Drugs / Andexanet
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02329327 | Apr 2015 → Sep 2020 | hemorrhagic disease | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02220725 | May 2014 → Aug 2015 | hemorrhagic disease | Portola Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02207725 | Mar 2014 → Apr 2015 | hemorrhagic disease | Portola Pharmaceuticals | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| 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. |
All press releases naming this drug 2 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 ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | andexanet | “BACKGROUND: Andexanet alfa (andexanet) is a recombinant modified human factor Xa decoy protein that has been shown to reverse the inhibition of factor Xa in healthy volunteers.” PMID 27573206 ↗ Aug 2016 |
| Route | Intravenous | “Intravenously Administered Andexanet Alfa” NCT02207725 ↗ |