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clopidogrel by chewing

Sheba Medical Center · Phase 3 active Small molecule Under review

clopidogrel by chewing is a antiplatelet Small molecule drug developed by Sheba Medical Center. It is currently in Phase 3 development for Atrial fibrillation for stroke prevention, Acute coronary syndrome, Myocardial infarction.

Clopidogrel inhibits platelet activation and aggregation by irreversibly inhibiting the P2Y12 receptor.

Clopidogrel is a small molecule medication used to study platelet aggregation and major bleeding outcomes in clinical trials. It is available in various forms, including a film-coated tablet and a form that can be chewed, which is being studied in clinical trials for its potential benefits in patients with non-ST elevation myocardial infarction.

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 nameclopidogrel by chewing
SponsorSheba Medical Center
Drug classantiplatelet
TargetP2Y12 receptor
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 3

Mechanism of action

This is achieved through the irreversible binding of clopidogrel's active metabolite to the P2Y12 receptor on platelet surfaces, preventing adenosine diphosphate (ADP) from binding and activating the receptor. As a result, platelet activation and aggregation are reduced, which in turn decreases the risk of thrombotic events such as myocardial infarction and stroke.

Approved indications

Common side effects

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 clopidogrel by chewing

What is clopidogrel by chewing?

clopidogrel by chewing is a antiplatelet drug developed by Sheba Medical Center, indicated for Atrial fibrillation for stroke prevention, Acute coronary syndrome, Myocardial infarction.

How does clopidogrel by chewing work?

Clopidogrel inhibits platelet activation and aggregation by irreversibly inhibiting the P2Y12 receptor.

What is clopidogrel by chewing used for?

clopidogrel by chewing is indicated for Atrial fibrillation for stroke prevention, Acute coronary syndrome, Myocardial infarction.

Who makes clopidogrel by chewing?

clopidogrel by chewing is developed by Sheba Medical Center (see full Sheba Medical Center pipeline at /company/sheba-medical-center).

What drug class is clopidogrel by chewing in?

clopidogrel by chewing belongs to the antiplatelet class. See all antiplatelet drugs at /class/antiplatelet.

What development phase is clopidogrel by chewing in?

clopidogrel by chewing is in Phase 3.

What are the side effects of clopidogrel by chewing?

Common side effects of clopidogrel by chewing include Bleeding, Thrombocytopenia, Neutropenia.

What does clopidogrel by chewing target?

clopidogrel by chewing targets P2Y12 receptor and is a antiplatelet.

Related

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