PRASUGREL HYDROCHLORIDE
Prasugrel hydrochloride helps patients with acute coronary syndrome who are undergoing percutaneous coronary intervention to open blocked arteries. It is used to lower the risk of future cardiovascular problems, such as heart attacks or blood clots forming in stents. This medication treats individuals experiencing unstable angina or specific types of heart attacks, including both NSTEMI and STEMI.
How PRASUGREL HYDROCHLORIDE Works
This medication works by having its active metabolite bind permanently to specific P2Y12 ADP receptors on the surface of platelets. By targeting these receptors, the drug prevents platelets from activating and clustering together. This action effectively reduces the formation of blood clots that can lead to serious cardiovascular events.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-08-28
- Routes
- ORAL
- Dosage Forms
- TABLET
PRASUGREL HYDROCHLORIDE Approval History
What PRASUGREL HYDROCHLORIDE Treats
5 indicationsPRASUGREL HYDROCHLORIDE is approved for 5 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Coronary Syndrome
- Unstable Angina
- Non-ST-Elevation Myocardial Infarction
- ST-Elevation Myocardial Infarction
- Stent Thrombosis
PRASUGREL HYDROCHLORIDE Boxed Warning
BLEEDING RISK Effient can cause significant, sometimes fatal, bleeding [see Warnings and Precautions (5.1 , 5.2) and Adverse Reactions (6.1) ] . Do not use Effient 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, Effient is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patie...
WARNING: BLEEDING RISK Effient can cause significant, sometimes fatal, bleeding [see Warnings and Precautions (5.1 , 5.2) and Adverse Reactions (6.1) ] . Do not use Effient 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, Effient 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 Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient 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 Effient [see Warnings and Precautions (5.1) ] . If possible, manage bleeding without discontinuing Effient. Discontinuing Effient, 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. Effient can cause significant, sometimes fatal, bleeding ( 5.1 , 5.2 , 6.1 ). Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke ( 4.1 , 4.2 ). In p
PRASUGREL HYDROCHLORIDE 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 HYDROCHLORIDE
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 HYDROCHLORIDE FDA Label Details
Indications & Usage
PRASUGREL HYDROCHLORIDE is indicated for the treatment of Acute Coronary Syndrome; Unstable Angina; Non-ST-Elevation Myocardial Infarction; ST-Elevation Myocardial Infarction; Stent Thrombosis.
WARNING: BLEEDING RISK Effient can cause significant, sometimes fatal, bleeding [see Warnings and Precautions (5.1 , 5.2) and Adverse Reactions (6.1) ] . Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack (TIA) or stroke [see Contraindications ...
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Full clinical data, patents, trials, and competitive landscape for prasugrel hydrochloride.
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