TICAGRELOR
Details
- Status
- Prescription
- First Approved
- 2018-09-04
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
TICAGRELOR Approval History
What TICAGRELOR Treats
7 indicationsTICAGRELOR is approved for 7 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myocardial Infarction
- Stroke
- Acute Coronary Syndrome
- Stent Thrombosis
- Coronary Artery Disease
- Acute Ischemic Stroke
- Transient Ischemic Attack
TICAGRELOR Boxed Warning
BLEEDING RISK • Ticagrelor, like other antiplatelet agents, can cause significant, sometimes fatal bleeding ( 5.1 , 6.1 ). • Do not use ticagrelor tablets in patients with active pathological bleeding or a history of intracranial hemorrhage (4.1 , 4.2 ). •Do not start ticagrelor tablets in patients undergoing urgent coronary artery bypass graft surgery (CABG) ( 5.1 , 6.1 ). • If possible, manage bleeding without discontinuing ticagrelor tablets. Stopping ticagrelor tablets increases the risk of ...
WARNING: BLEEDING RISK • Ticagrelor, like other antiplatelet agents, can cause significant, sometimes fatal bleeding ( 5.1 , 6.1 ). • Do not use ticagrelor tablets in patients with active pathological bleeding or a history of intracranial hemorrhage (4.1 , 4.2 ). •Do not start ticagrelor tablets in patients undergoing urgent coronary artery bypass graft surgery (CABG) ( 5.1 , 6.1 ). • If possible, manage bleeding without discontinuing ticagrelor tablets. Stopping ticagrelor tablets increases the risk of subsequent cardiovascular events ( 5.2 ). WARNING: BLEEDING RISK See full prescribing information for complete boxed warning. • Ticagrelor, like other antiplatelet agents, can cause significant, sometimes fatal bleeding. ( 5.1 , 6.1 ) • Do not use ticagrelor tablets in patients with active pathological bleeding or a history of intracranial hemorrhage. ( 4.1 , 4.2 ) • Do not start ticagrelor tablets in patients undergoing urgent coronary artery bypass graft surgery(CABG). ( 5.1 , 6.1 ) • If possible, manage bleeding without discontinuing ticagrelor tablets. Stopping ticagrelor tablets increases the risk of subsequent cardiovascular events. ( 5.2 )
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Active Pipeline
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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.
TICAGRELOR FDA Label Details
ProIndications & Usage
Ticagrelor is a P2Y 12 platelet inhibitor indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI). For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficac...
WARNING: BLEEDING RISK • Ticagrelor, like other antiplatelet agents, can cause significant, sometimes fatal bleeding ( 5.1 , 6.1 ). • Do not use ticagrelor tablets in patients with active pathological bleeding or a history of intracranial hemorrhage (4.1 , 4.2 ). •Do not start ticagrelor tablets in ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.