Fluconazole
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 |
|---|---|---|---|---|---|
| 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 139 · started per year
Also used as a comparator or background therapy in 75 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04930107 Comparator | Dec 2021 → Apr 2029 expected | vulvovaginal candidiasis | University of Manitoba | Active not recruiting | No outcome recorded |
| Phase 112 trials | ||||||
| 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| Phase 1 | NCT02532192 Background | Dec 2015 → Dec 2019 | lymphoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |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 1/22 trials | ||||||
| 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 216 trials | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT03253094 Comparator | Aug 2017 → May 2018 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
| Phase 2 | NCT01891331 Comparator | Aug 2013 → Dec 2014 | vulvovaginal candidiasis | Viamet | Completed | No outcome recorded |
| 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 2/33 trials | ||||||
| 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 | No outcome recorded |
| Phase 325 trials | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT04029116 Background | Oct 2019 → Sep 2021 | vulvovaginal candidiasis | Scynexis, Inc. | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01974375 Comparator | Aug 2012 → Jun 2014 | — | Asan Medical Center | Unknown | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT00666185 Comparator | Aug 2003 → Feb 2004 | oral candidiasis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
| Phase not applicable6 trials | ||||||
| — | 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 → Dec 2024 | vulvovaginal candidiasis | FEMPHARMA Kft. | Unknown | 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 | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2005-01-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Fluconazole Injection tevapharm.com ↗ |
| 2004-07-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Fluconazole Tablets And Injection tevapharm.com ↗ |
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 217 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 ↗212“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 ↗ “the recommended maximum dose of fluconazole daily is 200 mg.” NCT06859424 ↗ “Posaconazole, Voriconazole, or Fluconazole” NCT04988555 ↗ “50 mg Fluconazole daily (morning)” NCT06055257 ↗ “fluconazole” NCT05795491 ↗ |
| 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 |