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cidofovir

Trade name: vistide

Small moleculeapproved

Approved

Jun 26, 1996

Cidofovir is an antiviral nucleotide analogue with significant activity against cytomegalovirus (CMV) and other herpesviruses. Cidofovir suppresses cytomegalovirus (CMV) replication by selective inhibition of viral DNA synthesis. Biochemical data support selective inhibition of CMV DNA polymerase by cidofovir diphosphate, the active intracellular metabolite of cidofovir. Incorporation of cidofovir into the growing viral DNA chain results in reductions in the rate of viral DNA synthesis. Cidofovir is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome. — NCATS

Clinical trial activity

32 trials · 38 clinical orgs · 4 marketing orgs

Phase 1
9
Phase 2
13
Phase 3
4
Phase 4
3

Earliest trial started Apr 1, 1994 (NCT00000142)

Timeline

1990s

  1. Jan 1, 1994

    Earliest Phase 2 Sponsor(trial)

  2. Jun 26, 1996

    Gilead Sciences — Earliest FDA Approval

  3. Jun 26, 1996

    Gilead Sciences — NDA Organization

  4. Jan 1, 1997

    Earliest Phase 3 Sponsor(trial)

  5. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jun 27, 2012

    Mylan — Marketing Organization

  2. Jul 26, 2012

    Emcure — Marketing Organization

  3. Jul 26, 2012

    Avet Lifesciences — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 26, 1996

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC(=O)N(C[C@@H](CO)OCP(O)(O)=O)C=C1
Mol. weight
279.187 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warningProdrug

Sources

Also known as

  • 1-((3-hydroxy-2-phosphonylmethoxy)propyl)cytosine
  • 1-(3-hydroxy-2-phosphonylmethoxypropyl)cytosine
  • 1-(s)-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine
  • 1-(s)-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine
  • 1-[(s)-3-hydroxy-2-(phosphonomethoxy)propyl]cytosine
  • 1-[(s)-3-hydroxy-2-(phosphonomethoxy)propyl]cytosine
  • anhydrous cidofovir
  • cdv
  • cdv
  • cidofovir
  • cidofovir
  • cidofovir
  • cidofovir
  • cidofovir
  • cidofovir
  • cidofovir
  • cidofovir
  • cidofovir
  • cidofovir
  • cidofovir
  • cidofovir
  • cidofovir
  • cidofovir anhydrous
  • cidofovir anhydrous
  • cidofovir anhydrous
  • cidofovir dihydrate
  • cidofovir hydrate
  • cidofovir, (+-)-isomer
  • cidofovir monophosphate
  • cidofovir, (r)-isomer
  • cidofovir sodium
  • cidofovir, sodium salt
  • cidofovirum
  • cidofovirum
  • cidovir
  • gs-0504
  • gs-0504
  • gs 504
  • gs-504
  • hpmpc
  • (s)-1-(3-hydroxy-2-phosphonomethoxypropyl)cytosine
  • (s)-1-(3-hydroxy-2-phosphonomethoxypropyl)cytosine
  • (s)-1-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine
  • (s)-1-[3-hydroxy-2-(phosphonomethoxy)propyl]cytosine
  • (s)-1-[3-hydroxy-2-(phosphonylmethoxy)propyl]cytosine
  • (s)-1-[3-hydroxy-2-(phosphonylmethoxy)propyl]cytosine
  • ({[(s)-1-(4-amino-2-oxo-1,2-dihydropyrimidin-1-yl)-3-hydroxypropan-2-yl]oxy}methyl)phosphonic acid
  • ({[(s)-1-(4-amino-2-oxo-1,2-dihydropyrimidin-1-yl)-3-hydroxypropan-2-yl]oxy}methyl)phosphonic acid
  • [[(s)-2-(4-amino-2-oxo-1(2h)-pyrimidinyl)-1-(hydroxymethyl)ethoxy]methyl]phosphonic acid
  • [[(s)-2-(4-amino-2-oxo-1(2h)-pyrimidinyl)-1-(hydroxymethyl)ethoxy]methyl]phosphonic acid
  • [(s)-2-(4-amino-2-oxo-2h-pyrimidin-1-yl)-1-hydroxymethyl-ethoxymethyl]-phosphonic acid
  • [(s)-2-(4-amino-2-oxo-2h-pyrimidin-1-yl)-1-hydroxymethyl-ethoxymethyl]-phosphonic acid
  • (s)-(3-(4-amino-2-oxopyrimidin-1(2h)-yl)-1-hydroxypropan-2-yloxy)methylphosphonic acid
  • (s)-(3-(4-amino-2-oxopyrimidin-1(2h)-yl)-1-hydroxypropan-2-yloxy)methylphosphonic acid
  • (s)-hpmpc
  • (s)-hpmpc
  • sidofovir
  • vistide
  • vistide
  • vistide
  • vistide
  • vistide

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04055142Phase 3Sep 30, 2019Universidad Autonoma de Barcelona
NCT02931539Phase 3Dec 1, 2016Shire
NCT02567149Phase 2Jul 1, 2016University of Minnesota
NCT02555800Phase 2Dec 1, 2014Government of Mexico
NCT01946009N/ASep 1, 2013Fundacion SEIMC-GESIDA, Universidad Autonoma de Madrid
NCT01816646Phase 1Sep 1, 2013Gilead Sciences, University of Texas at Houston
NCT02976987Phase 2Feb 1, 2013CHU Brugmann, Free University of Brussels
NCT00956176N/ASep 1, 2012Gilead Sciences, University of Texas at Houston
NCT01295645Phase 2Mar 1, 2011University of Texas at Houston
NCT00989443Phase 1May 1, 2010Erasmus University Rotterdam, Mithra Pharmaceuticals
NCT00948506Phase 2Jul 1, 2009University of Pennsylvania
NCT00811408Phase 1Apr 1, 2008Institut Gustave Roussy
NCT02515877Phase 1Jan 1, 2008Institut Gustave Roussy, National Cancer Institute, France
NCT00550589Phase 2Sep 1, 2007AIDS Malignancy Consortium, Boston University, National Cancer Institute (NCI), The EMMES Corporation, University of California, San Francisco
NCT00138424Phase 1/Phase 2 (Phase 2)May 1, 2006National Institute of Allergy and Infectious Diseases (NIAID)
NCT01866397Phase 4Mar 31, 2002Medical University of Vienna, University of Vienna
NCT00001126Phase 1Jan 17, 2000National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002437Phase 2Nov 2, 1999Gilead Sciences
NCT00002384N/ANov 2, 1999Anderson Clinical Research, Gilead Sciences
NCT00002327Phase 1Nov 2, 1999Gilead Sciences
Showing 20 of 32 trials
Page 1 / 2

Organizations

Research & Development (38)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Gilead SciencesFor profit9631999
National Institute of Allergy and Infectious Diseases (NIAID)Government6641999
University of Texas at HoustonAcademic/Hospital3332011
Institut Gustave RoussyAcademic/Hospital2212008
Johns Hopkins UniversityAcademic/Hospital2211994
National Cancer Institute (NCI)Government2111996
Northwestern UniversityAcademic/Hospital2021994
University of California, San FranciscoAcademic/Hospital2021994
AIDS Malignancy ConsortiumAcademic/Hospital1112007
Anderson Clinical ResearchFor profit1011999
Baylor UniversityAcademic/Hospital1011994
Boston UniversityAcademic/Hospital1012007
CHU BrugmannAcademic/Hospital1012013
Erasmus University RotterdamAcademic/Hospital1012010
Free University of BrusselsAcademic/Hospital1112013
Fundacion SEIMC-GESIDAAcademic/Hospital1112013
Government of MexicoGovernment1112014
Icahn School of Medicine at Mount SinaiAcademic/Hospital1011994
Louisiana State UniversityAcademic/Hospital1011994
Medical University of ViennaAcademic/Hospital1112002
38 organizations
Page 1 / 2

Marketing (4)

OrganizationOrg typeRelationshipDate
Avet LifesciencesFor profitMKTGJul 26, 2012
EmcureFor profitMKTGJul 26, 2012
Gilead SciencesFor profitNDAJun 26, 1996
MylanFor profitMKTGJun 27, 2012