Drugs / Isavuconazonium
Isavuconazonium
also known as
isavuconazonium sulfate · AK1820 · BAL-8557-000 · BAL-8557-002 · BAL8557 · Cresemba · Isavuconazonium cation · Isavuconazonium ion
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | CRESEMBA | — | 2023-12-08 | fda.gov ↗ |
| Approved | US (FDA) | CRESEMBA | — | 2015-03-06 | fda.gov ↗ |
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT04096157 | Sep 2019 → Jan 2020 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03241550 | Oct 2017 → Jul 2019 | hematopoietic and lymphoid cell neoplasm | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02059590 | Apr 2013 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01813461 | Oct → Nov 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03816176 | Aug 2019 → Dec 2022 | Zygomycosis, invasive aspergillosis | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04707703 | Mar → Oct 2021 | COVID-19, invasive aspergillosis | Jeffrey Jenks, MD, MPH | Terminated | No outcome recorded |
| Phase 3 | NCT03471988 | Apr 2018 → Apr 2021 | systemic mycosis | Asahi Kasei Therapeutics Corporation | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-11-30 | Pfizer | Pfizer Enters into Agreement to Develop and Commercialize CRESEMBA® (isavuconazole) in China and Asia Pacific Region pfizer.com ↗ |
| 2017-07-19 | Pfizer | Pfizer Completes License Agreement For The Exclusive Commercialization Rights In Europe For CRESEMBA (isavuconazole) pfizer.com ↗ |
| 2017-06-14 | Pfizer | Pfizer Receives Exclusive Commercialization Rights in Europe for CRESEMBA, a Novel Treatment for Potentially Life-Threatening Fungal Infections Among Immunocompromised Patients pfizer.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Isavuconazonium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04707703 ↗ |
| Known as | AK1820 | “372.6 mg of AK1820 (isavuconazonium sulfate) is equivalent to 200 mg of isavuconazole.” NCT03471988 ↗ |
| Known as | BAL-8557-000 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1183349 ↗ |
| Known as | BAL-8557-002 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1183349 ↗ |
| Known as | BAL8557 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1183349 ↗ |
| Known as | Cresemba | ChEMBL registry synonym — accepted as the source's own label CHEMBL1183349 ↗ |
| Known as | Isavuconazonium cation | ChEMBL registry synonym — accepted as the source's own label CHEMBL1183349 ↗ |
| Known as | Isavuconazonium ion | ChEMBL registry synonym — accepted as the source's own label CHEMBL1183349 ↗ |
| Known as | isavuconazonium sulfate | “372.6 mg of AK1820 (isavuconazonium sulfate) is equivalent to 200 mg of isavuconazole.” NCT03471988 ↗ |
| Modality | Small molecule | “Isavuconazole, administered as the water-soluble prodrug isavuconazonium sulfate, is a new triazole agent used to treat invasive fungal infections.” PMID 34031051 ↗ Jul 2021 |
| Route | Oral | “oral” NCT01813461 ↗ |