Last Updated: May 12, 2026

CLINICAL TRIALS PROFILE FOR MYCAMINE


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All Clinical Trials for MYCAMINE

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MYCAMINE

Condition Name

Condition Name for MYCAMINE
Intervention Trials
Invasive Candidiasis 4
Candidemia 3
Candidiasis 3
Mycoses 2
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Condition MeSH

Condition MeSH for MYCAMINE
Intervention Trials
Candidiasis 11
Mycoses 8
Candidiasis, Invasive 7
Candidemia 4
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Clinical Trial Locations for MYCAMINE

Trials by Country

Trials by Country for MYCAMINE
Location Trials
United States 126
Canada 21
Brazil 11
France 6
Spain 5
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Trials by US State

Trials by US State for MYCAMINE
Location Trials
North Carolina 9
California 8
Texas 8
Missouri 6
Virginia 5
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Clinical Trial Progress for MYCAMINE

Clinical Trial Phase

Clinical Trial Phase for MYCAMINE
Clinical Trial Phase Trials
Phase 4 3
Phase 3 10
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for MYCAMINE
Clinical Trial Phase Trials
Completed 19
Terminated 4
Unknown status 2
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Clinical Trial Sponsors for MYCAMINE

Sponsor Name

Sponsor Name for MYCAMINE
Sponsor Trials
Astellas Pharma Inc 17
Children's Hospital Medical Center, Cincinnati 2
Seoul National University Hospital 2
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Sponsor Type

Sponsor Type for MYCAMINE
Sponsor Trials
Industry 20
Other 13
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Mycamine (Micafungin) Clinical Trials Update, Market Analysis and Projection

Last updated: May 10, 2026

What is Mycamine and what does its clinical evidence landscape look like?

Mycamine is the brand name for micafungin, an echinocandin antifungal. The clinical program is mature: micafungin has completed pivotal Phase 3 studies across major invasive fungal disease categories and is widely used in clinical practice. Publicly available updates in recent years largely reflect label management, safety follow-ups, real-world studies, and comparative effectiveness rather than new late-stage registrational trials.

Core clinical development footprint (registrational setting)

Micafungin’s clinical evidence is anchored in Phase 3 programs addressing:

  • Invasive candidiasis (IC)
  • Esophageal candidiasis (EC)
  • Candida prophylaxis in hematology/HSCT settings
  • Refractory invasive fungal disease (including contexts where other antifungals failed or were not suitable)

While trial-level details vary by indication and comparator, the overall evidentiary posture is established: micafungin is positioned as a standard-of-care option where Candida and invasive fungal disease require echinocandin coverage, especially in critically ill populations where resistance management and tolerability matter.

Are there active or ongoing late-stage trials right now for micafungin?

No determination can be made from the provided inputs. A complete, accurate “clinical trials update” requires current registries (e.g., ClinicalTrials.gov) and active protocol status by region, indication, and sponsor. Without verified trial records, a definitive “active vs inactive” statement would be incomplete.

What is the market for Mycamine (micafungin), and how does it compete?

Market structure

The micafungin market is part of the systemic antifungals for invasive fungal infections segment, dominated by echinocandins and expanded by broader antifungal classes (polyens, triazoles), with selection influenced by:

  • Site of infection (IC vs EC vs prophylaxis)
  • Patient severity (ICU, transplant, neutropenia)
  • Drug-drug interactions and renal/hepatic constraints
  • Resistance patterns (echinocandin susceptibility, azole resistance prevalence)

Primary competitive set

In systemic echinocandins, micafungin competes directly with:

  • Anidulafungin (eg, Eraxis)
  • Caspofungin (eg, Cancidas) These products share common clinical positioning (Candida coverage; invasive candidiasis and prophylaxis where applicable) and compete largely on cost, formulary access, dosing convenience, and guideline alignment.

Pricing and access dynamics

For established brands, market performance depends on:

  • Formulary placement in hospitals and integrated delivery networks
  • GPO contracting and rebating
  • Biosimilar/complex generics pressure (for micafungin, access can be affected by generic entry and local tendering)
  • Tender-driven procurement in EU and select APAC markets

A full projection requires country-level unit share and net price trajectories, which are not provided here.

What is the current demand driver profile for micafungin?

Micafungin demand is driven by:

  • Hospitalization incidence of invasive candidiasis and high-risk neutropenic/HSCT populations
  • Guideline adherence favoring echinocandins in IC and prophylaxis contexts
  • Antifungal stewardship decisions that reduce broad-spectrum exposure while maintaining efficacy
  • Resistance and tolerability considerations, especially where azole resistance or interactions constrain use of triazoles

Utilization hotspots

Demand concentrates in:

  • Academic and tertiary hospitals with transplant and oncology services
  • ICUs managing severe sepsis with suspected or confirmed fungal etiology
  • Hematology wards conducting prophylaxis during neutropenia

How could label and safety updates affect market uptake?

For an established agent like micafungin, label management can affect demand through:

  • Expansion or clarification of population coverage
  • Updates to contraindications, warnings, and monitoring requirements
  • New evidence that supports switch therapy or refined dosing strategies

However, without verified label-change dates and specific language, a precise impact model cannot be built here.

Market projection: what growth or decline scenario fits micafungin?

No deterministic projection can be produced from the provided inputs. A credible forecast requires at minimum:

  • Current global and regional micafungin sales, by channel (hospital vs specialty, public vs private)
  • Patent/generic entry timeline and contracting impacts
  • Uptake by indication mix changes
  • Competitor share movement (caspofungin, anidulafungin, and any substitutes)

Without those inputs, any numeric projection would be non-actionable.


Evidence and decision metrics: what should investors and R&D teams track for micafungin now?

Even with a mature drug, decision-making should focus on measurable market levers:

1) Hospital contract position

  • Formulary status for echinocandins in top GPOs
  • Net price trends vs competitors
  • Treatment path adherence (time-to-therapy, step-down outcomes that affect total cost)

2) Indication mix and dosing pattern

  • Share of IC vs prophylaxis vs EC
  • Average duration of therapy in real-world usage
  • Switch therapy uptake (IV to oral triazoles or continuation strategies)

3) Safety signals and risk management

  • Rates of discontinuation and infusion reactions in post-marketing cohorts
  • Any safety monitoring emphasis changes tied to label language

4) Competitor and substitute pressure

  • Net price undercuts by competing echinocandins
  • Tender cycles that shift volume away from micafungin
  • Any substitution due to local guideline changes or payer policies

Key Takeaways

  • Mycamine (micafungin) has a mature clinical evidence base across invasive candidiasis and key high-risk prophylaxis settings; ongoing updates in recent years typically reflect label management and real-world evidence rather than fresh late-stage registrational trials.
  • Market performance is contract-driven: hospital formulary access, GPO contracting, and net pricing vs anidulafungin and caspofungin determine share more than new clinical differentiation.
  • A numerical market projection cannot be produced without current sales, region-level utilization data, and generic/contracting timelines.
  • The most actionable monitoring set is formulary position, indication mix, net price trajectory, and safety-related discontinuation patterns.

FAQs

1) What class is Mycamine?
Mycamine is an echinocandin antifungal (micafungin).

2) What infections does micafungin treat in clinical practice?
Micafungin is used for invasive candidiasis and related Candida infections, including esophageal candidiasis and Candida prophylaxis in high-risk populations (e.g., hematology/HSCT settings).

3) Who are the main competitors?
The main direct competitors in echinocandins are caspofungin and anidulafungin.

4) What drives micafungin demand most?
Demand is driven by hospital incidence and risk profile (ICU, oncology, neutropenia/HSCT), plus formulary and contracting that determine net utilization.

5) Can you provide a forecast number for micafungin sales?
A forecast requires current sales baselines, regional shares, and contracting/generic timelines; those inputs are not provided here.


References

[1] U.S. Food and Drug Administration. Mycamine (micafungin) Prescribing Information. (Current approved label access varies by revision year).
[2] European Medicines Agency. Mycamine: Assessment history and EPAR documents for micafungin.

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