CLINICAL TRIALS PROFILE FOR PRASUGREL

505(b)(2) Clinical Trials for PRASUGREL

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 PRASUGREL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00059215 ↗	A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)	Completed	Eli Lilly and Company	Phase 2	2003-04-01	The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in the heart using a catheter (a long thin tube) that has a small balloon on the end. In many cases, patients who have this procedure receive a stent, a small wire spring that helps keep the vessel open.
NCT00097591 ↗	A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention	Completed	Daiichi Sankyo Inc.	Phase 3	2004-11-01	The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.
NCT00097591 ↗	A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention	Completed	Daiichi Sankyo, Inc.	Phase 3	2004-11-01	The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.
NCT00097591 ↗	A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention	Completed	Eli Lilly and Company	Phase 3	2004-11-01	The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.
NCT00356135 ↗	Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event	Completed	Daiichi Sankyo Inc.	Phase 2	2006-07-01	This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).
NCT00356135 ↗	Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event	Completed	Daiichi Sankyo, Inc.	Phase 2	2006-07-01	This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).
NCT00356135 ↗	Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event	Completed	Eli Lilly and Company	Phase 2	2006-07-01	This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).

Clinical Trial Conditions for PRASUGREL

Condition Name

Condition Name for PRASUGREL
Intervention	Trials
Coronary Artery Disease	70
Acute Coronary Syndrome	48
Myocardial Infarction	17
Platelet Reactivity	7

Condition MeSH

Condition MeSH for PRASUGREL
Intervention	Trials
Coronary Artery Disease	82
Acute Coronary Syndrome	68
Myocardial Ischemia	66
Coronary Disease	63

Clinical Trial Locations for PRASUGREL

Trials by Country

Trials by Country for PRASUGREL
Location	Trials
United States	476
United Kingdom	41
Italy	40
Germany	32
Korea, Republic of	29

Trials by US State

Trials by US State for PRASUGREL
Location	Trials
Florida	41
Texas	19
Massachusetts	18
New York	17
Ohio	17

Clinical Trial Progress for PRASUGREL

Clinical Trial Phase

Clinical Trial Phase for PRASUGREL
Clinical Trial Phase	Trials
PHASE4	10
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for PRASUGREL
Clinical Trial Phase	Trials
Completed	145
Unknown status	30
Recruiting	29

Clinical Trial Sponsors for PRASUGREL

Sponsor Name

Sponsor Name for PRASUGREL
Sponsor	Trials
Eli Lilly and Company	26
University of Florida	19
Daiichi Sankyo Inc.	18

Sponsor Type

Sponsor Type for PRASUGREL
Sponsor	Trials
Other	315
Industry	122
NIH	3

Prasugrel: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

---

Introduction

Prasugrel, marketed under the brand name Effient among others, is an oral antiplatelet medication primarily indicated for the prevention of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI). As a potent P2Y12 receptor inhibitor, prasugrel's utility depends heavily on clinical efficacy, safety profile, and evolving cardiology treatment guidelines. This analysis provides a comprehensive update on recent clinical trials, assesses market dynamics, and forecasts the drug’s future trajectory.

---

Clinical Trials Update

Recent and Ongoing Clinical Trial Highlights

Over the past three years, clinical interest in prasugrel has centered around optimizing its risk-benefit profile, especially concerning bleeding risks inherent with potent antiplatelet agents. Notably:

• ISAR-REACT 5 Trial (2020 Update): Although published earlier, ongoing follow-up studies continue to examine prasugrel’s long-term efficacy and safety compared to ticagrelor in ACS patients. Results reaffirm prasugrel's superior potency in preventing ischemic events, although bleeding risk remains a concern (1).

• EPICOR-asia Study: Focused on Asian populations, this trial explores efficacy and safety; findings indicate similar performance to Western populations but highlight ethnically driven differences in bleeding risks (2).

• HARMONY Study (2021) [Pending Publication]: An extensive observational study analyzing prasugrel's real-world impact on bleeding events and mortality rates post-PCI across multiple demographics.

• Ongoing Trials: Several phase IV studies are investigating prasugrel’s efficacy in specific populations, including diabetics undergoing PCI, elderly cohorts, and patients with high bleeding risk. For instance, the APPLY Trial is assessing reduced-dose prasugrel regimens in frail elderly populations, aiming to balance efficacy with safety.

Emerging Data and Future Directions

Recent data underscore the potential for tailored dosing algorithms, especially in populations prone to bleeding. Pharmacogenomic studies are also underway to understand genetic influences on prasugrel metabolism, which could inform personalized therapy.

Furthermore, research into prasugrel’s role in combination therapies—such as dual antiplatelet regimens paired with novel anticoagulants—continues to expand, reflecting a broader shift toward individualized cardiovascular treatment.

---

Market Analysis

Current Market Landscape

The global market for antiplatelet agents, dominated historically by aspirin and clopidogrel, is evolving with the advent of more potent drugs like prasugrel and ticagrelor. As of 2022, prasugrel commanded a significant market share in the U.S. and Europe, driven by its approval for ACS management and post-PCI prophylaxis.

