride
  • valacyclovir hydrochloride, (dl)-isomer
  • valacyclovir, (l)-isomer
  • valacyclovir, x-hydrochloride, (d)-isomer
  • valacyclovir, x-hydrochloride, (dl)-isomer
  • valcivir
  • valtrex
  • valtrex
  • valtrex
  • valtrex
  • valtrex
  • zelitrex
  • zelitrex

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07294547N/ANov 27, 2025National Taiwan University
NCT06914479Phase 1Nov 1, 2025University of Michigan
NCT07014397N/ANov 1, 2024University of Tehran
NCT06344195Phase 4Mar 27, 2024Dow University of Health Sciences, Duke University
NCT06316843Phase 2Oct 15, 2023Bateman Horne Center
NCT05712343Early Phase 1 (Phase 1)May 25, 2023University of California, San Francisco
NCT05446571Phase 3Dec 31, 2022APHP - Hôpital Necker, Assistance Publique - Hôpitaux de Paris
NCT05550194Phase 4Dec 31, 2022Columbia University, Vanderbilt University
NCT05536349Phase 2Dec 20, 2022Loxo Oncology, The Leukemia and Lymphoma Society, University of Texas at Houston
NCT05452928Phase 4Oct 1, 2022Aalborg University
NCT05468619Phase 1Sep 23, 2022National Institute of Allergy and Infectious Diseases (NIAID)
NCT05492591Phase 2Aug 15, 2022China National Biotec Group Co., Ltd, Chinese Academy of Medical Sciences
NCT05266040Phase 2May 1, 2022University of California, San Francisco
NCT05094414Phase 1Jul 1, 2021Government of Taiwan, Hualien Tzu Chi General Hospital, Tzu Chi University
NCT04710030Phase 2Feb 1, 2021Alzheimer's Association, Columbia University
NCT04448392Phase 1Nov 30, 2020University of Alabama, Birmingham
NCT04165122Phase 2Nov 15, 2019Heidelberg ImmunoTherapeutics GmbH
NCT04081480N/ASep 30, 2019Radboud University
NCT03626376Phase 4Oct 31, 2018New York University
NCT03699904Phase 2Oct 11, 2018Northern Ireland Clinical Trials Unit, Queen's University, Belfast
Showing 20 of 124 trials
Page 1 / 7

Organizations

Research & Development (118)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit18852001
University of WashingtonAcademic/Hospital111152002
Candel TherapeuticsFor profit9832005
Glaxo WellcomeFor profit6431999
Stanley Medical Research InstituteAcademic/Hospital6022005
National Institute of Allergy and Infectious Diseases (NIAID)Government5521997
University of Texas at HoustonAcademic/Hospital5412003
Methodist Cancer Center, Houston, TexasAcademic/Hospital4312007
National Institutes of Health (NIH)Government4022003
Ohio State UniversityAcademic/Hospital4022005
AstellasFor profit3322007
Columbia UniversityAcademic/Hospital3222018
Department of Veteran AffairsGovernment3322010
Kendle International Inc.For profit3012005
MylanFor profit3312005
PRACSFor profit3022005
Radboud UniversityAcademic/Hospital3332012
University of PittsburghAcademic/Hospital3332007
University of TorontoAcademic/Hospital3322010
Asociación Civil Impacta Salud y Educación, PeruAcademic/Hospital2012003
118 organizations
Page 1 / 6

Marketing (33)

OrganizationOrg typeRelationshipDate
Adaptis PharmaFor profitMKTGMay 24, 2010
AiPing Pharm IncFor profitMKTGMay 24, 2010
ApotexFor profitSYNApr 4, 2014
ApotexFor profitMKTGApr 4, 2014
Atlantide PharmaceuticalsFor profitMKTGMay 24, 2010
Aurobindo PharmaFor profitMKTGMay 24, 2010
Cadila HealthcareFor profitMKTGDec 29, 2017
Chartwell PharmaceuticalsFor profitMKTGMay 24, 2010
CiplaFor profitMKTGMay 24, 2010
Glaxo WellcomeFor profitNDA—
GlaxoSmithKlineFor profitNDA2Jun 23, 1995
Graviti PharmaceuticalsFor profitMKTGMay 24, 2010
Hetero Labs LtdFor profitMKTGApr 8, 2015
HikmaFor profitMKTGMay 24, 2010
HikmaFor profitSYNMay 24, 2010
Jubilant Innovation Ltd.For profitMKTGApr 3, 2012
MylanFor profitMKTGMay 24, 2010
MylanFor profitSYNMay 24, 2010
NovartisFor profitMKTGMay 24, 2010
PHARMOBEDIENTFor profitMKTGMay 24, 2010
Rising PharmaceuticalsFor profitMKTGMay 24, 2010
SandozFor profitMKTGMay 24, 2010
Sun PharmaceuticalsFor profitMKTGJan 31, 2007
TevaFor profitMKTGMay 24, 2010
Time-Cap Labs IncFor profitMKTGMay 24, 2010
Watson PharmaceuticalsFor profitMKTGMar 16, 2011
West-Ward PharmaceuticalFor profitMKTGMay 24, 2010
WockhardtFor profitSYNMay 24, 2010
WockhardtFor profitMKTGMay 24, 2010
Yiling Pharmaceutical Inc.For profitMKTGMar 18, 2020
Yiling Pharmaceutical Inc.For profitSYNMar 18, 2020
Zydus Discovery DMCCFor profitMKTGDec 29, 2017
Zydus Discovery DMCCFor profitSYNDec 29, 2017