Clinical Trials

Numerous clinical trials across multiple phases evaluate the efficacy and safety of micafungin sodium for candidemia, aspergillosis, invasive or catheter-related fungal infections, and prophylaxis in liver or hematopoietic stem cell transplant recipients. Industry sponsors such as Astellas Pharma, along with academic and government organizations including Nantes University Hospital and the National Institute of Child Health and Human Development, have conducted these studies in pediatric and transplant populations. Across these cohorts, recruitment statuses range from completed to terminated or unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04728971 UNKNOWN
Liver Transplantation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
 2022-10-01 PHASE4
NCT05784844 WITHDRAWN
Febrile Neutropenia
Wake Forest University Health Sciences
 2024-08 PHASE4
NCT06413056 COMPLETED
Neonatal Infection; Invasive Fungal Infections
Ain Shams University
 2022-10-20 PHASE4
NCT04738955 UNKNOWN
Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease
Shandong Provincial Hospital
 2021-02-01 PHASE4
NCT05496725 COMPLETED
Invasive Candidiasis
Yung Shin Pharm. Ind. Co., Ltd.
 2022-01-06 PHASE4
NCT03906916 TERMINATED
Invasive Candidiasis
Fadoi Foundation, Italy
 2018-07-18 PHASE4
NCT01950507 TERMINATED
Stem Cell Transplantation; Graft vs Host Disease
National Institutes of Health Clinical Center (CC)
 2014-02-20 PHASE1
NCT03421002 COMPLETED
Candidiasis, Systemic; Candida Meningitis
Astellas Pharma Global Development, Inc.
 2015-05-30 PHASE2
NCT03102658 COMPLETED
Morbid Obesity
Radboud University Medical Center
 2017-01 PHASE4
NCT02440178 COMPLETED
Acute Leukemia
Seoul National University Hospital
 2015-09-19 PHASE2
NCT01200355 COMPLETED
Acute Myelogenous Leukemia; Myelodysplastic Syndrome
Memorial Sloan Kettering Cancer Center
 2010-09-09 PHASE4
NCT02172768 COMPLETED
Acute Graft Versus Host Disease Grade II-IV; Allogeneic Stem Cell Transplant; Acute Myeloid Leucaemia; Myelo Dysplastic Syndrome
Radboud University Medical Center
 2014-10 PHASE2
NCT02244606 COMPLETED
Mycoses; Candidiasis, Invasive; Candidemia
Scynexis, Inc.
 2014-09 PHASE2
NCT01888458 COMPLETED
Invasive Fungal Infection
Nantes University Hospital
 2013-09 PHASE2
NCT01666769 COMPLETED
Invasive Candidiasis
Kevin Watt
 2013-01 PHASE1
NCT02164890 COMPLETED
Invasive Candidiasis
University Hospital, Limoges
 2014-06 PHASE4
NCT02145832 COMPLETED
Candidiasis
Institut National de la Santé Et de la Recherche Médicale, France
 2014-10 PHASE2; PHASE3
NCT01982071 TERMINATED
Candidemia; Candidiasis
Astellas Pharma China, Inc.
 2013-09-26 PHASE4
NCT02646774 TERMINATED
Invasive Aspergillosis
Astellas Pharma China, Inc.
 2014-03-01 PHASE4
NCT01773876 COMPLETED
Invasive Candidiasis
University Hospital, Grenoble
 2012-07 PHASE3
NCT02651038 COMPLETED
Candida Sepsis
Medical University of Vienna
 2012-05 PHASE4
NCT02646800 TERMINATED
Aspergillosis; Candidiasis
Astellas Pharma China, Inc.
 2014-03-21 PHASE4
NCT01417169 UNKNOWN
Neutropenia; Fungal Disease
Seoul National University Hospital
 2011-08 PHASE2
NCT00815516 TERMINATED
Candidiasis
Astellas Pharma Global Development, Inc.
 2013-02 PHASE3
NCT02057289 TERMINATED
Immunocompromised; Bone Marrow Transplant; Cancer
Children's Hospital Medical Center, Cincinnati
 2014-01 PHASE1
NCT01974375 UNKNOWN
Liver Transplant Recipient
Asan Medical Center
 2012-08 PHASE3
NCT01344681 COMPLETED
Febrile Neutropenia; Hematological Diseases
Yonsei University
 2011-06 PHASE2
NCT01058174 COMPLETED
Liver Transplantation; Mycoses
Astellas Pharma Inc
 2009-12-15 PHASE3
NCT01135589 UNKNOWN
Neutropenia; Hematopoietic Stem Cell Transplantation; Invasive Fungal Disease
Asan Medical Center
 2010-04 PHASE4
NCT01207128 WITHDRAWN
Aspergillosis
University of Arkansas
 2011-02 PHASE2
NCT01122368 COMPLETED
Mycoses
Astellas Pharma Inc
 2010-07-13 PHASE2
NCT00608335 COMPLETED
Oropharyngeal Candidiasis; Candidemia; Invasive Candidiasis; Esophageal Candidiasis
Astellas Pharma Inc
 2007-10-14 PHASE1
NCT00717860 COMPLETED
Fungal Infection
Merck Sharp & Dohme LLC
 2008-08 PHASE3
NCT00839540 COMPLETED
Candidemia
Gary E. Stein, Pharm.D.
 2008-12 PHASE4
NCT01090141 COMPLETED
Obesity; Nutrition Disorders; Overweight
University of Texas Southwestern Medical Center
 2009-11 PHASE4
NCT00842504 COMPLETED
Fungal Infection
Children's Hospital Medical Center, Cincinnati
 2007-07 PHASE1
NCT00794703 COMPLETED
Fungemia; Fungal Infections
Astellas Pharma Inc
 2008-11 PHASE3
NCT00607763 COMPLETED
Invasive Candidiasis; Esophageal Candidiasis; Oropharyngeal Candidiasis; Candidemia
Astellas Pharma Inc
 2007-10 PHASE1
NCT00606268 COMPLETED
Fungal Infections
Astellas Pharma Inc
 2007-11 PHASE1
NCT00304772 WITHDRAWN
Candidiasis; Sepsis
Kyoto University
 2006-08 PHASE4
NCT00376337 TERMINATED
Invasive Aspergillosis
Astellas Pharma Inc
 2006-06 PHASE2
NCT00809887 TERMINATED
Catheter-Related Fungal Infections
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2006-06 PHASE1
NCT00818584 COMPLETED
Candida
Astellas Pharma Inc
 2007-08 PHASE1
NCT00189709 COMPLETED
Invasive Candidiasis; Candidemia
Astellas Pharma Inc
 2004-08 PHASE3
NCT00105144 COMPLETED
Candidiasis; Candidemia
Astellas Pharma Inc
 2004-09 PHASE3
NCT00106288 COMPLETED
Candidiasis
Astellas Pharma Inc
 2003-01 PHASE3
NCT00665639 COMPLETED
Candidiasis, Oral
Astellas Pharma Inc
 2004-06 PHASE3
NCT00666185 COMPLETED
Candidiasis, Oral
Astellas Pharma Inc
 2003-08 PHASE3
NCT00048750 TERMINATED
Invasive Fungal Infections
Astellas Pharma Inc
 2003-01 PHASE3
NCT00047827 TERMINATED
Aspergillosis
Astellas Pharma Inc
 2002-12 PHASE2
NCT00423163 WITHDRAWN
Aspergillosis/Blood; Aspergillosis/Invasive
Astellas Pharma Inc
 2007-02 PHASE4

(data from https://clinicaltrials.gov, updated on 2022-08-16)

Check the Micafungin Sodium (FK-463) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Micafungin sodium functions as an echinocandin antifungal agent that selectively inhibits 1,3-beta-D-glucan synthase, thereby halting the synthesis of 1,3-beta-D-glucan, an essential polymer required for fungal cell wall structural integrity. This targeted enzymatic inhibition leads to osmotic fragility and subsequent cell lysis, rendering the compound effective in the treatment and prophylaxis of invasive fungal infections, candidemia, and 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>).

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