PRASUGREL (prasugrel hydrochloride)
Prasugrel is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular (CV) events, including stent thrombosis, in patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention (PCI). It is indicated for patients with unstable angina (UA), non-ST-elevation myocardial infarction (NSTEMI), or ST-elevation myocardial infarction (STEMI). Clinical data demonstrates that prasugrel reduces the composite endpoint of CV death, nonfatal MI, or nonfatal stroke compared to clopidogrel, a benefit primarily driven by a reduction in MI.
How PRASUGREL Works
Prasugrel is an inhibitor of platelet activation and aggregation. It is a prodrug that requires metabolic activation; its active metabolite binds irreversibly to the P2Y12 class of adenosine diphosphate (ADP) receptors on platelets. This binding prevents ADP-mediated activation of the GPIIb/IIIa complex, thereby inhibiting platelet aggregation for the remainder of the platelet's lifespan.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2017-07-12
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
PRASUGREL Approval History
What PRASUGREL Treats
7 indicationsPRASUGREL is approved for 7 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Thrombotic Cardiovascular Events
- Acute Coronary Syndrome
- Unstable Angina
- Non-ST-Elevation Myocardial Infarction
- ST-Elevation Myocardial Infarction
- Myocardial Infarction
- Stroke
PRASUGREL Boxed 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 ...
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
PRASUGREL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PRASUGREL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
83 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07582835 HI-TECH 2 | 2026-00247 | Ph 3 | recruiting | Study of the Long-term Effects of P2Y12 Inhibitor Monotherapy and Coagulation Markers After Percutaneous Coronary Angioplasty. |
| NCT07507500 STREAMLINE | STREAMLINE | Ph 4 | not yet recruiting | Dual Antiplatelet Therapy Strategies After Acute Myocardial Infarction Undergoing PCI: Prasugrel vs Ticagrelor & 12 Months vs 1-3 Months |
| NCT07025148 | IRB202401774 | Ph 4 | recruiting | Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2) |
| NCT03430661 | ID-076-103 | Ph 1 | completed | A Study to Investigate the Interaction Between ACT-246475 and Clopidogrel, Prasugrel, and Ticagrelor in Healthy Subjects |
| NCT01777503 | EudraCT Number: 2012-002882-37 | Ph 4 | completed | The Elderly ACS II Trial |
| NCT04668144 SWAP-6 results posted | SMF-02 | Ph 4 | completed | Pharmacodynamic and Pharmacokinetic of Switching From Cangrelor to Prasugrel in ACS Patients Undergoing PCI |
| NCT05223335 results posted | 21-011053 | Ph 4 | completed | Clopidogrel Monotherapy in Patients With High Bleeding Risk |
| NCT04006288 SWAP-AC results posted | IIS-RIVA02 | Ph 4 | completed | Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease |
| NCT01944800 ISAR-REACT 5 | GE IDE 00113 2013-002272-40 | Ph 4 | completed | Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome |
| NCT05643586 PROMICRO-3 | 2017/010 | Ph 4 | completed | Effects of Ticagrelor Versus Prasugrel on Coronary Microcirculation in Patients Undergoing Elective Percutaneous Coronary Intervention: Results of the PROtecting MICROcirculation During Coronary Angioplasty (PROMICRO)-3 Randomised Study |
| NCT03581409 | B-1712/439-001 | Ph 4 | completed | Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm |
| NCT01452152 PAPI-2 results posted | HP-00047385 9U01HL105198-06 | Ph 4 | terminated | Pharmacogenomics of Anti-platelet Intervention-2 (PAPI-2) Study |
| NCT05247385 | 4086/14/066 | Ph 4 | completed | Platelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel |
| NCT03672097 results posted | CS747S-B-A4003 | Ph 4 | completed | Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI) |
| NCT01014624 results posted | CS747S-B-U4001 | Ph 4 | completed | Prasugrel/Clopidogrel Maintenance Dose Washout Study |
| NCT02065479 results posted | UFJ 2014-12 IRB201702750 | Ph 4 | completed | A Pharmacodynamic Study Comparing Prasugrel Versus Ticagrelor in Patients Undergoing PCI With CYP2C19 Loss-of-function: |
| NCT03489863 results posted | IRB201703338 -A | Ph 4 | completed | Prasugrel Versus Ticagrelor in Patients With CYP2C19 Loss-of-function: a Validation Study |
| NCT02545933 VORA-PRATIC results posted | IIS 53376 | Ph 4 | completed | Vorapaxar in Patients With Prior Myocardial Infarction Treated With Prasugrel and Ticagrelor |
| NCT01365221 SWITCH 600/60 | SWITCH 600/60 | Ph 4 | completed | The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel |
| NCT01951001 | A-MATCH 2013-05-002-004 | Ph 4 | completed | Fixed-dose vs. Phenotype-based PrAsugrel Dose to MATCH Therapeutic Zone in Asians With Acute Coronary Syndrome |
| NCT02548611 SASSICAIA | GE IDE MucT002-14 | Ph 4 | terminated | Comparison of Loading Strategies With Antiplatelet Drugs in Patients Undergoing Elective Coronary Intervention |
| NCT03027934 | ESR-14-10619 | Ph 4 | withdrawn | A Single Center Study to Evaluate Ticagrelor Mechanism of Action in Inhibiting Juvenile Platelet ADP Response |
| NCT02866175 ENTRUST-AF-PCI results posted | DSE-EDO-01-15-EU 2016-002683-14 | Ph 3 | completed | Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention |
| NCT01979445 BRIDGE results posted | MDCO-CAN-13-02 | Ph 2 | completed | Cangrelor to Clopidogrel or Prasugrel Transition Study |
| NCT02978040 FABOLUS-FASTER | FABOLUS-FASTER | Ph 4 | completed | Randomized Comparison of Cangrelor, Tirofiban and Prasugrel in Patients With STEMI Referred for Primary PCI. |
| NCT02376283 results posted | 2012-004-04-02-CARD | Ph 4 | completed | P3AMI Antiplatelet Trial |
| NCT01560780 results posted | CLIN-007-11F | Ph 3 | completed | Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis |
| NCT01794000 results posted | 13038 H7T-MC-TADO, 2012-003837-41 | Ph 3 | terminated | A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD) |
| NCT02487732 | Adenosine diphosphate blockers | Ph 4 | completed | Comparison of Ticagrelor vs. Prasugrel on Inflammation, Arterial Stiffness, Endothelial Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients With Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Coronary Stenting |
| NCT01959451 TROPICAL-ACS | MucT001-13 | Ph 4 | completed | Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment For Acute Coronary Syndromes Trial |
| NCT01641510 PRAISE-GENE | PRAISE-GENE | Ph 3 | completed | PRAsugrel or clopIdogrel In Acute Coronary SyndromE With CYP2C19 GENEtic Variants |
| NCT01260584 results posted | CS747S-B-U4002 | Ph 4 | completed | The Influence of Smoking Status on Prasugrel and Clopidogrel Treated Subjects Taking Aspirin and Having Stable Coronary Artery Disease |
| NCT01612884 results posted | 1106005745 | Ph 4 | terminated | Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study) |
| NCT01830543 PIONEER AF-PCI results posted | CR100758 RIVAROXAFL3003, 2012-001491-11 | Ph 3 | completed | A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention |
| NCT02808767 PRAGUE-18 | EK-VP/04/2013 | Ph 4 | completed | Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction |
| NCT01531114 RESET 2D | RESET 2D Trial | Ph 3 | completed | PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus |
| NCT02215993 SAMPA | 51476 | Ph 4 | completed | Sampling P2Y12 Receptor Inhibition With Prasugrel and Ticagrelor in Patients Submitted to Thrombolysis |
| NCT01789814 results posted | PraCloBiv2013CK TMCcardintervCK2013 | Ph 4 | completed | Effect of Prasugrel Versus Clopidogrel on Platelet Function After Bivalirudin Cessation |
| NCT02587260 HI-TECH | NL51124.078.14 2014-004189-64 | Ph 4 | completed | Hunting for the Off-Target Properties of Ticagrelor on Endothelial Function in Humans (HI-TECH) |
| NCT01957540 | PATRASCARDIOLOGY-16 | Ph 4 | completed | Differential Effect of Ticagrelor Versus Prasugrel Maintenance Dose on Endothelial Function of Peripheral Vessels in Patients With Coronary Artery Disease |
| NCT02212028 results posted | Prasugrel-CRUSH | Ph 4 | completed | Pharmacological Effects of Crushing Prasugrel in STEMI Patients |
| NCT01700322 EST | CTH-C1 | Ph 4 | completed | Endothelium, Stenting, and Antiplatelet Therapy (EST) - Clopidogrel, Prasugrel, Ticagrelor Study |
| NCT01327534 ETAMI | ETAMI | Ph 3 | completed | Early Thienopyridine Treatment to Improve Primary PCI in Patients With Acute MI |
| NCT02507323 TIPRIS | 34665: Ticagrelor v Prasugrel | Ph 2 | withdrawn | Ticagrelor vs. Prasugrel Effects on Infarct Size |
| NCT01852019 results posted | MDCO-CAN-13-01 | Ph 2 | completed | Cangrelor Prasugrel Transition Study |
| NCT01774838 | Uni-Koeln-1649 | Ph 3 | completed | Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome |
| NCT01609647 PRAISE-HPR | PRAISE-HPR | Ph 3 | completed | Reloading Prasugrel or Clopidogrel on High Platelet Reactivity Before Percutaneous Coronary Intervention |
| NCT01493999 TREAT-HPR | PECS-002 | Ph 4 | completed | Prasugrel Versus Clopidogrel to TREAT High Platelet Reactivity |
| NCT01805570 | RAPID STUDY 2 | Ph 4 | completed | Rapid Activity of Platelet Inhibitor Drugs Study 2 |
| NCT01510171 RAPID | RAPID | Ph 4 | completed | Rapid Activity of Platelet Inhibitor Drugs Study |
Showing 50 of 83 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PRASUGREL FDA Label Details
Indications & Usage
FDA Label (PDF)PRASUGREL is indicated for the treatment of Thrombotic Cardiovascular Events; Acute Coronary Syndrome; Unstable Angina; Non-ST-Elevation Myocardial Infarction; ST-Elevation Myocardial Infarction; Myocardial Infarction; Stroke.
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 Contraindicati...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment