Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 have evaluated fluconazole's efficacy, pharmacokinetics, and drug interactions across various recruitment statuses, including active, completed, and terminated studies. Supported by academic and pharmaceutical sponsors such as Radboud University Medical Center and Boehringer Ingelheim, these research protocols primarily investigate invasive fungal infections, cryptococcal meningitis, esophageal and vulvovaginal candidiasis, and prophylaxis in immunocompromised populations, such as those with HIV or organ transplants.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07743593 NOT_YET_RECRUITING
Cryptococcal Antigenemia; HIV-1-infection; Cryptococcal Infection; Cryptococcal Meningitis
University of Minnesota
2027-01-05 PHASE3
NCT04930107 ACTIVE_NOT_RECRUITING
Candidiasis, Vulvovaginal
University of Manitoba
2021-12-07 EARLY_PHASE1
NCT06274554 RECRUITING
Crohn's Disease; Inflammatory Bowel Diseases
Weill Medical College of Cornell University
2024-10-04 PHASE3
NCT05421858 RECRUITING
Candidemia; Candidiasis, Invasive
Basilea Pharmaceutica
2024-12-11 PHASE3
NCT03828773 RECRUITING
Candidiasis; Fungal Infection; Acute Myeloid Leukemia; Genetic Predisposition; Aspergillosis
Bochud Pierre-Yves
2019-02-11
NCT07295314 NOT_YET_RECRUITING
Gut Microbiome; Healthy Adult Male; Antifungal Therapy
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
2026-01 EARLY_PHASE1
NCT03945448 RECRUITING
Cryptococcal Meningitis
Makerere University
2019-06-20 PHASE2; PHASE3
NCT06770530 RECRUITING
Cystectomy
Rigshospitalet, Denmark
2024-06-24 PHASE4
NCT07395024 ACTIVE_NOT_RECRUITING
Healthy Volunteer
Astellas Pharma Global Development, Inc.
2026-02-03 PHASE1
NCT07341672 NOT_YET_RECRUITING
Healthy Adult Subject
Sunshine Lake Pharma Co., Ltd.
2026-12-31 PHASE1
NCT06709196 RECRUITING
Cystectomy; Bladder Cancer Requiring Cystectomy; Postoperative Infections; Antibiotic Prophylaxis; Ileal Conduit
Rigshospitalet, Denmark
2025-01-07 PHASE4
NCT07396857 RECRUITING
Cardiovascular
Université de Sherbrooke
2025-11-01
NCT07565441 NOT_YET_RECRUITING
ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Jemincare
2026-05-11 PHASE1
NCT06616168 ACTIVE_NOT_RECRUITING
Bacterial Vaginosis
Danylo Halytsky Lviv National Medical University
2023-09-01 PHASE1
NCT07033962 NOT_YET_RECRUITING
Onychomycosis
Assiut University
2025-06
NCT05367089 RECRUITING
Candidiasis, Vulvovaginal; Recurrent Candidiasis of Vagina
Maastricht University Medical Center
2022-08-22 PHASE3
NCT05895162 COMPLETED
Vulvovaginal Candidiasis; Vaginal Yeast Infections
FEMPHARMA Kft.
2023-06-10
NCT07439250 COMPLETED
Healthy
Eli Lilly and Company
2026-03-02 PHASE1
NCT07342153 RECRUITING
Tinea Corporis; Dermatophytosis
Urooj Fatima
2025-11-01 PHASE4
NCT04368559 COMPLETED
Candidemia; Mycoses; Fungal Infection; Fungemia; Invasive Candidiasis; Pneumocystis; Mold Infection; Invasive Fungal Disease; Prophylaxis of Invasive Fungal Infections; Aspergillus
Mundipharma Research Limited
2020-05-11 PHASE3
NCT06922344 RECRUITING
Pityriasis Versicolor
Khyber Teaching Hospital
2025-03-01 PHASE4
NCT07311759 ACTIVE_NOT_RECRUITING
Chronic Paronychia
Cairo University
2024-08-17 PHASE3
NCT05178862 TERMINATED
Candidiasis, Invasive; Candidemia
Scynexis, Inc.
2022-08-03 PHASE3
NCT07636018 COMPLETED
Healthy Adults
Pfizer
2025-08-26 PHASE1
NCT06771063 RECRUITING
Vaginitis
Cisen Pharmaceutical CO., LTD.
