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didanosine

Trade name: videx

Small moleculeapproved

Approved

Oct 9, 1991

Didanosine was developed by Bristol-Myers Squibb in collaboration with the NIH for the treatment of HIV-1 infections. Upon administration the drug is metabolized to the active metabolite which inhibits HIV-1 reverse transcriptase both by competing with deoxyadenosine 5'-triphosphate and by its incorporation into viral DNA. Didanosine was approved by FDA under the name Videx (among the other names). — NCATS

Clinical trial activity

134 trials · 69 clinical orgs · 6 marketing orgs

Phase 1
29
Phase 2
74
Phase 3
24
Phase 4
9

Earliest trial started Oct 1, 1990 (NCT00001267)

Timeline

1990s

  1. Jan 1, 1990

    Earliest Phase 3 Sponsor(trial)

  2. Oct 9, 1991

    Bristol-Myers Squibb — Earliest FDA Approval

  3. Oct 9, 1991

    Bristol-Myers — Marketing Organization

  4. Oct 9, 1991

    Bristol-Myers Squibb — NDA Organization

  5. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

  6. Jan 1, 1999

    Bristol-Myers Squibb — Earliest Phase 1 Sponsor(trial)

2000s

  1. Dec 3, 2004

    Barr Laboratories — Marketing Organization

  2. Mar 8, 2007

    Aurobindo Pharma — Marketing Organization

2010s

  1. Apr 8, 2010

    Mylan — Marketing Organization

  2. Apr 8, 2010

    PHARMOBEDIENT — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewOct 9, 1991

Chemistry & pharmacology

Loading structure…

SMILES

OC[C@@H]1CC[C@@H](O1)N2C=NC3=C2N=CNC3=O
Mol. weight
236.2273 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Black box warningProdrug

Sources

Also known as

  • 2,3-dideoxyinosine
  • 2,3-dideoxyinosine
  • 2',3'-dideoxyinosine
  • 2',3'-dideoxyinosine
  • 9-[(2r,5s)-5-(hydroxymethyl)tetrahydrofuran-2-yl]-1,9-dihydro-6h-purin-6-one
  • 9-[(2r,5s)-5-(hydroxymethyl)tetrahydrofuran-2-yl]-1,9-dihydro-6h-purin-6-one
  • 9-((2r,5s)-5-hydroxymethyl-tetrahydro-furan-2-yl)-1,9-dihydro-purin-6-one
  • 9-((2r,5s)-5-hydroxymethyl-tetrahydro-furan-2-yl)-1,9-dihydro-purin-6-one
  • 9-((2r,5s)-5-(hydroxymethyl)-tetrahydrofuran-2-yl)-1h-purin-6(9h)-one
  • 9-((2r,5s)-5-(hydroxymethyl)-tetrahydrofuran-2-yl)-1h-purin-6(9h)-one
  • 9-((2s,5r)-5-hydroxymethyl-tetrahydro-furan-2-yl)-9h-purin-6-ol
  • 9-((2s,5r)-5-hydroxymethyl-tetrahydro-furan-2-yl)-9h-purin-6-ol
  • bmy-40900
  • bmy-40900
  • ddi
  • ddi
  • ddi
  • ddino
  • ddino
  • didanosina
  • didanosina
  • didanosine
  • didanosine
  • didanosine
  • didanosine
  • didanosine
  • didanosine
  • didanosine
  • didanosine
  • didanosine
  • didanosine
  • didanosine
  • didanosinum
  • didanosinum
  • dideoxyinosine
  • dideoxyinosine
  • dideoxyinosine
  • dideoxyinosine (ddi)
  • dideoxyinosine (ddi)
  • videx
  • videx
  • videx
  • videx
  • videx ec
  • videx ec

