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Warfarin Sodium Tablets
Warfarin Sodium Tablets is a Vitamin K antagonist (coumarin anticoagulant) Small molecule drug developed by Guangdong Raynovent Biotech Co., Ltd. It is currently in Phase 3 development for Atrial fibrillation for stroke prevention, Venous thromboembolism (deep vein thrombosis and pulmonary embolism) treatment and prevention, Mechanical heart valve thromboprophylaxis. Also known as: Casopitant (GW679769) oral tablets.
Warfarin inhibits vitamin K-dependent clotting factors (II, VII, IX, X) by blocking the vitamin K epoxide reductase enzyme, thereby reducing thrombin generation and preventing blood clot formation.
Warfarin Sodium Tablets are used to treat conditions such as Atrial Fibrillation, Thromboembolism, and Aortic Valve Diseases. Warfarin Sodium Tablets are a type of Vitamin K antagonist, which is an intervention studied in clinical trials for anticoagulation therapy.
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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.
| 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 | Warfarin Sodium Tablets |
|---|---|
| Also known as | Casopitant (GW679769) oral tablets |
| Sponsor | Guangdong Raynovent Biotech Co., Ltd |
| Drug class | Vitamin K antagonist (coumarin anticoagulant) |
| Target | Vitamin K epoxide reductase complex 1 (VKORC1) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Warfarin is a coumarin anticoagulant that acts as a competitive inhibitor of vitamin K epoxide reductase, preventing the recycling of vitamin K and the gamma-carboxylation of clotting factors II, VII, IX, and X. This results in the production of inactive clotting factors and a prolonged prothrombin time (PT/INR). The anticoagulant effect develops over 36-72 hours as existing clotting factors are cleared from circulation.
Approved indications
- Atrial fibrillation for stroke prevention
- Venous thromboembolism (deep vein thrombosis and pulmonary embolism) treatment and prevention
- Mechanical heart valve thromboprophylaxis
- Post-myocardial infarction thromboprophylaxis
Common side effects
- Bleeding (major and minor)
- Warfarin-induced skin necrosis
- Nausea
- Alopecia
- Rash
Key clinical trials
- Rivaroxaban vs Warfarin in Patients With Mechanical Heart Valves (PHASE3)
- Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device (PHASE4)
- Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprpsthetic Heart Valve Replacement (PHASE4)
- Sunitinib or Cediranib for Alveolar Soft Part Sarcoma (PHASE2)
- An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates (PHASE1)
- Drug-durg Interaction of RAY1225 With Warfarin, Atorvastatin, Metformin and Digoxin (PHASE1)
- Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement (PHASE4)
- Study to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple Cytochrome P450 (CYP450) Substrates in Participants With Moderate to Severe Atopic Dermatitis (EARLY_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:
- Warfarin Sodium Tablets CI brief — competitive landscape report
- Warfarin Sodium Tablets updates RSS · CI watch RSS
- Guangdong Raynovent Biotech Co., Ltd portfolio CI
Frequently asked questions about Warfarin Sodium Tablets
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Related
- Drug class: All Vitamin K antagonist (coumarin anticoagulant) drugs
- Target: All drugs targeting Vitamin K epoxide reductase complex 1 (VKORC1)
- Manufacturer: Guangdong Raynovent Biotech Co., Ltd — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Atrial fibrillation for stroke prevention
- Indication: Drugs for Venous thromboembolism (deep vein thrombosis and pulmonary embolism) treatment and prevention
- Indication: Drugs for Mechanical heart valve thromboprophylaxis
- Also known as: Casopitant (GW679769) oral tablets
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing