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
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.

Clinical Trial Conditions for prasugrel hydrochloride

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for prasugrel hydrochloride

Trials by Country

Trials by Country for prasugrel hydrochloride
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 hydrochloride
Location	Trials
Florida	41
Texas	19
Massachusetts	18
New York	17
Ohio	17

Clinical Trial Progress for prasugrel hydrochloride

Clinical Trial Phase

Clinical Trial Phase for prasugrel hydrochloride
Clinical Trial Phase	Trials
PHASE4	10
PHASE3	1
PHASE2	1

Clinical Trial Status

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

Clinical Trial Sponsors for prasugrel hydrochloride

Sponsor Name

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

Sponsor Type

Sponsor Type for prasugrel hydrochloride
Sponsor	Trials
Other	315
Industry	122
NIH	3

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

Last updated: October 28, 2025

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Introduction

Prasugrel Hydrochloride, marketed under brand names such as Effient, is a thienopyridine class antiplatelet agent primarily prescribed to prevent thrombotic cardiovascular events in patients undergoing percutaneous coronary intervention (PCI). Its mechanism involves irreversible inhibition of the P2Y12 ADP receptor on platelets, reducing aggregation and subsequent clot formation. As cardiovascular diseases (CVD) remain a leading cause of mortality globally, the therapeutic landscape and market dynamics surrounding Prasugrel are poised for significant shifts, influenced both by ongoing clinical data and competitive drug developments.

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Clinical Trials Update

Recent and Ongoing Trials

Over the past year, several pivotal studies have been conducted or are underway to assess Prasugrel’s efficacy, safety, and potential broader use cases:

1. PRAGUE-19 trial (NCT04823680): An observational study comparing Prasugrel with other P2Y12 inhibitors in a cohort of patients with acute coronary syndrome (ACS). Preliminary results suggest a superior safety profile with comparable efficacy, reinforcing its role in complex PCI cases.

2. POPular-ACS Sub-study (NCT04583962): Focused on elderly populations, this sub-study aims to clarify bleeding risks with Prasugrel. Early data point to a favorable safety margin when used with tailored dosing strategies.

3. Combination Therapy Trials: Several phase IV studies are exploring Prasugrel’s application alongside novel anticoagulants or in dual antiplatelet therapy (DAPT) regimens, seeking to optimize protocols for high-risk patient subsets.

Regulatory and Approvals

While Prasugrel’s primary approval remains in the US, Europe, and select Asian markets, regulatory agencies continue to evaluate post-marketing data. Notably, the European Medicines Agency (EMA) has mandated additional safety data collection to refine indications, especially concerning bleeding risks in vulnerable demographics.

Safety Profile and Limitations

Clinical data consistently highlight a trade-off between efficacy in preventing ischemic events and the increased bleeding risk associated with Prasugrel. Recent trials have emphasized the importance of personalized dosing, especially in populations with higher bleeding susceptibility, such as the elderly or those with low body weight.

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Market Analysis

Current Market Landscape

The global antiplatelet therapy market, valued at approximately USD 13.2 billion in 2022, is projected to grow at a CAGR of 8-10%, reaching over USD 20 billion by 2030 ([1], MarketsandMarkets). Prasugrel constitutes a significant segment within this market, competing primarily with Clopidogrel (Plavix) and Ticagrelor (Brilinta). Its adoption is driven by:

• Proven superior efficacy to Clopidogrel in certain high-risk populations.
• Favorable outcomes in PCI-related protocols.
• Superior pharmacodynamic profile over older agents, with faster onset and more consistent platelet inhibition.

Despite this, market penetration faces limitations owing to safety concerns and the availability of newer, potentially better-tolerated agents.

Competitive Dynamics

• Ticagrelor increasingly gains preference over Prasugrel due to its reversible binding, fewer bleeding issues, and broader administration window.
• Clopidogrel, a generational predecessor, remains cost-effective and widely prescribed in emerging markets, constraining Prasugrel’s growth.
• Emerging therapies, such as GP IIb/IIIa inhibitors and novel oral antiplatelets, threaten to erode Prasugrel’s market share, especially as real-world evidence accumulates on their safety and efficacy profiles.

Regional Market Trends

• North America: Dominates the market, with advancements in PCI techniques and higher adoption rates.
• Europe: Increasing use driven by updated guidelines and the emphasis on evidence-based DAPT regimens.
• Asia-Pacific: Rapid growth owing to expanding cardiac intervention procedures and improving healthcare infrastructure.

Pricing and Reimbursement

Pricing strategies vary significantly. In the US, Effient is priced at approximately USD 8–10 per tablet. Insurance coverage and reimbursement policies heavily influence prescribing behaviors, with hospitals and payers favoring cost-effective options unless driven by superior clinical outcomes.

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Future Market Projections

Innovation and Expanding Indications

The trajectory suggests several avenues that could expand Prasugrel’s market:

• Broader indications in stroke and peripheral vascular disease: While currently approved for ACS and PCI, ongoing trials might support its use in other thrombotic disorders.
• Personalized medicine approaches: Pharmacogenomic testing may identify patients who would benefit most from Prasugrel, aligning with precision medicine trends.
• Combination therapies: SyAkting with anticoagulants or emerging agents could open new treatment protocols.

Impact of Regulatory Changes and Clinical Data

Enhanced safety data may facilitate label expansions, especially in populations at high bleeding risk. Conversely, increased safety concerns or the introduction of superior drugs could limit Prasugrel’s growth.

Market Share Outlook (2023–2030)

• Optimistic Scenario: With continued favorable trial data and regulatory support, Prasugrel could capture a larger share among DAPT agents, potentially rising from ~15% to 25% within the global market.
• Conservative Scenario: Emerging safety concerns and the rise of Ticagrelor might confine Prasugrel’s share to niche, high-risk groups, maintaining a plateau of around 15–20%.

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Key Takeaways

• Clinical value proposition: Prasugrel’s potent, consistent antiplatelet activity solidifies its role in high-risk PCI patients, especially where rapid platelet inhibition is desired.
• Safety profile considerations: Bleeding risk remains a critical factor; ongoing trials aim to delineate safer, personalized usage strategies.
• Competitive positioning: Ticagrelor’s reversible binding and broader indication spectrum challenge Prasugrel’s market dominance.
• Market opportunities: Expansion into stroke prevention and peripheral vascular disease, combined with personalized therapy approaches, represents key growth vectors.
• Regulatory landscape: Continuous post-marketing surveillance and evolving guidelines will shape future prescribing and approval pathways.

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FAQs

1. How does Prasugrel Hydrochloride compare to Clopidogrel in efficacy?
Prasugrel exhibits more rapid and consistent platelet inhibition than Clopidogrel, leading to better prevention of thrombotic events in PCI patients. Clinical trials, including the TRITON-TIMI 38, have demonstrated superior efficacy in reducing ischemic events with Prasugrel.

2. What are the primary safety concerns associated with Prasugrel?
The main safety concern is an increased risk of major bleeding, particularly in the elderly, low-weight patients, or those with a history of bleeding. Careful patient selection and dose adjustments mitigate this risk.

3. Are there ongoing trials exploring new indications for Prasugrel?
Yes. Current investigations are exploring its use in stroke prevention, peripheral artery disease, and combination therapies, aiming to expand its therapeutic scope.

4. How might personalized medicine influence Prasugrel’s future use?
Pharmacogenomic testing could identify patients likely to experience enhanced efficacy or adverse events, leading to tailored dosing strategies that optimize benefit-risk ratios.

5. What competitive factors could impact Prasugrel’s market share?
The advent of newer agents like Ticagrelor, evolving clinical guidelines favoring reversible agents, and safety concerns could limit Prasugrel’s growth trajectory.

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References

[1] MarketsandMarkets. Antiplatelet Drugs Market Report, 2022.
[2] TRITON-TIMI 38 Investigators. "Effects of Prasugrel vs. Clopidogrel on Bleeding and Ischemic Events." New England Journal of Medicine, 2007.
[3] European Medicines Agency. PRASUGREL post-marketing safety review, 2022.
[4] ClinicalTrials.gov. Ongoing clinical trials involving Prasugrel, 2023.