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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

A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

Phase 1
Completed
Conditions
Hematological Malignancy
Interventions
First Posted Date
2017-08-07
Last Posted Date
2024-11-19
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
49
Registration Number
NCT03241550
Locations
🇺🇸

Children's Hospital Los Angeles, Los Angeles, California, United States

🇺🇸

University Hospital of Cleveland, Cleveland, Ohio, United States

🇺🇸

Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, United States

and more 13 locations

Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)

Phase 2
Completed
Conditions
Hematologic Malignancy
Myeloproliferative Disorder
Interventions
First Posted Date
2017-05-11
Last Posted Date
2025-05-16
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
99
Registration Number
NCT03149055
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Registry of Patients Treated With Systemic Mold-Active Triazoles

Completed
Conditions
Invasive Fungal Infection
Interventions
First Posted Date
2017-02-28
Last Posted Date
2024-10-21
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
2015
Registration Number
NCT03066011
Locations
🇺🇸

Emory University, Atlanta, Georgia, United States

🇺🇸

University of Arizona, Tucson, Arizona, United States

🇺🇸

Stanford Health Care, Palo Alto, California, United States

and more 52 locations

Isavuconazole in Preventing Invasive Fungal Infections in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome and Neutropenia

Phase 2
Completed
Conditions
Myelodysplastic Syndrome
Neutropenia
Acute Myeloid Leukemia
Interventions
First Posted Date
2017-01-13
Last Posted Date
2021-10-26
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
65
Registration Number
NCT03019939
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma

First Posted Date
2014-07-30
Last Posted Date
2025-05-16
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
93
Registration Number
NCT02203526
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Repaglinide and Caffeine

Phase 1
Completed
Conditions
Pharmacokinetics of Repaglinide
Pharmacokinetics of Caffeine
Healthy Subjects
Interventions
First Posted Date
2014-05-01
Last Posted Date
2014-05-01
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
24
Registration Number
NCT02128321
Locations
🇺🇸

Parexel Early Phase Clinical Unit, Baltimore, Maryland, United States

A Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole

Phase 1
Completed
Conditions
Pharmacokinetics of Isavuconazole
Healthy Subjects
Interventions
First Posted Date
2014-05-01
Last Posted Date
2014-05-01
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
24
Registration Number
NCT02128893
Locations
🇺🇸

Parexel Early Phase Clinical Unit, Baltimore, Maryland, United States

A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects

Phase 1
Completed
Conditions
Healthy Subjects
Pharmacokinetics of 14C-labeled Isavuconazonium Sulfate
Interventions
First Posted Date
2014-02-11
Last Posted Date
2014-02-11
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
6
Registration Number
NCT02059590
Locations
🇺🇸

Covance, Madison, Wisconsin, United States

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin

Phase 1
Completed
Conditions
Pharmacokinetics of Isavuconazole
Pharmacokinetics of Metformin
Healthy Subjects
Interventions
First Posted Date
2013-06-24
Last Posted Date
2013-06-24
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
24
Registration Number
NCT01884558
Locations
🇺🇸

California Clinical Trials Medical Group, Glendale, California, United States

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Methotrexate

Phase 1
Completed
Conditions
Pharmacokinetics of Isavuconazole
Pharmacokinetics of Methotrexate
Pharmacokinetics of 7-hydroxymethotrexate
Healthy Subjects
Interventions
First Posted Date
2013-06-24
Last Posted Date
2013-06-24
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
24
Registration Number
NCT01884636
Locations
🇺🇸

California Clinical Trials Medical Group, Glendale, California, United States

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