Last reviewed · How we verify
Andexanet
At a glance
| Generic name | Andexanet |
|---|---|
| Also known as | ALXN2070, Andexanet Alfa, PRT064445, Andexxa, Andexanet alpha |
| Sponsor | Portola Pharmaceuticals |
| Modality | Biologic |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Approved indications
- Direct acting anticoagulant adverse reaction
Common side effects
- Urinary tract infections
- Pneumonia
Serious adverse events
- Death
- Thromboembolic events
- Cerebrovascular accident
- Deep venous thrombosis
- Myocardial infarction
- Pulmonary embolism
- Infusion-related reaction
- Transient ischemic attack
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.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Andexanet CI brief — competitive landscape report
- Andexanet updates RSS · CI watch RSS
- Portola Pharmaceuticals portfolio CI