Numerous clinical trials evaluate the therapeutic efficacy and prophylactic utility of posaconazole across Phase 1 through Phase 4 studies and observational protocols. Supported by academic medical centers and major pharmaceutical sponsors, research targets fungal conditions—including mycoses, mucormycosis, and onychomycosis—as well as antifungal prophylaxis in patients with hematologic malignancies. The clinical landscape comprises actively recruiting, completed, terminated, and withdrawn studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07261150 | NOT_YET_RECRUITING | Histoplasmosis |
University of Minnesota |
2026-09-15 | PHASE3 |
| NCT07780565 | NOT_YET_RECRUITING | Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome |
M.D. Anderson Cancer Center |
2027-01-01 | PHASE1 |
| NCT07155226 | RECRUITING | Acute Lymphoblastic Leukaemia; Acute Myeloid Leukaemia; Higher-risk Myelodysplastic Syndromes |
AstraZeneca |
2026-01-09 | PHASE1; PHASE2 |
| NCT07723703 | NOT_YET_RECRUITING | Acute Myeloid Leukaemia; High Risk Myelodysplastic Syndrome |
Amphista Therapeutics Ltd |
2026-09-01 | PHASE1 |
| NCT04771130 | RECRUITING | Acute Myeloid Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasm |
BeOne Medicines |
2021-05-24 | PHASE1; PHASE2 |
| NCT03828773 | RECRUITING | Candidiasis; Fungal Infection; Acute Myeloid Leukemia; Genetic Predisposition; Aspergillosis |
Bochud Pierre-Yves |
2019-02-11 | |
| NCT07719348 | NOT_YET_RECRUITING | Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia; Myelodysplastic Syndrome Acute Myeloid Leukemia |
Servier |
2026-09-15 | PHASE1; PHASE2 |
| NCT04665037 | RECRUITING | Invasive Fungal Infection |
Merck Sharp & Dohme LLC |
2022-02-22 | PHASE2 |
| NCT06541067 | RECRUITING | Hematologic Malignancy |
Nantes University Hospital |
2024-11-08 | PHASE2 |
| NCT06802757 | RECRUITING | Breast Cancer |
Shandong Cancer Hospital and Institute |
2025-05-01 | PHASE2 |
| NCT05468372 | COMPLETED | Mucormycosis; Pulmonary (Etiology) |
Post Graduate Institute of Medical Education and Research, Chandigarh |
2022-07-01 | PHASE2 |
| 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 |
| NCT03717623 | RECRUITING | Posaconazole; Pharmacokinetics; Invasive Candidiases; Invasive Aspergillosis; Invasive Mycosis; Fungal Infection; Prophylaxis |
Melbourne Health |
2019-08-01 | PHASE4 |
| NCT03763396 | NOT_YET_RECRUITING | Brain Tumor, Recurrent; Cancer, Advanced; Glioma of Brain |
University Health Network, Toronto |
2024-06-01 | EARLY_PHASE1 |
| NCT04966585 | TERMINATED | Crohn Disease; CARD9 S12N Risk Allele |
Cedars-Sinai Medical Center |
2022-08-17 | PHASE4 |
| NCT04825275 | TERMINATED | Glioblastoma; Glioblastoma Multiforme; Glioblastoma Multiforme of Brain; Glioblastoma Multiforme, Adult |
Milton S. Hershey Medical Center |
2022-05-13 | EARLY_PHASE1 |
| NCT04294641 | COMPLETED | Chronic GVHD |
National Cancer Institute (NCI) |
2021-05-10 | PHASE2 |
| NCT06282718 | Not yet recruiting | Acute Respiratory Tract Infection |
European Clinical Research Alliance for Infectious Diseases (ECRAID)|UMC Utrecht|University of Oxford|Universiteit Antwerpen |
2024-02 | -- |
| NCT06158360 | Recruiting | Thyroid Cancer |
Ilsan Cha hospital |
2024-01-01 | -- |
| NCT04218851 | COMPLETED | Invasive Aspergillosis |
Merck Sharp & Dohme LLC |
2020-07-02 | PHASE2 |
| NCT05845359 | Withdrawn | Bariatric Surgery Candidate |
Montefiore Medical Center |
2023-09 | Phase 4 |
| NCT03318159 | COMPLETED | Aplastic Anemia; Myelodysplastic Syndromes; Fungal Infection |
Seoul National University Hospital |
2018-04-20 | PHASE2 |
| NCT06302842 | Active not recruiting | Supportive Care |
Istituto Auxologico Italiano |
2023-07-01 | Not Applicable |
| NCT05617638 | Recruiting | Pain |
Hospital Israelita Albert Einstein|Beneficência Portuguesa de São Paulo |
2023-06-27 | Not Applicable |
| NCT03796533 | UNKNOWN | Leukemia, Myeloid, Acute |
Hospices Civils de Lyon |
2018-12-10 | |
| NCT04966234 | UNKNOWN | Cystic Fibrosis; Aspergillosis |
Bambino Gesù Hospital and Research Institute |
2021-04-22 | PHASE2; PHASE3 |
| NCT02203773 | TERMINATED | Acute Myelogenous Leukemia; Myelogenous Leukemia; Treatment Naive AML |
AbbVie |
2014-10-06 | PHASE1 |
| NCT03760445 | WITHDRAWN | Leukemia, Myeloid, Acute |
Novartis Pharmaceuticals |
2019-11-15 | PHASE1; PHASE2 |
| NCT04194086 | COMPLETED | Leukemia, Acute |
Zhujiang Hospital |
2018-11-01 | PHASE1; PHASE2 |
| NCT03561415 | UNKNOWN | Fungal Infection |
Bayside Health |
2018-07-02 | PHASE2 |
| NCT03378479 | COMPLETED | Aspergillosis; Pulmonary, Invasive (Etiology) |
Universitaire Ziekenhuizen KU Leuven |
2017-12-27 | PHASE4 |
| NCT03434704 | COMPLETED | Transplant-Related Hematologic Malignancy; Leukemia, Acute; Myelodysplastic Syndromes; Graft Vs Host Disease; Fungal Infection |
Ciceri Fabio |
2018-06-18 | PHASE2 |
| NCT03631602 | UNKNOWN | IFD Post-HSCT |
Fujian Medical University |
2017-10-01 | PHASE2; PHASE3 |
| NCT02805946 | COMPLETED | Allogeneic Stem Cell Transplant; Acute Graft Versus Host Disease; Acute Myeloid Leucaemia; Myelo Dysplastic Syndrome |
Radboud University Medical Center |
2017-04-28 | PHASE4 |
| NCT01782131 | COMPLETED | Fungal Infections; Invasive Pulmonary Aspergillosis |
Merck Sharp & Dohme LLC |
2013-09-25 | PHASE3 |
| NCT02358499 | COMPLETED | Fungal Infections |
Children's Mercy Hospital Kansas City |
2015-01 | PHASE1 |
| NCT03336502 | COMPLETED | Fungal Infection |
Merck Sharp & Dohme LLC |
2017-12-20 | PHASE1 |
| NCT02875743 | COMPLETED | Aplastic Anemia; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Bone Marrow Transplantation |
King's College Hospital NHS Trust |
2016-12-07 | PHASE4 |
| NCT03614455 | COMPLETED | Pharmacokinetics |
Daiichi Sankyo |
2018-07-13 | EARLY_PHASE1 |
| NCT03246386 | COMPLETED | Morbid Obesity |
Radboud University Medical Center |
2017-11-05 | PHASE4 |
| NCT02452034 | COMPLETED | Neutropenia |
Merck Sharp & Dohme LLC |
2015-09-07 | PHASE1 |
| NCT02180165 | COMPLETED | Aspergillosis |
Merck Sharp & Dohme LLC |
2014-07-29 | PHASE3 |
| NCT03036046 | WITHDRAWN | Acute Myeloid Leukemia |
F2G Ltd |
2017-03 | PHASE1; PHASE2 |
| NCT03095547 | WITHDRAWN | Invasive Aspergillosis |
F2G Ltd |
2017-05 | PHASE1 |
| NCT02968134 | COMPLETED | Systemic Fungal Infections |
Royal Brisbane and Women's Hospital |
2017-01-16 | PHASE4 |
| NCT01200355 | COMPLETED | Acute Myelogenous Leukemia; Myelodysplastic Syndrome |
Memorial Sloan Kettering Cancer Center |
2010-09-09 | PHASE4 |
| NCT02387983 | COMPLETED | Fungal Infection |
Merck Sharp & Dohme LLC |
2015-05-06 | PHASE1 |
| NCT01901172 | COMPLETED | Neoplasms |
Hoffmann-La Roche |
2013-08 | PHASE1 |
| NCT01716234 | TERMINATED | Fungal Infections |
Merck Sharp & Dohme LLC |
2008-04-17 | PHASE1 |
| NCT01419678 | COMPLETED | Lung Transplant Infection; Fungal Infection |
University of Pittsburgh |
2011-10 | |
| NCT02020213 | WITHDRAWN | Clinical Infection |
Taichung Veterans General Hospital |
2013-12 | PHASE4 |
| NCT02714504 | COMPLETED | Fusariosis; Onychomycosis |
Universidade Federal do Rio de Janeiro |
2008-08 | |
| NCT02372357 | COMPLETED | Hematological Malignancy |
Universitaire Ziekenhuizen KU Leuven |
2012-02 | PHASE4 |
| NCT01377480 | COMPLETED | Chagas Disease |
Merck Sharp & Dohme LLC |
2011-07-06 | PHASE2 |
| NCT01984229 | COMPLETED | Healthy Volunteer |
Hoffmann-La Roche |
2013-12 | PHASE1 |
| NCT01667107 | TERMINATED | Fungal Infection |
Merck Sharp & Dohme LLC |
2013-01-23 | PHASE4 |
| NCT00936117 | COMPLETED | Leukemia; Fungal Infection |
M.D. Anderson Cancer Center |
2009-09 | PHASE2 |
| NCT01162967 | COMPLETED | Chagas Disease |
Hospital Universitari Vall d'Hebron Research Institute |
2010-09 | PHASE2 |
| NCT01075984 | COMPLETED | Fungal Infection |
Merck Sharp & Dohme LLC |
2010-02-23 | PHASE1 |
| NCT00550732 | COMPLETED | Mycoses |
Merck Sharp & Dohme LLC |
2007-12 | PHASE2 |
| NCT00750737 | COMPLETED | Invasive Fungal Infections; Hematologic Malignancies |
M.D. Anderson Cancer Center |
2008-06 | PHASE3 |
| NCT01777763 | COMPLETED | Fungal Infections |
Merck Sharp & Dohme LLC |
2009-06 | PHASE1 |
| NCT01367808 | COMPLETED | Pharmacokinetics and Pharmacodynamics of Sublingual Buprenorphine |
Turku University Hospital |
2011-02 | PHASE1 |
| NCT00799071 | COMPLETED | Chronic Granulomatous Disease |
Radboud University Medical Center |
2009-02 | PHASE2 |
| NCT00811928 | COMPLETED | Leukopenia |
Merck Sharp & Dohme LLC |
2008-11 | PHASE3 |
| NCT00811642 | COMPLETED | Fungal Infection |
Merck Sharp & Dohme LLC |
2008-11 | PHASE3 |
| NCT00817765 | COMPLETED | HIV Infection; Fungal Infection |
Radboud University Medical Center |
2009-01 | PHASE1 |
| NCT00423267 | COMPLETED | Coccidioidomycosis |
Merck Sharp & Dohme LLC |
2007-05 | PHASE3 |
| NCT00686543 | COMPLETED | Fungal Infection; Acute Myelogenous Leukemia; Neutropenia |
Merck Sharp & Dohme LLC |
2007-12 | PHASE4 |
| NCT00491764 | COMPLETED | Onychomycosis |
Merck Sharp & Dohme LLC |
2007-06 | PHASE2 |
| NCT00034632 | COMPLETED | Mycoses |
Merck Sharp & Dohme LLC |
2001-04 | PHASE3 |
| NCT00044486 | COMPLETED | Leukemia, Myelocytic, Acute; Myelodysplastic Syndromes; Neutropenia |
Merck Sharp & Dohme LLC |
2002-07 | PHASE3 |
| NCT00034645 | COMPLETED | Mycoses |
Merck Sharp & Dohme LLC |
1999-01 | PHASE3 |
| NCT00034658 | COMPLETED | Mycoses |
Merck Sharp & Dohme LLC |
1998-12 | PHASE3 |
| NCT00034671 | COMPLETED | Mycoses |
Merck Sharp & Dohme LLC |
2001-01 | PHASE2 |
| NCT00002399 | COMPLETED | Candidiasis, Oral; HIV Infections |
Schering-Plough |
PHASE2 | |
| NCT00177749 | TERMINATED | Fungal Infection |
University of Pittsburgh |
2004-08 | PHASE4 |
| NCT00002446 | COMPLETED | Candidiasis, Oral; HIV Infections |
Schering-Plough |
1998-08 | PHASE3 |
| NCT00033982 | COMPLETED | Granulomatous Disease, Chronic; Job's Syndrome; Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2002-04-11 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-05-08)
Check the
Posaconazole
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.