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micafungin

Trade name: mycamine

Small moleculeapproved

Approved

Mar 16, 2005

Micafungin (trade name Mycamine) is an echinocandin antifungal drug. Micafungin, the active ingredient in Mycamine, inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls, which is not present in mammalian cells. Micafungin is indicated for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis, abscesses and esophageal candidiasis. Possible histamine-mediated symptoms have been reported with Mycamine, including rash, pruritus, facial swelling and vasodilatation. — NCATS

Clinical trial activity

54 trials · 39 clinical orgs · 22 marketing orgs

Phase 1
9
Phase 2
26
Phase 3
14
Phase 4
18

Earliest trial started Oct 1, 1998 (NCT00001790)

Timeline

1990s

  1. Jan 1, 1998

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1999

    Astellas — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Mar 16, 2005

    Fujisawa — Earliest FDA Approval

  2. Mar 16, 2005

    Fujisawa — NDA Secondary Org

  3. Mar 16, 2005

    Fujisawa — NDA Organization

  4. Mar 16, 2005

    Astellas — Marketing Organization

  5. Mar 16, 2005

    Astellas — NDA Secondary Org

2010s

  1. May 17, 2019

    Fresenius — Marketing Organization

2020s

  1. Nov 5, 2020

    Apotex — Marketing Organization

  2. Nov 25, 2020

    Teva — Marketing Organization

  3. Dec 9, 2020

    Jiangsu Hansoh Pharmaceutical Co., Ltd. — Marketing Organization

  4. Jun 2, 2021

    Xellia Pharmaceuticals — Marketing Organization

  5. Jun 2, 2021

    Novo Nordisk — Marketing Organization

  6. Jun 16, 2021

    Par Pharmaceuticals — Marketing Organization

  7. Jun 16, 2021

    Endo Pharmaceuticals — Marketing Organization

  8. Jun 16, 2021

    Bristol-Myers Squibb — NDA Secondary Org

  9. Jun 16, 2021

    PH HEALTH — Marketing Organization

  10. Jul 9, 2021

    Hikma — Marketing Organization

  11. Jul 30, 2021

    Teva — NDA Secondary Org

  12. Sep 28, 2022

    Nanjing King-Friend — Marketing Organization

  13. Sep 28, 2022

    Meitheal — Marketing Organization

  14. Oct 24, 2022

    Zydus Discovery DMCC — Marketing Organization

  15. Sep 29, 2023

    Baxalta — Marketing Organization

  16. May 29, 2024

    Biocon Limited — Marketing Organization

  17. Apr 3, 2025

    Qilu Pharmaceutical Co., Ltd. — Marketing Organization

  18. Jan 21, 2026

    Zhejiang Hisun Pharmaceutical Co. Ltd. — Marketing Organization

  19. Feb 24, 2026

    Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization

  20. Mar 17, 2026

    Aspiro — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewMar 16, 2005

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCOc1ccc(-c2cc(-c3ccc(C(=O)N[C@H]4C[C@@H](O)[C@@H](O)NC(=O)[C@@H]5[C@@H](O)[C@@H](C)CN5C(=O)[C@H]([C@H](O)CC(N)=O)NC(=O)[C@H]([C@H](O)[C@@H](O)c5ccc(O)c(OS(=O)(=O)O)c5)NC(=O)[C@@H]5C[C@@H](O)CN5C(=O)[C@H]([C@@H](C)O)NC4=O)cc3)no2)cc1
Mol. weight
1270.29 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • fk463
  • fk463
  • fk463
  • fk463
  • fk 463
  • fk-463
  • fk-463
  • fk-463
  • fk-463
  • fungard
  • micafungin
  • micafungin
  • micafungin
  • micafungin
  • micafungin
  • micafungin
  • micafungin
  • micafungin
  • micafungin
  • micafungin
  • micafungin sodium
  • micafungin sodium
  • micafungin sodium
  • micafungin sodium
  • micafungin sodium
  • micafungin sodium
  • micafungin sodium [usan]
  • mycamine
  • mycamine
  • mycamine
  • mycamine
  • mycamine
  • mycamine
  • mycamine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05784844Phase 4Jan 31, 2024Wake Forest University
NCT06413056Phase 4Oct 20, 2022Ain Shams University
NCT05496725Phase 4Jan 6, 2022Yung Shin Pharm. Ind. Co., Ltd.
NCT04728971Phase 4Feb 1, 2021Jiao Tong University
NCT04738955Phase 4Feb 1, 2021Shandong Provincial Hospital
NCT03906916Phase 4Jul 18, 2018Federation of Associations of Hospital Doctors on Internal Medicine (FADOI) Foundation
NCT03102658Phase 4Jan 1, 2017Astellas, Radboud University, St. Antonius Hospital, Nieuwegein
NCT03421002Phase 2May 30, 2015Astellas, Bambino Gesù Hospital and Research Institute
NCT02440178Phase 2May 1, 2015Astellas, Seoul National University
NCT02172768Phase 2Oct 1, 2014Radboud University
NCT02244606Phase 2Sep 1, 2014Scynexis, Inc.
NCT02164890Phase 4Jun 30, 2014University of Limoges
NCT02145832Phase 2/Phase 3 (Phase 3)Jun 1, 2014Institut National de la Santé Et de la Recherche Médicale, France
NCT02646774Phase 4Mar 1, 2014Astellas
NCT02646800Phase 4Mar 1, 2014Astellas
NCT02057289Phase 1Jan 1, 2014Astellas, Good Samaritan Hospital, Cincinnati, University of Cincinnati
NCT01982071Phase 4Sep 1, 2013Astellas
NCT01888458Phase 2Sep 1, 2013Institut Paoli-Calmettes, University of Bordeaux, University of Lille, University of Lyon, University of Nantes, University of Paris
NCT00815516Phase 3Feb 1, 2013Astellas
NCT01666769Phase 1Jan 1, 2013Duke University
Showing 20 of 54 trials
Page 1 / 3

Organizations

Research & Development (39)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstellasFor profit322341999
Seoul National UniversityAcademic/Hospital3222011
National Cancer Institute (NCI)Government2221998
Radboud UniversityAcademic/Hospital2222014
University of CincinnatiAcademic/Hospital2212007
University of UlsanAcademic/Hospital2222010
Yonsei UniversityAcademic/Hospital2122011
Ain Shams UniversityAcademic/Hospital1112022
Bambino Gesù Hospital and Research InstituteAcademic/Hospital1012015
Cornell UniversityAcademic/Hospital1112010
Daegu Catholic UniversityAcademic/Hospital1012012
Duke UniversityAcademic/Hospital1112013
Federation of Associations of Hospital Doctors on Internal Medicine (FADOI) FoundationAcademic/Hospital1112018
Good Samaritan Hospital, CincinnatiAcademic/Hospital1012014
Hoosier Cancer Research NetworkAcademic/Hospital1112011
Institut National de la Santé Et de la Recherche Médicale, FranceAcademic/Hospital1112014
Institut Paoli-CalmettesAcademic/Hospital1012013
Jiao Tong UniversityAcademic/Hospital1112021
Kyoto UniversityAcademic/Hospital1112006
MerckFor profit1112008
39 organizations
Page 1 / 2

Marketing (26)

OrganizationOrg typeRelationshipDate
ApotexFor profitMKTGNov 5, 2020
AspiroFor profitMKTGMar 17, 2026
AstellasFor profitMKTGMar 16, 2005
AstellasFor profitNDA2Mar 16, 2005
BaxaltaFor profitMKTGSep 29, 2023
Biocon LimitedFor profitMKTGMay 29, 2024
Bristol-Myers SquibbFor profitNDA2Jun 16, 2021
Endo PharmaceuticalsFor profitMKTGJun 16, 2021
FreseniusFor profitMKTGMay 17, 2019
FujisawaFor profitNDA2Mar 16, 2005
FujisawaFor profitNDAMar 16, 2005
HikmaFor profitMKTGJul 9, 2021
Jiangsu Hansoh Pharmaceutical Co., Ltd.For profitMKTGDec 9, 2020
MeithealFor profitMKTGSep 28, 2022
Nanjing King-FriendFor profitMKTGSep 28, 2022
Novo NordiskFor profitMKTGJun 2, 2021
PH HEALTHFor profitMKTGJun 16, 2021
Par PharmaceuticalsFor profitMKTGJun 16, 2021
Qilu Pharmaceutical Co., Ltd.For profitMKTGApr 3, 2025
TevaFor profitMKTGNov 25, 2020
TevaFor profitSYNJul 30, 2021
TevaFor profitNDA2Jul 30, 2021
Xellia PharmaceuticalsFor profitMKTGJun 2, 2021
Yichang Humanwell Pharmaceutical Co.,LtdFor profitMKTGFeb 24, 2026
Zhejiang Hisun Pharmaceutical Co. Ltd.For profitMKTGJan 21, 2026
Zydus Discovery DMCCFor profitMKTGOct 24, 2022