apixaban
apixaban: developed by 2 companies · 14 clinical trials tracked · 2 FDA decisions.
apixaban evidence translation
What we can confirm
2 FDA records · 14 tracked trials
What it means
What to watch
Prepared research question
What is verified about apixaban, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence6 indications · 8 study sponsors
Related indications
Development Pipeline (3)
| Company | Phase |
|---|---|
| BRISTOL MYERS SQUIBB CO (BMY) | Approved |
| BRISTOL MYERS SQUIBB CO (BMY) | Approved |
| DR REDDYS LABORATORIES LTD (RDY) | Approved |
Clinical Trials (14)showing 10 most recent
A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants With Solid and Hematologic Cancers (ROXI-CAT-II)
Primary endpoint: Occurrence of Treatment-Emergent Adverse Events (TEAEs)
A Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention With REGN7508, a Monoclonal Antibody Against Factor XI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-EVEREST)
Primary endpoint: Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism
CSP #2037T - Veterans Affairs Learning Health System Initiative to Assess Novel Screening vs. Usual Care and Treatment With Apixaban vs. Rivaroxaban in Veterans With Atrial Fibrillation (VALIANT-AF-T) Trial
Primary endpoint: Onset of ISTH Major Bleeding Event
Safety and Efficacy of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation in the First Three Months After Mitral or Aortic Biological Valve Replacement or Repair
Primary endpoint: Major Bleeding
A Phase I, Randomized, Single-blind, Placebo-controlled Study to Further Characterize Andexanet Posology and Assess the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants
Primary endpoint: Anti-Factor (F) Xa activity
A Phase 2, Randomized, Multicenter, Open-label, Blinded-endpoint Study to Evaluate the Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against FXI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-ATLAS)
Primary endpoint: Incidence of any bleeding
A Phase 3, Multicenter, Randomized, Open-Label, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)
Primary endpoint: Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death]
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation
Primary endpoint: Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism
ANTICOAGULANT TREATMENT PATTERNS AND OUTCOMES AMONG NON-VALVULAR ATRIAL FIBRILLATION PATIENTS WITH HIGH RISK OF GASTROINTESTINAL BLEEDING IN FRANCE: A RETROSPECTIVE COHORT ANALYSIS USING SNDS DATABASE
Primary endpoint: Bleeding leading to hospitalization
A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab Relative to Apixaban on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With Cancer Associated VTE
Primary endpoint: Time to first event of centrally adjudicated VTE recurrence
FDA Decisions2 records
Frequently asked questions
Who is developing apixaban?
apixaban is being developed by BRISTOL MYERS SQUIBB CO, DR REDDYS LABORATORIES LTD.
How many clinical trials involve apixaban?
BioSniper tracks 14 clinical trials involving apixaban.
What is apixaban's latest FDA decision?
The most recent tracked FDA decision for apixaban is Tentative Approval for 1 INDICATIONS & USAGE Apixaban is a factor Xa inhibitor indicated: to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. ( 1.1 ) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. ( 1.2 ) for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. ( 1.3 , 1.4 , 1.5 ) 1.1 Reduction of Ris, dated March 2, 2020.