Last reviewed 2026-06-02 · How we verify

Anxa (ANDEXANET ALFA)

Anxa (generic name: ANDEXANET ALFA) is a Recombinant protein drug developed by Portola Pharamceuticals US. It is currently FDA-approved (first approved 2018) for Direct acting anticoagulant adverse reaction.

Anxa works by binding to and neutralizing factor Xa inhibitors, reversing anticoagulation.

At a glance

Mechanism of action

Coagulation factor Xa (recombinant), inactivated-zhzo exerts its procoagulant effect by binding and sequestering the FXa inhibitors, rivaroxaban and apixaban. Another observed procoagulant effect of the ANDEXXA protein is its ability to bind to, and inhibit the activity of, Tissue Factor Pathway Inhibitor (TFPI). Inhibition of TFPI activity can increase tissue factor (TF)-initiated thrombin generation.

Approved indications

• Direct acting anticoagulant adverse reaction

Boxed warnings

• WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: ( 5.1 ) • Arterial and venous thromboembolic events • Ischemic events, including myocardial infarction and ischemic stroke • Cardiac arrest • Sudden deaths Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed. WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, and SUDDEN DEATHS See full prescribing information for complete boxed warning Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: ( 5.1 ) • Arterial and venous thromboembolic events • Ischemic events, including myocardial infarction and ischemic stroke • Cardiac arrest • Sudden deaths Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.

Common side effects

• Urinary tract infections
• Pneumonia
• Infusion-related reactions
• Cerebrovascular accident (CVA)
• Deep venous thrombosis
• Acute myocardial infarction
• Pulmonary embolism
• Transient ischemic attack
• Thrombotic event and/or ischemic event
• Flushing
• Feeling hot
• Cough

Key clinical trials

• A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants (PHASE1)
• Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya
• Andexanet Alfa: Non-interventional Study in Stroke Units in Germany (DE)
• A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure (PHASE3)
• Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor (PHASE4)
• Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed
• A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing (PHASE2)
• A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Anxa CI brief — competitive landscape report
• Anxa updates RSS · CI watch RSS
• Portola Pharamceuticals US portfolio CI

Frequently asked questions about Anxa

Related

• Manufacturer: Portola Pharamceuticals US — full pipeline
• Therapeutic area: All drugs in Cardiovascular
• Indication: Drugs for Direct acting anticoagulant adverse reaction

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing