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Last Updated: September 26, 2021

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CLINICAL TRIALS PROFILE FOR MICAFUNGIN

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505(b)(2) Clinical Trials for Micafungin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT02372357 ↗ A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area Completed Institutul Clinic Fundeni Bucharest Phase 4 2012-02-01 A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage NCT02372357 ↗ A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area Completed Universitaire Ziekenhuizen Leuven Phase 4 2012-02-01 A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Micafungin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00047827 ↗ Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis Terminated Astellas Pharma Inc Phase 2 2002-12-01 The purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.
NCT00048750 ↗ Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU Terminated Astellas Pharma Inc Phase 3 2003-01-01 The purpose of this study is to determine the efficacy and safety of intravenous micafungin versus placebo as prophylactic therapy for invasive fungal infections in patients in the intensive care unit considered to be at high risk.
NCT00105144 ↗ Study of Micafungin in Patients With Invasive Candidiasis or Candidemia Completed Astellas Pharma Inc Phase 3 2004-09-01 The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.
NCT00106288 ↗ Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia Completed Astellas Pharma Inc Phase 3 2003-01-01 The purpose of this study is to determine the efficacy and safety of micafungin (FK463) versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or candidemia. Enrollment will include adult and pediatric patients.
NCT00189709 ↗ Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia Completed Astellas Pharma Taiwan, Inc. Phase 3 2004-08-01 To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Micafungin

Condition Name

Condition Name for Micafungin
Intervention Trials
Candidiasis 7
Candidemia 7
Invasive Candidiasis 6
Invasive Aspergillosis 3
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Condition MeSH

Condition MeSH for Micafungin
Intervention Trials
Mycoses 20
Candidiasis 19
Candidiasis, Invasive 12
Candidemia 8
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Clinical Trial Locations for Micafungin

Trials by Country

Trials by Country for Micafungin
Location Trials
United States 178
Canada 22
Brazil 12
France 10
Belgium 8
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Trials by US State

Trials by US State for Micafungin
Location Trials
Texas 13
North Carolina 11
California 11
Missouri 8
Pennsylvania 8
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Clinical Trial Progress for Micafungin

Clinical Trial Phase

Clinical Trial Phase for Micafungin
Clinical Trial Phase Trials
Phase 4 16
Phase 3 11
Phase 2/Phase 3 1
[disabled in preview] 22
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Clinical Trial Status

Clinical Trial Status for Micafungin
Clinical Trial Phase Trials
Completed 27
Terminated 8
Recruiting 6
[disabled in preview] 7
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Clinical Trial Sponsors for Micafungin

Sponsor Name

Sponsor Name for Micafungin
Sponsor Trials
Astellas Pharma Inc 20
Astellas Pharma China, Inc. 4
Radboud University 3
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Sponsor Type

Sponsor Type for Micafungin
Sponsor Trials
Industry 36
Other 33
NIH 4
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