2025-01-13 PHASE2
NCT06847464 COMPLETED
RSV Infection; Drug Drug Interaction (DDI)
Enanta Pharmaceuticals, Inc
2025-01-27 PHASE1
NCT05059145 UNKNOWN
Candidiasis, Vulvovaginal
Karolinska Institutet
2022-04-27 PHASE2
NCT05176379 UNKNOWN
Healthy
University of Oklahoma
2022-02-19 PHASE4
NCT06593457 COMPLETED
Healthy Volunteers
Nurix Therapeutics, Inc.
2024-08-20 PHASE1
NCT04495608 COMPLETED
Nephrolithiasis; Nephrocalcinosis; Hypercalciuria
Hospices Civils de Lyon
2021-01-13 PHASE2
NCT06345794 COMPLETED
Healthy
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
2024-04-03 PHASE1
NCT06173596 COMPLETED
Healthy
Alexion Pharmaceuticals, Inc.
2024-01-10 PHASE1
NCT04626258 UNKNOWN
Candidiasis, Vulvovaginal; Recurrent Candidiasis of Vagina
Maastricht University Medical Center
2021-03-01 PHASE4
NCT06822166 COMPLETED
Interaction Drug Food
Ahon Pharmaceutical Co., Ltd.
2023-12-04 PHASE1
NCT05074602 UNKNOWN
Recurrent Vulvovaginal Candidiasis
Jiangsu HengRui Medicine Co., Ltd.
2021-09-14 PHASE3
NCT05657613 COMPLETED
Drug Interactions
CTI BioPharma
2023-01-03 PHASE1
NCT05399641 COMPLETED
Vulvovaginal Candidiasis
Scynexis, Inc.
2022-05-01 PHASE3
NCT05661591 COMPLETED
Malignant Tumor
Jiangsu HengRui Medicine Co., Ltd.
2023-02-28 PHASE1
NCT03939273 UNKNOWN
Systemic Inflammatory Response Syndrome; Postoperative Shock; Coronary Artery Disease; Extracorporeal Circulation; Complications
Radboud University Medical Center
2022-03
NCT05471063 UNKNOWN
Cryptococcal Meningitis
Peking Union Medical College Hospital
2022-08-22
NCT07557966 COMPLETED
Safety; Efficacy; Intrastromal Injection; Fluconazole; Treatment; Fungal Keratitis
Tanta University
2022-01-01
NCT04734405 UNKNOWN
Recurrent Vulvovaginal Candidiasis
ProFem GmbH
2019-10-01 PHASE2; PHASE3
NCT05130723 Recruiting
Invasive Fungal Infections
Radboud University Medical Center
2022-10-18 --
NCT05862714 COMPLETED
Tinea Versicolor
Combined Military Hospital Abbottabad
2022-03-01 PHASE1
NCT04809649 WITHDRAWN
Coccidioidomycosis; Valley Fever
George R Thompson
2021-05-15 PHASE2
NCT05478772 COMPLETED
Health Volunteers
Concert Pharmaceuticals
2022-07-11 PHASE1
NCT05602597 COMPLETED
Relapsed or Refractory Lymphoma
Hutchmed
2022-06-01 PHASE1
NCT05147727 COMPLETED
Tumor
Jiangsu HengRui Medicine Co., Ltd.
2022-03-14 PHASE1
NCT04551963 COMPLETED
B-cell Malignancies
BeiGene
2020-11-15 PHASE1
NCT05076409 COMPLETED
Healthy
Boehringer Ingelheim
2021-10-19 PHASE1
NCT05848492 COMPLETED
Invasive Candidiases
Services Institute of Medical Sciences, Pakistan
2021-05-01 PHASE3
NCT03667690 COMPLETED
Candidemia; Mycoses; Fungal Infection; Invasive Candidiases
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
2018-10-07 PHASE3
NCT04956419 UNKNOWN
Acute Vulvovaginal Candidiasis
Jiangsu HengRui Medicine Co., Ltd.
2021-04-24 PHASE3
NCT04029116 COMPLETED
Recurrent Vulvovaginal Candidiasis
Scynexis, Inc.
2019-10-21 PHASE3
NCT04933682 COMPLETED
Healthy
Alexion Pharmaceuticals, Inc.
