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Drug

Micafungin

Approved · EMA
Late-stage development

Also known as Mycamine, Micafungina.

1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Mycamine (EMA)

Regulatory2008-04-25EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Micafungin
Aliases & brands
MycamineMicafungina
RxNorm CUI
325887
ChEMBL ID
CHEMBL457547
UNII
R10H71BSWG
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2008-04-25
Latest approval
2008-04-25
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2008-04-25Approval
Approval: Mycamine (EMA)
Indication: Mycamine is indicated for: Adults, adolescents ≥ 16 years of age and elderly treatment of invasive candidiasis; treatment of oesophageal candidiasis in patients for whomShow full indication

Mycamine is indicated for: Adults, adolescents ≥ 16 years of age and elderly treatment of invasive candidiasis; treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate; prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. Children (including neonates) and adolescents < 16 years of age treatment of invasive candidiasis. prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. The decision to use Mycamine should take into account a potential risk for the development of liver tumours. Mycamine should therefore only be used if other antifungals are not appropriate.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

44 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
44
registered trials across all phases
LATEST COMPLETION 2023
27
Late-stage (III+)
28
Completed
16
Discontinued
PHASE DISTRIBUTIONn = 44
Phase 18Phase 29Phase 2 / 31Phase 311Phase 415

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.