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ASA-withdrawn group

Hospital Universitari Vall d'Hebron Research Institute · Phase 3 active Small molecule

ASA-withdrawn group is a Small molecule drug developed by Hospital Universitari Vall d'Hebron Research Institute.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ASA-withdrawn group refers to a cohort of patients who discontinued aspirin therapy, typically studied to assess rebound thrombotic or cardiovascular effects.

ASA-withdrawn group refers to a cohort of patients who discontinued aspirin therapy, typically studied to assess rebound thrombotic or cardiovascular effects.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).

Likelihood of approval
56.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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Generic nameASA-withdrawn group
Also known assFlt y PlGF ratio less than 38.
SponsorHospital Universitari Vall d'Hebron Research Institute
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 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

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about ASA-withdrawn group

What is ASA-withdrawn group?

ASA-withdrawn group is a Small molecule drug developed by Hospital Universitari Vall d'Hebron Research Institute, indicated for Aspirin withdrawal effects in cardiovascular disease (study cohort, not a therapeutic indication).

How does ASA-withdrawn group work?

ASA-withdrawn group refers to a cohort of patients who discontinued aspirin therapy, typically studied to assess rebound thrombotic or cardiovascular effects.

What is ASA-withdrawn group used for?

ASA-withdrawn group is indicated for Aspirin withdrawal effects in cardiovascular disease (study cohort, not a therapeutic indication).

Who makes ASA-withdrawn group?

ASA-withdrawn group is developed by Hospital Universitari Vall d'Hebron Research Institute (see full Hospital Universitari Vall d'Hebron Research Institute pipeline at /company/hospital-universitari-vall-d-hebron-research-institute).

Is ASA-withdrawn group also known as anything else?

ASA-withdrawn group is also known as sFlt y PlGF ratio less than 38..

What development phase is ASA-withdrawn group in?

ASA-withdrawn group is in Phase 3.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing