Drugs / Fluconazole
Fluconazole
also known as
Diflucan · UK-49,858 · FCZ · FLZ · [3H]-Fluconazole · Alkanazole · BAYT-006267 · Canesten oral · +9 more
Small molecule targets CYP2C19, CYP2C9, CYP3A4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
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| Label expansions (2) | US (FDA) | DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER | — | 1993-12-30 – 1994-11-23 | fda.gov ↗ |
| Approved | US (FDA) | DIFLUCAN | — | 1990-01-29 | fda.gov ↗ |
Trials 141 · started per year
today
US approved 1990
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT07295314 | Jan 2026 → Oct 2027 expected | fungal infectious disease | Academic Medical Center - University of Amsterdam | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT04502277 | Sep → Dec 2020 | candidiasis | Sutphin Drugs | Unknown | No outcome recorded |
| Phase 0 | NCT00503542 | Feb 2007 → Feb 2008 | vaginitis | Agency for Healthcare Research and Quality (AHRQ) | Completed | No outcome recorded |
| Phase 148 trials · 1 missed | ||||||
| Phase 1 | NCT07565441 | May → Nov 2026 expected | autosomal dominant polycystic kidney disease | Jemincare | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07439250 | Mar → Apr 2026 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT07395024 | Feb → Jul 2026 overdue | — | Astellas Pharma Global Development, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT07636018 | Aug → Oct 2025 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06593457 | Aug → Oct 2024 | — | Nurix Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06345794 | Apr → Jun 2024 | — | DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06173596 | Jan → Apr 2024 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06822166 | Dec 2023 → Jan 2024 | — | Ahon Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05661591 | Feb → Mar 2023 | cancer | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05657613 | Jan → Jun 2023 | — | CTI BioPharma | Completed | No outcome recorded |
| Phase 1 | NCT05478772 | Jul → Aug 2022 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05602597 | Jun → Aug 2022 | lymphoma | Hutchmed | Completed | No outcome recorded |
| Phase 1 | NCT05147727 | Mar → May 2022 | neoplasm | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04933682 | Jun → Aug 2021 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04850651 | Apr → May 2021 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04464577 | Apr → Jun 2021 | — | Bristol-Myers Squibb | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT04871724 | Mar 2021 | respiratory syncytial virus infectious disease | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT04702464 | Jan → May 2021 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04551963 | Nov 2020 → Feb 2022 | B-cell neoplasm | BeiGene | Completed | Mixed |
| Phase 1 | NCT05140096 | Jan → Apr 2020 | — | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT04038008 | Jul → Sep 2019 | — | Pharmtechnology LLC | Completed | No outcome recorded |
| Phase 1 | NCT04193319 | Jul → Sep 2019 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03942029 | Jun → Dec 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04201054 | Mar → Apr 2019 | — | Parc de Salut Mar | Completed | No outcome recorded |
| Phase 1 | NCT03634345 | Sep → Dec 2018 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03610945 | Jul → Aug 2018 | metabolic dysfunction-associated steatohepatitis | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT03451110 | Feb → Mar 2018 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03135106 | Apr → Sep 2017 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02730442 | Feb → Jun 2016 | invasive aspergillosis | F2G Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02325011 | Nov 2014 → Feb 2015 | — | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02222922 | Oct 2014 → Nov 2019 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02275975 | Jul → Aug 2014 | — | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02122770 | Apr 2014 → Jun 2017 | — | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02093728 | Apr → Jun 2014 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02093390 | Mar → Apr 2014 | endometriosis, prostate cancer | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01950507 | Feb 2014 → May 2018 | graft versus host disease | National Institutes of Health Clinical Center (CC) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01924299 | Aug → Nov 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01772290 | Feb → May 2013 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01386593 | May 2011 → Jan 2012 | — | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 1 | NCT01169402 | Jul 2010 → Feb 2013 | cardiac arrest, fungal infectious disease | Michael Cohen-Wolkowiez | Completed | No outcome recorded |
| Phase 1 | NCT01153724 | May → Jul 2010 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | Missed primary |
| Phase 1 | NCT00935363 | Feb → Mar 2010 | — | University of California, San Francisco | Withdrawn | No outcome recorded |
| Phase 1 | NCT00964106 | Aug 2009 → Aug 2011 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00911235 | May → Jul 2009 | overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00797420 | Nov 2008 → Jan 2010 | candidiasis | Daniel Benjamin | Completed | No outcome recorded |
| Phase 1 | NCT02195466 | Jun → Jul 2003 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00000788 | ? → Jun 1994 | HIV infectious disease, candidiasis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00000826 | ? → May 1999 | HIV infectious disease, bacterial infectious disease, fungal infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/24 trials · 2 missed | ||||||
| Phase 1/2 | NCT03036046 | Mar → Sep 2017 | acute myeloid leukemia | F2G Ltd | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT01354314 | Nov 2010 → Mar 2016 | AIDS dementia complex | Johns Hopkins University | Completed | Missed primary |
| Phase 1/2 | NCT00885703 | Apr 2010 → Jan 2017 | Cryptococcal meningitis, HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 1/2 | NCT01026714 | Nov 2009 → Aug 2010 | — | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 213 trials | ||||||
| Phase 2 | NCT04495608 | Jan 2021 → Jul 2024 | idiopathic hypercalciuria, nephrocalcinosis, nephrolithiasis | Hospices Civils de Lyon | Completed | No outcome recorded |
| Phase 2 | NCT04273178 | Jan 2020 → Jan 2022 | fungal infectious disease | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 2 | NCT03476317 | Jul 2018 → Dec 2020 | Crohn disease | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase 2 | NCT02765256 | Aug 2016 → Dec 2018 | Crohn disease | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT01683760 | Sep 2012 → Oct 2014 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02941068 | Mar 2012 → Jun 2016 | intestinal perforation | Nanjing PLA General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02366884 | Jul 2011 → Dec 2022 | neoplasm | Dr. Frank Arguello Cancer Clinic | Unknown | No outcome recorded |
| Phase 2 | NCT02997059 | Jul 2008 → Jun 2014 | Crohn disease | University Hospital, Lille | Completed | No outcome recorded |
| Phase 2 | NCT00145249 | May 2005 → Apr 2008 | Cryptococcal meningitis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00166166 | Jul 2002 → Jan 2013 | hyperlipidemia | Emory University | Terminated | No outcome recorded |
| Phase 2 | NCT00004938 | Aug 1996 | sporotrichosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00004808 | Sep 1991 → ? | blastomycosis, histoplasmosis, sporotrichosis | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 2 | NCT00002399 | — | HIV infectious disease, oral candidiasis | Schering-Plough | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT02145832 | Oct 2014 → Nov 2015 | candidiasis | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 2/3 | NCT01715922 | May 2012 → Sep 2015 | Cryptococcal meningitis, HIV infectious disease | ANRS, Emerging Infectious Diseases | Unknown | No outcome recorded |
| Phase 2/3 | NCT00002533 | Feb 1993 → Jun 2006 | head and neck cancer, infectious disease, mouth disorder | University of Miami | Completed | No outcome recorded |
| Phase 324 trials · 1 met primary · 3 missed | ||||||
| Phase 3 | NCT07743593 | Jan 2027 → Aug 2031 expected | Cryptococcal meningitis, HIV infectious disease | University of Minnesota | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06274554 | Oct 2024 → Dec 2028 expected | Crohn disease | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 3 | NCT05848492 | May → Oct 2021 | candidiasis, invasive | Services Institute of Medical Sciences, Pakistan | Completed | No outcome recorded |
| Phase 3 | NCT03171584 | Jul 2017 → Jun 2019 | — | Assiut University | Unknown | No outcome recorded |
| Phase 3 | NCT01953744 | Feb 2014 → Apr 2015 | cutaneous leishmaniasis | Hospital Universitário Professor Edgard Santos | Terminated | Missed primary |
| Phase 3 | NCT01825031 | Jun 2013 → Mar 2016 | HIV infectious disease | Medical Research Council | Completed | Missed primary |
| Phase 3 | NCT01806623 | Mar → Nov 2013 | vulvovaginal candidiasis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02111629 | May 2012 → Feb 2013 | vaginal discharge | National University of Colombia | Completed | No outcome recorded |
| Phase 3 | NCT00734539 | Nov 2008 → Dec 2011 | candidiasis | Daniel Benjamin | Completed | Missed primary |
| Phase 3 | NCT01524081 | Jul 2008 → Jul 2011 | appendicitis, intestinal obstruction, peptic ulcer perforation | The Faculty Hospital Na Bulovce | Completed | No outcome recorded |
| Phase 3 | NCT00353561 | Jun 2004 → Apr 2006 | diabetes mellitus, vulvovaginal candidiasis | Indian Council of Medical Research | Completed | No outcome recorded |
| Phase 3 | NCT00313131 | Jan 2004 → May 2005 | bacterial vaginosis, candidiasis | University of Sherbrooke | Completed | No outcome recorded |
| Phase 3 | NCT00170430 | May 2003 → Dec 2006 | bacterial infectious disease, fungal infectious disease, sexually transmitted disease | University of Washington | Completed | No outcome recorded |
| Phase 3 | NCT00056368 | Mar 2003 → Oct 2004 | candidiasis | Pfizer | Completed | Met primary |
| Phase 3 | NCT00645242 | Nov 2002 → Mar 2003 | dermatophytosis of scalp or beard | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00001937 | Nov 1999 → Dec 2000 | aspergillosis, candidiasis | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT00003883 | Oct 1998 → Jul 2002 | cancer | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT00163111 | Sep 1998 → May 2003 | candidemia | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00002446 | Aug 1998 → ? | HIV infectious disease, oral candidiasis | Schering-Plough | Completed | No outcome recorded |
| Phase 3 | NCT00000676 | ? → Nov 1993 | HIV infectious disease, candidiasis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT00002277 | — | HIV infectious disease, fungal infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00002122 | — | HIV infectious disease, Mycobacterium avium complex disease, fungal infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00001017 | ? → Jul 1991 | Cryptococcal meningitis, HIV infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00002339 | — | HIV infectious disease, esophageal candidiasis | Pfizer | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT06922344 | Mar → Dec 2025 overdue | pityriasis versicolor | Khyber Teaching Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06709196 | Jan 2025 → Jan 2027 expected | urinary bladder cancer | Rigshospitalet, Denmark | Recruiting | No outcome recorded |
| Phase 4 | NCT06770530 | Jun 2024 → Jun 2027 expected | urinary bladder disorder | Rigshospitalet, Denmark | Recruiting | No outcome recorded |
| Phase 4 | NCT05176379 | Feb 2022 → Dec 2024 overdue | — | University of Oklahoma | Recruiting | No outcome recorded |
| Phase 4 | NCT04122560 | Nov 2019 → Mar 2021 | candidiasis, obesity disorder | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02663674 | Dec 2015 → Jun 2018 | coccidioidomycosis | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 4 | NCT01535469 | Jul 2012 → Jun 2015 | Cryptococcal meningitis | University of Minnesota | Completed | No outcome recorded |
| Phase 4 | NCT00537888 | Sep 2007 → Dec 2010 | fungal lung infectious disease | Capital Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT02181946 | May → Jul 2001 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT00001542 | Jul 1996 → Nov 2001 | AIDS, oral candidiasis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT00001107 | ? → Nov 2005 | candidiasis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT00000951 | ? → May 2002 | HIV infectious disease, oral candidiasis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase not applicable34 trials | ||||||
| — | NCT07396857 | Nov 2025 → Dec 2026 expected | cardiovascular disorder | University of Sherbrooke | Recruiting | No outcome recorded |
| — | NCT07033962 | Jun 2025 → Jun 2026 overdue | tinea unguium | Assiut University | Not yet recruiting | No outcome recorded |
| — | NCT05471063 | Aug 2022 → Feb 2023 | Cryptococcal meningitis | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| — | NCT07557966 | Jan → Dec 2022 | fungal keratitis | Tanta University | Completed | No outcome recorded |
| — | NCT07816510 | Mar → Aug 2021 | dermatophytosis | Chittagong Medical College | Completed | No outcome recorded |
| — | NCT03828773 | Feb 2019 → Nov 2027 expected | acute myeloid leukemia, aspergillosis, candidiasis | Bochud Pierre-Yves | Recruiting | No outcome recorded |
| — | NCT02624453 | Jul 2015 → Mar 2018 | Cryptococcal meningitis | ANRS, Emerging Infectious Diseases | Unknown | No outcome recorded |
| — | NCT02183779 | Jun 2014 → Oct 2016 | Raynaud disease | University Hospital, Grenoble | Unknown | No outcome recorded |
| — | NCT01096706 | Jul 2011 → Jan 2012 | heart disorder, vascular disorder | University of Edinburgh | Completed | No outcome recorded |
| — | NCT00936182 | Jul 2009 → Jul 2010 | autism spectrum disorder | The Center for Autism and Related Disorders | Unknown | No outcome recorded |
| — | NCT01447511 | May 2009 → Jun 2013 | — | University of Minnesota | Completed | No outcome recorded |
| — | NCT00023530 | Sep 2001 → Aug 2006 | graft versus host disease, leukemia, myelodysplastic syndrome, plasma cell myeloma | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| — | NCT00226538 | Aug 1999 → ? | — | Hadassah Medical Organization | Completed | No outcome recorded |
| — | NCT00002113 | — | Cryptococcal meningitis, HIV infectious disease | Pfizer | Completed | No outcome recorded |
| — | NCT00002305 | — | Cryptococcal meningitis, HIV infectious disease | Pfizer | Completed | No outcome recorded |
| — | NCT00002068 | — | Cryptococcal meningitis, HIV infectious disease | Pfizer | Completed | No outcome recorded |
| — | NCT00002074 | — | Cryptococcal meningitis, HIV infectious disease | Pfizer | Completed | No outcome recorded |
| — | NCT00002325 | — | HIV infectious disease, coccidioidomycosis | Pfizer | Completed | No outcome recorded |
| — | NCT00002112 | — | HIV infectious disease, oral candidiasis | Pfizer | Completed | No outcome recorded |
| — | NCT00002132 | — | HIV infectious disease, esophageal candidiasis | Janssen Pharmaceuticals | Completed | No outcome recorded |
| — | NCT00002010 | — | HIV infectious disease, meningitis | Pfizer | Completed | No outcome recorded |
| — | NCT00002038 | — | HIV infectious disease, candidiasis | Pfizer | Completed | No outcome recorded |
| — | NCT00000744 | ? → Dec 1995 | HIV infectious disease, esophageal candidiasis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00002306 | — | Cryptococcal meningitis, HIV infectious disease | Pfizer | Completed | No outcome recorded |
| — | NCT00002304 | — | HIV infectious disease, esophageal candidiasis | Pfizer | Completed | No outcome recorded |
| — | NCT00002076 | — | Cryptococcal meningitis, HIV infectious disease | Pfizer | Completed | No outcome recorded |
| — | NCT00002075 | — | Cryptococcal meningitis, HIV infectious disease | Pfizer | Completed | No outcome recorded |
| — | NCT00002282 | — | HIV infectious disease, oral candidiasis | Pfizer | Completed | No outcome recorded |
| — | NCT00000708 | ? → Jul 1991 | Cryptococcal meningitis, HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00002294 | — | Cryptococcal meningitis, HIV infectious disease | Pfizer | Completed | No outcome recorded |
| — | NCT00000639 | ? → Sep 1997 | Cryptococcal meningitis, HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00000627 | ? → Nov 1994 | HIV infectious disease, histoplasmosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00002040 | — | Cryptococcal meningitis, HIV infectious disease | Pfizer | Completed | No outcome recorded |
| — | NCT00002077 | — | Cryptococcal meningitis, HIV infectious disease | Pfizer | Completed | No outcome recorded |
| Comparator or background therapy75 trials | ||||||
| Phase 0 | NCT04930107 Comparator | Dec 2021 → Apr 2029 expected | vulvovaginal candidiasis | University of Manitoba | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07341672 Comparator | Dec 2026 → Apr 2027 expected | — | Sunshine Lake Pharma Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06847464 Background | Jan → May 2025 | respiratory syncytial virus infectious disease | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT06616168 Background | Sep 2023 → Aug 2026 overdue | bacterial vaginosis | Danylo Halytsky Lviv National Medical University | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05862714 Comparator | Mar → Sep 2022 | pityriasis versicolor | Combined Military Hospital Abbottabad | Completed | No outcome recorded |
