Overview
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.
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/06/04 | Not Applicable | Recruiting | Shanghai Children's Medical Center | ||
2022/11/30 | Phase 4 | Active, not recruiting | |||
2022/06/22 | N/A | Recruiting | Poznan University of Medical Sciences | ||
2021/12/01 | Phase 1 | Completed | |||
2021/01/13 | Phase 3 | Terminated | Jeffrey Jenks, MD, MPH | ||
2020/09/16 | N/A | Completed | |||
2019/09/19 | Phase 1 | Completed | |||
2019/05/28 | Phase 2 | Active, not recruiting | |||
2019/01/25 | Phase 2 | Completed | |||
2018/03/21 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Astellas Pharma US, Inc. | 0469-0420 | INTRAVENOUS | 40.0 mg in 1 mL | 5/30/2023 | |
| Astellas Pharma US, Inc. | 0469-2860 | ORAL | 40 mg in 1 1 | 5/30/2023 | |
| Astellas Pharma US, Inc. | 0469-0520 | ORAL | 100 mg in 1 1 | 5/30/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 10/15/2015 | ||
Authorised | 10/15/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| CRESEMBA CAPSULES 100MG | SIN15716P | CAPSULE | 100 mg | 6/13/2019 | |
| CRESEMBA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 200MG | SIN15717P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200 mg | 6/13/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CRESEMBA isavuconazole (as isavuconazonium sulfate) 40 mg capsule blister pack | 437390 | Medicine | A | 3/25/2025 | |
| CRESEMBA isavuconazole (as isavuconazonium sulfate) 200 mg powder for injection vial | 305480 | Medicine | A | 5/17/2019 | |
| CRESEMBA isavuconazole (as isavuconazonium sulfate) 100 mg capsule blister pack | 305452 | Medicine | A | 5/17/2019 |