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Bevyxxa (BETRIXABAN)
Bevyxxa (Betrixaban) is a small molecule factor Xa inhibitor developed by Portola Pharma Inc, targeting coagulation factor X to prevent venous thromboembolism. It was FDA-approved in 2017 for patients at risk of venous thromboembolus. Bevyxxa is a patented medication with no generic manufacturers available. Key safety considerations include bleeding risks, which can be severe. As a factor Xa inhibitor, Bevyxxa works by blocking the action of factor Xa in the coagulation cascade.
At a glance
| Generic name | BETRIXABAN |
|---|---|
| Sponsor | Portola Pharms Inc |
| Drug class | Factor Xa Inhibitor |
| Target | Coagulation factor X |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2017 |
Approved indications
- At risk of venous thromboembolus
Common side effects
Key clinical trials
- Computerized Decision Support for Prevention of VTE in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT) (NA)
- Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF (NA)
- Study Evaluating Betrixaban in Pediatric Participants (PHASE1)
- A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment (PHASE1)
- A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing (PHASE2)
- A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers (PHASE1)
- A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations (PHASE1)
- Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study) (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bevyxxa CI brief — competitive landscape report
- Bevyxxa updates RSS · CI watch RSS
- Portola Pharms Inc portfolio CI