| Phase 1 | NCT05076409 Background | Oct 2021 → Jan 2022 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03028103 Background | Mar 2017 → Oct 2019 | diffuse large B-cell lymphoma, mantle cell lymphoma, marginal zone lymphoma, mediastinal malignant lymphoma | Epizyme, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02809768 Background | Apr → Aug 2016 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02532192 Background | Dec 2015 → Dec 2019 | lymphoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT00860275 Comparator | Apr → Jun 2009 | Alzheimer disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT01042704 Background | Feb 2008 → Jan 2011 | plasma cell myeloma | Robert Redner, MD | Completed | No outcome recorded |
| Phase 1 | NCT01511770 Comparator | Aug 2002 | — | Dr. Reddy's Laboratories Limited | Completed | No outcome recorded |
| Phase 1 | NCT01511757 Comparator | Jun 2002 | — | Dr. Reddy's Laboratories Limited | Completed | No outcome recorded |
| Phase 1/2 | NCT04988555 Background | Feb 2022 → Jun 2027 expected | acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, plasma cell myeloma | Sumitomo Pharma America, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT00509834 Background | Jul 2008 → Jan 2009 | candidemia | AM-Pharma | Withdrawn | No outcome recorded |
| Phase 2 | NCT06859424 Background | Jul 2025 → Jun 2028 expected | B-cell chronic lymphocytic leukemia, acute myeloid leukemia, chronic myeloid leukemia, chronic myelomonocytic leukemia +3 | Center for International Blood and Marrow Transplant Research | Recruiting | No outcome recorded |
| Phase 2 | NCT06771063 Comparator | Jan → Jul 2025 overdue | vaginitis | Cisen Pharmaceutical CO., LTD. | Recruiting | No outcome recorded |
| Phase 2 | NCT05059145 Comparator | Apr 2022 → Dec 2024 | vulvovaginal candidiasis | Karolinska Institutet | Unknown | No outcome recorded |
| Phase 2 | NCT03112031 Background | Oct 2017 → Jul 2018 | HIV infectious disease, meningoencephalitis, streptococcal meningitis | Oxford University Clinical Research Unit, Vietnam | Completed | Missed primary |
| Phase 2 | NCT03253094 Comparator | Aug 2017 → May 2018 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | Met primary |
| Phase 2 | NCT02971007 Comparator | Nov 2016 → May 2017 | vulvovaginal candidiasis | Matinas BioPharma Nanotechnologies, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02734862 Comparator | Jul 2016 → Jun 2019 | candidemia | Cidara Therapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02733432 Comparator | Jun → Nov 2016 | vulvovaginal candidiasis | Cidara Therapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02679456 Comparator | Nov 2015 → Aug 2016 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02244606 Comparator | Sep 2014 → Jun 2016 | candidemia | Scynexis, Inc. | Completed | Met primary |
| Phase 2 | NCT03159845 Background | Jan 2014 → Sep 2019 | disease related to hematopoietic stem cell transplant | Azienda Ospedaliero, Universitaria Pisana | Completed | No outcome recorded |
| Phase 2 | NCT01562132 Comparator | Sep 2013 → Jul 2014 | cryptococcosis | Yale University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01891331 Comparator | Aug 2013 → Dec 2014 | vulvovaginal candidiasis | Viamet | Completed | Missed primary |
| Phase 2 | NCT01501708 Background | Dec 2011 → Jun 2017 | disease related to hematopoietic stem cell transplant, leukemia | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 2 | NCT00012467 Background | Jan 2000 → Jul 2001 | Cryptococcal meningitis, HIV infectious disease | InterMune | Completed | No outcome recorded |
| Phase 2 | NCT00000776 Background | ? → Sep 1996 | Cryptococcal meningitis, HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/3 | NCT06666322 Comparator | May 2025 → Apr 2032 expected | Cryptococcal meningitis, HIV infectious disease | University of Minnesota | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04734405 Comparator | Oct 2019 → Nov 2022 | vulvovaginal candidiasis | ProFem GmbH | Unknown | No outcome recorded |
| Phase 2/3 | NCT03945448 Comparator | Jun 2019 → Jun 2027 expected | Cryptococcal meningitis | Makerere University | Recruiting | Missed primary |
| Phase 3 | NCT06774144 Comparator | Oct 2025 → Dec 2028 expected | fungal infectious disease | Fernanda P Silveira, MD, MS | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT06055257 Background | Jan 2025 → Dec 2027 expected | osteoradionecrosis of the mandible | Sunnybrook Health Sciences Centre | Recruiting | No outcome recorded |
| Phase 3 | NCT05421858 Comparator | Dec 2024 → Jan 2028 expected | candidemia | Basilea Pharmaceutica | Recruiting | No outcome recorded |
