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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYCAMINE (micafungin sodium) is an intravenous echinocandin antifungal agent approved in 2005 for treating invasive fungal infections, particularly candidemia and esophageal candidiasis. It works by inhibiting fungal cell wall synthesis through 1,3-beta-D-glucan inhibition. The drug is administered IV and has demonstrated linear pharmacokinetics across dose ranges of 50–150 mg in adults and weight-based dosing in pediatric patients.
$0.249MPart D
LOE ApproachingDeclining
Product is approaching loss of exclusivity with modest Part D presence ($249K in 2023), signaling reduced commercial investment and potential team restructuring.
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
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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.