NDAINTRAVENOUSINJECTABLEPriority Review
Approved
Mar 2005
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
5
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 25m ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Mycamine (micafungin sodium) is an intravenous echinocandin antifungal agent approved in 2005 for treatment of invasive fungal infections, including Candida and Aspergillus species in immunocompromised patients. It works by inhibiting fungal cell wall synthesis through 1,3-beta-D-glucan synthase inhibition. The drug is indicated for esophageal candidiasis, candidemia, acute disseminated candidiasis, and prophylaxis in stem cell transplant patients.
$0.249MPart D
LOE ApproachingProduct approaching loss of exclusivity with minimal Part D utilization signals a mature/declining franchise with limited growth opportunities for commercial expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections
Started Mar 2015
2,555 enrolled
Invasive Fungal Infections
Use of Micafungin (Mycamine®) as Antifungal Prophylaxis in Haematology and Onco-haematology
Started Jul 2014
150 enrolled
Antifungal ProphylaxisHaemopathy
A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
Started Nov 2008
288 enrolled
FungemiaFungal Infections
Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
Started Oct 2007
84 enrolled
Oropharyngeal CandidiasisCandidemiaInvasive Candidiasis+1 more
Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
Started Oct 2007
9 enrolled
Invasive CandidiasisEsophageal CandidiasisOropharyngeal Candidiasis+1 more
Worked on MYCAMINE at Astellas? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.