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Cresemba (ISAVUCONAZONIUM)
Isavuconazonium sulfate is a prodrug that converts to isavuconazole, an azole antifungal.
At a glance
| Generic name | ISAVUCONAZONIUM |
|---|---|
| Sponsor | Astellas Pharma |
| Drug class | Azole Antifungal |
| Target | ATP-binding cassette sub-family G member 2 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2015 |
Mechanism of action
Isavuconazonium sulfate is converted in the body to its active form, isavuconazole. Isavuconazole is an azole antifungal that works by inhibiting fungal growth.
Approved indications
- Invasive Aspergillosis
- Invasive Mucormycosis
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Headache
- Elevated liver chemistry tests
- Hypokalemia
- Constipation
- Dyspnea
- Cough
- Peripheral edema
- Back pain
- Edema peripheral
Drug interactions
- Ketoconazole
- Lopinavir/ritonavir
- Rifampin
- Atorvastatin
- Cyclosporine
- Sirolimus
- Tacrolimus
- Midazolam
- Bupropion
Key clinical trials
- A Study to Understand How the Use of Paxlovid Affected the Healthcare Use in People With Pre-existing Conditions.
- Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi (PHASE4)
- Post Marketing Surveillance (PMS) Study of Cresemba in Korea.
- Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT) (PHASE2)
- A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants (PHASE2)
- 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 (PHASE1)
- A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients (PHASE1)
- Registry of Patients Treated With Systemic Mold-Active Triazoles
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cresemba CI brief — competitive landscape report
- Cresemba updates RSS · CI watch RSS
- Astellas Pharma portfolio CI