NDAINTRAVENOUSPOWDERPriority Review
Approved
Mar 2015
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
6
Mechanism of Action
isavuconazole, an azole antifungal [see ()] .
Clinical Trials (5)
Post Marketing Surveillance (PMS) Study of Cresemba in Korea.
Started Oct 2021
600 enrolled
AspergillosisMucormycosis
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
Started Sep 2019
17 enrolled
Healthy Subjects
A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
Started Aug 2019
31 enrolled
Invasive MucormycosisInvasive Aspergillosis
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
Started Oct 2017
49 enrolled
Hematological Malignancy
A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects
Started Apr 2013
6 enrolled
Pharmacokinetics of 14C-labeled Isavuconazonium SulfateHealthy Subjects
Loss of Exclusivity
LOE Date
Dec 8, 2026
9 months away
Patent Expiry
Apr 30, 2026
Exclusivity Expiry
Jun 8, 2031
Patent Records (2)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 6812238 | Oct 31, 2025Expired | Substance | — |
| 6812238*PED | Apr 30, 2026 | — |
Company
Astellas
China - Shenyang