2021-06-07 PHASE1
NCT04464577 WITHDRAWN
Healthy Participants
Bristol-Myers Squibb
2021-04-01 PHASE1
NCT04933682 Completed
Healthy
Alexion Pharmaceuticals Inc.
2021-06-23 Phase 1
NCT04850651 COMPLETED
Healthy Subjects
Jiangsu HengRui Medicine Co., Ltd.
2021-04-16 PHASE1
NCT04702464 COMPLETED
Healthy Volunteers
Celgene
2021-01-12 PHASE1
NCT04871724 COMPLETED
RSV Infection
Enanta Pharmaceuticals, Inc
2021-03-12 PHASE1
NCT04122560 COMPLETED
Fluconazole; Candidiasis; Invasive Fungal Infections; Obesity
Radboud University Medical Center
2019-11-30 PHASE4
NCT03476317 COMPLETED
Crohn Disease
Children's Hospital of Philadelphia
2018-07-12 PHASE2
NCT04502277 UNKNOWN
Candidiasis
Sutphin Drugs
2020-09-01 EARLY_PHASE1
NCT03840616 COMPLETED
Recurrent Vulvovaginal Candidiasis
Mycovia Pharmaceuticals Inc.
2019-03-13 PHASE3
NCT03167957 WITHDRAWN
Vulvovaginal Candidiases; Yeast Infection; Vulvovaginitis; Yeast Infection Vaginal; Candidiasis, Vulvovaginal
Matinas BioPharma Nanotechnologies, Inc.
2019-12 PHASE2
NCT05140096 COMPLETED
Healthy Volunteers
Acerta Pharma BV
2020-01-03 PHASE1
NCT01503515 COMPLETED
Fungal Infection; Hematopoietic and Lymphoid Cell Neoplasm
Children's Oncology Group
2013-03-21 PHASE3
NCT03942029 COMPLETED
Healthy
Eli Lilly and Company
2019-06-21 PHASE1
NCT02532192 WITHDRAWN
Lymphoma
M.D. Anderson Cancer Center
2015-12 PHASE1
NCT02222922 COMPLETED
Neoplasms
Pfizer
2014-10-17 PHASE1
NCT03028103 COMPLETED
Diffuse Large B Cell Lymphoma; Primary Mediastinal Lymphoma; Mantle Cell Lymphoma; Advanced Solid Tumor; Marginal Zone Lymphoma
Epizyme, Inc.
2017-03-27 PHASE1
NCT04038008 COMPLETED
Bioequivalence
Pharmtechnology LLC
2019-07-26 PHASE1
NCT04193319 COMPLETED
Advanced Cancer
Jiangsu HengRui Medicine Co., Ltd.
2019-07-19 PHASE1
NCT03159845 COMPLETED
Stem Cell Transplant Complications
Azienda Ospedaliero, Universitaria Pisana
2014-01-01 PHASE2
NCT03621072 COMPLETED
Bioequivalence
Pfizer
2019-06-03 PHASE1
NCT02734862 COMPLETED
Candidemia; Mycoses; Fungal Infection; Fungemia; Invasive Candidiasis
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
2016-07-26 PHASE2
NCT04201054 COMPLETED
Healthy Volunteers
Parc de Salut Mar
2019-03-25 PHASE1
NCT03821480 COMPLETED
Bioequivalence
Pfizer
2019-01-28 PHASE1
NCT03634345 COMPLETED
Dermatitis, Atopic
Pfizer
2018-09-12 PHASE1
NCT02765256 COMPLETED
Crohn's Disease
University of Pennsylvania
2016-08 PHASE2
NCT03610945 COMPLETED
NASH - Nonalcoholic Steatohepatitis
Enanta Pharmaceuticals, Inc
2018-07-19 PHASE1
NCT03112031 COMPLETED
Meningitis Streptococcal; Hiv; Meningitis; Meningoencephalitis
Oxford University Clinical Research Unit, Vietnam
2017-10-10 PHASE2
NCT01307579 COMPLETED
Acute Myeloid Leukemia; Adult Acute Monoblastic Leukemia; Adult Acute Monocytic Leukemia; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With Maturation; Adult Acute Myeloid Leukemia With Minimal Differentiation; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A; Adult Acute Myeloid Leukemia Without Maturation; Adult Acute Myelomonocytic Leukemia; Alkylating Agent-Related Acute Myeloid Leukemia; Childhood Acute Monoblastic Leukemia; Childhood Acute Monocytic Leukemia; Childhood Acute Myeloid Leukemia in Remission; Childhood Acute Myeloid Leukemia With Maturation; Childhood Acute Myeloid Leukemia With Minimal Differentiation; Childhood Acute Myeloid Leukemia Without Maturation; Childhood Acute Myelomonocytic Leukemia; Fungal Infection; Myeloid Neoplasm; Neutropenia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia; Untreated Childhood Myeloid Neoplasm
Children's Oncology Group
2011-04-04 PHASE3
NCT02663674 TERMINATED
Coccidioidomycosis
National Institute of Allergy and Infectious Diseases (NIAID)
2015-12-29 PHASE4
NCT01950507 TERMINATED
Stem Cell Transplantation; Graft vs Host Disease
National Institutes of Health Clinical Center (CC)
2014-02-20 PHASE1
NCT03253094 COMPLETED
Candida Vulvovaginitis
Scynexis, Inc.
2017-08-01 PHASE2
NCT03451110 COMPLETED
Healthy Subjects
Eisai Inc.
2018-02-05 PHASE1
NCT03002012 TERMINATED
Cryptococcosis; Cryptococcal Infections; AIDS-Related Opportunistic Infections
University of Minnesota
2017-11-15 PHASE3
NCT02624453 UNKNOWN
Cryptococcal Meningitis
ANRS, Emerging Infectious Diseases
2015-07
NCT00761267 COMPLETED
Candidemia
Pfizer
2009-02 PHASE3
NCT03135106 COMPLETED
Healthy
Janssen Research & Development, LLC
2017-04-14 PHASE1
NCT03036046 WITHDRAWN
Acute Myeloid Leukemia
F2G Ltd
2017-03 PHASE1; PHASE2
NCT02122770 COMPLETED
Advanced Solid Tumors
Millennium Pharmaceuticals, Inc.
2014-04-01 PHASE1
NCT02971007 COMPLETED
Vulvovaginitis; Yeast Infection; Yeast Infection Vaginal; Candidiasis, Vulvovaginal
Matinas BioPharma Nanotechnologies, Inc.
2016-11 PHASE2
NCT00885703 COMPLETED
Cryptococcal Meningitis; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
2010-04-16 PHASE1; PHASE2
NCT02733432 COMPLETED
Candidiasis, Vulvovaginal; Mycoses; Yeast Infection; Moniliasis, Vulvovaginal; Vaginitis, Monilial
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
2016-06-08 PHASE2
NCT02183779 UNKNOWN
Raynaud Disease; Hyperemia; Cold
University Hospital, Grenoble
2014-06
NCT02679456 COMPLETED
Vulvovaginal Candidiasis
Scynexis, Inc.
2015-11 PHASE2
NCT02809768 COMPLETED
Healthy Participants
Eisai Inc.
2016-04 PHASE1
NCT02730442 COMPLETED
Invasive Aspergillosis
F2G Ltd
2016-02 PHASE1
NCT02244606 COMPLETED
Mycoses; Candidiasis, Invasive; Candidemia
Scynexis, Inc.
2014-09 PHASE2
NCT02941068 COMPLETED
Intra-abdominal Perforation
Nanjing PLA General Hospital
2012-03 PHASE2
NCT01354314 COMPLETED
HIV Associated Neurocognitive Disorder
Johns Hopkins University
2010-11 PHASE1; PHASE2
NCT01825031 COMPLETED
Human Immunodeficiency Virus
Anna Griffiths, MRC
2013-06 PHASE3
NCT02136030 UNKNOWN
Cryptococcal Meningitis
TTY Biopharm
2011-02
NCT02145832 COMPLETED
Candidiasis
Institut National de la Santé Et de la Recherche Médicale, France
2014-10 PHASE2; PHASE3
NCT01715922 UNKNOWN
Cryptococcal Meningitis; HIV
ANRS, Emerging Infectious Diseases
2012-05 PHASE2; PHASE3
NCT02079298 COMPLETED
Ductus Arteriosis, Patent; Bacterial Infections and Mycoses
Anders Rane, MD, PhD, Senior professor
2014-04 PHASE4
NCT02180828 COMPLETED
Candidiasis, Vulvovaginal
Peking University Shenzhen Hospital
2014-07 PHASE4
NCT01535469 COMPLETED
Cryptococcal Meningitis; Cryptococcus Neoformans; Cryptococcosis
University of Minnesota
2012-07-01 PHASE4
NCT01953744 TERMINATED
Cutaneous Leishmaniasis
Hospital Universitário Professor Edgard Santos
2014-02 PHASE3
NCT02325011 COMPLETED
Healthy Subjects
Jazz Pharmaceuticals
2014-11 PHASE1
NCT01891331 COMPLETED
Candidiasis, Vulvovaginal
Viamet
2013-08 PHASE2
NCT01683760 COMPLETED
Very Low Birth Weight Infant
Seoul National University Hospital
2012-09 PHASE2
NCT02275975 COMPLETED
Healthy
Kowa Research Institute, Inc.
2014-07 PHASE1
NCT01562132 TERMINATED
Cryptococcal Infection Disseminated
Yale University
2013-09 PHASE2
NCT02093728 COMPLETED
Solid Tumours
AstraZeneca
2014-04 PHASE1
NCT02997059 COMPLETED
Crohn's Disease Aggravated
University Hospital, Lille
2008-07 PHASE2
NCT01974375 UNKNOWN
Liver Transplant Recipient
Asan Medical Center
2012-08 PHASE3
NCT02180100 COMPLETED
Vulvovaginal Candidiasis
Peking University Shenzhen Hospital
2013-08 PHASE4
NCT02093390 COMPLETED
Prostate Cancer; Endometriosis
Millennium Pharmaceuticals, Inc.
2014-03 PHASE1
NCT01806623 COMPLETED
Vulvovaginal Candidiasis
Pfizer
2013-03-05 PHASE3
NCT01924299 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2013-08 PHASE1
NCT00841971 COMPLETED
Mycoses; Fungemia; Central Nervous System Fungal Infections; Lung Diseases, Fungal
University of Pittsburgh
2010-02 PHASE4
NCT01447511 COMPLETED
Healthy
University of Minnesota
2009-05
NCT01772290 COMPLETED
Healthy Volunteer
Genentech, Inc.
2013-02 PHASE1
NCT01497223 COMPLETED
Vulvovaginal Candidiasis
MethylGene Inc.
2011-12 PHASE2
NCT01169402 COMPLETED
Cardiopulmonary Arrest; Fungal Infection
Michael Cohen-Wolkowiez
2010-07 PHASE1
NCT02111629 COMPLETED
Vaginal Discharge
Universidad Nacional de Colombia
2012-05 PHASE3
NCT00166166 TERMINATED
Hyperlipidemia
Emory University
2002-07 PHASE2
NCT03929861 COMPLETED
Pharmacology, Clinical
Bayer
2012-07-31 PHASE1
NCT01058174 COMPLETED
Liver Transplantation; Mycoses
Astellas Pharma Inc
2009-12-15 PHASE3
NCT01290198 COMPLETED
Healthy Volunteers
University Hospital, Grenoble
2011-02
NCT01096706 COMPLETED
Vascular Disease; Heart Disease
University of Edinburgh
2011-07
NCT01386593 COMPLETED
Metabolic Detoxication, Phase I
University Hospital, Basel, Switzerland
2011-05 PHASE1
NCT01392430 COMPLETED
HIV Infection
Chiang Mai University
2009-06
NCT00734539 COMPLETED
Candidiasis
Daniel Benjamin
2008-11 PHASE3
NCT01176058 TERMINATED
Candidemia
Pfizer
2010-12 PHASE3
NCT00964106 COMPLETED
Drug Interactions
GlaxoSmithKline
2009-08-26 PHASE1
NCT01524081 COMPLETED
Acute Appendicitis; Perforated Gastroduodenal Ulcer; Small Bowel Obstruction
The Faculty Hospital Na Bulovce
2008-07 PHASE3
NCT00537888 UNKNOWN
Pulmonary Candidiasis
Capital Medical University
2007-09 PHASE4
NCT01026714 COMPLETED
Healthy Volunteers
University Hospital, Geneva
2009-11 PHASE1; PHASE2
NCT00936182 UNKNOWN
Autism Spectrum Disorder
The Center for Autism and Related Disorders
2009-07
NCT01153724 COMPLETED
Healthy; Pulmonary Disease, Chronic Obstructive
Boehringer Ingelheim
2010-05 PHASE1
NCT00496197 COMPLETED
Candidiasis
Pfizer
2007-07 PHASE4
NCT00811928 COMPLETED
Leukopenia
Merck Sharp & Dohme LLC
2008-11 PHASE3
NCT00689338 COMPLETED
Invasive Candidiasis
Pfizer
2008-07 PHASE3
NCT00935363 WITHDRAWN
Healthy
University of California, San Francisco
2010-02 PHASE1
NCT01060566 COMPLETED
Cystic Fibrosis
Vertex Pharmaceuticals Incorporated
2010-02 PHASE1
NCT00797420 COMPLETED
Candidiasis
Daniel Benjamin
2008-11 PHASE1
NCT00911235 COMPLETED
Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence
Pfizer
2009-05 PHASE1
NCT00860275 COMPLETED
Alzheimer Disease
Bristol-Myers Squibb
2009-04 PHASE1
NCT00423267 COMPLETED
Coccidioidomycosis
Merck Sharp & Dohme LLC
2007-05 PHASE3
NCT00740389 COMPLETED
HIV; AIDS; Fungal Infection
Tibotec Pharmaceuticals, Ireland
2008-09 PHASE1
NCT00304772 WITHDRAWN
Candidiasis; Sepsis
Kyoto University
2006-08 PHASE4
NCT00830856 COMPLETED
Cryptococcal Meningitis; HIV Infections
University of Zimbabwe
2006-10
NCT00145249 COMPLETED
Cryptococcal Meningitis
National Institute of Allergy and Infectious Diseases (NIAID)
2005-05 PHASE2
NCT00503542 COMPLETED
Vaginitis
Agency for Healthcare Research and Quality (AHRQ)
2007-02 EARLY_PHASE1
NCT00553137 COMPLETED
Oropharyngeal Candidiasis
Netherlands Organisation for Scientific Research
2006-11 PHASE4
NCT00170430 COMPLETED
Bacterial Diseases; Other Mycoses; Sexually Transmitted Infection
University of Washington
2003-05 PHASE3
NCT00075803 COMPLETED
Lymphoma; Infection; Leukemia
Medical College of Wisconsin
2003-11 PHASE3
NCT00189709 COMPLETED
Invasive Candidiasis; Candidemia
Astellas Pharma Inc
2004-08 PHASE3
NCT00002533 COMPLETED
Head and Neck Cancer; Infection; Oral Complications
University of Miami
1993-02 PHASE2; PHASE3
NCT00353561 COMPLETED
Diabetes Mellitus; Vulvovaginal Candidiasis
Indian Council of Medical Research
2004-06 PHASE3
NCT00666185 COMPLETED
Candidiasis, Oral
Astellas Pharma Inc
2003-08 PHASE3
NCT02195466 COMPLETED
Healthy
Boehringer Ingelheim
2003-06 PHASE1
NCT01511770 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
2002-08 PHASE1
NCT00003883 COMPLETED
Cancer
Fred Hutchinson Cancer Center
1998-10 PHASE3
NCT01511757 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
2002-06 PHASE1
NCT02181946 COMPLETED
HIV Infections
Boehringer Ingelheim
2001-05 PHASE4
NCT00001017 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
PHASE3
NCT00000708 COMPLETED
Meningitis, Cryptococcal; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002446 COMPLETED
Candidiasis, Oral; HIV Infections
Schering-Plough
1998-08 PHASE3
NCT00023530 COMPLETED
Bone Marrow Transplantation; Blood Disease; Hematopoietic Stem Cell Transplantation; Leukemia; Multiple Myeloma; Myelodysplastic Syndromes; Graft vs Host Disease
National Heart, Lung, and Blood Institute (NHLBI)
2001-09
NCT00313131 COMPLETED
Bacterial Vaginosis; Candidiasis; Vaginitis
Université de Sherbrooke
2004-01 PHASE3
NCT00001107 COMPLETED
Candidiasis
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE4
NCT00002074 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00056368 COMPLETED
Candidiasis
Pfizer
2003-03 PHASE3
NCT00002282 COMPLETED
Candidiasis, Oral; HIV Infections
Pfizer
NCT00002277 COMPLETED
Mycoses; HIV Infections
Pfizer
PHASE3
NCT00000951 COMPLETED
Candidiasis, Oral; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE4
NCT00002113 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00002399 COMPLETED
Candidiasis, Oral; HIV Infections
Schering-Plough
PHASE2
NCT00002112 COMPLETED
Candidiasis, Oral; HIV Infections
Pfizer
NCT00000744 COMPLETED
Candidiasis; Candidiasis, Esophageal; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00226538 COMPLETED
Healthy Volunteers
Hadassah Medical Organization
1999-08
NCT00002068 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00002038 COMPLETED
Candidiasis; Mycoses; HIV Infections
Pfizer
NCT00000639 COMPLETED
Meningitis, Cryptococcal; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00012467 COMPLETED
Meningitis, Cryptococcal; HIV Infections
InterMune
2000-01 PHASE2
NCT00002339 COMPLETED
Candidiasis, Esophageal; HIV Infections
Pfizer
PHASE3
NCT00000776 COMPLETED
Meningitis, Cryptococcal; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE2
NCT00002325 COMPLETED
Mycoses; HIV Infections; Coccidioidomycosis
Pfizer
NCT00002132 COMPLETED
Candidiasis, Esophageal; HIV Infections
Janssen Pharmaceuticals
NCT00002075 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00000676 COMPLETED
Candidiasis; Mycoses; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE3
NCT00002304 COMPLETED
Candidiasis, Esophageal; HIV Infections
Pfizer
NCT00004808 COMPLETED
Histoplasmosis; Sporotrichosis; Blastomycosis
National Center for Research Resources (NCRR)
1991-09 PHASE2
NCT00000826 COMPLETED
Bacterial Infections; Mycoses; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE1
NCT00000788 COMPLETED
Candidiasis; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE1
NCT00163111 COMPLETED
Candidiasis
Pfizer
1998-09 PHASE3
NCT00479947 UNKNOWN
Vaginal Candidiasis
Faith Mediplex
2007-05 PHASE1
NCT00002394 COMPLETED
Candidiasis, Oral; HIV Infections
Novartis
NCT00001065 COMPLETED
Candidiasis, Oral; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE2
NCT00000627 COMPLETED
HIV Infections; Histoplasmosis
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002294 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00001937 COMPLETED
Aspergillosis; Candidiasis; Fungemia; Mycoses
National Cancer Institute (NCI)
1999-11 PHASE3
NCT00002306 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00002122 COMPLETED
Mycoses; Mycobacterium Avium-Intracellulare Infection; HIV Infections
Pfizer
PHASE3
NCT00001542 COMPLETED
Acquired Immunodeficiency Syndrome; Candidiasis; Oral Candidiasis
National Institute of Allergy and Infectious Diseases (NIAID)
1996-07 PHASE4
NCT00002076 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00002077 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00002133 COMPLETED
Candidiasis, Oral; HIV Infections
Janssen, LP
NCT00004938 COMPLETED
Sporotrichosis
National Institute of Allergy and Infectious Diseases (NIAID)
1996-08 PHASE2
NCT00058682 COMPLETED
Candida; Candidiasis
National Cancer Institute (NCI)
2003-04 PHASE3
NCT00002305 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00002010 COMPLETED
Meningitis; HIV Infections
Pfizer
NCT00005920 TERMINATED
Candidiasis, Oral; HIV Infections
Merck Sharp & Dohme LLC
PHASE2
NCT00002040 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00002341 COMPLETED
Candidiasis, Oral; HIV Infections
Janssen, LP
NCT00199264 TERMINATED
Candidiasis Vulvaginitis
J. Uriach and Company
2004-06 PHASE2
NCT00645242 COMPLETED
Tinea Capitis
Pfizer
2002-11 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the Fluconazole product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fluconazole selectively inhibits fungal lanosterol 14-alpha-demethylase, suppressing the conversion of lanosterol to ergosterol and thereby disrupting fungal cell membrane structure and permeability. This loss of membrane integrity inhibits fungal cell growth and viability, providing clinical relevance in the management and prevention of invasive fungal infections, candidiasis, and cryptococcal meningitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.