Isavuconazonium

Generic Name: Isavuconazonium

Brand Names: Cresemba

Drug Type: Small Molecule

Chemical Formula: C_₃₅H_₃₅F_₂N_₈O_₅S

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

Clinical Trials

Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

Not Applicable

Recruiting

Conditions: Aspergillosis Invasive
Mucormycosis

Interventions: Other: Theraputic drug monitoring
Drug: Isavuconazole

First Posted Date: 2024-06-04

Last Posted Date: 2024-12-13

Lead Sponsor: Shanghai Children's Medical Center

Target Recruit Count: 200

Registration Number: NCT06440915

Locations: 🇨🇳
Shanghai Children's Medical Center, Shanghai, China

Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi

Phase 4

Active, not recruiting

Conditions: Invasive Fungal Disease

Interventions: Drug: Isavuconazole

First Posted Date: 2022-11-30

Last Posted Date: 2025-02-05

Lead Sponsor: Pfizer

Target Recruit Count: 35

Registration Number: NCT05630976

Locations: 🇨🇳
Zibo Central Hospital, Zibo, Shandong, China
🇨🇳
The First Affiliated Hospital of USTC, Anhui Province Hospital, Hefei, Anhui, China
🇨🇳
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

and more 11 locations

Translational PKPD Modeling of Anti-infective Drugs Used in Pediatric Units.

Active, not recruiting

Conditions: Population Modeling of Anti-infective Drugs

Interventions: Drug: Patients requiring cefotaxime treatment
Drug: Patients requiring fluconazole treatment
Drug: Patients requiring meropenem treatment
Drug: Patients requiring isavuconazole treatment
Drug: Patients requiring anidulafungin treatment

First Posted Date: 2022-06-22

Last Posted Date: 2022-06-22

Lead Sponsor: Poznan University of Medical Sciences

Target Recruit Count: 150

Registration Number: NCT05426499

Locations: 🇵🇱
Szpital Kliniczny im. Karola Jonschera Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Poznań, Szpitalna 27/33, Poland
🇵🇱
Wielkopolskie Centrum Onkologii, Poznań, Garbary 15, Poland
🇵🇱
Poznan University of Medical Sciences, Department of Clinical Pharmacy and Biopharmacy, Poznań, Rokietnicka 7, Poland

and more 1 locations

A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and Its Active Metabolite (ACP-5862) When Administered Alone and With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole in Healthy Adult Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Acalabrutinib
Drug: Fluconazole
Drug: Isavuconazole

First Posted Date: 2021-12-01

Last Posted Date: 2021-12-01

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 30

Registration Number: NCT05140096

Locations: 🇺🇸
Celerion, Tempe, Arizona, United States

Isavuconazole for the Prevention of COVID-19-associated Pulmonary Aspergillosis

Phase 3

Terminated

Conditions: Aspergillosis Invasive
Severe Acute Respiratory Syndrome Coronavirus 2

Interventions: Drug: Placebo
Drug: Isavuconazonium Injection [Cresemba]

First Posted Date: 2021-01-13

Last Posted Date: 2022-11-25

Lead Sponsor: Jeffrey Jenks, MD, MPH

Target Recruit Count: 8

Registration Number: NCT04707703

Locations: 🇺🇸
University of California Irvine, Orange, California, United States
🇺🇸
University of California Davis, Sacramento, California, United States
🇺🇸
University of California San Diego, San Diego, California, United States