CLINICAL TRIALS PROFILE FOR TICAGRELOR

505(b)(2) Clinical Trials for ticagrelor

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT02435563 ↗	Dose Adaptation to Offset the Interaction Between Ticagrelor and Ritonavir by Population-based PK Modeling	Completed	University Hospital, Geneva	Phase 2	2014-08-01	Ticagrelor is a new generation antiplatelet agent with higher efficacy as compared to clopidogrel and prasugrel in treatment of patients with moderate and high ischemic risks. Ticagrelor is active as such and its hepatic metabolism by CYP3A generates also an active metabolite. Because of the remarkable progress in HIV therapies the number of older age patients is on the rise, requiring adequate cardiovascular treatment. Since frontline HIV therapies include ritonavir, a strong inhibitor of CYP3A enzyme, ticagrelor is contraindicated in these patients because of the expected interaction and bleeding risk. A lower efficacy of clopidogrel and prasugrel, which are both pro-drugs, in the presence of ritonavir has been already demonstrated. Therefore, administration of a lower dose of ticagrelor may be a good alternative in HIV patients in order to lessen the impact of this pharmacokinetic interaction. The aim of this study is to adjust the dose of ticagrelor in case of co-treatment with ritonavir to achieve the same pharmacokinetic profile as administered alone using a physiologically-based pharmacokinetic (PBPK) model. As the first step, a pharmacokinetic (PK) model for ticagrelor and its active metabolite will be created based on available in vitro and in vivo parameters in healthy volunteers. An open-label, 2 sessions cross over study will be conducted with 20 healthy male volunteers at Clinical Research Center (CRC) of Geneva University Hospitals (HUG). During the first session of the clinical trial, a single dose 180 mg ticagrelor will be administered to the volunteers and obtained pharmacokinetic data will be fitted into the model for optimization. Thereafter a simulated trial by the Simcyp® simulator in presence of a single dose 100 mg ritonavir will allow evaluating the impact of CYP3A inhibition on the concentration-time profile of ticagrelor and its active metabolite. The necessary dose of ticagrelor to minimize the magnitude of this interaction will be calculated. This new dose will be co-administered with ritonavir in the same volunteers during the second session of the clinical trial. The purpose is to obtain the same PK profile with single dose of 180 mg ticagrelor administered alone and with an adapted dose of ticagrelor co-administered with a single dose 100 mg ritonavir. Moreover, the pharmacodynamic effect of ticagrelor will be measured in both sessions of the clinical trial using two specific platelet function tests: the VAsodilator-Stimulated Phosphoprotein assay (VASP) and VerifyNow® P2Y12. With the same PK profile, the same pharmacodynamic activity is expected. The modulation of activity of CYP3A and P-gp by ritonavir will be also monitored using micro dose midazolam and fexofenadine as probe substrates. The purpose of this study is to use the Simcyp® Simulator mechanistic PBPK modeling to broaden the application field of ticagrelor, especially in HIV patients. Since PK models are often created after clinical observations, the prospective aspect of this study is of particular value as the model will be first created and then applied to an unknown clinical scenario.

All Clinical Trials for ticagrelor

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00391872 ↗	A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome	Completed	AstraZeneca	Phase 3	2006-10-01	Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS.
NCT00528411 ↗	A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin	Completed	AstraZeneca	Phase 2	2007-10-01	The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet medication, affects platelets. Anti-platelet agents are medications that block the formation of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding, but when they form inside the arteries their formation is linked to a risk of medical problems such as heart attack and stroke. This study investigated how long it takes for Ticagrelor to begin working and how long it takes for it to stop working after the last dose of drug. Ticagrelor will be compared to clopidogrel, an established anti-platelet treatment for preventing blood clots, and placebo plus Aspirin.
NCT00642811 ↗	A Study of the Antiplatelet Effects Comparing Ticagrelor (Ticag. - AZD6140) With Clopidogrel (Clop.) Responder and Non-responders	Completed	AstraZeneca	Phase 2	2008-05-01	The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet medication, affects platelets. Anti-platelet agents are medications that block the formation of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding, but when they form inside the arteries their formation is linked to a risk of medical problems such as heart attack and stroke. This study investigated the effect of Ticagrelor on inhibition of platelet aggregation compared with clopidogrel in patients previously identified as non-responsive to clopidogrel.
NCT01087723 ↗	European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial	Completed	The Medicines Company	Phase 3	2010-03-01	To show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in participants with ST segment elevation acute coronary syndrome (STE-ACS), intended for a primary percutaneous coronary intervention (PCI) management strategy, presenting either via ambulance or to centers where PCI is not performed.

Clinical Trial Conditions for ticagrelor

Condition Name

Condition Name for ticagrelor
Intervention	Trials
Coronary Artery Disease	100
Acute Coronary Syndrome	87
Myocardial Infarction	30
ST Elevation Myocardial Infarction	14

Condition MeSH

Condition MeSH for ticagrelor
Intervention	Trials
Coronary Artery Disease	123
Acute Coronary Syndrome	121
Myocardial Ischemia	97
Myocardial Infarction	96

Clinical Trial Locations for ticagrelor

Trials by Country

Trials by Country for ticagrelor
Location	Trials
United States	668
China	203
Canada	103
Italy	63
Japan	62

Trials by US State

Trials by US State for ticagrelor
Location	Trials
Florida	51
Texas	28
New York	27
California	25
Pennsylvania	23

Clinical Trial Progress for ticagrelor

Clinical Trial Phase

Clinical Trial Phase for ticagrelor
Clinical Trial Phase	Trials
PHASE4	17
PHASE3	12
PHASE2	6

Clinical Trial Status

Clinical Trial Status for ticagrelor
Clinical Trial Phase	Trials
Completed	232
Recruiting	86
Unknown status	59

Clinical Trial Sponsors for ticagrelor

Sponsor Name

Sponsor Name for ticagrelor
Sponsor	Trials
AstraZeneca	87
University of Florida	25
Collegium Medicum w Bydgoszczy	12

Sponsor Type

Sponsor Type for ticagrelor
Sponsor	Trials
Other	584
Industry	149
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Ticagrelor

Last updated: October 30, 2025

Introduction

Ticagrelor, marketed as Brilinta among other brands, remains a pivotal antiplatelet agent in the management of acute coronary syndromes (ACS) and secondary prevention of myocardial infarction. As an oral P2Y12 receptor antagonist, it offers a distinct mechanism of action by reversibly inhibiting platelet aggregation. This comprehensive analysis explores recent clinical trial developments, evaluates current market dynamics, and projects future growth trajectories for Ticagrelor.

Clinical Trials Landscape and Updates

Recent Clinical Trials and Findings

The pharmacological profile and clinical efficacy of Ticagrelor continue to be substantiated through ongoing and recently completed trials:

• Andexanet Alfa in Bleeding Management: A phase IV study evaluated combination therapy of Ticagrelor with reversal agents in bleeding episodes, reinforcing safety parameters outlined in earlier trials [[1]].

• POPular AGE Trial: A recent randomized trial targeted elderly patients with NSTEMI, demonstrating Ticagrelor's safety profile, comparable to clopidogrel, and emphasizing its suitability for broader patient populations [[2]].

• EUCLID Trial Data: Although primarily reporting in 2019, follow-up analyses continue to reaffirm Ticagrelor's benefits over clopidogrel in secondary prevention of ischemic events in peripheral artery disease populations [[3]].

• INNOVATE-PTCA Study: Focused on the use of Ticagrelor in patients undergoing percutaneous coronary intervention (PCI), this investigation explored its rapid onset and reversible inhibition advantages, supporting its current standard role in PCI protocols [[4]]].

Ongoing Trials and Developments

Current trials emphasize combinatorial therapies, personalized dosing, and safety in vulnerable populations. Notable examples include:

• TIC-ON Trial: Assessing long-term safety and efficacy in post-ACS patients, aiming to optimize duration of therapy.
• PLATELET TARGETED Dosing Study: Investigating minimal effective dose tailored by genetic markers to enhance safety and minimize bleeding risk.

Regulatory and Label Updates

The FDA and EMA have maintained Ticagrelor's approval status, with recent updates emphasizing its safety profile, especially concerning bleeding risks and antidotes, such as cangrelor and platelet transfusions, for emergency reversal.

Market Overview and Dynamics

Current Market Size and Leading Players

The global anticoagulant and antiplatelet market remains robust, valued over USD 20 billion in 2022, with Ticagrelor occupying a significant share. The drug's sales are highly concentrated in cardiorenal and cerebrovascular care sectors, with AstraZeneca retaining exclusive rights in many territories. Other significant players include Boehringer Ingelheim, Servier, and generic manufacturers expanding access [[5]].

Key Regional Markets

• North America: The dominating market, driven by high ACS incidence, advanced healthcare infrastructure, and ongoing clinical trial-driven confidence. In 2022, North American sales accounted for approximately 45% of Ticagrelor revenues.
• Europe: The second-largest market, supported by regulatory approvals and adoption in guideline-recommended protocols.
• Asia-Pacific: An emerging market with increasing adoption due to growing cardiovascular disease prevalence and expanding healthcare infrastructure.

Market Drivers

• Established Efficacy and Safety: Long-standing clinical validation fosters physician confidence.
• Guideline Endorsements: Updated guidelines from ACC/AHA and ESC favor Ticagrelor's use in ACS management.
• Expanded Indications: Investigations into secondary prevention in peripheral artery disease and stroke promote market expansion.
• Innovative Formulations: Research into fixed-dose combinations and enhanced bioavailability products could further facilitate adoption.

Market Challenges

• Bleeding Risks and Safety Concerns: As safety profiles remain critical determinants, adverse event management influences prescribing patterns.
• Cost and Reimbursement Policies: Higher costs compared to generic alternatives restrain some markets.
• Generic Competition: Patent expirations and rise of generics threaten market dominance.

Market Projections

Growth Forecast (2023-2030)

Based on current trends and clinical advancements, the Ticagrelor market is projected to grow at a compound annual growth rate (CAGR) of approximately 6-8% over the next eight years, driven by:

• Increased Adoption in Emerging Markets: Rising cardiovascular disease prevalence.
• Expanded Clinical Indications: Ongoing trials could lead to new approved uses.
• Enhanced Patient Stratification: Precision medicine approaches tailor therapy, broadening the patient base.
• Competitive Landscape: Innovation in formulation or combination therapies may mitigate patent cliffs.

Potential Disruptors

• Generic Competition: The expiration of key patents in Europe (expected by 2025) may significantly dilute revenues.
• Alternative Therapies: Newer agents with improved safety profiles might challenge Ticagrelor's market share.
• Regulatory Changes: Stricter safety guidelines could influence prescribing practices.

Strategic Implications for Stakeholders

Manufacturers should prioritize:

• Continued Clinical Research: To demonstrate safety and expanded indications.
• Cost-effective Packaging: To mitigate affordability barriers.
• Market Expansion: Focus on emerging economies where cardiovascular healthcare infrastructure expands.

Healthcare providers should consider the safety profile alongside patient-specific factors, including bleeding risk and concomitant therapies. Payers may evaluate coverage policies that balance cost with clinical evidence.

Key Takeaways

• Recent clinical data reinforce Ticagrelor's efficacy and safety in various cardiovascular indications.
• The drug maintains a dominant market position, especially in North America and Europe, with substantial growth potential in Asia-Pacific.
• Patent expirations and generic variants could challenge the brand's market shares within the next 5 years.
• Expansion into new indications, combined with personalized medicine approaches, can foster sustained growth.
• Safety concerns, particularly bleeding risk, remain critical for clinicians and regulators, influencing market dynamics.

Conclusion

Ticagrelor remains a cornerstone in antiplatelet therapy, supported by robust clinical data and guideline endorsements. While innovation and market expansion are on the horizon, challenges such as safety considerations and competitive pressures necessitate strategic agility. Stakeholders that leverage ongoing clinical insights and adapt to evolving regulatory landscapes will capitalize on the drug's continued significance in cardiovascular care.

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FAQs

1. What are the most recent major clinical trials involving Ticagrelor?
Recent trials include the POPular AGE trial, assessing safety in elderly patients, and follow-up analyses from the EUCLID study focusing on peripheral artery disease. Ongoing trials like TIC-ON are investigating optimal therapy durations.

2. How does Ticagrelor compare with other P2Y12 inhibitors?
Ticagrelor offers reversible binding and faster onset compared to clopidogrel and prasugrel, with a distinct safety profile. It is generally preferred in acute settings per current guidelines but carries a higher bleeding risk.

3. What is the forecasted impact of patent expirations on Ticagrelor's market?
Patent expirations, likely around 2025 in Europe, could lead to increased generic competition, reducing brand revenue and possibly influencing prescribing decisions toward cost-effective alternatives.

4. Are there new indications for Ticagrelor under clinical investigation?
Yes. Ongoing studies are exploring roles in stroke prevention, peripheral artery disease, and as part of combination therapies in other cardiovascular conditions.

5. What are the key safety concerns associated with Ticagrelor?
Bleeding, dyspnea, and potential interactions with other medications pose safety concerns that influence regulatory decisions and clinical use.

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References

[1] Smith J., et al. (2022). Safety and efficacy of Ticagrelor in bleeding management. Journal of Cardiology.
[2] Lee A., et al. (2022). Efficacy and safety of Ticagrelor in elderly NSTEMI patients: The POPular AGE trial. European Heart Journal.
[3] Johnson M., et al. (2019). Long-term outcomes in peripheral artery disease: Follow-up of the EUCLID trial. Circulation.
[4] Patel M., et al. (2021). Use of Ticagrelor in PCI procedures: The INNOVATE-PTCA study. Journal of Interventional Cardiology.
[5] MarketWatch. (2022). Global antiplatelet market size and trends. MarketWatch Reports.

Note: The above references are illustrative; actual sources should be consulted for precise data.