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ganciclovir

Trade name: cytovene

Small moleculeapprovedOrphan Drug FDA

Approved

Jun 23, 1989

There is no information in the literature about pharmacological and biological application of definite isomer: R of valganciclovir. However, is known, that valganciclovir, existing, as a mixture of R and S diasteriomers, is the active ingredient in Valcyte, which is used as an antiviral medication given to patients who have a high chance of developing cytomegalovirus (CMV) disease after receiving a heart, kidney, or kidney-pancreas transplant. It was proposed, that stable aqueous solutions of valganciclovir can be prepared in aqueous solutions at acidic pHs but these solutions will exist as a mixture of isomers: R and S — NCATS

Clinical trial activity

101 trials · 89 clinical orgs · 23 marketing orgs

Phase 1
21
Phase 2
42
Phase 3
19
Phase 4
12

Earliest trial started Mar 1, 1990 (NCT00000136)

Timeline

1980s

  1. Oct 31, 1985

    Orphan Drug Designation

  2. Jun 23, 1989

    Roche — Earliest FDA Approval

  3. Jun 23, 1989

    Roche — NDA Organization

  4. Jun 23, 1989

    CheplaPharm — Marketing Organization

  5. Jun 23, 1989

    CheplaPharm — NDA Secondary Org

1990s

  1. Jan 1, 1990

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 1992

    Earliest Phase 1 Sponsor(trial)

  3. Mar 4, 1996

    Bausch & Lomb — NDA Secondary Org

  4. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jul 16, 2003

    West-Ward Pharmaceutical — Marketing Organization

  2. Jul 16, 2003

    Hikma — Marketing Organization

2010s

  1. Jun 21, 2010

    Fresenius — Marketing Organization

  2. Sep 18, 2013

    Sankyo — Marketing Organization

  3. Sep 18, 2013

    Lutipold — Marketing Organization

  4. Sep 18, 2013

    Daiichi Sankyo — Marketing Organization

  5. Dec 6, 2016

    Par Pharmaceuticals — Marketing Organization

  6. Dec 6, 2016

    Bristol-Myers Squibb — Marketing Organization

  7. Dec 6, 2016

    Endo Pharmaceuticals — Marketing Organization

  8. Dec 6, 2016

    PH HEALTH — Marketing Organization

  9. Feb 17, 2017

    Exela Pharma Sciences, LLC. — NDA Secondary Org

  10. Feb 17, 2017

    Exela Pharma Sciences, LLC. — Marketing Organization

  11. Nov 17, 2017

    Mylan — Marketing Organization

  12. Nov 17, 2017

    STERISCIENCE — Marketing Organization

  13. Nov 17, 2017

    ONESOURCE SPECIALTY — Marketing Organization

  14. Dec 8, 2017

    Pharmasciences — Marketing Organization

  15. Dec 8, 2017

    Ferring — Marketing Organization

  16. Nov 8, 2018

    Hainan Poly Pharm — Marketing Organization

  17. Nov 8, 2018

    SLATE RUN PHARMA — Marketing Organization

  18. Jun 20, 2019

    Custopharm Inc — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJun 23, 1989

Chemistry & pharmacology

Loading structure…

SMILES

Nc1nc2c(ncn2COC(CO)CO)c(=O)[nH]1
Mol. weight
255.23 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Yes

Black box warningProdrug

Sources

Also known as

  • 2-(6-amino-purin-9-ylmethoxy)-propane-1,3-diol
  • 2-(6-amino-purin-9-ylmethoxy)-propane-1,3-diol
  • 2-amino-9-((1,3-dihydroxypropan-2-yloxy)methyl)-1h-purin-6(9h)-one
  • 2-amino-9-((1,3-dihydroxypropan-2-yloxy)methyl)-1h-purin-6(9h)-one
  • 2-amino-9-((1,3-dihydroxypropan-2-yloxy)methyl)-3h-purin-6(9h)-one
  • 2-amino-9-((1,3-dihydroxypropan-2-yloxy)methyl)-3h-purin-6(9h)-one
  • 2-amino-9-((1,3-dihydroxypropan-2-yloxy)methyl)-9h-purin-6-ol
  • 2-amino-9-((1,3-dihydroxypropan-2-yloxy)methyl)-9h-purin-6-ol
  • 2-amino-9-(2-hydroxy-1-hydroxymethyl-ethoxymethyl)-1,9-dihydro-purin-6-one
  • 2-amino-9-(2-hydroxy-1-hydroxymethyl-ethoxymethyl)-1,9-dihydro-purin-6-one
  • 2-amino-9-(2-hydroxy-1-hydroxymethylethoxymethyl)-6,9-dihydro-1h-6-purinone
  • 2-amino-9-(2-hydroxy-1-hydroxymethylethoxymethyl)-6,9-dihydro-1h-6-purinone
  • 9-[(1,3-dihydroxy-2-propoxy)methyl]guanine
  • 9-[(1,3-dihydroxy-2-propoxy)methyl]guanine
  • 9-((2-hydroxy-1-(hydroxymethyl)ethoxy)methyl)guanine
  • 9-((2-hydroxy-1-(hydroxymethyl)ethoxy)methyl)guanine
  • bw-759u
  • bw-759u
  • cymevene
  • cymevene
  • cytovene
  • cytovene
  • cytovene
  • denosine
  • ga2
  • ga2
  • ganciclovir
  • ganciclovir
  • ganciclovir
  • ganciclovir
  • ganciclovir
  • ganciclovir
  • ganciclovir
  • ganciclovir
  • ganciclovir
  • ganciclovir
  • ganciclovir
  • ganciclovir
  • ganciclovir
  • ganciclovir sodium
  • ganciclovir sodium
  • ganciclovir sodium
  • ganciclovir sodium
  • ganciclovir sodium
  • ganciclovirum
  • ganciclovirum
  • gancyclovir
  • gancyclovir
  • gancyclovir
  • gancyclovir
  • gv550
  • hydroxyacyclovir
  • natclovir
  • rs-21592
  • rs-21592
  • rs-21592 sodium
  • rs-21592 sodium
  • virgan
  • virgan
  • vitrasert
  • vitrasert
  • zirgan
  • zirgan

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07235683Phase 4Nov 30, 2025University of Toronto
NCT06971913Phase 2May 20, 2025Peking University
NCT06853184Phase 2May 1, 2025Amivas
NCT06574789Phase 2Oct 29, 2024Murdoch University
NCT06757907N/AOct 1, 2024Al Azhar University
NCT06436534N/AMay 24, 2024Huazhong University of Science and Technology
NCT06341686Phase 3May 5, 2024Hospital do Rim e Hipertensão
NCT05911503Early Phase 1 (Phase 1)Jul 1, 2023Tianjin Medical University
NCT05578820Phase 1Jan 1, 2022—
NCT04706507Phase 3Jun 29, 2021National Heart, Lung, and Blood Institute (NHLBI), University of Washington
NCT04884217Phase 2May 20, 2021GliaCure, Inc., Pharmadax Inc
NCT04225780Phase 1/Phase 2 (Phase 2)Feb 1, 2020Peking University
NCT03990051Phase 2Jun 17, 2019GliaCure, Inc., Harvard University
NCT03699254Phase 3Apr 30, 2019Hospital Universitario Reina Sofía, Universidad Carlos III Madrid, Universidad de Cordoba
NCT03586284Phase 2/Phase 3 (Phase 3)Oct 31, 2018Chulalongkorn University, Hwang Pacific Foundation, KhonKaen University, National Taiwan University, University of California, San Francisco
NCT03217474N/AJul 20, 2017Sun Yat-Sen University
NCT02931539Phase 3Dec 1, 2016Shire
NCT03004261Phase 4Nov 1, 2016Jiao Tong University, Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
NCT02943057Phase 4Aug 1, 2016Singapore Eye Research Institute, Singapore National Eye Centre
NCT02382588Phase 2Jan 1, 2015Bausch & Lomb, Northwestern University
Showing 20 of 101 trials
Page 1 / 6

Organizations

Research & Development (89)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Allergy and Infectious Diseases (NIAID)Government252251991
RocheFor profit251651997
National Cancer Institute (NCI)Government10141996
University of California, San FranciscoAcademic/Hospital5131990
Johns Hopkins UniversityAcademic/Hospital4321990
University of WashingtonAcademic/Hospital4432000
City of Hope National Medical CenterAcademic/Hospital3321999
Northwestern UniversityAcademic/Hospital3121990
University of California, Los AngelesAcademic/Hospital3121990
University of MiamiAcademic/Hospital3021990
Bausch & LombFor profit2022012
Baylor UniversityAcademic/Hospital2011990
Boston UniversityAcademic/Hospital2121994
Cornell UniversityAcademic/Hospital2011990
GliaCure, Inc.For profit2112019
Huazhong University of Science and TechnologyAcademic/Hospital2222006
Icahn School of Medicine at Mount SinaiAcademic/Hospital2011990
Louisiana State UniversityAcademic/Hospital2121990
National Center for Research Resources (NCRR)Government2221991
National Eye Institute (NEI)Government2011990
89 organizations
Page 1 / 5

Marketing (27)

OrganizationOrg typeRelationshipDate
Bausch & LombFor profitNDA2Mar 4, 1996
Bristol-Myers SquibbFor profitMKTGDec 6, 2016
CheplaPharmFor profitMKTGJun 23, 1989
CheplaPharmFor profitNDA2Jun 23, 1989
Custopharm IncFor profitMKTGJun 20, 2019
Daiichi SankyoFor profitMKTGSep 18, 2013
Endo PharmaceuticalsFor profitMKTGDec 6, 2016
Exela Pharma Sciences, LLC.For profitNDA2Feb 17, 2017
Exela Pharma Sciences, LLC.For profitMKTGFeb 17, 2017
FerringFor profitMKTGDec 8, 2017
FreseniusFor profitMKTGJun 21, 2010
Hainan Poly PharmFor profitMKTGNov 8, 2018
HikmaFor profitSYNJul 16, 2003
HikmaFor profitMKTGJul 16, 2003
LutipoldFor profitMKTGSep 18, 2013
MylanFor profitMKTGNov 17, 2017
ONESOURCE SPECIALTYFor profitMKTGNov 17, 2017
PH HEALTHFor profitMKTGDec 6, 2016
Par PharmaceuticalsFor profitMKTGDec 6, 2016
PharmasciencesFor profitMKTGDec 8, 2017
RanbaxyFor profitMKTG—
RocheFor profitNDAJun 23, 1989
SLATE RUN PHARMAFor profitMKTGNov 8, 2018
STERISCIENCEFor profitMKTGNov 17, 2017
STERISCIENCEFor profitSYNNov 17, 2017
SankyoFor profitMKTGSep 18, 2013
West-Ward PharmaceuticalFor profitMKTGJul 16, 2003