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Isavuconazonium

Generic Name
Isavuconazonium
Brand Names
Cresemba
Drug Type
Small Molecule
Chemical Formula
C35H35F2N8O5S
CAS Number
742049-41-8
Unique Ingredient Identifier
VH2L779W8Q
Background

Isavuconazonium is a second-generation triazole antifungal approved on March 6, 2015 by the FDA for the treatment of invasive aspergillosis and invasive mucormycosis, marketed by Astellas under the brand Cresemba. It is the prodrug form of isavuconazole, the active moiety, and it is available in oral and parenteral formulations. Due to low solubility in water of isavuconazole on its own, the isovuconazonium formulation is favorable as it has high solubility in water and allows for intravenous administration. This formulation also avoids the use of a cyclodextrin vehicle for solubilization required for intravenous administration of other antifungals such as voriconazole and posaconazole, eliminating concerns of nephrotoxicity associated with cyclodextrin. Isovuconazonium has excellent oral bioavailability, predictable pharmacokinetics, and a good safety profile, making it a reasonable alternative to its few other competitors on the market.

Indication

Indicated in the treatment of invasive aspergillosis and invasive mucormycosis.

Associated Conditions
Disseminated mucormycosis, Invasive Aspergillosis

Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi

Phase 3
Completed
Conditions
Aspergillosis
Invasive Fungal Infections
Interventions
First Posted Date
2008-03-12
Last Posted Date
2024-12-11
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
149
Registration Number
NCT00634049
Locations
🇺🇸

UMASS Memorial Medical Center, Worcester, Massachusetts, United States

🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

🇺🇸

Upstate Infectious Diseases Association LLP, Albany, New York, United States

and more 93 locations

Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections

Phase 3
Completed
Conditions
Mycoses
Candidiasis, Invasive
Candidemia
Interventions
First Posted Date
2006-12-19
Last Posted Date
2024-12-10
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
450
Registration Number
NCT00413218
Locations
🇺🇸

Idaho Falls Infectious Diseases PLLC, Idaho Falls, Idaho, United States

🇺🇸

Somero Research Corporation, Palm Desert, California, United States

🇺🇸

Loyola University Hospital, Maywood, Illinois, United States

and more 110 locations

Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

Phase 3
Completed
Conditions
Aspergillosis
Invasive Fungal Infection
Interventions
First Posted Date
2006-12-19
Last Posted Date
2024-12-10
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
527
Registration Number
NCT00412893
Locations
🇦🇷

Hospital Italiano de Buenos Aires, Ciudad Autonoma, Argentina

🇺🇸

University of Alabama, Birmingham, Alabama, United States

🇺🇸

University of Chicago, Division of Infectious Diseases, Chicago, Illinois, United States

and more 78 locations

Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy

Phase 2
Completed
Conditions
Acute Myeloid Leukemia
Interventions
First Posted Date
2006-12-19
Last Posted Date
2023-05-10
Lead Sponsor
Basilea Pharmaceutica
Target Recruit Count
18
Registration Number
NCT00413439
Locations
🇩🇪

University Cologne, Cologne, Germany

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