CRESEMBA (isavuconazonium sulfate) · ASTELLAS
Cresemba (isavuconazonium sulfate) is an azole antifungal indicated for the treatment of invasive aspergillosis and invasive mucormycosis. The injection formulation is approved for use in adults and pediatric patients 1 year of age and older. The capsule formulation is approved for adults and pediatric patients 6 years of age and older who weigh at least 16 kg. Clinical guidelines allow for the initiation of therapy before laboratory and histopathology results are finalized, provided that specimens are collected prior to the first dose; treatment should be adjusted once the causative organism is identified.
How CRESEMBA Works
Isavuconazonium sulfate is a prodrug that is converted into the active moiety, isavuconazole. As an azole antifungal, isavuconazole exerts its effect by inhibiting the synthesis of ergosterol, a critical component of the fungal cell membrane, typically through the inhibition of the enzyme lanosterol 14-alpha-demethylase.
Details
- Status
- Prescription
- First Approved
- 2015-03-06
- Patent Cliff
- 2028
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- CAPSULE, POWDER
CRESEMBA Approval History
What CRESEMBA Treats
2 indicationsCRESEMBA is approved for 2 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Invasive Aspergillosis
- Invasive Mucormycosis
CRESEMBA Competitive Set
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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 CRESEMBA
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
ASTELLAS's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03816176 results posted | 9766-CL-0107 2018-003975-36 | Ph 2 | completed | A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants |
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.
CRESEMBA FDA Label Details
Indications & Usage
FDA Label (PDF)CRESEMBA ® is an azole antifungal indicated for the treatment of: Invasive aspergillosis and Invasive mucormycosis as follows: • CRESEMBA for injection : adults and pediatric patients 1 year of age and older • CRESEMBA capsules : adults and pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater 1.1 Invasive Aspergillosis CRESEMBA ® is indicated for the treatment of invasive aspergillosis as follows: CRESEMBA for injection : adults and pediatric patients 1 year of age and older [see Clinical Studies and Clinical Pharmacology ] CRESEMBA capsules : adults and pediatri...
CRESEMBA Patents & Exclusivity
Patents (6 active)
Exclusivity
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 26 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 4 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.