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valganciclovir

Trade name: Valcyte

Small moleculeapproved

Approved

Mar 29, 2001

Valganciclovir, sold under the brand name Valcyte among others, is an antiviral medication used to treat cytomegalovirus (CMV) infection in those with HIV/AIDS or following organ transplant. It is often used long term as it only suppresses rather than cures the infection. Valganciclovir is taken by mouth. — Wikipedia

Clinical trial activity

97 trials · 108 clinical orgs · 18 marketing orgs

Phase 1
17
Phase 2
57
Phase 3
32
Phase 4
16

Earliest trial started Jan 1, 1997 (NCT00002377)

Timeline

1990s

  1. Jan 1, 1997

    Roche — Earliest Phase 3 Sponsor(trial)

2000s

  1. Mar 29, 2001

    Roche — Earliest FDA Approval

  2. Mar 29, 2001

    Roche — NDA Organization

  3. Mar 29, 2001

    CheplaPharm — Marketing Organization

  4. Mar 29, 2001

    CheplaPharm — NDA Secondary Org

  5. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  6. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  7. Aug 28, 2009

    Braun Beteiligungs GmbH — NDA Secondary Org

2010s

  1. Nov 4, 2014

    Dr. Reddy's Laboratories — Marketing Organization

  2. Nov 4, 2014

    Endo Pharmaceuticals — Marketing Organization

  3. Nov 4, 2014

    Strides Pharma Science — Marketing Organization

  4. Mar 18, 2016

    Hetero Labs Ltd — Marketing Organization

  5. Mar 31, 2016

    Aurobindo Pharma — Marketing Organization

  6. Jul 18, 2016

    Actavis — Marketing Organization

  7. Jul 18, 2016

    Allergan PLC (2015) — Marketing Organization

  8. Nov 9, 2018

    Cipla — Marketing Organization

2020s

  1. Jan 6, 2020

    Ajanta Pharma Ltd — Marketing Organization

  2. Feb 3, 2020

    Granules India — Marketing Organization

  3. Mar 3, 2021

    Mylan — Marketing Organization

  4. Feb 17, 2022

    Airis Pharma Pvt Ltd — Marketing Organization

  5. Feb 17, 2022

    MSN Laboratories — Marketing Organization

  6. Apr 11, 2023

    Appco Pharma — Marketing Organization

  7. Jun 11, 2024

    Sandoz — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewMar 29, 2001

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)[C@H](N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21
Mol. weight
354.37 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningProdrug

Sources

Also known as

  • cymeval
  • cymeval
  • ganciclovir l-valyl ester
  • l-valine, ester with ganciclovir
  • l-valine, ester with ganciclovir
  • ro-1079070/194
  • ro-1079070/194
  • rs-079070-194
  • rs-079070-194
  • valcyt
  • valcyte
  • valcyte
  • valcyte
  • valcyte
  • valganciclovir
  • valganciclovir
  • valganciclovir
  • valganciclovir
  • valganciclovir
  • valganciclovir
  • valganciclovir
  • valganciclovir
  • valganciclovir
  • valganciclovir
  • valganciclovir hcl
  • valganciclovir hcl
  • valganciclovir hcl
  • valganciclovir hydrochloride
  • valganciclovir hydrochloride
  • valganciclovir hydrochloride
  • valganciclovir hydrochloride
  • valganciclovir hydrochloride
  • valgancyclovir
  • valgancyclovir

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07235683Phase 4Nov 30, 2025University of Toronto
NCT07294547N/ANov 27, 2025National Taiwan University
NCT07079735Phase 2/Phase 3 (Phase 3)Sep 12, 2025Columbia University, Cornell University
NCT07138989Phase 2Aug 19, 2025Sun Yat-Sen University
NCT06798909Phase 3Jul 22, 2025National Institute of Allergy and Infectious Diseases (NIAID), University of California, San Francisco
NCT07266467Phase 4May 13, 2025Anhui Medical University, Capital Medical University, Central South University, Fudan University, Guangzhou Medical University, Huazhong University of Science and Technology, Jiao Tong University, Jinlin University, Qianfo Mountain Hospital, Shandong Province, Qingdao University, Southern Medical University, Sun Yat-Sen University, Zhengzhou University
NCT06334497Phase 3Aug 14, 2024Assistance Publique - Hôpitaux de Paris
NCT05708755Phase 2Apr 30, 2024New York University
NCT06391918Phase 1Mar 4, 2024GenVivo, Inc.
NCT06302140Phase 1Feb 28, 2024Viracta Therapeutics, Inc.
NCT06034925Phase 4Nov 6, 2023Medical University of South Carolina, Takeda
NCT06102525Phase 1/Phase 2 (Phase 2)Oct 31, 2023Rznomics, Inc., Sungkyunkwan University, University of Ulsan
NCT05431244N/AJul 1, 2022Sungkyunkwan University
NCT04724447Phase 1/Phase 2 (Phase 2)Oct 31, 2021Laureate Institute for Brain Research
NCT05041426Phase 2Oct 31, 2021Merck, University of Pittsburgh
NCT05166577Phase 1/Phase 2 (Phase 2)Oct 7, 2021Viracta Therapeutics, Inc.
NCT05011058Phase 2Aug 31, 2021Viracta Therapeutics, Inc.
NCT03915366Phase 2/Phase 3 (Phase 3)Jan 1, 2020Centre Hospitalier Cocody, Fundación para la Investigación Biomédica del Hospital 12 de Octubre, Government of Mozambique, Institut National de la Santé Et de la Recherche Médicale, France, Katholieke Universiteit Leuven, Makerere University, PENTA Foundation, Universidad Complutense de Madrid, Universidade Eduardo Mondlane, University of Barcelona, University of Bordeaux, University of Lincoln, University of Zimbabwe, University Teaching Hospital, Lusaka, Zambia, Wellcome Trust
NCT04116411Phase 2Sep 4, 2019Karolinska Institute
NCT04064697Phase 3Aug 31, 2019Government of France, University of Lyon
Showing 20 of 97 trials
Page 1 / 5

Organizations

Research & Development (108)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RocheFor profit231151997
National Institute of Allergy and Infectious Diseases (NIAID)Government8742000
National Cancer Institute (NCI)Government7332001
University of California, San FranciscoAcademic/Hospital6342000
University of WashingtonAcademic/Hospital4332001
Viracta Therapeutics, Inc.For profit4422018
National Institutes of Health (NIH)Government3122002
University of BarcelonaAcademic/Hospital3222004
University of PittsburghAcademic/Hospital3332006
ChimerixFor profit2212015
City of Hope National Medical CenterAcademic/Hospital2122001
Cornell UniversityAcademic/Hospital2122004
Dr. Reddy's LaboratoriesFor profit2212011
Fonds NutsOhraAcademic/Hospital2012012
GenentechFor profit2022016
HemaQuest PharmaceuticalsFor profit2212008
Institut National de la Santé Et de la Recherche Médicale, FranceAcademic/Hospital2012004
Karolinska InstituteAcademic/Hospital2222006
Lambda Therapeutic Research LtdFor profit2012011
Leiden UniversityAcademic/Hospital2212012
108 organizations
Page 1 / 6

Marketing (22)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGJul 18, 2016
Airis Pharma Pvt LtdFor profitMKTGFeb 17, 2022
Ajanta Pharma LtdFor profitMKTGJan 6, 2020
Allergan PLC (2015)For profitMKTGJul 18, 2016
Appco PharmaFor profitMKTGApr 11, 2023
Aurobindo PharmaFor profitMKTGMar 31, 2016
Aurobindo PharmaFor profitSYNNov 17, 2022
Braun Beteiligungs GmbHFor profitNDA2Aug 28, 2009
CheplaPharmFor profitMKTGMar 29, 2001
CheplaPharmFor profitNDA2Mar 29, 2001
CiplaFor profitMKTGNov 9, 2018
Dr. Reddy's LaboratoriesFor profitMKTGNov 4, 2014
Dr. Reddy's LaboratoriesFor profitSYNDec 12, 2017
Endo PharmaceuticalsFor profitMKTGNov 4, 2014
Granules IndiaFor profitMKTGFeb 3, 2020
Granules IndiaFor profitSYNJan 31, 2020
Hetero Labs LtdFor profitMKTGMar 18, 2016
MSN LaboratoriesFor profitMKTGFeb 17, 2022
MylanFor profitMKTGMar 3, 2021
RocheFor profitNDAMar 29, 2001
SandozFor profitMKTGJun 11, 2024
Strides Pharma ScienceFor profitMKTGNov 4, 2014