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Brilinta (ticagrelor)
At a glance
| Generic name | ticagrelor |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | P2Y12 Platelet Inhibitor [EPC] |
| Target | Equilibrative nucleoside transporter 1, P2Y purinoceptor 12, P2Y purinoceptor 12 |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| Annual revenue | 1100 |
Approved indications
- Acute coronary syndrome
- Myocardial Reinfarction Prevention
- Percutaneous coronary intervention
- Peripheral vascular disease
Boxed warnings
- 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 )
Common side effects
- Bleeding (non-CABG major)
- Dyspnea
Serious adverse events
- Fatal bleeding
- Intracranial bleeding
- Intrapericardial bleeding with cardiac tamponade
- Hypovolemic shock or severe hypotension
- Major bleeding (life-threatening)
- CABG-related bleeding
Key clinical trials
- An Open-label, Randomized, Controlled, Multicenter Study to Evaluate DUAL Antithrombotic Therapy With Rivaroxaban Plus Ticagrelor vs. Rivaroxaban Plus Clopidogrel in Patients With Atrial Fibrillation (Phase 4)
- Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Ticagrelor (N/A)
- A Prospective, Randomized, Controlled, Analyst-blinded, Parallel Group Study to Investigate the Effect of Antithrombotic Triple Therapy With Ticagrelor and Acetylsalicylic Acid in Combination With Dab (Phase 4)
- Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence: A Parallel Single-blinded Randomized Trial (Phase 3)
- Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation (Phase 4)
- P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI With Biologically Active Stents (P2BiTO) Registry (N/A)
- Pharmacodynamic Comparison of Prasugrel Versus Ticagrelor in Patients With CYP2C19 Loss-of-function Genotype: a Validation Study in Patients With Stable Coronary Artery Disease (Phase 4)
- An Open-label, Randomised, Parallel-group, Fixed-sequence Study to Assess the Effect of Oral Ticagrelor on the Pharmacokinetics of Oral Rosuvastatin in Healthy Participants (Phase 1)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 10300065 | 2036-01-27 | Method of Use |
| 8425934 | 2030-04-17 | Formulation |
| 8425934*PED | 2030-10-17 | Compound |
| 10300065*PED | 2036-07-27 | Compound |
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 |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Brilinta CI brief — competitive landscape report
- Brilinta updates RSS · CI watch RSS
- AstraZeneca portfolio CI