Drugs / ASP1128
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04742517 | Nov 2017 → Sep 2018 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT03941483 | Nov 2019 → Jul 2021 | acute kidney injury | Astellas Pharma Inc | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2019-10-28 | Astellas Pharma Inc | Regulatory U.S. FDA Grants Fast Track Designation to Astellas for the Development of ASP1128 for Patients at Risk for Acute Kidney Injury astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP1128 for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgery. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2019-10-28 | Astellas Pharma Inc | U.S. FDA Grants Fast Track Designation to Astellas for the Development of ASP1128 for Patients at Risk for Acute Kidney Injury astellas.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ASP1128 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04742517 ↗ |
| Route | Intravenous | “Intravenous Infusion” NCT03941483 ↗ |