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT01363011Phase 3May 1, 2011Gilead Sciences
NCT00928187Phase 3Nov 1, 2009CHU Fann Dakar, CHU Sanou Souro, Bobo-Dioulasso, French National Agency for Research on AIDS and Viral Hepatitis, Gilead Sciences, Janssen Pharmaceutica NV, University of Yaounde
NCT00668356Phase 2Sep 1, 2009University of Paris
NCT00091936N/AAug 1, 2009National Institute of Allergy and Infectious Diseases (NIAID), University of Kwa-Zulu Natal
NCT00427297Phase 3Sep 1, 2007National Institutes of Health (NIH), University of Nairobi, University of Washington
NCT00364793Phase 1/Phase 2 (Phase 2)Feb 1, 2007Bristol-Myers Squibb
NCT00332306Phase 3Jun 1, 2006Indian Council of Medical Research, National Institute for Research in Tuberculosis, Chennai, India
NCT00109590Phase 2Jun 1, 2006Harvard University, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Tulane University
NCT00122538Phase 2Feb 1, 2006CHU Sanou Souro, Bobo-Dioulasso, French National Agency for Research on AIDS and Viral Hepatitis
NCT00102960Phase 3Jul 1, 2005National Institute of Allergy and Infectious Diseases (NIAID), Stellenbosch University, University of the Witwatersrand
NCT00084136Phase 4May 1, 2005AIDS Clinical Trials Group, Brown University, National Institute of Allergy and Infectious Diseases (NIAID), University of Colorado, Denver, University of Zimbabwe
NCT00338390Phase 3Apr 1, 2005Hospital de Granollers
NCT00080522N/AFeb 1, 2005National Institute of Allergy and Infectious Diseases (NIAID)
NCT00074581Phase 3Feb 1, 2005HIV Prevention Trials Network, National Institute of Allergy and Infectious Diseases (NIAID), University of North Carolina at Chapel Hill
NCT00618176Phase 4Jan 1, 2005Government of China, Tsinghua University
NCT00142337Phase 2Dec 1, 2004Government of France
NCT00256828Phase 4Jun 1, 2004Clinical Trial Agency of HIV Study Group
NCT00002207N/AFeb 1, 2004Bristol-Myers Squibb
NCT00342355Phase 4Jan 1, 2004National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
NCT00158470Phase 3Sep 1, 2003French National Agency for Research on AIDS and Viral Hepatitis, Tropical Diseases Hospital, Ho Chi Minh City
Showing 20 of 134 trials
Page 1 / 7

Organizations

Research & Development (69)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Allergy and Infectious Diseases (NIAID)Government737151999
Bristol-Myers SquibbFor profit481841997
Glaxo WellcomeFor profit18351999
National Institutes of Health (NIH)Government6141999
Triangle PharmaceuticalsFor profit6221999
French National Agency for Research on AIDS and Viral HepatitisGovernment5521999
Gilead SciencesFor profit5221999
National Cancer Institute (NCI)Government4231990
RocheFor profit4231999
DuPontFor profit3021999
Pharmacia & UpjohnFor profit3231999
UpjohnFor profit3021999
AjinomotoFor profit2221999
CHU Sanou Souro, Bobo-DioulassoAcademic/Hospital2022006
Harvard UniversityAcademic/Hospital2122002
MerckFor profit2211999
Northwestern UniversityAcademic/Hospital2121999
Schering-PloughFor profit2021999
University of North Carolina at Chapel HillAcademic/Hospital2021999
AbbottFor profit1111999
69 organizations
Page 1 / 4

Marketing (8)

OrganizationOrg typeRelationshipDate
Aurobindo PharmaFor profitSYNAug 14, 2012
Aurobindo PharmaFor profitMKTGMar 8, 2007
Barr LaboratoriesFor profitMKTGDec 3, 2004
Bristol-MyersFor profitMKTGOct 9, 1991
Bristol-Myers SquibbFor profitSYNOct 9, 1991
Bristol-Myers SquibbFor profitNDAOct 9, 1991
MylanFor profitMKTGApr 8, 2010
PHARMOBEDIENTFor profitMKTGApr 8, 2010