Andexanet alfa

Generic Name
Andexanet alfa
Brand Names
Andexxa, Ondexxya
Drug Type
Biotech
Chemical Formula
-
CAS Number
1262449-58-0
Unique Ingredient Identifier
BI009E452R
Background

Andexanet alfa is a recombinant human coagulation Factor Xa that promotes blood coagulation. It was developed by Portola Pharmaceuticals and was approved in in May 2018. It is marketed as Andexxa for intravenous injection or infusion and is indicated for the reversal of anticoagulation in combination with rivaroxaban and apixaban in cases of life-threatening...

Indication

Andexanet alfa is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding . Andexxa has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any Factor Xa inhibitors other than apixaban and rivaroxaban .

Associated Conditions
Severe Life-threatening, uncontrollable Bleeding
Associated Therapies
-

A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure

Phase 3
Withdrawn
Conditions
Interventions
First Posted Date
2023-07-03
Last Posted Date
2024-10-26
Lead Sponsor
AstraZeneca
Target Recruit Count
800
Registration Number
NCT05926349
Locations
🇬🇧

Research Site, London, United Kingdom

Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya

Recruiting
Conditions
Interventions
First Posted Date
2023-06-12
Last Posted Date
2024-12-17
Lead Sponsor
AstraZeneca
Target Recruit Count
100
Registration Number
NCT05898412
Locations
🇳🇱

Research Site, Amsterdam, Netherlands

Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed

First Posted Date
2022-09-21
Last Posted Date
2023-11-28
Lead Sponsor
AstraZeneca
Target Recruit Count
5480
Registration Number
NCT05548777
Locations
🇺🇸

Research Site, Agoura Hills, California, United States

Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery

Phase 2
Terminated
Conditions
First Posted Date
2020-01-18
Last Posted Date
2023-03-22
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
10
Registration Number
NCT04233073
Locations
🇯🇵

Clinical Trial Site, Tokyo, Japan

Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor

First Posted Date
2018-09-07
Last Posted Date
2024-07-03
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
530
Registration Number
NCT03661528
Locations
🇬🇧

Research Site, Newcastle-upon-Tyne, United Kingdom

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