Drugs / Micafungin
Micafungin
also known as
FK463 · Mycamine · Micafungin sodium · Fungard · Funguard · MCA · Micafungin na · Micafungin sodium salt · +3 more
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | MYCAMINE | — | 2008-01-22 – 2019-12-20 | fda.gov ↗ |
| Approved | EU (EMA) | Mycamine | — | 2008-04-25 | europa.eu ↗ |
| Approved | US (FDA) | MYCAMINE | — | 2005-03-16 | fda.gov ↗ |
Trials 44
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT02057289 | Jan → Nov 2014 | cancer, immunodeficiency disease | Children's Hospital Medical Center, Cincinnati | Terminated | No outcome recorded |
| Phase 1 | NCT01666769 | Jan 2013 → Feb 2016 | candidiasis, invasive | Kevin Watt | Completed | No outcome recorded |
| Phase 1 | NCT00606268 | Nov 2007 → Mar 2009 | fungal infectious disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00608335 | Oct 2007 → Sep 2011 | candidemia, esophageal candidiasis, oral candidiasis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00607763 | Oct 2007 → Oct 2009 | candidemia, esophageal candidiasis, oral candidiasis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00818584 | Aug → Oct 2007 | candidiasis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00842504 | Jul 2007 → Dec 2009 | fungal infectious disease | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 1 | NCT00809887 | Jun 2006 → Jun 2008 | fungal infectious disease | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00001790 | Oct 1998 → Sep 2000 | fungal infectious disease, neutropenia | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 211 trials · 1 missed | ||||||
| Phase 2 | NCT02440178 | Sep 2015 → Jun 2017 | acute leukemia | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03421002 | May 2015 → Apr 2018 | candidiasis, fungal meningitis | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02172768 | Oct 2014 → Jun 2016 | acute graft versus host disease, acute myeloid leukemia, myelodysplastic syndrome | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01888458 | Sep 2013 → Apr 2016 | fungal infectious disease | Nantes University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01417169 | Aug 2011 → Dec 2014 | fungal infectious disease, neutropenia | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01344681 | Jun 2011 → Mar 2014 | neutropenia | Yonsei University | Completed | No outcome recorded |
| Phase 2 | NCT01122368 | Jul 2010 → Dec 2011 | fungal infectious disease | Astellas Pharma Inc | Completed | Missed primary |
| Phase 2 | NCT00376337 | Jun 2006 → Sep 2008 | invasive aspergillosis | Astellas Pharma Inc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00047827 | Dec 2002 → Feb 2003 | invasive aspergillosis | Astellas Pharma Inc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00036179 | Feb 1999 → Jan 2002 | candidiasis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT00036166 | Jan 1999 → Jan 2002 | aspergillosis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02145832 | Oct 2014 → Nov 2015 | candidiasis | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 311 trials · 3 met primary | ||||||
| Phase 3 | NCT00815516 | Feb 2013 → Dec 2014 | candidiasis | Astellas Pharma Global Development, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01974375 | Aug 2012 → Jun 2014 | — | Asan Medical Center | Unknown | Met primary |
| Phase 3 | NCT01058174 | Dec 2009 → May 2012 | fungal infectious disease | Astellas Pharma Inc | Completed | Met primary |
| Phase 3 | NCT00794703 | Nov 2008 → Nov 2009 | fungal infectious disease | Astellas Pharma Inc | Completed | Met primary |
| Phase 3 | NCT00105144 | Sep 2004 → Apr 2006 | candidemia | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00189709 | Aug 2004 → Jul 2006 | candidemia | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00665639 | Jun → Dec 2004 | oral candidiasis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00666185 | Aug 2003 → Feb 2004 | oral candidiasis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00106288 | Jan 2003 → Dec 2005 | candidiasis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00048750 | Jan → Jun 2003 | fungal infectious disease | Astellas Pharma Inc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00001937 | Nov 1999 → Dec 2000 | aspergillosis, candidiasis | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT06413056 | Oct 2022 → May 2023 | candidiasis, invasive | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT04728971 | Oct 2022 → Oct 2025 | — | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT04738955 | Feb 2021 → Jan 2023 | fungal infectious disease | Shandong Provincial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02805049 | Jan 2017 → Jun 2018 | infectious disease with sepsis, peritonitis | Nîmes University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03102658 | Jan → Jul 2017 | morbid obesity | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02646800 | Mar → Dec 2014 | aspergillosis, candidiasis | Astellas Pharma Inc | Terminated | No outcome recorded |
| Phase 4 | NCT02646774 | Mar 2014 → Jun 2015 | invasive aspergillosis | Astellas Pharma Inc | Terminated | No outcome recorded |
| Phase 4 | NCT01982071 | Sep 2013 → Aug 2015 | candidemia | Astellas Pharma Inc | Terminated | No outcome recorded |
| Phase 4 | NCT02651038 | May 2012 → Jan 2015 | candidemia | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT01200355 | Sep 2010 → Apr 2017 | acute myeloid leukemia, myelodysplastic syndrome | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 4 | NCT01135589 | Apr 2010 → May 2012 | disease related to hematopoietic stem cell transplant, fungal infectious disease, neutropenia | Asan Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT00423163 | Feb 2007 → ? | invasive aspergillosis | Astellas Pharma Inc | Withdrawn | No outcome recorded |
| Comparator or background therapy12 trials | ||||||
| Phase 1 | NCT01950507 Background | Feb 2014 → May 2018 | graft versus host disease | National Institutes of Health Clinical Center (CC) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02244606 Comparator | Sep 2014 → Jun 2016 | candidemia | Scynexis, Inc. | Completed | Met primary |
| Phase 2 | NCT01207128 Comparator | Feb 2011 → Jan 2012 | invasive aspergillosis | University of Arkansas | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05178862 Background | Aug 2022 → Nov 2025 | candidemia | Scynexis, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01773876 Comparator | Jul 2012 → Feb 2015 | candidiasis, invasive | University Hospital, Grenoble | Completed | No outcome recorded |
| Phase 3 | NCT00717860 Comparator | Aug 2008 → Jul 2010 | fungal infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT07072923 Comparator | Sep 2025 → Jul 2027 expected | osteomyelitis | University of Arizona | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05784844 Comparator | Aug 2024 → Apr 2025 | neutropenia | Wake Forest University Health Sciences | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03906916 Background | Jul → Dec 2018 | candidiasis, invasive | Fadoi Foundation, Italy | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01090141 Comparator | Nov 2009 → May 2010 | obesity disorder | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00839540 Comparator | Dec 2008 → May 2010 | candidemia | Gary E. Stein, Pharm.D. | Completed | No outcome recorded |
| Phase 4 | NCT00304772 Comparator | Aug 2006 → Dec 2008 | candidiasis, infectious disease with sepsis | Kyoto University | Withdrawn | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2022-10-26 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Micafungin for Injection zyduslife.com ↗
Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Micafungin for Injection, 50 mg/vial and 100 mg/vial, single-dose vials (USRLD: Mycamine®). |
| 2006-04-20 | Astellas Pharma Inc | Regulatory Approval for Candin Antifungal Agent Funguard for Pediatrics in Japan astellas.com ↗
Astellas Pharma Inc. ("Astellas"; headquarters: Tokyo; President and CEO: Toichi Takenaka) has today announced that the candin antifungal agent, "Funguard® for Infusion" (generic name: micafungin sodium), was approved for pediatrics in Japan on April 20, 2006. |
| 2006-04-13 | Astellas Pharma Inc | Regulatory MAA Submission for Candin Antifungal Agent Micafungin in EU astellas.com ↗
submitted a Marketing Authorization Application (MAA) for candin antifungal agent "micafungin" (generic name) for the treatment of systemic fungal infections to the European Medicines Agency (EMEA) on April 11. |
All press releases naming this drug 9 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Micafungin | “Calcium sulfate beads will be loaded with best available antibiotics based on surgeon/infectious disease specialist determination from the following options (vancomycin,...” NCT07072923 ↗51“Micafungin (FK463) is a new lipopeptide compound (echinocandin) with activity against Aspergillus and Candida species.” PMID 16678903 ↗ May 2006 “The patients included in this protocol require routine treatment with caspofungin or micafungin.” NCT02805049 ↗ “Micafungin” NCT05178862 ↗ |
| Known as | FK463 | “Micafungin (FK463) is a new lipopeptide compound (echinocandin) with activity against Aspergillus and Candida species.” PMID 16678903 ↗ May 2006 |
| Known as | Fungard | ChEMBL registry synonym — accepted as the source's own label CHEMBL457547 ↗ |
| Known as | Funguard | ChEMBL registry synonym — accepted as the source's own label CHEMBL457547 ↗ |
| Known as | MCA | “Micafungin (MCA) has broad-spectrum fungicidal activity against Candida spp.” PMID 29596222 ↗ Oct 2018 |
| Known as | Micafungin na | ChEMBL registry synonym — accepted as the source's own label CHEMBL457547 ↗ |
| Known as | Micafungin sodium | “Micafungin sodium 150 mg/day, once daily IV, for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.” NCT00717860 ↗ |
| Known as | Micafungin sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL457547 ↗ |
| Known as | Micafungina | ChEMBL registry synonym — accepted as the source's own label CHEMBL457547 ↗ |
| Known as | Micafungine | ChEMBL registry synonym — accepted as the source's own label CHEMBL457547 ↗ |
| Known as | Mycamin | “Pharmacokinetics of Micafungin (Mycamin ®) as Antifungal Prophylaxis Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an...” NCT02172768 ↗ |
| Known as | Mycamine | “Micafungin (trade name Mycamine) is an echinocandin antifungal drug developed by Astellas Pharma.” NCT02057289 ↗3“Mycamine 50mg - 10 mg/mL of micafungin” NCT02145832 ↗ “with micafungin (MYCAMINE 100 mg)” NCT01773876 ↗ “Micafungin (Mycamine)” NCT00607763 ↗ |
| Action | Inhibit | “micafungin has a low potential to cause drug-drug interactions through inhibition of CYP3A4” NCT01950507 ↗ |
| Modality | Peptide | “cell wall-active antifungal lipopeptide” NCT00001790 ↗ |
| Route | Intravenous | “Intravenous FK463 will be administered daily as a one hour infusion” NCT00001790 ↗ |
| Target | CYP3A4 | “micafungin has a low potential to cause drug-drug interactions through inhibition of CYP3A4” NCT01950507 ↗ |