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)
Mechanism and Biochemical Profile
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>).