| Phase 3 | NCT07311759 Comparator | Aug 2024 → Dec 2025 overdue | paronychia | Cairo University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05367089 Comparator | Aug 2022 → Apr 2026 overdue | vulvovaginal candidiasis | Maastricht University Medical Center | Recruiting | No outcome recorded |
| Phase 3 | NCT05178862 Comparator | Aug 2022 → Nov 2025 | candidemia | Scynexis, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT05074602 Comparator | Sep 2021 → Sep 2023 | vulvovaginal candidiasis | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04956419 Comparator | Apr → Sep 2021 | vulvovaginal candidiasis | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04368559 Comparator | May 2020 → Jan 2026 | aspergillosis, candidemia, pneumocystosis | Mundipharma Research Limited | Completed | Met primary |
| Phase 3 | NCT04029116 Background | Oct 2019 → Sep 2021 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | Met primary |
| Phase 3 | NCT03840616 Comparator | Mar 2019 → Dec 2020 | vulvovaginal candidiasis | Mycovia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03667690 Comparator | Oct 2018 → Oct 2021 | candidemia | Cidara Therapeutics Inc. | Completed | Met primary |
| Phase 3 | NCT03002012 Background | Nov 2017 → Mar 2018 | cryptococcosis | University of Minnesota | Terminated | No outcome recorded |
| Phase 3 | NCT01503515 Comparator | Mar 2013 → Dec 2019 | fungal infectious disease, hematopoietic and lymphoid cell neoplasm | Children's Oncology Group | Completed | Missed primary |
| Phase 3 | NCT01974375 Comparator | Aug 2012 → Jun 2014 | — | Asan Medical Center | Unknown | Met primary |
| Phase 3 | NCT01307579 Comparator | Apr 2011 → Jun 2018 | acute myeloblastic leukemia with maturation, acute myeloblastic leukemia without maturation, acute myeloid leukemia and myelodysplastic syndromes related to alkylating agent, acute myeloid leukemia with minimal differentiation +9 | Children's Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT01176058 Comparator | Dec 2010 → Nov 2011 | candidemia | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT01058174 Comparator | Dec 2009 → May 2012 | fungal infectious disease | Astellas Pharma Inc | Completed | Met primary |
| Phase 3 | NCT00761267 Background | Feb 2009 → Feb 2018 | candidemia | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00811928 Comparator | Nov 2008 → May 2010 | leukopenia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00689338 Background | Jul 2008 → May 2010 | candidiasis, invasive | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00423267 Comparator | May 2007 → May 2009 | coccidioidomycosis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00189709 Comparator | Aug 2004 → Jul 2006 | candidemia | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00075803 Comparator | Nov 2003 → Sep 2006 | infectious disease, leukemia, lymphoma | Medical College of Wisconsin | Completed | Missed primary |
| Phase 3 | NCT00666185 Comparator | Aug 2003 → Feb 2004 | oral candidiasis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT07342153 Comparator | Nov 2025 → Feb 2026 overdue | tinea corporis | Urooj Fatima | Recruiting | No outcome recorded |
| Phase 4 | NCT04626258 Comparator | Mar 2021 → Mar 2024 | vulvovaginal candidiasis | Maastricht University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02180828 Comparator | Jul 2014 → Sep 2015 | vulvovaginal candidiasis | Peking University Shenzhen Hospital | Completed | Met primary |
| Phase 4 | NCT02079298 Comparator | Apr 2014 → Sep 2015 | infectious disease, patent ductus arteriosus | Karolinska Institutet | Completed | No outcome recorded |
| Phase 4 | NCT02180100 Comparator | Aug 2013 → Jun 2014 | vulvovaginal candidiasis | Peking University Shenzhen Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00841971 Comparator | Feb 2010 → Jul 2013 | fungal lung infectious disease | University of Pittsburgh | Completed | Missed primary |
| Phase 4 | NCT00634166 Background | Sep 2007 → Dec 2013 | — | Mylan Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00496197 Background | Jul 2007 → Jun 2010 | candidiasis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00553137 Comparator | Nov 2006 → Dec 2007 | oral candidiasis | Netherlands Organisation for Scientific Research | Completed | No outcome recorded |
| Phase 4 | NCT00304772 Comparator | Aug 2006 → Dec 2008 | candidiasis, infectious disease with sepsis | Kyoto University | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT05434104 Comparator | Apr 2026 → Dec 2027 expected | bacterial vaginosis, vulvovaginal candidiasis | Guy's and St Thomas' NHS Foundation Trust | Recruiting | No outcome recorded |
| — | NCT05895162 Background | Jun 2023 → Apr 2026 | vulvovaginal candidiasis | FEMPHARMA Kft. | Completed | No outcome recorded |
| — | NCT05795491 Comparator | Apr → May 2023 | vulvovaginal candidiasis | Cairo University | Completed | No outcome recorded |
| — | NCT03939273 Comparator | Mar 2022 → Mar 2023 | autoinflammatory syndrome, coronary artery disorder | Radboud University Medical Center | Unknown | No outcome recorded |
| — | NCT01290198 Comparator | Feb 2011 → Apr 2012 | — | University Hospital, Grenoble | Completed | No outcome recorded |
| — | NCT00830856 Background | Oct 2006 → Oct 2008 | Cryptococcal meningitis, HIV infectious disease | University of Zimbabwe | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2023-10-23 | Lupin Limited | Regulatory Lupin Receives Approval from U.S.FDA for Fluconazole Tablets, USP lupin.com ↗ |
| 2019-10-31 | Scynexis, Inc. | Results SCYNEXIS Announces Oral Presentation of Data from Ibrexafungerp Phase 2b DOVE Study at the 3rd ISIDOG Congress scynexis.com ↗
In the DOVE study, fluconazole was the predominant rescue therapy when patients in the fluconazole arm failed therapy, underscoring the need for new VVC therapeutic options |
| 2017-02-17 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Fluconazole Tablets USP and Clobetasol Propionate Spray zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Fluconazole Tablets USP in strengths of 50 mg, 100 mg, 150 mg and 200 mg and Clobetasol Propionate Spray, 0.05%. |
| 2016-10-05 | Scynexis, Inc. | Results SCYNEXIS Announces Complete Results from Two Phase 2 Studies of Oral SCY-078 in Patients with Candida spp. Infections and Closing of a $15 Million Term Loan scynexis.com ↗
During the study period, there were no reports of mycological failures in the SCY-078 750mg group (n=7) versus two infection-related failures (one fungemia and one abdominal sepsis) in the fluconazole group (n=7). |
| 2016-08-01 | Scynexis, Inc. | Results SCYNEXIS Announces Interim Results from Phase 2 Study of Oral SCY-078 in Patients with Invasive Candidiasis scynexis.com ↗
Two of the seven patients treated with 750mg of SCY-078 reported GI events (29%), compared to three of the seven patients treated with fluconazole (43%). |
| 2016-06-08 | Scynexis, Inc. | Results SCYNEXIS, Inc. Announces Positive Results in its Proof-of-Concept Phase 2 Study of SCY-078, the First Member of a Novel Class of Glucan Synthase Inhibitors scynexis.com ↗
Results seen with fluconazole in this trial were in-line with results published in fluconazole’s label. |
| 2005-01-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Fluconazole Injection tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval of the Company's ANDA for Fluconazole Injection, 2 mg/mL in 200 mg and 400 mg bags. |
| 2004-07-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Fluconazole Tablets And Injection tevapharm.com ↗ |
All press releases naming this drug 10 releases
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 219 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fluconazole | “'Topical Antimicrobial/Antifungal Medications' Various topical antimicrobials and antifungals include: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin;...” NCT00634166 ↗214“All patients received azoles as prophylaxis (fluconazole as prophylaxis and itraconazole or voriconazole as secondary prophylaxis), combination with liposomal amphotericin B at...” NCT01501708 ↗ “A Randomized, Open Label, Comparative Multicenter Study Of Voriconazole Versus Conventional Amphotericin B Followed By Fluconazole In The Treatment Of Candidaemia In Non...” NCT00163111 ↗ “For all patients without documented proven or probable invasive fungal disease (IFD), patients will receive fluconazole during the treatment in the laminar air flow units (LAF).” NCT04273178 ↗ “3. Fluconazole 1200mg/day for 14 days Consolidation Therapy: Fluconazole 800mg/day from 2 to 10 weeks Secondary Prophylaxis: Fluconazole 200mg/day through 1 year minimum” NCT06666322 ↗ “Fluconazole will be administered every day for 8 consecutive days with a single dose of NX-5948/placebo coadministered on Day 4” NCT06593457 ↗ “Control women with candida will be given a fluconazole 150mg capsule to take orally the same day.” NCT05434104 ↗ “hLF1-11 (0.5mg IV bolus daily for 14 days) + fluconazole (up to 1g IV four times daily; 14 days)” NCT00509834 ↗ “Itraconazole, Amphotericin B liposomal, Fluconazole, Terbinafine, Voriconazole” NCT02366884 ↗ “Fluconazole is used for recipients with risk factors for yeast infections” NCT06774144 ↗ “Arm (2) will receive Fluconazole (300mg once weekly for 3monthes).” NCT03171584 ↗ |
