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
| 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 Stop: Enrollment |
| Phase 3 | NCT03471988 | Apr 2018 → Apr 2021 | systemic mycosis | Asahi Kasei Therapeutics Corporation | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2023-12-11 | Basilea Pharmaceutica | Regulatory Basilea announces that FDA approves expanded use of antifungal Cresemba® (isavuconazole) in the United States in children with invasive aspergillosis and invasive mucormycosis basilea.com ↗
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that its license partner Astellas Pharma US, Inc. (“Astellas”) received the approval of Cresemba® (isavuconazole) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients by the US Food and Drug Administration (FDA). |
| 2015-07-30 | Astellas Pharma Inc | Results Astellas Provides Update on Phase 3 Study Evaluating Isavuconazole in Patients with Candidemia and Other Invasive Candida Infections astellas.com ↗
Results from the study demonstrated that the trial did not meet its primary endpoint of non-inferiority in overall treatment response in isavuconazole-treated patients at the end of IV therapy compared to caspofungin. |
| 2015-03-09 | Astellas Pharma Inc | Regulatory Astellas Receives FDA Approval for CRESEMBA® (isavuconazonium sulfate) for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis astellas.com ↗
“We’re pleased with the FDA’s approval of CRESEMBA for use in treating patients with these life-threatening infections,” said Bernie Zeiher, M.D., executive vice president, Global Development and therapeutic area head of Infectious Disease at Astellas. |
| 2015-03-07 | Basilea Pharmaceutica | Regulatory Basilea reports U.S. FDA approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) approved Astellas' New Drug Application (NDA) for the use of isavuconazole for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). |
| 2015-01-23 | Basilea Pharmaceutica | Regulatory Basilea announces that FDA's Anti-Infective Drugs Advisory Committee recommends approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis basilea.com ↗ |
| 2015-01-23 | Astellas Pharma Inc | Regulatory Astellas Announces FDA Anti-Infective Drugs Advisory Committee Recommends Approval of CRESEMBA® (isavuconazonium) for Treatment of Invasive Aspergillosis and Mucormycosis astellas.com ↗
“We’re pleased with today’s positive recommendation for the approval of CRESEMBA for both indications,” said Bernie Zeiher, M.D., executive vice president, Global Development and therapeutic area head of Infectious Disease at Astellas. |
| 2014-10-09 | Basilea Pharmaceutica | Results Basilea reports that further subgroup and health economic analyses of isavuconazole phase 3 studies will be presented at IDWeek conference basilea.com ↗
For invasive aspergillosis patients treated with isavuconazole, the difference in fewer drug-related adverse events reached statistical significance. |
| 2014-09-06 | Basilea Pharmaceutica | Regulatory Basilea's partner Astellas receives notification from U.S. FDA of acceptance of filing of isavuconazole NDA for the treatment of invasive aspergillosis and invasive mucormycosis basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application for isavuconazole submitted by Basilea's license partner Astellas Pharma Inc. |
| 2014-08-21 | Basilea Pharmaceutica | Regulatory European Medicines Agency accepts Basilea's isavuconazole Marketing Authorization Application for review basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) announces today that the European Medicines Agency (EMA) has accepted its isavuconazole Marketing Authorization Application (MAA) for review. |
| 2014-07-17 | Basilea Pharmaceutica | Regulatory Basilea submits isavuconazole European Marketing Authorization Application for the treatment of invasive mold infections basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that it submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis (zygomycosis). |
| 2014-07-17 | Basilea Pharmaceutica | Regulatory Basilea reports that isavuconazole received QIDP designation from U.S. FDA for the treatment of invasive candidiasis basilea.com ↗
Basel, Switzerland, July 16, 2014 - Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the oral and intravenous treatment of invasive candidiasis, a life-threatening invasive fungal infection caused by Candida yeasts. |
| 2014-07-10 | Basilea Pharmaceutica | Regulatory Basilea's partner Astellas submits isavuconazole U.S. NDA for the treatment of invasive aspergillosis and invasive mucormycosis basilea.com ↗
Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that its co-development partner Astellas Pharma Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (zygomycosis). |
| 2014-07-09 | Astellas Pharma Inc | Regulatory Astellas Submits U.S. New Drug Application for Isavuconazole for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis astellas.com ↗
Astellas today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients. |
| 2014-05-14 | Basilea Pharmaceutica | Results Basilea reports additional data on positive isavuconazole phase 3 SECURE study at ECCMID basilea.com ↗
Treatment emergent adverse events for isavuconazole were statistically fewer relative to the study comparator voriconazole in the System Organ Classes of hepatobiliary (8.9% vs. 16.2%), skin (33.5% vs. 42.5%) and eye disorders (15.2% vs. 26.6%). |
All press releases naming this drug 82 releases
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 ↗ |