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fluconazole

Trade name: diflucan

Small moleculeapproved

Approved

Jan 29, 1990

Fluconazole, a synthetic antifungal agent of the imidazole class, is used to treat vaginal candidiasis. It inhibits the fungal lanosterol 14 alpha-demethylase which thereby prevents the formation of ergosterol which is an essential component in the fungal cell membrane. Indicated for the treatment of fungal infections. — NCATS

Clinical trial activity

219 trials · 200 clinical orgs · 34 marketing orgs

Phase 1
77
Phase 2
79
Phase 3
54
Phase 4
21

Earliest trial started Sep 1, 1991 (NCT00004808)

Timeline

1990s

  1. Jan 29, 1990

    Pfizer — Earliest FDA Approval

  2. Jan 29, 1990

    Pfizer — NDA Organization

  3. Jan 1, 1991

    Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

  5. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. May 1, 2003

    Ranbaxy — Marketing Organization

  2. May 9, 2003

    Pliva — Marketing Organization

  3. Sep 25, 2003

    Gedeon Richter Ltd. — Marketing Organization

  4. Oct 30, 2003

    Hospira — Marketing Organization

  5. Jul 29, 2004

    Ani Pharmaceuticals — Marketing Organization

  6. Jul 29, 2004

    Apotex — Marketing Organization

  7. Jul 29, 2004

    Dr. Reddy's Laboratories — Marketing Organization

  8. Jul 29, 2004

    Fresenius — Marketing Organization

  9. Jul 29, 2004

    Mylan — Marketing Organization

  10. Jul 29, 2004

    West-Ward Pharmaceutical — Marketing Organization

  11. Jul 29, 2004

    Roxane Laboratories — Marketing Organization

  12. Jul 29, 2004

    Sun Pharmaceuticals — Marketing Organization

  13. Jul 29, 2004

    Taro Pharmaceuticals — Marketing Organization

  14. Jul 29, 2004

    Teva — Marketing Organization

  15. Jul 29, 2004

    Chartwell Pharmaceuticals — Marketing Organization

  16. Jul 29, 2004

    Boehringer Ingelheim — Marketing Organization

  17. Jul 29, 2004

    Baxter — Marketing Organization

  18. Jul 29, 2004

    PHARMOBEDIENT — Marketing Organization

  19. Aug 23, 2005

    Hikma — Marketing Organization

  20. Sep 28, 2005

    Unique Pharmaceuticals Ltd, India — Marketing Organization

  21. Sep 28, 2005

    THINQ Pharma CRO Ltd. — Marketing Organization

  22. Jan 25, 2006

    Glenmark Pharmaceuticals — Marketing Organization

  23. Oct 7, 2008

    Aurobindo Pharma — Marketing Organization

  24. Jul 30, 2009

    Inforlife — Marketing Organization

2010s

  1. May 26, 2010

    Baxalta — Marketing Organization

  2. May 26, 2010

    Renaissance Pharma — Marketing Organization

  3. May 26, 2010

    Woodward — Marketing Organization

  4. Mar 7, 2011

    Harris Laboratories, Incorporated — Marketing Organization

  5. Feb 16, 2017

    Zydus Discovery DMCC — Marketing Organization

2020s

  1. Sep 21, 2023

    Hainan Poly Pharm — Marketing Organization

  2. Sep 21, 2023

    ZHEJIANG POLY PHARM — Marketing Organization

  3. Oct 20, 2023

    Lupin — Marketing Organization

  4. Jan 8, 2026

    FDC — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJan 29, 1990

Chemistry & pharmacology

Loading structure…

SMILES

OC(CN1C=NC=N1)(CN2C=NC=N2)C3=CC=C(F)C=C3F
Mol. weight
306.2708 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • 2-(2,4-difluorophenyl)-1,3-di(1h-1,2,4-triazol-1-yl)propan-2-ol
  • 2-(2,4-difluorophenyl)-1,3-di(1h-1,2,4-triazol-1-yl)propan-2-ol
  • 2,4-difluoro-alpha,alpha-bis(1h-1,2,4-triazol-1-ylmethyl)benzyl alcohol
  • 2,4-difluoro-alpha,alpha-bis(1h-1,2,4-triazol-1-ylmethyl)benzyl alcohol
  • biozole
  • biozole
  • canesten oral
  • diflucan
  • diflucan
  • diflucan
  • diflucan
  • diflucan in sodium chloride
  • diflucan one
  • difluconazole
  • elazor
  • elazor
  • fluconazol
  • fluconazol
  • fluconazole
  • fluconazole
  • fluconazole
  • fluconazole
  • fluconazole
  • fluconazole
  • fluconazole
  • fluconazole
  • fluconazole
  • fluconazole
  • fluconazole
  • fluconazole in sodium chloride
  • fluconazolum
  • fluconazolum
  • flunazol
  • triflucan
  • triflucan
  • triflucan
  • uk-49858
  • uk-49858

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07295314Early Phase 1 (Phase 1)Jan 31, 2026University of Amsterdam, ZonMw: The Netherlands Organisation for Health Research and Development
NCT07044765Phase 1Aug 31, 2025Aju Pharm
NCT07034781Phase 1Aug 31, 2025Aju Pharm
NCT07033962N/AJun 30, 2025Assiut University
NCT06933459Phase 1May 24, 2025Aju Pharm
NCT06954766Phase 2May 12, 2025Chong Kun Dang Pharmaceutical
NCT06988670Phase 2May 5, 2025Extend Biosciences
NCT06916130Phase 1Apr 21, 2025Addpharma Inc.
NCT06931327Phase 1Mar 29, 2025Aju Pharm
NCT06922344Phase 4Mar 1, 2025Khyber Medical University Peshawer
NCT06847464Phase 1Jan 27, 2025Enanta Pharmaceuticals
NCT06771063Phase 2Jan 13, 2025Cisen Pharmaceutical
NCT06274554Phase 3Oct 4, 2024Cornell University, The Leona M. and Harry B. Helmsley Charitable Trust
NCT07311759Phase 3Aug 17, 2024Cairo University
NCT06770530Phase 4Jun 24, 2024University of Copenhagen
NCT06345794Phase 1Apr 3, 2024Eli Lilly
NCT06173596Phase 1Dec 21, 2023Alexion
NCT06822166Phase 1Dec 4, 2023Fosun, Shandong Province Qianfoshan Hospital
NCT06616168Phase 1Sep 1, 2023Lviv National Medical University
NCT05881187N/AJun 15, 2023Sohag University
Showing 20 of 219 trials
Page 1 / 11

Organizations

Research & Development (200)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit383441998
National Institute of Allergy and Infectious Diseases (NIAID)Government191551991
Chong Kun Dang PharmaceuticalFor profit7722019
Hengrui Therapeutics, Inc.For profit6622019
National Cancer Institute (NCI)Government5311998
Scynexis, Inc.For profit5522014
University of MinnesotaAcademic/Hospital5332001
Aju PharmFor profit4412025
AstellasFor profit4322003
Boehringer IngelheimFor profit4422001
Chonbuk National UniversityAcademic/Hospital4012019
Cidara TherapeuticsFor profit4422016
Duke UniversityAcademic/Hospital4332001
University of WashingtonAcademic/Hospital4331998
Bristol-Myers SquibbFor profit3212009
Eli LillyFor profit3312013
Enanta PharmaceuticalsFor profit3312018
National Heart, Lung, and Blood Institute (NHLBI)Government3132001
National Institutes of Health (NIH)Government3122008
Radboud UniversityAcademic/Hospital3222006
200 organizations
Page 1 / 10

Marketing (50)

OrganizationOrg typeRelationshipDate
Ani PharmaceuticalsFor profitMKTGJul 29, 2004
Ani PharmaceuticalsFor profitSYNJul 29, 2004
ApotexFor profitMKTGJul 29, 2004
Aurobindo PharmaFor profitMKTGOct 7, 2008
Aurobindo PharmaFor profitSYNSep 18, 2009
BaxaltaFor profitMKTGMay 26, 2010
BaxaltaFor profitSYNJul 29, 2004
BaxterFor profitMKTGJul 29, 2004
Boehringer IngelheimFor profitMKTGJul 29, 2004
Chartwell PharmaceuticalsFor profitMKTGJul 29, 2004
Dr. Reddy's LaboratoriesFor profitMKTGJul 29, 2004
Dr. Reddy's LaboratoriesFor profitSYNJul 29, 2004
FDCFor profitMKTGJan 8, 2026
FreseniusFor profitMKTGJul 29, 2004
Gedeon Richter Ltd.For profitMKTGSep 25, 2003
Glenmark PharmaceuticalsFor profitMKTGJan 25, 2006
Glenmark PharmaceuticalsFor profitSYNJan 25, 2006
Hainan Poly PharmFor profitMKTGSep 21, 2023
Hainan Poly PharmFor profitSYNSep 21, 2023
Harris Laboratories, IncorporatedFor profitMKTGMar 7, 2011
HikmaFor profitMKTGAug 23, 2005
HikmaFor profitSYNJul 29, 2004
HikmaFor profitSYNJul 29, 2004
HospiraFor profitMKTGOct 30, 2003
InforlifeFor profitMKTGJul 30, 2009
LupinFor profitMKTGOct 20, 2023
LupinFor profitSYNOct 20, 2023
MylanFor profitMKTGJul 29, 2004
MylanFor profitSYNMar 25, 2005
MylanFor profitSYNApr 10, 2003
PHARMOBEDIENTFor profitMKTGJul 29, 2004
PfizerFor profitNDAJan 29, 1990
PlivaFor profitMKTGMay 9, 2003
RanbaxyFor profitMKTGMay 1, 2003
Renaissance PharmaFor profitMKTGMay 26, 2010
Roxane LaboratoriesFor profitMKTGJul 29, 2004
Sun PharmaceuticalsFor profitMKTGJul 29, 2004
THINQ Pharma CRO Ltd.For profitMKTGSep 28, 2005
Taro PharmaceuticalsFor profitMKTGJul 29, 2004
Taro PharmaceuticalsFor profitSYNDec 18, 2006
TevaFor profitSYNJul 29, 2004
TevaFor profitSYNJul 29, 2004
TevaFor profitMKTGJul 29, 2004
TevaFor profitSYNJan 13, 2005
Unique Pharmaceuticals Ltd, IndiaFor profitMKTGSep 28, 2005
Unique Pharmaceuticals Ltd, IndiaFor profitSYNSep 28, 2005
West-Ward PharmaceuticalFor profitMKTGJul 29, 2004
WoodwardFor profitMKTGMay 26, 2010
ZHEJIANG POLY PHARMFor profitMKTGSep 21, 2023
Zydus Discovery DMCCFor profitMKTGFeb 16, 2017