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clopidogrel by chewing
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.
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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 | clopidogrel by chewing |
|---|---|
| Sponsor | Sheba Medical Center |
| Drug class | antiplatelet |
| Target | P2Y12 receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 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
- Atrial fibrillation for stroke prevention
- Acute coronary syndrome
- Myocardial infarction
Common side effects
- Bleeding
- Thrombocytopenia
- Neutropenia
Key clinical trials
- Bioequivalence Study of Two Formulations of Clopidogrel Film-coated Tablets 75 mg in Healthy Male Subjects Under Fasting Conditions (PHASE1)
- Chewing Clopidogrel in Addition to Regular Oral Clopidogrel Treatment to Improve Platelets Aggregation in Patient With NON ST ELEVATION MI (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:
- clopidogrel by chewing CI brief — competitive landscape report
- clopidogrel by chewing updates RSS · CI watch RSS
- Sheba Medical Center portfolio CI
Frequently asked questions about clopidogrel by chewing
What is clopidogrel by chewing?
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Who makes clopidogrel by chewing?
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Related
- Drug class: All antiplatelet drugs
- Target: All drugs targeting P2Y12 receptor
- Manufacturer: Sheba Medical Center — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Atrial fibrillation for stroke prevention
- Indication: Drugs for Acute coronary syndrome
- Indication: Drugs for Myocardial infarction
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing