{"id":"andexanet","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Urinary tract infections","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Pneumonia","drugRate":"5%","severity":"common","organSystem":""}],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Death","drugRate":"18%","severity":"serious"},{"effect":"Thromboembolic events","drugRate":"10.7%","severity":"serious"},{"effect":"Cerebrovascular accident","drugRate":"4.5%","severity":"serious"},{"effect":"Deep venous thrombosis","drugRate":"2.6%","severity":"serious"},{"effect":"Myocardial infarction","drugRate":"2.1%","severity":"serious"},{"effect":"Pulmonary embolism","drugRate":"1.2%","severity":"serious"},{"effect":"Infusion-related reaction","drugRate":"0.5%","severity":"serious"},{"effect":"Transient ischemic attack","drugRate":"0.2%","severity":"serious"}]},"trials":[],"_chembl":{"chemblId":"CHEMBL3301583","moleculeType":"Protein"},"aliases":["ALXN2070","Andexanet Alfa","PRT064445","Andexxa","Andexanet alpha"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"_dailymed":{"setId":"2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c","title":"ANDEXXA (ANDEXANET ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTRAZENECA PHARMACEUTICALS LP]"},"ecosystem":[],"mechanism":{},"_scrapedAt":"2026-03-28T01:01:36.435Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"url":"https://en.wikipedia.org/wiki/Andexanet_alfa","title":"Andexanet alfa","extract":"Andexanet alfa, sold under the brand name Andexxa among others, is an antidote for the medications rivaroxaban and apixaban, when reversal of anticoagulation is needed due to uncontrolled bleeding. It has not been found to be useful for other factor Xa inhibitors. It is given by injection into a vein."},"references":[],"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Direct acting anticoagulant adverse reaction","diseaseId":"direct-acting-anticoagulant-adverse-reaction","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07312851","phase":"PHASE1","title":"A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2026-01-19","conditions":"Healthy Participants","enrollment":186},{"nctId":"NCT05898412","phase":"","title":"Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2023-10-06","conditions":"Hemorrhage","enrollment":217},{"nctId":"NCT05127941","phase":"","title":"Andexanet Alfa: Non-interventional Study in Stroke Units in Germany (DE)","status":"ACTIVE_NOT_RECRUITING","sponsor":"University Hospital, Essen","startDate":"2021-12-08","conditions":"Intracranial Hemorrhages","enrollment":141},{"nctId":"NCT05926349","phase":"PHASE3","title":"A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure","status":"WITHDRAWN","sponsor":"AstraZeneca","startDate":"2024-08-02","conditions":"Urgent Surgery","enrollment":""},{"nctId":"NCT03661528","phase":"PHASE4","title":"Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2019-06-06","conditions":"Acute Intracranial Hemorrhage","enrollment":530},{"nctId":"NCT05548777","phase":"","title":"Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2022-09-15","conditions":"Anticoagulant-related Major Bleed","enrollment":5480},{"nctId":"NCT03330457","phase":"PHASE2","title":"A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing","status":"TERMINATED","sponsor":"Portola Pharmaceuticals","startDate":"2015-08-06","conditions":"Bleeding","enrollment":18},{"nctId":"NCT03083704","phase":"PHASE1","title":"A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa","status":"COMPLETED","sponsor":"Portola Pharmaceuticals","startDate":"2017-02-26","conditions":"Bleeding","enrollment":153},{"nctId":"NCT02207725","phase":"PHASE3","title":"A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban","status":"COMPLETED","sponsor":"Portola Pharmaceuticals","startDate":"2014-03","conditions":"Bleeding","enrollment":68},{"nctId":"NCT01758432","phase":"PHASE2","title":"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)","status":"COMPLETED","sponsor":"Portola Pharmaceuticals","startDate":"2012-12","conditions":"Healthy Volunteers","enrollment":54},{"nctId":"NCT03218241","phase":"PHASE1","title":"Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote","status":"COMPLETED","sponsor":"Portola Pharmaceuticals","startDate":"2012-06","conditions":"Healthy","enrollment":32},{"nctId":"NCT04233073","phase":"PHASE2","title":"Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery","status":"TERMINATED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2021-06-27","conditions":"Surgery","enrollment":10},{"nctId":"NCT03310021","phase":"PHASE2","title":"A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects","status":"COMPLETED","sponsor":"Portola Pharmaceuticals","startDate":"2017-08-28","conditions":"Bleeding","enrollment":108},{"nctId":"NCT03578146","phase":"PHASE2","title":"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)","status":"COMPLETED","sponsor":"Portola Pharmaceuticals","startDate":"2012-12","conditions":"Healthy Volunteers","enrollment":48},{"nctId":"NCT03551730","phase":"PHASE2","title":"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)","status":"COMPLETED","sponsor":"Portola Pharmaceuticals","startDate":"2012-12","conditions":"Healthy Volunteers","enrollment":27},{"nctId":"NCT03551743","phase":"PHASE2","title":"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)","status":"COMPLETED","sponsor":"Portola Pharmaceuticals","startDate":"2012-12","conditions":"Healthy Volunteers","enrollment":28},{"nctId":"NCT02220725","phase":"PHASE3","title":"A Study in Older Subject to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Rivaroxaban","status":"COMPLETED","sponsor":"Portola Pharmaceuticals","startDate":"2014-05","conditions":"Bleeding","enrollment":80},{"nctId":"NCT02329327","phase":"PHASE3","title":"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)","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2015-04-10","conditions":"Bleeding","enrollment":479},{"nctId":"NCT03537521","phase":"","title":"Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists (RADOA). Focus on New Antidots","status":"WITHDRAWN","sponsor":"Cardioangiologisches Centrum Bethanien","startDate":"2020-04","conditions":"Severe Bleeding, Urgent Surgery","enrollment":""}],"_emaApprovals":[],"_faersSignals":[{"count":26,"reaction":"DEATH"},{"count":21,"reaction":"HEPARIN RESISTANCE"},{"count":18,"reaction":"CEREBRAL HAEMORRHAGE"},{"count":18,"reaction":"CEREBRAL INFARCTION"},{"count":16,"reaction":"ACUTE MYOCARDIAL INFARCTION"},{"count":16,"reaction":"PULMONARY EMBOLISM"},{"count":15,"reaction":"ISCHAEMIC STROKE"},{"count":14,"reaction":"DRUG INTERACTION"},{"count":14,"reaction":"OFF LABEL USE"},{"count":10,"reaction":"DRUG INEFFECTIVE"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":548,"therapeuticAreas":["Cardiovascular"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Andexanet","genericName":"Andexanet","companyName":"Portola Pharmaceuticals","companyId":"portola-pharmaceuticals","modality":"Biologic","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":3,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}