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acenocumarol
acenocumarol is a Small molecule drug developed by Hospital Universitari Vall d'Hebron Research Institute. It is currently in Phase 3 development. Also known as: SINTROM.
Acenocoumarol is a small molecule inhibitor of the Vitamin K epoxide reductase complex subunit 1, specifically inhibiting isoform 1. It is used to treat various conditions, including intracranial hemorrhages, as indicated by clinical trials such as the Start or STop Anticoagulants Randomised Trial (SoSTART).
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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).
| 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 | acenocumarol |
|---|---|
| Also known as | SINTROM |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension
- Start or STop Anticoagulants Randomised Trial (SoSTART) (PHASE3)
- Evolution of COVID-19 in Anticoagulated or Antiaggregated Patients (CORONA Study)
- Triple or Dual Antithrombotic Therapy After PCI (TRIDUAL-PCI) Coronary Intervention in Patients With Non-valvular Atrial Fibrillation. Real-world Italian Multicenter Registry (TRIDUAL-PCI)
- Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation (PHASE3)
- Dual Antiplatelet Therapy Versus Oral Anticoagulation for a Short Time to Prevent Cerebral Embolism After TAVI (PHASE4)
- Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients
- Severity Factors and Needed Observation Time at ED of Patients Wih Head Injury
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:
- acenocumarol CI brief — competitive landscape report
- acenocumarol updates RSS · CI watch RSS
- Hospital Universitari Vall d'Hebron Research Institute portfolio CI
Frequently asked questions about acenocumarol
What is acenocumarol?
Who makes acenocumarol?
Is acenocumarol also known as anything else?
What development phase is acenocumarol in?
Related
- Manufacturer: Hospital Universitari Vall d'Hebron Research Institute — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: SINTROM
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing