MICAFUNGIN SODIUM · ASPIRO
Micafungin sodium is an echinocandin antifungal indicated for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses in adult and pediatric patients. In pediatric patients younger than 4 months of age, its use is specifically indicated for these conditions provided there is no evidence of meningoencephalitis or ocular dissemination. It is also indicated for the treatment of esophageal candidiasis and as prophylaxis against Candida infections in patients undergoing hematopoietic stem cell transplantation (HSCT). It has not been adequately studied for use in endocarditis, osteomyelitis, or meningoencephalitis due to Candida.
How MICAFUNGIN SODIUM Works
Micafungin is an antifungal agent in the echinocandin class. It acts by noncompetitively inhibiting the synthesis of 1,3-beta-D-glucan, an essential component of the fungal cell wall that is not present in mammalian cells. This leads to osmotic instability and fungal cell death. It demonstrates concentration-dependent activity against most species of Candida.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2005-03-16
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
Companies
MICAFUNGIN SODIUM Approval History
What MICAFUNGIN SODIUM Treats
6 indicationsMICAFUNGIN SODIUM is approved for 6 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Candidemia
- Disseminated Candidiasis
- Candida Peritonitis
- Abscess
- Esophageal Candidiasis
- Candida Infections
MICAFUNGIN SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MICAFUNGIN SODIUM
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01344681 | 4-2011-0794 | Ph 2 | completed | Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MICAFUNGIN SODIUM FDA Label Details
Indications & Usage
Micafungin for injection is indicated for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies and Use in Specific Populations ]. Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations ] . Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies ...
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MYCAMINE
Full clinical data, patents, trials, and competitive landscape for micafungin sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment