CLINICAL TRIALS PROFILE FOR PRASUGREL HYDROCHLORIDE

505(b)(2) Clinical Trials for prasugrel hydrochloride

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 hydrochloride

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 hydrochloride

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for prasugrel hydrochloride

Trials by Country

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−

Trials by Country for prasugrel hydrochloride
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 hydrochloride
Location	Trials
Florida	36
Texas	19
Massachusetts	18
Ohio	17
New York	17

Clinical Trial Progress for prasugrel hydrochloride

Clinical Trial Phase

Clinical Trial Phase for prasugrel hydrochloride
Clinical Trial Phase	Trials
Phase 4	117
Phase 3	46
Phase 2/Phase 3	3

Clinical Trial Status

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

Clinical Trial Sponsors for prasugrel hydrochloride

Sponsor Name

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

Sponsor Type

Sponsor Type for prasugrel hydrochloride
Sponsor	Trials
Other	302
Industry	121
NIH	3

Prasugrel Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Prasugrel Hydrochloride

Prasugrel hydrochloride is an oral antiplatelet agent that has been widely recognized for its efficacy in preventing thrombotic cardiovascular events. Developed by Daiichi Sankyo and its Japanese research partner Ube Industries, Ltd., prasugrel has been approved in over 80 countries worldwide, including Europe, the United States, and Japan, for the prevention of atherothrombotic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI)[4].

Clinical Trials Overview

PRASFIT-ACS Study

One of the pivotal clinical trials for prasugrel hydrochloride is the PRASFIT-ACS study. This double-blind randomized phase 3 trial compared the efficacy and safety of prasugrel (20 mg loading dose/3.75 mg maintenance dose) plus aspirin to clopidogrel (300 mg loading dose/75 mg maintenance dose) plus aspirin in Japanese patients with ACS undergoing PCI. The study demonstrated that prasugrel reduced the incidence of cardiovascular events by 23% compared to clopidogrel, without an increase in clinically relevant bleeding[1].

PRASFIT-Elective Study

In addition to the PRASFIT-ACS study, Daiichi Sankyo conducted the PRASFIT-Elective phase 3 clinical study, which evaluated the efficacy and safety of prasugrel in elective patients with stable angina and chronic myocardial infarction undergoing PCI. These studies collectively supported the submission of a New Drug Application (NDA) in Japan for commercial approval of prasugrel for patients undergoing PCI[1].

PRASTRO-I and PRASTRO-II Studies

The PRASTRO-I and PRASTRO-II studies focused on ischemic cerebrovascular disease patients. The PRASTRO-I study aimed to verify the non-inferiority of prasugrel (3.75 mg daily) compared to clopidogrel (75 mg daily) in reducing cerebro-cardiovascular events but did not achieve its primary endpoint. However, the PRASTRO-II study, which evaluated the safety of prasugrel in older or lighter patients, achieved its intended purpose, showing no new safety concerns and comparable or better outcomes in terms of clinically relevant bleeding and cerebro-cardiovascular events[4].

Market Analysis

Current Market Size and Growth Projections

The prasugrel hydrochloride market has been experiencing robust growth driven by the increasing incidence of cardiovascular diseases globally. As of 2023, the market size was valued at USD 1200 million and is projected to reach USD 2500 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8% from 2024 to 2031[3].

Key Drivers of Market Growth

Several factors are driving the growth of the prasugrel hydrochloride market:

• Rising Prevalence of Cardiovascular Diseases: Cardiovascular diseases are the leading cause of mortality worldwide, accounting for approximately 17.9 million deaths annually. This increasing prevalence underscores the need for effective antiplatelet therapies like prasugrel hydrochloride[2].
• Advancements in Drug Formulations: Innovations such as sustained-release formulations and AI-driven drug development are enhancing the efficacy and patient compliance of prasugrel hydrochloride[2].
• Increasing Healthcare Expenditure: Growing healthcare expenditure and expanding access to advanced treatments in emerging economies are contributing to the market's growth[2].
• Strategic Partnerships: Collaborations between pharmaceutical companies are fostering innovation and improving access to prasugrel hydrochloride in underserved regions[2].

Geographical Market Segments

The prasugrel hydrochloride market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Emerging markets in Asia and Africa are experiencing a surge in demand due to increasing urbanization, changing lifestyles, and rising healthcare awareness[3].

Application Segments

The market is also categorized based on applications such as Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), Thrombosis Prevention, and Ischemic Heart Disease. Prasugrel hydrochloride's effectiveness in reducing thrombotic events following PCI and its therapeutic applications in these areas are key drivers of market demand[3].

Market Trends and Innovations

Innovative Drug Delivery Mechanisms

The development of innovative drug delivery mechanisms, such as sustained-release formulations, is enhancing patient compliance and the overall efficacy of prasugrel hydrochloride. These advancements are expected to significantly boost market growth[2].

AI-Driven Drug Development

The use of AI in drug development is accelerating innovation and reducing production costs. This trend is expected to continue, driving further growth in the prasugrel hydrochloride market[2].

Expanding Access to Healthcare

Improvements in healthcare infrastructure in emerging economies are making prasugrel hydrochloride more accessible. This expanded access, combined with favorable government policies, is driving the rapid adoption of prasugrel hydrochloride in regions such as Asia-Pacific and Latin America[2].

Regulatory Environment

Expedited Regulatory Approvals

Expedited regulatory approvals, particularly in regions with high cardiovascular disease prevalence, have been instrumental in the market growth of prasugrel hydrochloride. These approvals have facilitated quicker access to this critical therapeutic option for patients in need[2].

Patient Outcomes and Healthcare Costs

Improved Patient Outcomes

Prasugrel hydrochloride has proven to be more effective than traditional antiplatelet therapies in certain patient populations, offering better outcomes in terms of reduced hospitalization rates and improved survival rates. This has reinforced its adoption in clinical practice and contributed to its market demand[2].

Reduction in Healthcare Costs

By preventing life-threatening complications, prasugrel hydrochloride helps in reducing healthcare costs associated with cardiovascular disease complications. This cost-effectiveness further enhances its market appeal[2].

Key Takeaways

• Clinical Efficacy: Prasugrel hydrochloride has demonstrated significant efficacy in reducing cardiovascular events in patients with ACS undergoing PCI.
• Market Growth: The market is projected to grow from USD 1200 million in 2023 to USD 2500 million by 2031, driven by increasing cardiovascular disease prevalence and advancements in drug formulations.
• Innovations: Sustained-release formulations and AI-driven drug development are key innovations driving market growth.
• Geographical Expansion: Emerging markets in Asia and Africa are experiencing rapid growth due to expanding access to healthcare and favorable government policies.
• Regulatory Environment: Expedited regulatory approvals have facilitated quicker market entry for prasugrel hydrochloride.

FAQs

What is prasugrel hydrochloride used for?

Prasugrel hydrochloride is used to prevent blood clots in patients with acute coronary syndrome (ACS) or those undergoing percutaneous coronary intervention (PCI)[2].

What were the key findings of the PRASFIT-ACS study?

The PRASFIT-ACS study showed that prasugrel reduced the incidence of cardiovascular events by 23% compared to clopidogrel, without an increase in clinically relevant bleeding[1].

How is the prasugrel hydrochloride market expected to grow?

The market is expected to grow from USD 1200 million in 2023 to USD 2500 million by 2031, at a CAGR of 8% from 2024 to 2031[3].

What are the main drivers of the prasugrel hydrochloride market?

Key drivers include the rising prevalence of cardiovascular diseases, advancements in drug formulations, increasing healthcare expenditure, and expanding access to treatments in emerging economies[2].

Are there any ongoing clinical trials for prasugrel hydrochloride?

Yes, there are ongoing clinical trials, including a Japanese domestic phase 3 trial for patients with ischemic cerebrovascular disease, which is expected to complete in the near future[1].

Sources

1. Daiichi Sankyo Announces Positive Phase 3 Study Results for Prasugrel Hydrochloride in Japanese Patients with Acute Coronary Syndrome Undergoing PCI. Daiichi Sankyo. Retrieved December 31, 2024.
2. Prasugrel Hydrochloride Market: Paving the Way for Advanced Cardiovascular Care. Market Research Intellect. Retrieved December 31, 2024.
3. Prasugrel Hydrochloride Market Size and Projections. Market Research Intellect. Retrieved December 31, 2024.
4. Daiichi Sankyo Announces Phase 3 Clinical Trial (PRASTRO-I and PRASTRO-II) Results for Prasugrel Hydrochloride in Ischemic Cerebrovascular Disease Patients. Daiichi Sankyo. Retrieved December 31, 2024.