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ribavirin

Trade name: virazole

Small moleculeapprovedCOVID-19

Approved

Dec 31, 1985

Ribavirin elaidate (CP-4033; TRX-201), a Lipid Vector Technology derivative of ribavirin. It inhibits elongation factor F4E (elF4E), which stimulates cell growth. Translational Therapeutics Inc. received orphan drug status from the U.S. Food and Drug Administration (FDA) in 2011 for ribavirin elaidate in the treatment of aggressive follicular, medullary and anaplastic thyroid carcinoma. — NCATS

Clinical trial activity

784 trials · 438 clinical orgs · 17 marketing orgs

Phase 1
62
Phase 2
520
Phase 3
267
Phase 4
158

Earliest trial started Oct 1, 1997 (NCT00001729)

Timeline

1980s

  1. Dec 31, 1985

    Viratek, Inc — Earliest FDA Approval

  2. Dec 31, 1985

    Bausch Health Companies — NDA Secondary Org

  3. Dec 31, 1985

    Viratek, Inc — NDA Organization

  4. Dec 31, 1985

    Bausch Health Companies — Marketing Organization

1990s

  1. Jan 1, 1997

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 1998

    Earliest Phase 2 Sponsor(trial)

  3. Jun 3, 1998

    Merck — NDA Secondary Org

  4. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Dec 3, 2002

    Roche — NDA Secondary Org

  2. Jul 29, 2003

    Schering — NDA Secondary Org

  3. Jul 29, 2003

    Schering-Plough — NDA Secondary Org

  4. Apr 6, 2004

    Chartwell Pharmaceuticals — Marketing Organization

  5. Apr 6, 2004

    CASI Pharmaceuticals, Inc. — Marketing Organization

  6. Apr 6, 2004

    Kadmon — Marketing Organization

  7. Oct 4, 2004

    Teva — Marketing Organization

  8. Oct 28, 2005

    Zydus Discovery DMCC — Marketing Organization

  9. Dec 5, 2005

    Heritage Pharma — Marketing Organization

  10. Oct 3, 2006

    Sandoz — Marketing Organization

  11. Oct 3, 2006

    Novartis — Marketing Organization

  12. Sep 17, 2009

    Aurobindo Pharma — Marketing Organization

2010s

  1. Aug 12, 2014

    Beximco — Marketing Organization

  2. Oct 6, 2016

    Navinta — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 31, 1985

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCCCC\C=C\CCCCCCCC(=O)OC[C@H]1O[C@H]([C@H](O)[C@@H]1O)N2C=NC(=N2)C(N)=O
Mol. weight
508.6508 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

Yes

Black box warningProdrug

Sources

Also known as

  • 1-beta-d-ribofuranosyl-1,2,4-triazole-3-carboxamide
  • 1-beta-d-ribofuranosyl-1,2,4-triazole-3-carboxamide
  • 1-beta-d-ribofuranosyl-1,2,4-triazole-3-carboxamidine
  • 1-beta-d-ribofuranosyl-1h-1,2,4-triazole-3-carboxamide
  • 1-beta-d-ribofuranosyl-1h-1,2,4-triazole-3-carboxamide
  • 6-(2-(1h-imidazol-4-yl)ethylamino)-5-oxohexanoic acid
  • copegus
  • copegus
  • copegus
  • dicarbamin
  • imidazolyl ethanamide pentandioic acid
  • imidazolyl ethanamide pentandioic acid
  • imidazolyl ethanamide pentandioic acid
  • ingavirin
  • ingavirin
  • ingavirin
  • ingavirin
  • pentanedioic acid imidazolyl ethanamide
  • rbv
  • rbv
  • rbv
  • rebetol
  • rebetol
  • rebetol
  • ribamide
  • ribamidil
  • ribamidine
  • ribamidine
  • ribapak
  • ribasphere
  • ribasphere
  • ribavarin
  • ribavarin
  • ribavarin
  • ribavarin
  • ribavirin
  • ribavirin
  • ribavirin
  • ribavirin
  • ribavirin
  • ribavirin
  • ribavirin
  • ribavirin
  • ribavirin
  • ribavirin
  • ribavirin
  • ribavirin
  • ribavirin
  • ribavirina
  • ribavirina
  • ribavirin amidine
  • ribavirine
  • ribavirine
  • ribavirinum
  • ribavirinum
  • ribofluranosyl carboxamide
  • ribofluranosyl carboxamide
  • tcnr
  • tribavirin
  • tribavirin
  • tribavirin
  • tribavirin
  • viramid
  • viramid
  • virazid
  • virazid
  • virazole
  • virazole
  • virazole
  • vitaglutam

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06860334Phase 2Jul 1, 2025University of Liverpool
NCT06744777Phase 3Dec 17, 2024Khyber Medical University Peshawar
NCT06212336Phase 2/Phase 3 (Phase 3)Jul 1, 2024Alex Ekwueme Federal University Teaching Hospital, Alliance for International Medical Action, Bernhard Nocht Institute for Tropical Medicine, Centre de Recherche Médicale de Lambaréné, Federal Medical Centre, Owo, Government of Cote d'Ivoire, Government of France, Irrua Specialist Teaching Hospital, Medecins Sans Frontieres, University of Bordeaux, University of Hamburg, University of North Carolina at Chapel Hill
NCT06488300Phase 2Jul 1, 2024University of Oxford
NCT06222723Phase 2Jan 31, 2024Bernhard Nocht Institute for Tropical Medicine
NCT06315400Phase 4Dec 19, 2023Valenta Pharm JSC
NCT05940545Phase 1/Phase 2 (Phase 2)Jul 12, 2023University of Liverpool
NCT05446233Phase 1Nov 15, 2022Sunshine Lake Pharma Co., Ltd.
NCT05504876Phase 1Nov 7, 2022Jinlin University, Sunshine Lake Pharma Co., Ltd.
NCT05467826Phase 4Sep 1, 2022Peking University
NCT05616598Phase 2/Phase 3 (Phase 3)Mar 1, 2022Benha University
NCT05216497Phase 3Oct 6, 2021Valenta Pharm JSC
NCT05269290Phase 3Sep 23, 2021Valenta Pharm JSC
NCT04907682Phase 2Jul 30, 2021Alliance for International Medical Action, Bernhard Nocht Institute for Tropical Medicine, Federal Medical Centre, Owo, Institut National de la Santé Et de la Recherche Médicale, France, Irrua Specialist Teaching Hospital, University of Bordeaux, University of Hamburg
NCT05395416Phase 2/Phase 3 (Phase 3)Jun 21, 2021Sunshine Lake Pharma Co., Ltd., Tsinghua University
NCT04828564Phase 2/Phase 3 (Phase 3)Apr 30, 2021Ankara Yildirim Beyazıt University, Koç University, MonitorCRO, The Scientific and Technological Research Council of Turkey, Umraniye Education and Research Hospital, University of Ankara
NCT04959786Phase 2/Phase 3 (Phase 3)Apr 1, 2021Mansoura University
NCT05229510Phase 1Mar 12, 2021Bausch Health Companies
NCT04551768Phase 1Feb 28, 2021Bausch Health Companies
NCT04605588Phase 2Dec 2, 2020Rutgers University, SynaVir
Showing 20 of 784 trials
Page 1 / 40

Organizations

Research & Development (438)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RocheFor profit885452000
MerckFor profit796752002
Gilead SciencesFor profit737242008
AbbVieFor profit524532009
Bristol-Myers SquibbFor profit484241999
National Institute of Allergy and Infectious Diseases (NIAID)Government302451997
VertexFor profit301942004
Johnson and JohnsonFor profit262252009
Janssen Pharmaceutica NVFor profit19042009
Boehringer IngelheimFor profit181732006
French National Agency for Research on AIDS and Viral HepatitisGovernment171722000
Kaohsiung Medical UniversityAcademic/Hospital141132005
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government141341997
Bausch Health CompaniesFor profit12951999
Harvard UniversityAcademic/Hospital12442000
National Taiwan UniversityAcademic/Hospital12921998
Schering-PloughFor profit12141998
TibotecFor profit11722007
Cairo UniversityAcademic/Hospital10442009
Cornell UniversityAcademic/Hospital10652004
438 organizations
Page 1 / 22

Marketing (20)

OrganizationOrg typeRelationshipDate
Aurobindo PharmaFor profitMKTGSep 17, 2009
Bausch Health CompaniesFor profitNDA2Dec 31, 1985
Bausch Health CompaniesFor profitMKTGDec 31, 1985
BeximcoFor profitMKTGAug 12, 2014
CASI Pharmaceuticals, Inc.For profitMKTGApr 6, 2004
Chartwell PharmaceuticalsFor profitMKTGApr 6, 2004
Heritage PharmaFor profitSYNDec 5, 2005
Heritage PharmaFor profitMKTGDec 5, 2005
KadmonFor profitMKTGApr 6, 2004
MerckFor profitNDA2Jun 3, 1998
NavintaFor profitMKTGOct 6, 2016
NovartisFor profitMKTGOct 3, 2006
RocheFor profitNDA2Dec 3, 2002
SandozFor profitMKTGOct 3, 2006
ScheringFor profitNDA2Jul 29, 2003
Schering-PloughFor profitNDA2Jul 29, 2003
TevaFor profitMKTGOct 4, 2004
TevaFor profitSYNMar 28, 2011
Viratek, IncFor profitNDADec 31, 1985
Zydus Discovery DMCCFor profitMKTGOct 28, 2005