Drugs / Andexanet alfa
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Ondexxya | — | 2019-04-26 | europa.eu ↗ |
Trials 12 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07312851 | Jan → Jun 2026 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03083704 | Feb → Sep 2017 | hemorrhagic disease | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03218241 | Jun → Sep 2012 | — | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT04233073 | Jun → Nov 2021 | — | Alexion Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03310021 | Aug 2017 → Aug 2019 | hemorrhagic disease | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03330457 | Aug 2015 → Feb 2016 | hemorrhagic disease | Portola Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT03551743 | Dec 2012 → Sep 2015 | — | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03578146 | Dec 2012 → Sep 2015 | — | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03551730 | Dec 2012 → Sep 2015 | — | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01758432 | Dec 2012 → Sep 2015 | — | Portola Pharmaceuticals | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05926349 | Aug 2024 → Jan 2027 | — | AstraZeneca | Withdrawn | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03661528 | Jun 2019 → May 2023 | intracerebral hemorrhage | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Andexanet alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03083704 ↗ |
| Known as | andexanet | “We randomly assigned, in a 1:1 ratio, patients who had taken factor Xa inhibitors within 15 hours before having an acute intracerebral hemorrhage to receive andexanet or usual care.” PMID 38749032 ↗ May 2024 |
| Known as | Andexxa | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301583 ↗ |
| Known as | Ondexxya | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301583 ↗ |
| Known as | PRT-4445 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301583 ↗ |
| Known as | PRT064445 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03218241 ↗ |
| Known as | rfXa Inhibitor Antidote | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301583 ↗ |
| Action | Inhibit | “Tissue factor pathway inhibitor inhibitor” CHEMBL3301583 ↗ |
| Modality | Protein / enzyme biologic | “Andexanet alfa, a modified, catalytically inactive, recombinant human FXa derivative” PMID 29296829 ↗ Sep 2017 |
| Route | Intravenous | “intravenously administered PRT064445” NCT01758432 ↗ |
| Target | TFPI | “Tissue factor pathway inhibitor inhibitor” CHEMBL3301583 ↗ |