MYCAMINE (micafungin sodium)
MYCAMINE is indicated for the treatment of Candidemia; Disseminated Candidiasis; Candida Peritonitis; Abscess; Esophageal Candidiasis; Candida Infections.
How MYCAMINE Works
Micafungin is an antifungal agent of the echinocandin class. It works by inhibiting the synthesis of 1,3-beta-D-glucan, an essential polysaccharide component of the fungal cell wall that is not present in mammalian cells. This inhibition results in osmotic instability and cell death in susceptible *Candida* species.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2005-03-16
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE
MYCAMINE Approval History
What MYCAMINE Treats
6 indicationsMYCAMINE is approved for 6 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Candidemia
- Disseminated Candidiasis
- Candida Peritonitis
- Abscess
- Esophageal Candidiasis
- Candida Infections
MYCAMINE 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 MYCAMINE
3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
MYCAMINE FDA Label Details
Indications & Usage
FDA Label (PDF)MYCAMINE is indicated for the treatment of Candidemia; Disseminated Candidiasis; Candida Peritonitis; Abscess; Esophageal Candidiasis; Candida Infections.
Track MYCAMINE with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
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