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)
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>).