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Comparator: Micafungin sodium
Comparator: Micafungin sodium is a Echinocandin antifungal Small molecule drug developed by Merck Sharp & Dohme LLC. 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.
Micafungin sodium inhibits fungal cell wall synthesis by targeting 1,3-beta-D-glucan synthase, leading to fungal cell death.
Micafungin sodium is a comparator used in clinical studies for treating fungal infections, febrile neutropenia, and hematological diseases. It is compared to caspofungin acetate in these studies, suggesting that micafungin sodium is used as a reference treatment for these conditions.
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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. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Comparator: Micafungin sodium |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| 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. It has broad-spectrum activity against Candida and Aspergillus species.
Approved indications
- Candidemia and acute disseminated candidiasis
- Esophageal candidiasis
- Prophylaxis of Candida infections in hematopoietic stem cell transplant recipients
- Aspergillus infections (invasive aspergillosis)
Common side effects
- Phlebitis at infusion site
- Elevated liver enzymes (AST/ALT)
- Headache
- Nausea
- Rash
- Fever
- Hypokalemia
Key clinical trials
- A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED) (PHASE3)
- Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases (PHASE2)
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:
- Comparator: Micafungin sodium CI brief — competitive landscape report
- Comparator: Micafungin sodium updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Comparator: Micafungin sodium
What is Comparator: Micafungin sodium?
How does Comparator: Micafungin sodium work?
What is Comparator: Micafungin sodium used for?
Who makes Comparator: Micafungin sodium?
What drug class is Comparator: Micafungin sodium in?
What development phase is Comparator: Micafungin sodium in?
What are the side effects of Comparator: Micafungin sodium?
What does Comparator: Micafungin sodium target?
Related
- Drug class: All Echinocandin antifungal drugs
- Target: All drugs targeting 1,3-beta-D-glucan synthase
- Manufacturer: Merck Sharp & Dohme LLC — 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
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing