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ASA-withdrawn group
ASA-withdrawn group is a Small molecule drug developed by Hospital Universitari Vall d'Hebron Research Institute. It is currently in Phase 3 development for Aspirin withdrawal effects in cardiovascular disease (study cohort, not a therapeutic indication). Also known as: sFlt y PlGF ratio less than 38..
ASA-withdrawn group refers to a cohort of patients who discontinued aspirin therapy, typically studied to assess rebound thrombotic or cardiovascular effects.
ASA-withdrawn group refers to a cohort of patients who discontinued aspirin therapy, typically studied to assess rebound thrombotic or cardiovascular effects. Used for Aspirin withdrawal effects in cardiovascular disease (study cohort, not a therapeutic indication).
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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| Generic name | ASA-withdrawn group |
|---|---|
| Also known as | sFlt y PlGF ratio less than 38. |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
This is not a drug itself, but rather a control or comparator group in clinical trials examining the effects of aspirin withdrawal. Studies of ASA-withdrawn groups help evaluate whether discontinuation of antiplatelet therapy leads to increased thrombotic events, inflammation, or other adverse cardiovascular outcomes compared to continued aspirin use or placebo.
Approved indications
- Aspirin withdrawal effects in cardiovascular disease (study cohort, not a therapeutic indication)
Common side effects
Key clinical trials
- ATILA Project: Aspirin Versus Tirofiban in Endovascular Treatment for Patients With Acute Ischemic Stroke Due to Tandem Lesion (PHASE4)
- Comparative Study of USG Guided ESPB vs USG Guided PVB For Post-op Analgesia In Patient's After Open Renal Surgeries (PHASE2, PHASE3)
- Detection of False Positives From First-trimester Preeclampsia Screening (StopPRE) at the Second-trimester of Pregnancy (PHASE3)
- Aspirin Withdrawal and Clinical Outcome in Patients With Moderate to High Cardiovascular Risk But Without Cardiovascular Disease (NA)
- Time Based Strategy to Reduce Clopidogrel Associated Bleeding Related to Coronary Artery Bypass Graft (CABG) (NA)
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:
- ASA-withdrawn group CI brief — competitive landscape report
- ASA-withdrawn group updates RSS · CI watch RSS
- Hospital Universitari Vall d'Hebron Research Institute portfolio CI
Frequently asked questions about ASA-withdrawn group
What is ASA-withdrawn group?
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What is ASA-withdrawn group used for?
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Is ASA-withdrawn group also known as anything else?
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Related
- Manufacturer: Hospital Universitari Vall d'Hebron Research Institute — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Aspirin withdrawal effects in cardiovascular disease (study cohort, not a therapeutic indication)
- Also known as: sFlt y PlGF ratio less than 38.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing