Andexanet alfa: Clinical Trials

6 completed, 1 terminated, 1 withdrawn. 2 Phase 2, 2 Phase 3, 1 Phase 1, 1 Phase 4.

By phase and status

Phase	Trials	Status
Phase 2	2	Completed 1, Terminated 1
Phase 3	2	Completed 1, Withdrawn 1
Phase 1	1	Completed 1
Phase 4	1	Completed 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants Andexanet alfa, Rivaroxaban, Apixaban - Healthy Participants	Phase 1	Completed	AstraZeneca	191	2026-01-19	2026-07-09
A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure Andexanet alfa, Usual Care - Urgent Surgery	Phase 3	Withdrawn	AstraZeneca		2024-08-02	2024-10-26
Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya Andexanet alfa - Hemorrhage		Completed	AstraZeneca	217	2023-10-06	2026-04-17
Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed Andexanet alfa, 4F-PCC - Anticoagulant-related Major Bleed		Completed	AstraZeneca	5480	2022-09-15	2023-11-28
Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery andexanet alfa - Surgery	Phase 2	Terminated	Alexion Pharmaceuticals, Inc.	10	2021-06-27	2023-03-22
Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor andexanet alfa, Usual Care - Acute Intracranial Hemorrhage	Phase 4	Completed	Alexion Pharmaceuticals, Inc.	530	2019-06-06	2024-07-03
A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects Andexanet alfa, Apixaban, Rivaroxaban - Bleeding	Phase 2	Completed	Portola Pharmaceuticals	108	2017-08-28	2023-02-24
A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study) Andexanet - Bleeding	Phase 3	Completed	Alexion Pharmaceuticals, Inc.	479	2015-04-10	2022-02-16

Conditions studied

Hemorrhage (3)  ·  Thrombosis (2)

Sponsors

AstraZeneca (4)  ·  Alexion Pharmaceuticals, Inc. (3)  ·  Portola Pharmaceuticals (1)

Countries

United States (5)  ·  Germany (4)  ·  France (3)  ·  Netherlands (3)  ·  United Kingdom (3)  ·  Austria (2)  ·  Belgium (2)  ·  Canada (2)  ·  Israel (2)  ·  Japan (2)  ·  Spain (2)  ·  Czechia (1)  ·  Denmark (1)  ·  Finland (1)  ·  Greece (1)

Results publications

PMID 38264861, PMID 27573206, PMID 28009495, PMID 30730782, PMID 33966491, PMID 34645283, PMID 35710578, PMID 36802876, PMID 37314165, PMID 37753225, PMID 38749032, PMID 39002730, PMID 39167819, PMID 39524040, PMID 40289797, PMID 42093656

NIH funding

2018 (1), 2025 (1)