Clinical Trials

Numerous clinical trials evaluate voriconazole across Phase 1 through Phase 4—as well as pharmacokinetic, safety, and drug-interaction studies in healthy adults and pediatric patients with haematological malignancies—focusing on fungal infections such as chronic pulmonary aspergillosis, candidemia, invasive candidiasis, scedosporium infection, and blastomycosis. Conducted by both pharmaceutical sponsors and academic institutions, these studies encompass completed, active not recruiting, and terminated recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06582186 NOT_YET_RECRUITING
Aspergillosis Invasive; Fungal Infection; Hematologic Malignancy
University Hospital, Grenoble
2024-10 PHASE4
NCT07215273 RECRUITING
Invasive Mould Infection
Elion Therapeutics, Inc.
2026-02-13 PHASE2
NCT07156201 RECRUITING
KCNT1-Related Epilepsy
Actio Biosciences, Inc.
2025-08-28 PHASE1
NCT06510699 RECRUITING
Fungal Infection; Haematological Malignancy; Blood Cancer; Infectious Disease
The University of Queensland
2025-04-14 PHASE2
NCT07457203 NOT_YET_RECRUITING
Drug Drug Interaction (DDI)
Beijing Union Pharmaceutical Factory Ltd
2026-04 PHASE1
NCT07426042 NOT_YET_RECRUITING
Drug-Drug Interactions
Min Kyu Park
2026-04 PHASE1
NCT06680544 NOT_YET_RECRUITING
Dermatophyte Infection
Sheikh Zayed Medical College
2024-11-15 PHASE2
NCT06493409 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
2024-08-26 PHASE1
NCT04294641 COMPLETED
Chronic GVHD
National Cancer Institute (NCI)
2021-05-10 PHASE2
NCT04824417 COMPLETED
Chronic Pulmonary Aspergillosis
Post Graduate Institute of Medical Education and Research, Chandigarh
2021-03-01 PHASE3
NCT05268718 UNKNOWN
Keratitis, Ulcerative; Antibiotic Resistance, Microbial; Photothermal Therapy
Second Affiliated Hospital, Zhejiang University, School of Medicine
2021-08-01 EARLY_PHASE1
NCT05708625 UNKNOWN
Leishmaniasis, Cutaneous
Zagazig University
2022-01-01 PHASE3
NCT04865419 TERMINATED
Haematological Malignancies
AstraZeneca
2021-06-11 PHASE1
NCT05458102 TERMINATED
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Gilead Sciences
2022-08-19 PHASE1
NCT05264142 UNKNOWN
Healthy
University Hospital, Geneva
2022-04-01 PHASE1
NCT03672292 TERMINATED
Invasive Pulmonary Aspergillosis
Scynexis, Inc.
2019-01-22 PHASE2
NCT07773909 COMPLETED
Acute Myeloid Leukemia
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
2022-06-01 PHASE4
NCT04072640 UNKNOWN
Cryptococcal Meningitis; HIV/AIDS
First Affiliated Hospital of Zhejiang University
2021-01-25 EARLY_PHASE1
NCT04551963 COMPLETED
B-cell Malignancies
BeiGene
2020-11-15 PHASE1
NCT03827278 UNKNOWN
Talaromyces in Human Immunodeficiency Virus Negative; To Compare Voriconazole and Amphotericin Sequential Itraconazole Therapy; To Dynamically Monitor the Anti-Interferon-γ Autoantibodies
Guangxi Medical University
2018-12-30
NCT04576325 COMPLETED
Asthma
TFF Pharmaceuticals, Inc.
2020-11-15 PHASE1
NCT04865419 Terminated
Haematological Malignancies
AstraZeneca
2021-06-11 Phase 1|Phase 2
NCT03471988 COMPLETED
Deep Mycosis
Asahi Kasei Therapeutics Corporation
2018-04-16 PHASE3
NCT04824417 Active not recruiting
Chronic Pulmonary Aspergillosis
Post Graduate Institute of Medical Education and Research Chandigarh|PGIMER
2021-03-01 Phase 3
NCT02283905 TERMINATED
Blastomycosis
University of Manitoba
2015-06 PHASE4
NCT04229303 COMPLETED
Allergic Bronchopulmonary Aspergillosis
Zambon SpA
2020-02-11 PHASE1
NCT04872231 COMPLETED
Healthy
TFF Pharmaceuticals, Inc.
2019-11-22 PHASE1
NCT05330000 COMPLETED
Healthy Adults
The Affiliated Hospital of Qingdao University
2020-05-22 PHASE1
NCT04552353 COMPLETED
Antimycotic for Systematic Use
Yung Shin Pharm. Ind. Co., Ltd.
2020-06-13 PHASE4
NCT03613389 UNKNOWN
Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy
Cairo University
2020-01-01
NCT04229303 Completed
Allergic Bronchopulmonary Aspergillosis
Zambon SpA
2020-02-11 Phase 1
NCT04238884 UNKNOWN
Invasive Fungal Infections
Instituto de Investigación Hospital Universitario La Paz
2020-01-02 PHASE4
NCT04145583 COMPLETED
Anesthesia; Sedation
Sichuan Haisco Pharmaceutical Group Co., Ltd
2019-12-14 PHASE1
NCT01503515 COMPLETED
Fungal Infection; Hematopoietic and Lymphoid Cell Neoplasm
Children's Oncology Group
2013-03-21 PHASE3
NCT04743544 Unknown status
Adverse Drug Reactions
Dokuz Eylul University|University of Liverpool
2019-11-01 --
NCT03731169 COMPLETED
Aspergillosis Invasive; Fungal Infection
University Health Network, Toronto
2018-01-10 PHASE4
NCT01782131 COMPLETED
Fungal Infections; Invasive Pulmonary Aspergillosis
Merck Sharp & Dohme LLC
2013-09-25 PHASE3
NCT03327727 TERMINATED
Invasive Aspergillosis; Invasive Pulmonary Aspergillosis
Vical
2018-02-20 PHASE2
NCT03799809 UNKNOWN
Aspergilloma
All India Institute of Medical Sciences
2016-12-01 PHASE2; PHASE3
NCT05380245 COMPLETED
Healthy
Abdul Wali Khan University Mardan
2018-11-01 PHASE4
NCT02689713 WITHDRAWN
Pain; Thermal Injury; Burns; Hyperalgesia
Kenneth Hargreaves
2018-06-15 PHASE2
NCT03760276 COMPLETED
Fungal Infection
Seoul National University Hospital
2018-08-20 PHASE1
NCT02731638 COMPLETED
Corneal Ulcer; Fungal Keratitis
University of California, San Francisco
2016-09 PHASE3
NCT04110860 COMPLETED
Tinea Versicolor
Sara Botros
2018-02-15 PHASE2
NCT03515382 COMPLETED
Healthy
Lakefront Biotherapeutics NV
2018-03-16 PHASE1
NCT01950507 TERMINATED
Stem Cell Transplantation; Graft vs Host Disease
National Institutes of Health Clinical Center (CC)
2014-02-20 PHASE1
NCT03230058 UNKNOWN
Infection, Fungal
L.V. Prasad Eye Institute
2017-01-01 PHASE2; PHASE3
NCT02180165 COMPLETED
Aspergillosis
Merck Sharp & Dohme LLC
2014-07-29 PHASE3
NCT02227797 COMPLETED
Fungal Infection
Masonic Cancer Center, University of Minnesota
2015-01-19 PHASE1
NCT02014558 COMPLETED
Acute Myeloid Leukemia
Astellas Pharma Global Development, Inc.
2013-10-09 PHASE1; PHASE2
NCT03554239 WITHDRAWN
Infection
University Hospital, Toulouse
2016-12
NCT03138785 UNKNOWN
Treatment
Farabi Eye Hospital
2015-01-01
NCT02576366 COMPLETED
Drug Interactions; Kidney Transplantation
Universitaire Ziekenhuizen KU Leuven
2016-06 PHASE4
NCT02396225 TERMINATED
Invasive Aspergillosis
University of Aarhus
2015-03
NCT01887457 SUSPENDED
Immunocompromised Patient; Aspergillosis; Fusarium
Brynn Chappell
2014-09 PHASE2
NCT02906176 COMPLETED
Healthy Volunteers
Seoul National University Hospital
2016-09 PHASE1
NCT00893555 COMPLETED
Invasive Fungal Infection; Hematological Malignancy
Jan-Willem C Alffenaar
2009-04 PHASE3
NCT02234739 UNKNOWN
Invasive Pulmonary Aspergillosis; COPD
Red Cross Hospital, Hangzhou, China
2014-10 PHASE4
NCT02912156 COMPLETED
Fungus Infection
Yung Shin Pharm. Ind. Co., Ltd.
2016-06 PHASE4
NCT02381080 COMPLETED
B-Cell Chronic Lymphocytic Leukemia
Janssen Research & Development, LLC
2015-05-19 PHASE1
NCT02110316 WITHDRAWN
Voriconazole; Bioavailability; Critically Ill
University Medical Center Groningen
2015-06 PHASE4
NCT01621321 COMPLETED
Allergic Bronchopulmonary Aspergillosis
Post Graduate Institute of Medical Education and Research, Chandigarh
2013-06 PHASE2; PHASE3
NCT00997035 COMPLETED
Corneal Ulcer; Eye Infections, Fungal
University of California, San Francisco
2010-05 PHASE3
NCT02631954 COMPLETED
Aspergillus Infections; Candida Infections; Fungal Infections
Chong Kun Dang Pharmaceutical
2015-09 PHASE1
NCT01576315 COMPLETED
Cystic Fibrosis; Aspergillus Infections
Rennes University Hospital
2014-06 PHASE2
NCT00413218 COMPLETED
Candidiasis, Invasive; Candidemia; Mycoses
Astellas Pharma Inc
2007-03-08 PHASE3
NCT01416025 COMPLETED
Fungal Infection
Johns Hopkins University
2012-01 PHASE4
NCT02714504 COMPLETED
Fusariosis; Onychomycosis
Universidade Federal do Rio de Janeiro
2008-08
NCT01344512 COMPLETED
Pediatrics; Ceftazidime; Ciprofloxacin; Voriconazole
University Hospital, Bordeaux
2011-06
NCT01188759 WITHDRAWN
Aspergillosis; Invasive Pulmonary Aspergillosis; Neuroaspergillosis
Pfizer
2012-05 PHASE3
NCT01185405 WITHDRAWN
Invasive Fungal Infection
Asan Medical Center
2010-08
NCT01092832 TERMINATED
Candidiasis
Pfizer
2010-10 PHASE3
NCT01383993 COMPLETED
Aspergillosis, Aspergilloma
Pfizer
2011-09 PHASE2
NCT00836875 TERMINATED
Invasive Aspergillosis
Pfizer
2009-05 PHASE3
NCT01787032 COMPLETED
Healthy
Boehringer Ingelheim
2013-01 PHASE1
NCT00412893 COMPLETED
Aspergillosis; Invasive Fungal Infection
Astellas Pharma Inc
2007-03-07 PHASE3
NCT01539330 COMPLETED
Healthy
Martin-Luther-Universität Halle-Wittenberg
2009-02 PHASE4
NCT01657201 COMPLETED
Systemic Mycotic Infection
Samyang Biopharmaceuticals Corporation
2012-09 PHASE1
NCT00792246 COMPLETED
Graft Versus Host Disease; Stem Cell Transplantation
Phillip Brian Smith
2008-12 PHASE1
NCT00996736 COMPLETED
Corneal Ulcer; Eye Infections, Fungal
University of California, San Francisco
2010-04 PHASE3
NCT01207128 WITHDRAWN
Aspergillosis
University of Arkansas
2011-02 PHASE2
NCT01466803 COMPLETED
Healthy
Turku University Hospital
2011-10 PHASE1
NCT00890708 COMPLETED
Mycoses
Seoul National University Hospital
2008-11
NCT00353158 COMPLETED
Healthy Volunteers; Fungal Infections; Bacterial Infections
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
2007-05-25 PHASE1
NCT00531479 COMPLETED
Aspergillosis
Pfizer
2008-07 PHASE3
NCT01367808 COMPLETED
Pharmacokinetics and Pharmacodynamics of Sublingual Buprenorphine
Turku University Hospital
2011-02 PHASE1
NCT01104376 COMPLETED
Efavirenz, Metabolism and Pharmacokinetics Changes
Indiana University
2010-03
NCT00904995 COMPLETED
Leukemia; Fungal Infection
M.D. Anderson Cancer Center
2009-05 PHASE3
NCT00833482 COMPLETED
Human Immunodeficiency Virus Type 1 (HIV-1); HIV Infections
Bristol-Myers Squibb
2009-09 PHASE1
NCT00496197 COMPLETED
Candidiasis
Pfizer
2007-07 PHASE4
NCT00689338 COMPLETED
Invasive Candidiasis
Pfizer
2008-07 PHASE3
NCT01030653 COMPLETED
Healthy
Manjunath Prakash Pai
2009-11 PHASE4
NCT00624143 UNKNOWN
Pediatric Acute Leukemia Induction
All India Institute of Medical Sciences
2008-02 PHASE3
NCT00556998 COMPLETED
Pharmacokinetics
Pfizer
2008-06 PHASE2
NCT00418951 COMPLETED
Acute Myelogenous Leukemia; Myelodysplastic Syndrome
M.D. Anderson Cancer Center
2006-11 PHASE2
NCT00548262 COMPLETED
Candidemia; Invasive Candidiasis
Pfizer
2008-02 PHASE4
NCT00739934 COMPLETED
Candidiasis; Candidemia
Pfizer
2008-12 PHASE2
NCT00855101 COMPLETED
Healthy Volunteers
Pfizer
2009-04 PHASE1
NCT00150345 COMPLETED
Possible Fungal Infection
Pfizer
2005-01 PHASE3
NCT00942773 COMPLETED
Healthy
Seoul National University Hospital
2008-12 PHASE1
NCT01080651 COMPLETED
Invasive Aspergillosis
Seoul National University Hospital
2008-12 PHASE1
NCT00289991 COMPLETED
Antifungal Prophylaxis of Invasive Fungal Infections
Pfizer
2006-03 PHASE3
NCT00620074 TERMINATED
Aspergillosis
Pfizer
2008-08 PHASE4
NCT00740389 COMPLETED
HIV; AIDS; Fungal Infection
Tibotec Pharmaceuticals, Ireland
2008-09 PHASE1
NCT00159822 COMPLETED
Aspergillosis
Pfizer
2005-07 PHASE2; PHASE3
NCT00386802 COMPLETED
Invader Fungal Infection
PETHEMA Foundation
2006-08 PHASE4
NCT00940017 COMPLETED
Aspergillosis; Candidemia
Pfizer
2008-09 PHASE4
NCT00557362 COMPLETED
Fungal Keratitis
University of California, San Francisco
2007-11 PHASE1; PHASE2
NCT00300677 COMPLETED
Infections, Fungal
Pfizer
2007-03 PHASE4
NCT00238355 TERMINATED
Infection; Unspecified Adult Solid Tumor, Protocol Specific
OHSU Knight Cancer Institute
2003-08 PHASE2
NCT00143312 COMPLETED
Prophylaxis Of Invasive Fungal Infections
Pfizer
2005-02 PHASE4
NCT00288197 COMPLETED
Invasive Fungal Infections
Pfizer
2006-01 PHASE4
NCT00455364 TERMINATED
Infection
University of Chicago
2007-04 PHASE4
NCT00075803 COMPLETED
Lymphoma; Infection; Leukemia
Medical College of Wisconsin
2003-11 PHASE3
NCT00079222 COMPLETED
Cancer
Jonsson Comprehensive Cancer Center
2003-11
NCT00003031 COMPLETED
Infection; Pulmonary Complications
European Organisation for Research and Treatment of Cancer - EORTC
1997-06 PHASE3
NCT00059878 COMPLETED
Infection; Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2003-08 PHASE2
NCT00001810 COMPLETED
Aspergillosis; Candidiasis; Fungemia; Mycoses
National Cancer Institute (NCI)
1999-04 PHASE3
NCT00163111 COMPLETED
Candidiasis
Pfizer
1998-09 PHASE3
NCT00015665 COMPLETED
Mycoses
National Institute of Allergy and Infectious Diseases (NIAID)
2001-04 PHASE3
NCT00647907 COMPLETED
Candidiasis; Cryptococcosis; Aspergillosis
Pfizer
2003-04 PHASE4
NCT00005912 COMPLETED
Aspergillosis; Candidiasis; Fungal Diseases; Mycoses
National Cancer Institute (NCI)
2000-06 PHASE1
NCT00152594 TERMINATED
Leukemia, Myelocytic, Acute
University of Cologne
2004-10 PHASE3
NCT00001940 COMPLETED
Mycoses
National Cancer Institute (NCI)
1999-12 PHASE3
NCT00174473 COMPLETED
Neutropenia
Pfizer
2003-06 PHASE1; PHASE2
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
NCT00066599 COMPLETED
Kidney Cancer; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Neuroblastoma; Neutropenia; Sarcoma
National Cancer Institute (NCI)
2003-06 PHASE2
NCT00001757 COMPLETED
Mycoses
National Institute of Allergy and Infectious Diseases (NIAID)
1997-11 PHASE3
NCT00423163 WITHDRAWN
Aspergillosis/Blood; Aspergillosis/Invasive
Astellas Pharma Inc
2007-02 PHASE4
NCT00001646 COMPLETED
Acquired Immunodeficiency Syndrome; Aspergillosis; HIV Infections; Immunologic Deficiency Syndromes; Neutropenia
National Institute of Allergy and Infectious Diseases (NIAID)
1997-08 PHASE3
NCT00136968 COMPLETED
Fungal Infection
Pfizer
2005-04 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-09-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Voriconazole selectively binds to fungal cytochrome P450-dependent 14-alpha-sterol demethylase, inhibiting the conversion of lanosterol to ergosterol and causing the accumulation of toxic 14-alpha-methyl sterols that compromise fungal cell membrane integrity and inhibit fungal cell growth. This disruption of cell membrane synthesis produces potent antifungal activity against pathogenic fungal species, providing the molecular basis for its clinical efficacy in managing invasive candidiasis and chronic pulmonary aspergillosis.

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.