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Sintrom (ACENOCOUMAROL)
Sintrom (generic name: ACENOCOUMAROL) is a acenocoumarol drug. It is currently in Phase 3 development for Pulmonary embolism, Venous thrombosis.
Acenocoumarol works by blocking the enzyme that helps produce clotting factors in the liver.
Sintrom (Acenocoumarol) is a small molecule anticoagulant medication that targets Vitamin K epoxide reductase complex subunit 1. It works by inhibiting the production of vitamin K-dependent clotting factors, thereby preventing the formation of blood clots. Sintrom is approved to treat pulmonary embolism and venous thrombosis. The commercial status of Sintrom is unclear, but it is a generic version of a patented medication. Key safety considerations include the risk of bleeding and the need for regular monitoring of international normalized ratio (INR) levels.
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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 | ACENOCOUMAROL |
|---|---|
| Drug class | acenocoumarol |
| Target | Vitamin K epoxide reductase complex subunit 1 |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Think of your blood as a liquid that can clot to stop bleeding when you're injured. Clotting factors are like special proteins that help your blood turn into a solid to stop the bleeding. Acenocoumarol stops the liver from making these clotting factors, which helps prevent blood clots from forming in the first place.
Approved indications
- Pulmonary embolism
- Venous thrombosis
Common side effects
- Drug interaction
- International normalised ratio increased
- Hypocoagulable state
- Cardiac failure
- Haemorrhage intracranial
- Upper gastrointestinal haemorrhage
- Haematoma
- Abdominal wall haematoma
- Acute kidney injury
- Subdural haematoma
- Anaemia
- Retroperitoneal haematoma
Key clinical trials
- Anticoagulation Therapy in Non-device-related Intra-cardiac Thrombus (PHASE3)
- Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS
- Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension
- Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) (PHASE4)
- Biomarkers and Antithrombotic Treatment in Cervical Artery Dissection - TREAT-CAD (PHASE3)
- LV Thrombus After Acute AMI: A Randomized Controlled Trial (NA)
- Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin (PHASE2)
- Rivaroxaban Plus Aspirin to Manage Recurrent Venous Thromboembolic Events (PHASE2,PHASE3)
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:
- Sintrom CI brief — competitive landscape report
- Sintrom updates RSS · CI watch RSS
Frequently asked questions about Sintrom
What is Sintrom?
How does Sintrom work?
What is Sintrom used for?
What is the generic name of Sintrom?
What drug class is Sintrom in?
What development phase is Sintrom in?
What are the side effects of Sintrom?
What does Sintrom target?
Related
- Drug class: All acenocoumarol drugs
- Target: All drugs targeting Vitamin K epoxide reductase complex subunit 1
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Pulmonary embolism
- Indication: Drugs for Venous thrombosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing