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
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).
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.
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.

Clinical Trial Conditions for PRASUGREL

Condition Name

Condition Name for PRASUGREL
Intervention	Trials
Coronary Artery Disease	67
Acute Coronary Syndrome	46
Myocardial Infarction	17
Platelet Reactivity	7

Condition MeSH

Condition MeSH for PRASUGREL
Intervention	Trials
Coronary Artery Disease	78
Myocardial Ischemia	66
Acute Coronary Syndrome	65
Coronary Disease	63

Clinical Trial Locations for PRASUGREL

Trials by Country

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Trials by Country for PRASUGREL
Location	Trials
United States	470
United Kingdom	40
Italy	38
Germany	31
Korea, Republic of	29

Trials by US State

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Trials by US State for PRASUGREL
Location	Trials
Florida	36
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
Phase 4	117
Phase 3	46
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for PRASUGREL
Clinical Trial Phase	Trials
Completed	145
Unknown status	30
Recruiting	22

Clinical Trial Sponsors for PRASUGREL

Sponsor Name

Sponsor Name for PRASUGREL
Sponsor	Trials
Eli Lilly and Company	26
Daiichi Sankyo Inc.	18
Daiichi Sankyo, Inc.	18

Sponsor Type

Sponsor Type for PRASUGREL
Sponsor	Trials
Other	302
Industry	121
NIH	3

Prasugrel: Clinical Trials, Market Analysis, and Projections

Introduction to Prasugrel

Prasugrel, a potent antiplatelet drug, is used to prevent blood clots in patients with acute coronary syndrome (ACS) who are undergoing percutaneous coronary intervention (PCI). It belongs to the class of ADP receptor antagonists, which have revolutionized the treatment of cardiovascular diseases.

Clinical Trials: Key Findings

HOST-REDUCE-POLYTECH-ACS Trial

One of the significant clinical trials involving prasugrel is the HOST-REDUCE-POLYTECH-ACS trial. This study aimed to compare the safety and efficacy of reduced-dose prasugrel (5 mg) versus regular-dose prasugrel (10 mg) in east Asian patients undergoing PCI for ACS.

• Primary Endpoint: The trial showed that after 1 month of regular-dose dual antiplatelet therapy (DAPT), reduced-dose prasugrel (5 mg) was superior to regular-dose prasugrel (10 mg) in terms of net adverse events, which included death, myocardial infarction, stent thrombosis, clinically driven revascularization, stroke, and BARC 2 or higher bleeding. The net adverse events rate was 7.2% for the 5 mg group versus 10.1% for the 10 mg group (hazard ratio 0.70, 95% CI 0.52-0.92, p = 0.012)[1].

• Bleeding Events: Notably, the trial also demonstrated a significant reduction in BARC ≥2 bleeding events in the 5 mg prasugrel group compared to the 10 mg group (2.9% vs. 5.9%, p < 0.001)[1].

TRITON-TIMI 38 Study

The TRITON-TIMI 38 study is another pivotal trial that compared prasugrel with clopidogrel in patients with ACS undergoing PCI. This Phase III study involved up to 13,000 patients and focused on preventing heart attack, stroke, and death.

• Platelet Inhibition: Early data from this study showed that prasugrel achieved more consistent and higher levels of platelet inhibition compared to clopidogrel. In one Phase I study, 100% of prasugrel-treated patients achieved greater than 25% inhibition of platelet aggregation, compared to 42.4% of clopidogrel-treated patients[3].

• Clinical Outcomes: The TRITON-TIMI 38 study highlighted that prasugrel reduced the composite endpoint of death, myocardial infarction, or stroke compared to clopidogrel, although it also increased the risk of bleeding events[3].

Comparison with Ticagrelor

A recent analysis compared the efficacy and safety of prasugrel with ticagrelor in patients with ACS treated with PCI. This study found that prasugrel was associated with a lower incidence of the composite endpoint of all-cause death, myocardial infarction, or stroke compared to ticagrelor. The incidence of bleeding events was comparable between the two groups[4].

Market Analysis

Global Market Overview

The global prasugrel hydrochloride market is expected to grow significantly over the forecast period from 2025 to 2031. Here are some key points from the market analysis:

• Market Segmentation: The market is segmented by type (5 mg and 10 mg) and application (hospital and drug stores). The 5 mg segment is gaining traction due to the clinical evidence supporting its efficacy and safety profile[2][5].

• Key Players: Major players in the prasugrel hydrochloride market include Daiichi Sankyo, Amneal Pharmaceuticals, Apotex, Ube, Ascend Laboratories, Liberty Pharmaceuticals, and Panacea Biotec. These companies are driving the market through their extensive distribution networks and continuous research and development efforts[5].

• Regional Analysis: The market is expected to be dominated by regions with high prevalence of cardiovascular diseases, such as North America, Europe, and Asia-Pacific. The growing awareness and adoption of advanced antiplatelet therapies in these regions are key drivers of market growth[2].

Market Projections

• Revenue and Volume Forecast: The global prasugrel hydrochloride market is projected to grow at a significant compound annual growth rate (CAGR) from 2025 to 2031. The revenue is expected to increase substantially, driven by the increasing demand for effective antiplatelet therapies and the expanding patient population[2][5].

• Competitive Landscape: The market is competitive, with several generic and branded players. The introduction of generic versions of prasugrel has increased market competition, but branded products still maintain a significant market share due to their established reputation and clinical evidence[5].

Factors Influencing the Market

Clinical Evidence

The superior clinical outcomes of prasugrel, especially the reduced-dose regimen, are a significant factor driving market growth. Studies like the HOST-REDUCE-POLYTECH-ACS trial have provided robust evidence supporting the use of 5 mg prasugrel, which is expected to increase its adoption rate[1].

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market dynamics. As more countries approve the use of prasugrel, especially the reduced-dose regimen, the market is expected to expand. Regulatory bodies are increasingly recognizing the benefits of prasugrel over other antiplatelet agents, which supports its market growth[4].

Patient Population

The growing prevalence of cardiovascular diseases, particularly ACS, is a key driver of the prasugrel hydrochloride market. As the global population ages and the incidence of heart diseases increases, the demand for effective antiplatelet therapies like prasugrel is expected to rise[3].

Challenges and Opportunities

Challenges

• Bleeding Risks: One of the significant challenges associated with prasugrel is the risk of bleeding events. Although the reduced-dose regimen has shown a better safety profile, bleeding remains a concern that could impact market growth[1][4].

• Generic Competition: The entry of generic versions of prasugrel into the market could reduce the market share of branded products. However, the established clinical evidence and brand loyalty are expected to mitigate this impact to some extent[5].

Opportunities

• Emerging Markets: There is a significant opportunity for growth in emerging markets where the awareness and adoption of advanced antiplatelet therapies are increasing. Companies can leverage this trend to expand their market presence[2].

• Research and Development: Continuous research and development in the field of antiplatelet therapies offer opportunities for innovation and differentiation. New formulations or dosing regimens could further enhance the market position of prasugrel[3].

Key Takeaways

• Clinical Superiority: Prasugrel, especially the reduced-dose regimen, has demonstrated clinical superiority over other antiplatelet agents in terms of efficacy and safety.
• Market Growth: The global prasugrel hydrochloride market is expected to grow significantly driven by increasing demand, clinical evidence, and expanding patient population.
• Competitive Landscape: The market is competitive with both branded and generic players, but clinical evidence and brand reputation are key differentiators.
• Regulatory and Patient Factors: Regulatory approvals and the growing prevalence of cardiovascular diseases are crucial factors influencing market growth.

FAQs

What is the primary use of prasugrel in clinical practice?

Prasugrel is primarily used to prevent blood clots in patients with acute coronary syndrome (ACS) who are undergoing percutaneous coronary intervention (PCI).

Which clinical trial demonstrated the superiority of reduced-dose prasugrel?

The HOST-REDUCE-POLYTECH-ACS trial demonstrated that reduced-dose prasugrel (5 mg) is superior to regular-dose prasugrel (10 mg) in terms of net adverse events and bleeding risks[1].

How does prasugrel compare to ticagrelor in clinical outcomes?

Prasugrel has been shown to have a lower incidence of the composite endpoint of all-cause death, myocardial infarction, or stroke compared to ticagrelor in patients with ACS treated with PCI[4].

What are the key factors driving the growth of the prasugrel hydrochloride market?

The growth of the prasugrel hydrochloride market is driven by clinical evidence, increasing demand for antiplatelet therapies, expanding patient population, and regulatory approvals[2][5].

Who are the main players in the prasugrel hydrochloride market?

The main players in the prasugrel hydrochloride market include Daiichi Sankyo, Amneal Pharmaceuticals, Apotex, Ube, Ascend Laboratories, Liberty Pharmaceuticals, and Panacea Biotec[5].

Sources

1. American College of Cardiology: "HOST-REDUCE-POLYTECH-ACS Trial".
2. Cognitive Market Research: "Prasugrel Hydrochloride Market Report 2024".
3. Eli Lilly and Company: "Results of Early Data Show More Consistent Platelet Inhibition with Prasugrel Compared to Clopidogrel".
4. JAMA Cardiology: "Ticagrelor or Prasugrel for Patients With Acute Coronary Syndrome".
5. Valuates Reports: "Global Prasugrel Hydrochloride Market Research Report 2024".