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
Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects
- Conditions
- Pharmacokinetics of 14C-labeled IsavuconazoleHealthy Subjects
- Interventions
- First Posted Date
- 2013-03-19
- Last Posted Date
- 2013-03-19
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 8
- Registration Number
- NCT01813461
- Locations
- 🇺🇸
Covance, Madison, Wisconsin, United States
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Sirolimus in Healthy Subjects
- Conditions
- Healthy SubjectsPharmacokinetics of IsavuconazolePharmacokinetics of Sirolimus
- Interventions
- First Posted Date
- 2013-03-13
- Last Posted Date
- 2013-03-13
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 22
- Registration Number
- NCT01809860
- Locations
- 🇺🇸
Covance, Dallas, Texas, United States
A Study to Assess the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Mycophenolate Mofetil in Healthy Adult Subjects
- Conditions
- Healthy SubjectsPharmacokinetics of IsavuconazolePharmacokinetics of Plasma Mycophenolic Acid (MPA)Pharmacokinetics of Plasma Phenolic Glucuronide of MPA (MPAG)
- Interventions
- First Posted Date
- 2012-10-22
- Last Posted Date
- 2012-10-22
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 24
- Registration Number
- NCT01711489
- Locations
- 🇺🇸
Parexel International, LLC, Glendale, California, United States
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Adult Subjects
- Conditions
- Healthy SubjectsPharmacokinetics of IsavuconazolePharmacokinetics of Prednisolone
- Interventions
- First Posted Date
- 2012-10-22
- Last Posted Date
- 2012-10-22
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 21
- Registration Number
- NCT01711827
- Locations
- 🇺🇸
Parexel International, LLC, Glendale, California, United States
Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole
- Conditions
- Healthy VolunteersPharmacokinetics of IsavuconazolePharmacokinetics of Lopinavir/Ritonavir
- Interventions
- First Posted Date
- 2012-08-08
- Last Posted Date
- 2015-02-23
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 68
- Registration Number
- NCT01660477
- Locations
- 🇺🇸
Parexel International, Glendale, California, United States
Drug Interaction Study of Isavuconazole and Warfarin in Healthy Male Subjects
- Conditions
- Pharmacokinetics of IsavuconazolePharmacokinetics of S- and R-warfarinPharmacodynamics of WarfarinHealthy Volunteers
- Interventions
- First Posted Date
- 2012-08-06
- Last Posted Date
- 2012-08-28
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 20
- Registration Number
- NCT01657825
- Locations
- 🇺🇸
Spaulding Clinical, West Bend, Wisconsin, United States
Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects
- Conditions
- Healthy Adult VolunteersPharmacokinetics of IsavuconazolePharmacokinetics of Ketoconazole
- Interventions
- First Posted Date
- 2012-08-06
- Last Posted Date
- 2015-09-01
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 24
- Registration Number
- NCT01657838
- Locations
- 🇺🇸
Spaulding Clinical, West Bend, Wisconsin, United States
Study of the Pharmacokinetics of Isavuconazole in Healthy Non-Elderly and Elderly Male and Female Subjects
- Conditions
- Healthy VolunteersPharmacokinetics of IsavuconazoleSafety and Tolerability in Elderly
- Interventions
- First Posted Date
- 2012-08-06
- Last Posted Date
- 2015-09-01
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 28
- Registration Number
- NCT01657890
- Locations
- 🇺🇸
Parexel International, Glendale, California, United States
Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Dextromethorphan in Healthy Adult Subjects
- Conditions
- Healthy Adult VolunteersPharmacokinetics of IsavuconazolePharmacokinetics of Dextromethorphan
- Interventions
- First Posted Date
- 2012-07-27
- Last Posted Date
- 2015-02-23
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 24
- Registration Number
- NCT01651325
- Locations
- 🇺🇸
Parexel, Baltimore, Maryland, United States
Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Atorvastatin
- Conditions
- Pharmacokinetics of IsavuconazoleHealthy VolunteersPharmacokinetics of Atorvastatin
- Interventions
- First Posted Date
- 2012-07-10
- Last Posted Date
- 2015-02-23
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 24
- Registration Number
- NCT01635946
- Locations
- 🇺🇸
Clinical Pharmacology of Miami, Miami, Florida, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.