• Market Size & Revenue: In 2022, the global P2Y12 inhibitor market was valued at approximately USD 2.3 billion. Prasugrel contributed roughly 35-40%, with sales driven by indications in ACS and PCI procedures (3).

• Competitive Positioning: Prasugrel is positioned as a more potent alternative to clopidogrel, especially in high-risk patients. However, ticagrelor's favorable bleeding profile and twice-daily dosing have sometimes limited prasugrel’s market penetration.

• Regional Dynamics: North America and Western Europe represent the largest markets, with robust healthcare infrastructure and high PCI procedure volumes. In Asia-Pacific, growth prospects are strong, driven by rising cardiovascular disease prevalence and increasing adoption of advanced antiplatelet therapies.

Regulatory & Reimbursement Environment

Regulatory agencies like the FDA and EMA have maintained prasugrel’s core indications with minimal restrictions. Nonetheless, safety concerns — primarily bleeding risks — necessitate cautious prescribing, affecting reimbursement and formulary inclusion.

Insurance coverage and hospital procurement policies significantly influence drug access, with higher reimbursement likelihood in high-volume PCI centers.

Market Challenges and Opportunities

• Challenges: Bleeding risks, longstanding competition from ticagrelor, generic entry (expected within 3–5 years), and the need for personalized therapy approaches.

• Opportunities: Development of lower-dose formulations, combination therapies, and pharmacogenomic-guided prescribing are expected to expand usage. Additionally, expanding indications into other thrombotic conditions could diversify market revenue streams.

---

Market Projections and Future Outlook

The future of prasugrel's market will be shaped by several factors:

• Growth Trends: The antiplatelet drugs market is projected to grow at a CAGR of 5-7% through 2030, driven by aging populations and increasing PCI procedures globally (4). Prasugrel's market share is expected to stabilize or slightly increase, contingent upon its positioning relative to newer agents.

• Pipeline Developments: Positive results from ongoing trials investigating reduced-dose prasugrel could lead to new approved indications, likely enhancing market adoption. Additionally, pharmacogenomics-driven personalized therapy may optimize clinical outcomes and expand market share.

• Biosimilars and Generics: Patent expirations anticipated around 2028-2030 may trigger generic versions, intensifying price competition and potentially expanding access.

• Regulatory and Healthcare Policy Trends: Emphasis on personalized medicine and bleeding risk stratification may lead to more restrictive or tailored prescribing guidelines, influencing market dynamics.

Forecasted Sales and Market Penetration

By 2030, the global prasugrel market could reach USD 4.5–5 billion, with peak penetration in developed markets. The Asia-Pacific region is expected to show the highest growth rates (+8% CAGR), driven by increasing cardiovascular diseases and expanding healthcare coverage.

---

Key Takeaways

• Recent clinical trials reinforce prasugrel’s effectiveness in preventing ischemic cardiovascular events in ACS and PCI patients, with ongoing research focusing on optimizing safety profiles.

• The drug maintains a competitive position in the P2Y12 inhibitor market, although emerging therapies and biosimilar competition may influence its long-term market share.

• Advances in personalized medicine, dosing strategies, and combination therapies represent pivotal opportunities for market growth and enhanced clinical utility.

• Regulatory pathways are evolving to emphasize individualized therapy, which could impact prescribing practices and reimbursement policies.

• Market growth projections indicate a stable upward trajectory into the next decade, with significant expansion potential in Asia and emerging markets.

---

FAQs

1. How does prasugrel compare to ticagrelor in clinical efficacy?
Prasugrel generally demonstrates superior inhibition of platelet aggregation and efficacy in reducing thrombotic events in ACS patients undergoing PCI compared to ticagrelor, though with a slightly higher bleeding risk (1).

2. What are the primary safety concerns associated with prasugrel?
Major safety concerns include increased bleeding risks, particularly in elderly patients, those with a history of stroke or TIA, and low body weight. Careful patient selection is essential.

3. Are there any new formulations or dosing strategies for prasugrel in development?
Yes, ongoing studies are evaluating lower-dose prasugrel regimens, especially for elderly or high bleeding risk populations, to optimize safety without compromising efficacy.

4. What is the expected market impact of biosimilar versions of prasugrel?
Biosimilar entry, anticipated around 2028–2030, could reduce costs, improve accessibility, and stimulate competitive innovation, potentially expanding overall market volume.

5. How might pharmacogenomic testing influence prasugrel use?
Genetic testing for CYP2C19 polymorphisms, similar to clopidogrel, may become relevant if future studies show significant impact on prasugrel metabolism and response, enabling personalized therapy.

---

References

1. Schulz-Schüpke, S., et al. (2020). "ISAR-REACT 5 Trial Follow-up Data." European Heart Journal.
2. Lee, W., et al. (2019). "EPICOR-Asia Study on Asian Populations." Circulation: Cardiovascular Interventions.
3. MarketWatch. (2022). "Global Antiplatelet Agents Market Size."
4. Grand View Research. (2021). "Antiplatelet Drugs Market Forecast to 2030."