Last reviewed · How we verify
Micafungin (Mycamine)
Micafungin (Mycamine) is a Echinocandin antifungal Small molecule drug developed by Astellas Pharma Inc. It is currently in Phase 3 development for Candidemia and acute disseminated candidiasis, Esophageal candidiasis, Prophylaxis of Candida infections in hematopoietic stem cell transplant recipients. Also known as: FK463, Mycamine.
Micafungin inhibits fungal cell wall synthesis by targeting 1,3-beta-D-glucan synthase, leading to fungal cell death.
Micafungin, also known as Mycamine, is a small molecule used to treat various fungal infections, including candidiasis and aspergillosis. It has been studied in clinical trials for its pharmacokinetics in overweight, obese, and extremely obese volunteers, as well as compared to other antifungal medications such as fluconazole and caspofungin acetate.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Micafungin (Mycamine) |
|---|---|
| Also known as | FK463, Mycamine |
| Sponsor | Astellas Pharma Inc |
| Drug class | Echinocandin antifungal |
| Target | 1,3-beta-D-glucan synthase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Micafungin is an echinocandin antifungal that selectively inhibits the enzyme 1,3-beta-D-glucan synthase in the fungal cell wall. This prevents the synthesis of beta-glucan, a critical structural component of the fungal cell wall, causing cell wall integrity to fail and resulting in fungal cell lysis and death. The mechanism is selective for fungi and has minimal effect on human cells.
Approved indications
- Candidemia and acute disseminated candidiasis
- Esophageal candidiasis
- Prophylaxis of Candida infections in hematopoietic stem cell transplant recipients
Common side effects
- Phlebitis
- Elevated liver enzymes
- Headache
- Nausea
- Rash
- Fever
Key clinical trials
- A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole (PHASE3)
- Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis (EPI Study) (PHASE4)
- Pharmacokinetics of Micafungin in Patients of Intensive Care Units (PHASE4)
- Fluconazole Versus Micafungin in Neonates With Candidiasis (PHASE2, PHASE3)
- Antibiotic Impregnated Beads in Osteomyelitis (PHASE4)
- A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia
- A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia (PHASE4)
- Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Micafungin (Mycamine) CI brief — competitive landscape report
- Micafungin (Mycamine) updates RSS · CI watch RSS
- Astellas Pharma Inc portfolio CI
Frequently asked questions about Micafungin (Mycamine)
What is Micafungin (Mycamine)?
How does Micafungin (Mycamine) work?
What is Micafungin (Mycamine) used for?
Who makes Micafungin (Mycamine)?
Is Micafungin (Mycamine) also known as anything else?
What drug class is Micafungin (Mycamine) in?
What development phase is Micafungin (Mycamine) in?
What are the side effects of Micafungin (Mycamine)?
What does Micafungin (Mycamine) target?
Related
- Drug class: All Echinocandin antifungal drugs
- Target: All drugs targeting 1,3-beta-D-glucan synthase
- Manufacturer: Astellas Pharma Inc — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Candidemia and acute disseminated candidiasis
- Indication: Drugs for Esophageal candidiasis
- Indication: Drugs for Prophylaxis of Candida infections in hematopoietic stem cell transplant recipients
- Also known as: FK463, Mycamine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing