Last reviewed 2026-04-20 · How we verify

Effient (PRASUGREL)

Effient works by blocking the P2Y12 receptor on platelets, preventing them from aggregating and forming blood clots.

Effient, a P2Y12 receptor antagonist marketed by Cosette, is indicated for Acute Coronary Syndrome with PCI and faces competition from multiple off-patent generics in the same class. Its key strength lies in its mechanism of action, which effectively prevents platelet aggregation and clot formation, offering a robust alternative to older therapies. The primary risk is the key composition patent expiry in 2028, which could lead to increased generic competition and revenue erosion.

At a glance

Mechanism of action

Prasugrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets.

Approved indications

• Acute Coronary Syndrome with PCI
• ST-Elevation Myocardial Infarction with PCI

Boxed warnings

• WARNING: BLEEDING RISK Prasugrel can cause significant, sometimes fatal, bleeding [see Warnings and Precautions (5.1 , 5.2) and Adverse Reactions (6.1) ] . Do not use prasugrel in patients with active pathological bleeding or a history of transient ischemic attack (TIA) or stroke [see Contraindications (4.1 , 4.2) ] . In patients ≥75 years of age, prasugrel is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior myocardial infarction [MI]) where its effect appears to be greater and its use may be considered [see Use in Specific Populations (8.5) ] . Do not start prasugrel in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue prasugrel at least 7 days prior to any surgery [see Warnings and Precautions (5.2) ] . Additional risk factors for bleeding include: body weight <60 kg, propensity to bleed, concomitant use of medications that increase the risk of bleeding (e.g., warfarin, heparin, fibrinolytic therapy, chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs]) [see Warnings and Precautions (5.1) ] . Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of prasugrel [see Warnings and Precautions (5.1) ] . If possible, manage bleeding without discontinuing prasugrel. Discontinuing prasugrel, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular (CV) events [see Warnings and Precautions (5.3) ] . WARNING: BLEEDING RISK See full prescribing information for complete boxed warning. Prasugrel can cause significant, sometimes fatal, bleeding (5.1 , 5.2 , 6.1) . Do not use prasugrel in patients with active pathological bleeding or a history of transient ischemic attack or stroke (4.1 , 4.2) . In patients ≥75 years of age, prasugrel is generally not recommended, except in high-risk patients (diabetes or prior myocardial infarction [MI]), where its use may be considered (8.5) . Do not start prasugrel in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue prasugrel at least 7 days prior to any surgery (5.2) . Additional risk factors for bleeding include: body weight <60 kg, propensity to bleed, concomitant use of medications that increase the risk of bleeding (5.1) . Suspect bleeding in any patient who is hypotensive and has recently undergone invasive or surgical procedures (5.1) . If possible, manage bleeding without discontinuing prasugrel. Stopping prasugrel increases the risk of subsequent cardiovascular events (5.3) .

Common side effects

• TIMI Major or Minor bleeding
• TIMI Major bleeding
• Life-threatening
• Fatal
• Symptomatic intracranial hemorrhage (ICH)
• Requiring inotropes
• Requiring surgical intervention
• Requiring transfusion (≥4 units)
• TIMI Minor bleeding
• epistaxis
• gastrointestinal hemorrhage
• hemoptysis

Drug interactions

• Opioids
• Warfarin
• Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
• Inducers or Inhibitors of Cytochrome P450 Enzymes
• Aspirin (75 mg to 325 mg per day)
• Heparin
• GPIIb/IIIa Inhibitors
• Statins
• Digoxin
• Drugs that Elevate Gastric pH (Proton Pump Inhibitors and H2 Blockers)

Key clinical trials

• Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent (PHASE4)
• Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI (PHASE4)
• Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention (PROMOTE) (PHASE4)
• Multivessel TALENT (NA)
• The Switching Antiplatelet-9 (SWAP-9) Study (PHASE4)
• Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial (NA)
• ARCANGELO (itAlian pRospective Study on CANGrELOr)
• Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion (PHASE4)

Primary sources

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

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Effient CI brief — competitive landscape report
• Effient updates RSS · CI watch RSS
• Cosette portfolio CI