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
| 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 · 4 met primary | ||||||
| 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 | NCT03578146 | Dec 2012 → Sep 2015 | — | Portola Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01758432 | Dec 2012 → Sep 2015 | — | Portola Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT03551730 | Dec 2012 → Sep 2015 | — | Portola Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT03551743 | Dec 2012 → Sep 2015 | — | Portola Pharmaceuticals | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT05926349 | Aug 2024 → Jan 2027 | — | AstraZeneca | Withdrawn | No outcome recorded Stop: Business |
| Phase 41 trial · 1 met primary | ||||||
| Phase 4 | NCT03661528 | Jun 2019 → May 2023 | intracerebral hemorrhage | Alexion Pharmaceuticals, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2023-06-05 | AstraZeneca | Results Andexxa Phase IV trial stopped early after achieving pre-specified criteria on haemostatic efficacy versus usual care astrazeneca.com ↗
The decision is based on achieving pre-specified stopping criteria of superior haemostatic efficacy, the ability to limit the expansion of a potentially life-threatening bleed in the brain, versus usual care. |
| 2022-03-29 | AstraZeneca | Regulatory Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors astrazeneca.com ↗
Ondexxya (andexanet alfa) has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. |
| 2015-03-02 | Janssen Research & Development, LLC | Results Findings to be Presented at Annual Scientific Session of the American College of Cardiology (ACC) About an Additional Potential Reversal Strategy for and Real-World Safety Performance of XARELTO® jnj.com ↗ |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-06-05 | AstraZeneca | Andexxa Phase IV trial stopped early after achieving pre-specified criteria on haemostatic efficacy versus usual care astrazeneca.com ↗ |
| 2022-03-29 | AstraZeneca | Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors astrazeneca.com ↗ |
| 2015-03-02 | Janssen Research & Development, LLC | Findings to be Presented at Annual Scientific Session of the American College of Cardiology (ACC) About an Additional Potential Reversal Strategy for and Real-World Safety Performance of XARELTO® jnj.com ↗ |
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 NCT03330457 ↗ |
| 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 NCT03551743 ↗ |
| 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 ↗ |