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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

Drug Interaction Study of Multiple Doses of Isavuconazole and a Single Dose of Bupropion

Phase 1
Completed
Conditions
Healthy Volunteers
Pharmacokinetics of Isavuconazole
Pharmacokinetics of Bupropion
Interventions
First Posted Date
2012-07-10
Last Posted Date
2015-09-01
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
24
Registration Number
NCT01635972
Locations
🇺🇸

Clinical Pharmacology of Miami, Miami, Florida, United States

Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone

Phase 1
Completed
Conditions
Pharmacokinetics of Isavuconazole
Pharmacokinetics of Ethinyl Estradiol and Norethindrone
Healthy Volunteers
Interventions
Drug: Oral Contraceptive (ethinyl estradiol / norethindrone)
First Posted Date
2012-05-15
Last Posted Date
2012-07-16
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
24
Registration Number
NCT01597986
Locations
🇺🇸

Clinical Pharmacology of Miami, Miami, Florida, United States

Drug Interaction Study of Isavuconazole and Digoxin

Phase 1
Completed
Conditions
Pharmacokinetics of Isavuconazole
Pharmacokinetics of Digoxin
Healthy Volunteers
Interventions
First Posted Date
2012-04-20
Last Posted Date
2015-09-01
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
24
Registration Number
NCT01582412
Locations
🇺🇸

Parexel International, Baltimore, Maryland, United States

Drug Interaction Study of Isavuconazole and Methadone

Phase 1
Completed
Conditions
Pharmacokinetics of Isavuconazole
Pharmacokinetics of Methadone
Healthy Volunteers
Interventions
First Posted Date
2012-04-20
Last Posted Date
2012-07-02
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
24
Registration Number
NCT01582425
Locations
🇺🇸

Parexel International, LLC, Glendale, California, United States

Study of the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization

Phase 1
Completed
Conditions
Pharmacokinetics of Isavuconazole
Healthy Volunteers
Interventions
First Posted Date
2012-03-29
Last Posted Date
2012-07-09
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
161
Registration Number
NCT01565720
Locations
🇺🇸

Parexel, Glendale, California, United States

A Study to Assess the Safety and Pharmacokinetics of Isavuconazole in Healthy Chinese Volunteers

Phase 1
Completed
Conditions
Pharmacokinetics of BAL4815
Pharmacokinetics of BAL8728
Healthy Volunteers
Interventions
First Posted Date
2012-03-16
Last Posted Date
2013-02-01
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
36
Registration Number
NCT01555918
Locations
🇨🇳

Huashan Hospital, Shanghai, China

Study of the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole.

Phase 1
Completed
Conditions
Pharmacokinetics of Isavuconazole
Healthy Volunteers
Renal Impaired
Interventions
First Posted Date
2012-03-16
Last Posted Date
2015-09-01
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
49
Registration Number
NCT01555866
Locations
🇺🇸

DaVita Research, Denver, Colorado, United States

🇺🇸

DaVita Clinical Research, Minneapolis, Minnesota, United States

🇺🇸

Clinical Pharmacology Miami, Miami, Florida, United States

Drug Interaction Study of Isavuconazole and Tacrolimus

Phase 1
Completed
Conditions
Pharmacokinetics of Isavuconazole
Pharmacokinetics of Tacrolimus
Healthy Volunteers
Interventions
First Posted Date
2012-02-17
Last Posted Date
2012-02-17
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
24
Registration Number
NCT01535547
Locations
🇺🇸

Covance, Madison, Wisconsin, United States

Drug Interaction Study of Isavuconazole and Cyclosporine

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2011-12-19
Last Posted Date
2011-12-19
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
24
Registration Number
NCT01494597
Locations
🇺🇸

Covance, Madison, Wisconsin, United States

Drug Interaction Study of Isavuconazole and Midazolam

Phase 1
Completed
Conditions
Pharmacokinetics of Isavuconazole
Pharmacokinetics of Midazolam
Healthy Volunteers
Interventions
First Posted Date
2011-08-01
Last Posted Date
2011-08-01
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
24
Registration Number
NCT01406171
Locations
🇺🇸

Covance Clinical Research, Madison, Wisconsin, United States

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