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BAY 59-7939
BAY 59-7939 is a Direct Factor Xa inhibitor Small molecule drug developed by Bayer. It is currently in Phase 3 development for Thromboembolism prevention in patients undergoing hip or knee replacement surgery, Atrial fibrillation stroke prevention.
BAY 59-7939 is a direct Factor Xa inhibitor that blocks the coagulation cascade to prevent thrombus formation.
Rivaroxaban, also known as Xarelto, is an anticoagulant medication used to treat and prevent blood clots. It has been studied in clinical trials for various conditions, including aortic stenosis, aortic regurgitation, thrombosis, and intracranial hemorrhages, among others.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care. -
Big-pharma sponsor
+3.0pp
Bayer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | BAY 59-7939 |
|---|---|
| Sponsor | Bayer |
| Drug class | Direct Factor Xa inhibitor |
| Target | Factor Xa |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Factor Xa is a serine protease critical to the intrinsic and extrinsic coagulation pathways. By selectively inhibiting Factor Xa, BAY 59-7939 reduces thrombin generation and fibrin clot formation. This anticoagulant effect prevents venous and arterial thromboembolism without requiring monitoring of coagulation parameters.
Approved indications
- Thromboembolism prevention in patients undergoing hip or knee replacement surgery
- Atrial fibrillation stroke prevention
Common side effects
- Bleeding
- Elevated liver enzymes
Key clinical trials
- The Impact of Factor Xa Inhibition on Thrombosis, Platelet Activation, and Endothelial Function in Peripheral Artery Disease (PHASE4)
- Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure (PHASE4)
- Epunamin Combined With DECP for Relapsed/Refractory Multiple Myeloma
- FENOX Trial (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants) (NA)
- PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years (PHASE3)
- Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease (PHASE3)
- AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms (PHASE3)
- Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia (PHASE4)
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:
- BAY 59-7939 CI brief — competitive landscape report
- BAY 59-7939 updates RSS · CI watch RSS
- Bayer portfolio CI
Frequently asked questions about BAY 59-7939
What is BAY 59-7939?
How does BAY 59-7939 work?
What is BAY 59-7939 used for?
Who makes BAY 59-7939?
What drug class is BAY 59-7939 in?
What development phase is BAY 59-7939 in?
What are the side effects of BAY 59-7939?
What does BAY 59-7939 target?
Related
- Drug class: All Direct Factor Xa inhibitor drugs
- Target: All drugs targeting Factor Xa
- Manufacturer: Bayer — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Thromboembolism prevention in patients undergoing hip or knee replacement surgery
- Indication: Drugs for Atrial fibrillation stroke prevention
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing