NDAINTRAVENOUSPOWDERPriority Review
Approved
Mar 2015
Lifecycle
LOE Approaching
Competitive Pressure
35/100
Clinical Trials
7
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 3h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CRESEMBA (isavuconazonium sulfate) is an IV azole antifungal approved in 2015 for invasive aspergillosis and mucormycosis in immunocompromised patients. It is a prodrug of isavuconazole that inhibits fungal cell wall synthesis by targeting lanosterol 14α-demethylase. The drug addresses a critical need in treating serious invasive fungal infections in hospitalized and immunosuppressed populations.
LOE Approaching6mo to LOE
Product is approaching loss of exclusivity with 6.5 months of patent protection remaining; expect reduced commercial infrastructure and consolidation of field teams.
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 (7)
Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi
Started Feb 2023
70 enrolled
Invasive Fungal Disease
Post Marketing Surveillance (PMS) Study of Cresemba in Korea.
Started Oct 2021
94 enrolled
AspergillosisMucormycosis
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
Started Sep 2019
17 enrolled
Healthy Subjects
A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
Started Aug 2019
31 enrolled
Invasive MucormycosisInvasive Aspergillosis
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
Started Oct 2017
49 enrolled
Hematological Malignancy
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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.