MICAFUNGIN (micafungin sodium)
Micafungin is an echinocandin antifungal indicated for use in adult and pediatric patients 4 months of age and older for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, and esophageal candidiasis. It is also indicated for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation. Limitations of use: Micafungin has not been adequately studied in patients with endocarditis, osteomyelitis, or meningoencephalitis due to Candida, and its efficacy against non-Candida fungi has not been established.
How MICAFUNGIN Works
Micafungin is an antifungal agent in the echinocandin class. It works by noncompetitively inhibiting the enzyme 1,3-beta-D-glucan synthase, which is essential for the synthesis of 1,3-beta-D-glucan, a major structural component of the fungal cell wall. This leads to osmotic instability and cell lysis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-06-16
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
MICAFUNGIN Approval History
What MICAFUNGIN Treats
9 indicationsMICAFUNGIN is approved for 9 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Candidemia
- Disseminated Candidiasis
- Candida Peritonitis
- Abscess
- Esophageal Candidiasis
- Candida Infections
- Endocarditis
- Osteomyelitis
MICAFUNGIN 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
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
26 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02145832 TINN | C11-11 2012-001916-41 | Ph 2, Ph 3 | completed | Fluconazole Versus Micafungin in Neonates With Candidiasis |
| NCT02646774 | ACN-MA-MYC-IA-2012 | Ph 4 | terminated | Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis |
| NCT01982071 | ACN-MA-MYC-IC-2012 | Ph 4 | terminated | A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia |
| NCT01122368 INTENSE | 9463-EC-0002 2008-006409-18 | Ph 2 | completed | A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects |
| NCT01058174 TENPIN | 9463-EC-0001 2008-005214-49 | Ph 3 | completed | Liver Transplant European Study Into the Prevention of Fungal Infection |
| NCT03421002 | 9463-CL-6001 2014-003087-20, 800_OPBG_2014 | Ph 2 | completed | Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis |
| NCT02646800 | ACN-MA-MYC-registry-2013 | Ph 4 | terminated | Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp |
| NCT05784844 | IRB00088805 | Ph 4 | withdrawn | Antimicrobial Revision in Persistent Febrile Neutropenia |
| NCT02244606 results posted | SCY-078-202 | Ph 2 | completed | Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis |
| NCT06413056 | micafungin in neonates | Ph 4 | completed | Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection |
| NCT00839540 results posted | PA-07-004 | Ph 4 | completed | Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins |
| NCT05496725 | YSP-RNH3001-01 | Ph 4 | completed | Evaluate Bioequivalence of Micafungin (50mg/Vial) |
| NCT02440178 results posted | SNUH-micafungin | Ph 2 | completed | Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia |
| NCT03906916 EPICA1 | FADOI.02.2017 | Ph 4 | terminated | Comparison of Two Diagnostic Tests in Patients With Suspected Invasive Candidiasis in Internal Medicine Wards and Who Are Currently Timely Treated With Micafungin |
| NCT01950507 | 130197 13-H-0197 | Ph 1 | terminated | Evaluation of Budesonide and How It Interacts With Antifungal Drugs in People With Gastrointestinal Graft-Versus-Host Disease |
| NCT02172768 MATADOR | MATADOR | Ph 2 | completed | Pharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease |
| NCT01090141 Micafungin results posted | BJ-07-003 | Ph 4 | completed | Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers |
| NCT03102658 MICADO | UMCN-AKF 16.02 | Ph 4 | completed | Micafungin Pharmacokinetics in Obese Patients |
| NCT01666769 | Pro00039552 | Ph 1 | completed | Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation |
| NCT02057289 Micafungin | 2013-4868 | Ph 1 | terminated | A Pharmacokinetic Study of Pediatric Micafungin Prophylaxis |
| NCT01200355 results posted | 10-038 | Ph 4 | completed | Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome |
| NCT01888458 MycaCOORD | RC13_0008 | Ph 2 | completed | Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation (MycaCOORD) |
| NCT02651038 Mica-HDF | Mica_HDF | Ph 4 | completed | Pharmacokinetics of Micafungin During Continuous Venovenous Hemofiltration |
| NCT00815516 MAGIC-2 results posted | 9463-CL-2303 2012-000780-24 | Ph 3 | terminated | Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis |
| NCT01773876 EMPIRICUS | 1126 2011-005451-14 | Ph 3 | completed | Empirical Antifungal Treatment in ICUS |
| 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 FDA Label Details
Indications & Usage
FDA Label (PDF)MICAFUNGIN is indicated for the treatment of Candidemia; Disseminated Candidiasis; Candida Peritonitis; Abscess; Esophageal Candidiasis; Candida Infections; Endocarditis; Osteomyelitis; Meningoencephalitis.
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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