BEVYXXA
Peakbetrixaban
NDAORALCAPSULEPriority Review
Approved
Jun 2017
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
7
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 12h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BEVYXXA (betrixaban) is an oral Factor Xa inhibitor anticoagulant approved in 2017 for the prevention of venous thromboembolism (VTE) in hospitalized patients. It is a small molecule direct anticoagulant that blocks Factor Xa, a key enzyme in the coagulation cascade, reducing clot formation. The drug represents an alternative to injectable anticoagulants for acute hospitalized patients requiring thromboembolism prophylaxis.
Peak4.4 years to LOE
Product is in peak commercial phase with high competitive pressure (8/10), indicating mature market dynamics and established sales infrastructure requiring defense-focused strategies.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
BRAVO - Betrixaban Registry Using Real Time Observations in Acute Medical Illness to Assess Venous Thrombosis and Bleeding Outcomes
Started Sep 2018
0Venous Thromboses
Study Evaluating Betrixaban in Pediatric Participants
Started Jul 2018
21 enrolled
VTE Prophylaxis
A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations
Started Sep 2015
52 enrolled
Healthy
A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing
Started Aug 2015
18 enrolled
Bleeding
Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)
Started Mar 2012
7,513 enrolled
Venous Thromboembolism (VTE)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.