PRT064445 clinical trials
Also written Andexanet alfa, Andexxa and PRT064445.
How each study uses PRT064445 is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
Approvals
The first approval found in each region, with its record
- United States
- 3 May 2018 · Andexxa · BLA 125586 (FDA, Purple Book)
- European Union
- 26 Apr 2019 · Ondexxya · EMEA/H/C/004108 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
14 studies that test it; most in 2012 (5)
| Year | Studies |
|---|---|
| 2012 | 5 |
| 2014 | 2 |
| 2015 | 2 |
| 2017 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2024 | 1 |
| 2026 | 1 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 14 · Other 0
Portola Pharmaceuticals (9) · Alexion Pharmaceuticals, Inc. (3) · AstraZeneca (2)
Often tested with
Tested in the same studies.
Rivaroxaban (2) · Apixaban (2) · Enoxaparin (1) · Edoxaban (1)
Studies
Open first, then newest update. How each study uses PRT064445 is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 14
- A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy ParticipantsCompletedPhase 1AstraZenecaNCT07312851Written as Andexanet alfa
- A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or ProcedureWithdrawnPhase 3AstraZenecaNCT05926349Written as Andexanet alfa
- Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa InhibitorCompletedPhase 4Alexion Pharmaceuticals, Inc.NCT03661528Written as andexanet alfa
- A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet AlfaCompletedPhase 1Portola PharmaceuticalsNCT03083704Written as Andexanet alfa (Gen 1 Process 2)
- A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of ApixabanCompletedPhase 3Portola PharmaceuticalsNCT02207725Written as Andexanet
- A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban DosingTerminatedPhase 2Portola PharmaceuticalsNCT03330457Written as Andexanet alfa (bolus)
- Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4)CompletedPhase 2Portola PharmaceuticalsNCT01758432Written as PRT064445/Apixaban
- Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor AntidoteCompletedPhase 1Portola PharmaceuticalsNCT03218241Written as PRT064445
- Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent SurgeryTerminatedPhase 2Alexion Pharmaceuticals, Inc.NCT04233073Written as andexanet alfa
- Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 3 of 4)CompletedPhase 2Portola PharmaceuticalsNCT03551730Written as PRT064445/Enoxaparin
- Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 2 of 4)CompletedPhase 2Portola PharmaceuticalsNCT03578146Written as PRT064445/Rivaroxaban
- Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 4 of 4)CompletedPhase 2Portola PharmaceuticalsNCT03551743Written as PRT064445/Edoxaban
- A Study in Older Subject to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of RivaroxabanCompletedPhase 3Portola PharmaceuticalsNCT02220725Written as Andexanet
- 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)CompletedPhase 3Alexion Pharmaceuticals, Inc.NCT02329327Written as Andexanet
Given beside what is tested · 1 — PRT064445 is usual care or a partner of the new treatment
Codes
What other systems call PRT064445 · ClinicalTrials.gg INT006271
- RxNorm 2045114One source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| RxNorm | 2045114 | — | One source FDA |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.