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Clopidogrel (SR25990)
Clopidogrel (SR25990) is a P2Y12 receptor antagonist / Thienopyridine antiplatelet agent Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Acute coronary syndrome (unstable angina, NSTEMI, STEMI), Secondary prevention of atherothrombotic events in patients with established cardiovascular disease, Stroke prevention in patients with recent ischemic stroke or transient ischemic attack. Also known as: Plavix.
Clopidogrel is a thienopyridine antiplatelet agent that irreversibly inhibits ADP-induced platelet aggregation by blocking the P2Y12 adenosine diphosphate receptor on platelets.
Clopidogrel is a small molecule medication used to treat certain conditions. It has been studied in clinical trials for long-term safety in neonates and infants with systemic to pulmonary artery shunt palliation.
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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. -
Big-pharma sponsor
+3.0pp
Sanofi is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 (SR25990) |
|---|---|
| Also known as | Plavix |
| Sponsor | Sanofi |
| Drug class | P2Y12 receptor antagonist / Thienopyridine antiplatelet agent |
| Target | P2Y12 receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Clopidogrel is a prodrug that requires hepatic metabolism to form its active metabolite, which then binds irreversibly to the P2Y12 receptor on platelet surfaces. This prevents ADP-mediated platelet activation and aggregation, reducing thrombotic events. The drug is used to prevent blood clots in patients at risk of cardiovascular events.
Approved indications
- Acute coronary syndrome (unstable angina, NSTEMI, STEMI)
- Secondary prevention of atherothrombotic events in patients with established cardiovascular disease
- Stroke prevention in patients with recent ischemic stroke or transient ischemic attack
Common side effects
- Bleeding
- Dyspepsia
- Diarrhea
- Rash
- Thrombotic thrombocytopenic purpura (TTP)
Key clinical trials
- Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation (PHASE3)
- Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease (PHASE3)
- Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) (PHASE3)
- Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects (PHASE1)
- Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Pantoprazole 80 mg in Healthy Subjects (PHASE1)
- Interaction Study of Clopidogrel 600/150 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects (PHASE1)
- Pharmacodynamic and Pharmacokinetic Study of 2 Different Dose Regimen of Clopidogrel in CYP2C19 Genotyped Healthy Subjects (PHASE1)
- Interaction Study of Clopidogrel 300/75 mg Given Alone or With Omeprazole 80 mg 12 Hours Apart in Healthy Subjects (PHASE1)
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 (SR25990) CI brief — competitive landscape report
- Clopidogrel (SR25990) updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about Clopidogrel (SR25990)
What is Clopidogrel (SR25990)?
How does Clopidogrel (SR25990) work?
What is Clopidogrel (SR25990) used for?
Who makes Clopidogrel (SR25990)?
Is Clopidogrel (SR25990) also known as anything else?
What drug class is Clopidogrel (SR25990) in?
What development phase is Clopidogrel (SR25990) in?
What are the side effects of Clopidogrel (SR25990)?
What does Clopidogrel (SR25990) target?
Related
- Drug class: All P2Y12 receptor antagonist / Thienopyridine antiplatelet agent drugs
- Target: All drugs targeting P2Y12 receptor
- Manufacturer: Sanofi — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Acute coronary syndrome (unstable angina, NSTEMI, STEMI)
- Indication: Drugs for Secondary prevention of atherothrombotic events in patients with established cardiovascular disease
- Indication: Drugs for Stroke prevention in patients with recent ischemic stroke or transient ischemic attack
- Also known as: Plavix
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing