Drugs / pudexacianinium
pudexacianinium
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05495581 | Aug 2022 → Apr 2023 | impaired renal function disease | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04878471 | Jun → Jul 2021 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT03698305 | Oct 2018 → May 2019 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05457842 | Aug → Sep 2022 | breast cancer, melanoma | Astellas Pharma Inc | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04238481 | Oct 2020 → Nov 2021 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05999747 | Mar 2024 → Oct 2025 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05754333 | Aug 2023 → Dec 2024 | — | Astellas Pharma Global Development, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2020-10-28 | Astellas Pharma Inc | Regulatory Astellas Receives U.S. FDA Fast Track Designation for ASP5354, an Investigational Near-Infrared Fluorescence Imaging Agent astellas.com ↗
Astellas Receives U.S. FDA Fast Track Designation for ASP5354, an Investigational Near-Infrared Fluorescence Imaging Agent |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2020-10-28 | Astellas Pharma Inc | Astellas Receives U.S. FDA Fast Track Designation for ASP5354, an Investigational Near-Infrared Fluorescence Imaging Agent astellas.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pudexacianinium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05495581 ↗ |
| Known as | ASP-5354 CHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802270 ↗ |
| Known as | ASP5354 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03698305 ↗ |
| Known as | pudexacianinium chloride | “Adults participants with with normal renal function or mild renal impairment received a single IV 3 mg dose (3 vials of 1 mg) of pudexacianinium chloride administered...” NCT05754333 ↗ |
| Known as | Pudexacianinium ion | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802270 ↗ |
| Modality | Diagnostic / imaging agent | “an Investigational Imaging Product” NCT03698305 ↗ |
| Route | Intravenous | “ASP5354 administered intravenously as a single dose to healthy subjects” NCT03698305 ↗ |