Drugs / Isavuconazole
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Cresemba | — | 2015-10-15 | europa.eu ↗ |
Trials 35 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 124 trials | ||||||
| Phase 1 | NCT05140096 | Jan → Apr 2020 | — | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT02128893 | Jan → Feb 2014 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02128321 | Jan → Feb 2014 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01884558 | Feb 2013 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01884636 | Feb → Mar 2013 | methotrexate toxicity, voriconazole toxicity | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01555918 | Aug → Nov 2012 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01635946 | Aug 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01635972 | Jun → Jul 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01660477 | Jun → Oct 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01657890 | Jun 2012 → Jan 2013 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01657825 | Jun → Jul 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01657838 | May 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01651325 | May 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01582425 | Apr → Jun 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01597986 | Apr → Jun 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01711489 | Mar → Apr 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01555866 | Mar 2012 → Apr 2013 | impaired renal function disease | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01565720 | Mar → Jun 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01582412 | Mar → May 2012 | digitalis poisoning, voriconazole toxicity | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01711827 | Feb → Mar 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01535547 | Dec 2011 → Jan 2012 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01494597 | Nov → Dec 2011 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01809860 | Nov 2011 → Jan 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01406171 | May → Jun 2011 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03327727 | Feb 2018 → Jan 2019 | invasive aspergillosis | Vical | Terminated | No outcome recorded |
| Phase 2 | NCT03149055 | May 2017 → Aug 2019 | myeloproliferative neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03019939 | Mar 2017 → Aug 2020 | acute myeloid leukemia, myelodysplastic syndrome, neutropenia | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00413439 | May 2006 → Jun 2007 | acute myeloid leukemia | Basilea Pharmaceutica | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT04680884 | Dec 2020 → Sep 2023 | acute respiratory failure, immunodeficiency disease | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 3 | NCT00634049 | Apr 2008 → Jan 2014 | aspergillosis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00413218 | Mar 2007 → Mar 2015 | candidemia | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00412893 | Mar 2007 → Mar 2013 | invasive aspergillosis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06756191 | Jan → Jul 2025 overdue | fungal lung infectious disease | Bin Cao | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05630976 | Feb 2023 → Apr 2025 | fungal infectious disease | Pfizer | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06440915 | Jun 2024 → Jun 2026 overdue | Zygomycosis, invasive aspergillosis | Shanghai Children's Medical Center | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02203526 Background | Aug 2014 → Sep 2026 expected | primary central nervous system lymphoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03964090 Background | Jun 2019 → Jul 2027 expected | central nervous system non-hodgkin lymphoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04876716 Background | May 2021 → May 2024 | invasive aspergillosis | Erasmus Medical Center | Terminated | No outcome recorded |
Press releases naming this drug 2 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 ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 43 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | isavuconazole | “Voriconazole or isavuconazole or posaconazole will be dosed according to the SPC and according to the route of administration (IV or orally) that is preferred by the treating physician.” NCT04876716 ↗37“IV isavuconazole (200 mg every 8 hours for 2 days followed by 200 mg per day until ICU discharge or for a total duration of 14 days)” NCT04680884 ↗ “Liposomal amphotericin B (AmBisome®) combination with Isavuconazole” NCT06756191 ↗ |
| Known as | BAL-4815 | ChEMBL registry synonym — accepted as the source's own label CHEMBL409153 ↗ |
| Known as | ISAV | “Isavuconazole (ISAV) is an extended spectrum mold-active triazole and has superior tolerability and fewer significant drug-drug interactions compared with other triazoles.” PMID 32236406 ↗ May 20211“Isavuconazole (ISAV) is a novel, broad-spectrum, triazole antifungal agent (IV and by mouth [PO]) developed for the treatment of IFD.” PMID 27169478 ↗ May 2016 |
| Known as | Isavuconazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL409153 ↗ |
| Action | Inhibit | “a 14-α-demethylase inhibitor” PMID 25902926 ↗ May 2015 |
| Modality | Small molecule | “Isavuconazole is a triazole with broad-spectrum antifungal activity.” PMID 37185921 ↗ Apr 2023 |
| Route | Intravenous | “Administered by intravenous infusion.” NCT00413218 ↗ |
| Target | CYP3A4 | “Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole” NCT05140096 ↗ |