BRILINTA (ticagrelor)
Brilinta helps patients manage the risk of serious cardiovascular events like heart attacks and strokes. It is used for individuals with acute coronary syndrome, those with a history of heart attacks, or patients with coronary artery disease who are at high risk for complications. This medication also helps prevent blood clots in patients who have received stents and reduces the risk of subsequent strokes in people who have recently experienced a minor stroke or a mini-stroke.
How BRILINTA Works
This medication works by targeting the P2Y12 ADP-receptor on the surface of platelets. By reversibly binding to these receptors, the drug and its active metabolite prevent the signals that normally cause platelets to activate and clump together. This action helps keep blood flowing and reduces the likelihood of dangerous clots forming in the cardiovascular system.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-07-20
- Patent Cliff
- 2036
- Revenue
- $158M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
BRILINTA Approval History
What BRILINTA Treats
7 indicationsBRILINTA is approved for 7 conditions since its original approval in 2011. 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
BRILINTA Boxed Warning
BLEEDING RISK BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal bleeding ( 5.1 , 6.1 ). Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage ( 4.1 , 4.2 ). Do not start BRILINTA in patients undergoing urgent coronary artery bypass graft surgery (CABG) ( 5.1 , 6.1 ). If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events ( 5.2 ). WARNIN...
WARNING: BLEEDING RISK BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal bleeding ( 5.1 , 6.1 ). Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage ( 4.1 , 4.2 ). Do not start BRILINTA in patients undergoing urgent coronary artery bypass graft surgery (CABG) ( 5.1 , 6.1 ). If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events ( 5.2 ). WARNING: BLEEDING RISK See full prescribing information for complete boxed warning. BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal bleeding. ( 5.1 , 6.1 ) Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage. ( 4.1 , 4.2 ) Do not start BRILINTA in patients undergoing urgent coronary artery bypass graft surgery (CABG). ( 5.1 , 6.1 ) If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events. ( 5.2 )
BRILINTA 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 BRILINTA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
157 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. |
| NCT03331484 CAPITAL PCI AF | MRL-PCI AF | Ph 3 | completed | The Safety and Efficacy Of Rivaroxaban and Ticagrelor for Patients With Atrial Fibrillation After Percutaneous Coronary Intervention |
| 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 |
| NCT06451198 OPTION2 | B2024-187 | Ph 4 | recruiting | IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome |
| NCT02505399 TIRATROP | RC31/14/7445 | Ph 4 | completed | TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement |
| NCT02110303 DIAMOND | DIAMOND-14/SS/0089 | Ph 2, Ph 3 | completed | DIAMOND - Dual Antiplatelet Therapy to Reduce Myocardial Injury |
| NCT03869268 WILLOW TREE results posted | STH20370 | Ph 4 | completed | The Impact of Aspirin Dose Modification on the Innate Immune Response - Will Lower Dose Aspirin Therapy Reduce the Response to Endotoxin |
| NCT03430661 | ID-076-103 | Ph 1 | completed | A Study to Investigate the Interaction Between ACT-246475 and Clopidogrel, Prasugrel, and Ticagrelor in Healthy Subjects |
| NCT03357874 TROUPER | 2017-41 2017-002839-42 | Ph 3 | completed | TicagRelor Or Clopidogrel in Severe and Terminal Chronic Kidney Disease Patients Undergoing PERcutaneous Coronary Intervention for an Acute Coronary Syndrome. |
| NCT02733341 results posted | 2015CAR77 | Ph 4 | completed | The Effect of IV Cangrelor and Oral Ticagrelor Study |
| NCT06554821 | D3560C00817 | Ph 1 | completed | A Study to Investigate the Effect of Oral Ticagrelor on the Pharmacokinetics of Oral Rosuvastatin When Given in Healthy Participants |
| NCT03551964 DAPT-SHOCK-AMI | 13062017-23-1 2018-002161-19 | Ph 4 | completed | Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction |
| NCT06584812 | TY601A-P1-03 | Ph 1 | completed | Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of Tiprogrel in Healthy Subjects |
| NCT06667349 TISSARA | NICVD IRB-40/2023 | Ph 4 | completed | TISSARA Trial: Ticagrelor Intervention to Reduce Stent Thrombosis and Acute MI Risk |
| NCT03708588 results posted | 18-078_18-911 | Ph 4 | completed | Chewed Versus Integral Pill of Ticagrelor |
| NCT04240834 LD-ASPIRIN | 2019XK320061 | Ph 4 | recruiting | Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome (ACS) at High-Risk for Ischemia After Percutaneous Coronary Intervention |
| NCT03161678 results posted | HP-00074967 | Ph 4 | completed | CES1 Crossover Trial of Clopidogrel and Ticagrelor |
| NCT03119012 SMART-CHOICEII | CHOICEII16453143 | Ph 4 | terminated | P2Y12 Inhibitor Monotherapy Versus Extended DAPT in Patients Treated With Bioresorbable Scaffold |
| NCT04588727 | D2911C00001 | Ph 1 | completed | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AZD3366 in Healthy Subjects, Japanese and Chinese Subjects |
| NCT05093790 results posted | CV006-037 2020-005209-18 | Ph 2 | completed | A Study to Evaluate BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in a Thrombosis Chamber Model in Participants With Stable Coronary Artery Disease and Healthy Participants |
| 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 |
| NCT02053909 TARGET results posted | Brilinta ISSBRIL0220 | Ph 4 | completed | Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis |
| NCT05516784 | 56795 | Ph 4 | completed | Impact of CYP2C19 Genotype-guided Clopidogrel and Ticagrelor Treatment on Platelet Function Test and Metabolomics Profile |
| NCT03789916 SDAT-IRC | 72.18 | Ph 3 | recruiting | SAPT Versus DAPT in Incomplete Revascularization After CABG |
| NCT02486367 results posted | UH IRB # 06-14-33 | Ph 4 | completed | Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR) |
| NCT02677545 PRECISE-MRI | D5130C00171; me10Bonati | Ph 2 | completed | Ticagrelor Versus Clopidogrel in Carotid Artery Stenting |
| NCT02335099 results posted | 17224 | Ph 1, Ph 2 | completed | Determine the Safety/Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis |
| NCT02325466 results posted | GCO 13-1925 | Ph 3 | completed | Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease Patients With Type 2 Diabetes |
| NCT01813435 results posted | ECRI-12-001, 02EU11 | Ph 3 | completed | GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation |
| NCT05247385 | 4086/14/066 | Ph 4 | completed | Platelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel |
| NCT02539160 results posted | ESR-15-10953 | Ph 4 | completed | Impact of Chronic Kidney Disease on the Effects of Ticagrelor in Patients With Diabetes and Coronary Artery Disease |
| NCT03437044 OPTIMUS-6 results posted | ESR 13396 | Ph 4 | completed | Low Maintenance Dose Ticagrelor Versus Clopidogrel in Diabetes Patients Undergoing PCI |
| NCT01742117 TAILOR-PCI results posted | 11-006837 5U01HL128606, 3U01HL128606-03S1 | Ph 4 | completed | Tailored Antiplatelet Therapy Following PCI |
| NCT02874092 TIMERA results posted | 15-01003 | Ph 4 | completed | Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis |
| NCT01846559 | STH17062 | Ph 4 | completed | The Antiplatelet and Immune Response Trial |
| NCT02639143 | ESR-14-10167 | Ph 4 | completed | Rapid P2Y12 Receptor Inhibition Attenuates Inflammatory Cell Infiltration in Thrombus Aspirated From the STEMI Patients |
| NCT03078465 PL-PLATELET | NFH20170307 | Ph 3 | withdrawn | Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After PCI |
| NCT02675205 TIC-TAC | AGR_2014-33 2014-005720-10 | Ph 3 | completed | Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm |
| NCT02230527 results posted | 14-799 | Ph 2, Ph 3 | terminated | Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia |
| NCT03492931 HESTIA4 | D5136C00010 | Ph 1 | completed | PK Study of Ticagrelor in Children Aged Less Than 24 Months, With Sickle Cell Disease (HESTIA4) |
| NCT02341729 ticagrelor | AGO/2013/011 | Ph 4 | completed | Effects and Plasma Concentration of Ticagrelor, After Crushed and Non-crushed Intake, After Acute Coronary Syndrome |
| NCT03615924 HESTIA3 results posted | D5136C00009 | Ph 3 | terminated | Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease |
| NCT02282332 results posted | AZ_ISSBRIL0304 | Ph 4 | completed | NIRS Ticagrelor Evaluation |
| NCT02270242 TWILIGHT results posted | GCO 14-1383 | Ph 4 | completed | Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention |
| NCT02931045 AFFECT EV results posted | KB/112/2016 | Ph 4 | completed | Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction |
| NCT03354429 THALES results posted | D5134C00003 2016-004232-37 | Ph 3 | completed | THALES - Acute STroke or Transient IscHaemic Attack Treated With TicAgreLor and ASA for PrEvention of Stroke and Death |
| NCT02617290 ALPHEUS | P141103 | Ph 3 | completed | Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting |
| 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: |
Showing 50 of 157 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.
BRILINTA FDA Label Details
Indications & Usage
FDA Label (PDF)BRILINTA is indicated for the treatment of Myocardial Infarction; Stroke; Acute Coronary Syndrome; Stent Thrombosis; Coronary Artery Disease; Acute Ischemic Stroke; Transient Ischemic Attack.
WARNING: BLEEDING RISK BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal bleeding ( 5.1 , 6.1 ). Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage ( 4.1 , 4.2 ). Do not start BRILINTA in patients undergoing urgent...
BRILINTA Patents & Exclusivity
Patents (4 active)
Pro Intelligence Preview
Deep insights for BRILINTA
Revenue Insights
- • Q4-2025: $158M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 20 active patents
Trial Analysis
- • 165 total trials
- • Stage: Mature
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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