| Known as | [3H]-Fluconazole | ChEMBL registry synonym — accepted as the source's own label CHEMBL106 ↗ |
| Known as | Alkanazole | ChEMBL registry synonym — accepted as the source's own label CHEMBL106 ↗ |
| Known as | BAYT-006267 | ChEMBL registry synonym — accepted as the source's own label CHEMBL106 ↗ |
| Known as | Canesten oral | ChEMBL registry synonym — accepted as the source's own label CHEMBL106 ↗ |
| Known as | Diflucan | “The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the Single-dose Relative Bioavailability of Flucanazole 40mgm/ml 35 ml Suspension and...” NCT04502277 ↗4“Diflucan® is manufactured by Fareva Amboise, France (MAH: PFIZER PHARMA PFE GmbH, Germany). Each hard capsule contains 200 mg of fluconazole.” NCT04038008 ↗ “In case of history of zoster or fungal infection a prophylaxis with Acyclovir or Diflucan should be also considered.” NCT01042704 ↗ “Drug: Diflucan (fluconazole)” NCT00496197 ↗ “Fluconazole Diflucan” NCT02971007 ↗ |
| Known as | Diflucan one | ChEMBL registry synonym — accepted as the source's own label CHEMBL106 ↗ |
| Known as | Difluconazole | ChEMBL registry synonym — accepted as the source's own label CHEMBL106 ↗ |
| Known as | FCZ | “To compare the safety and effectiveness of fluconazole (FCZ) and amphotericin B (AMB), alone or in combination with flucytosine (FLC), as treatment for acute cryptococcal meningitis” NCT00000708 ↗2“The objectives were to assess the influence of antifungal treatment with Fluconazole (FCZ) on the rate of ASCA and endoscopic recurrence at 6 months.” NCT02997059 ↗ “Fluconazole (FCZ)” NCT02195466 ↗ |
| Known as | Fluconazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL106 ↗ |
| Known as | Fluconazol 200ml (fluconazolum 400mg; Baxter; Czech Republic) | “Fluconazol 200ml (fluconazolum 400mg; Baxter; Czech Republic)” NCT01524081 ↗ |
| Known as | Fluconazole Kabi | “Fluconazole Kabi, Fresenius 2mg/ml Fluconazole will be administered at a loading dose of 25 mg/kg on the first day and followed by a maintenance dose of 12 mg/kg or 20 mg/kg...” NCT02145832 ↗ |
| Known as | Fluconazoli | ChEMBL registry synonym — accepted as the source's own label CHEMBL106 ↗ |
| Known as | FLZ | “The overall aim of this study is to investigate if vaginally applied 1% chlorhexidine gluconate (CHG) could be an alternative treatment to oral fluconazole (FLZ), both during...” NCT05059145 ↗1“Participants ingested fluconazole (150 mg; FLZ, CYP450 inhibitor) or placebo (PLC, microcrystalline cellulose)” PMID 41420405 ↗ Dec 2025 |
| Known as | NSC-758661 | ChEMBL registry synonym — accepted as the source's own label CHEMBL106 ↗ |
| Known as | Triflucan | ChEMBL registry synonym — accepted as the source's own label CHEMBL106 ↗ |
| Known as | UK-49,858 | “Multi-Center Evaluation of Fluconazole (UK-49,858) as Treatment for Acute Cryptococcal Meningitis in Patients Who Have Failed to Respond or Have Experienced Unacceptable...” NCT00002306 ↗4“Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired...” NCT00002074 ↗ “Double Blind Placebo Controlled Study of Fluconazole (UK-49,858) for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome” NCT00002294 ↗ “Comparison of Fluconazole (UK-49,858) and Amphotericin B for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome” NCT00001017 ↗ “A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis” NCT00002068 ↗ |
| Known as | Zoltec | ChEMBL registry synonym — accepted as the source's own label CHEMBL106 ↗ |
| Action | Inhibit | “fluconazole was used to inhibit cytochrome P450 2C9-mediated epoxyeicosatrienoic acid synthesis” PMID 21555712 ↗ May 2011 |
| Modality | Small molecule | “Fluconazole is a triazole antifungal agent” NCT00000627 ↗ |
| Route | Intravenous | “Patients who are unable to take the drug orally may receive it intravenously until oral administration is possible.” NCT00000627 ↗ |
| Route | Oral | “Patients who are unable to take the drug orally may receive it intravenously until oral administration is possible.” NCT00000627 ↗ |
| Target | CYP2C9 | “fluconazole was used to inhibit cytochrome P450 2C9-mediated epoxyeicosatrienoic acid synthesis” PMID 21555712 ↗ May 2011 |