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.
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 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 exclusivity-patent outlook

Last updated: May 22, 2026

Prasugrel hydrochloride (Effient and generic equivalents) is an established antiplatelet for acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). Near-term clinical-trials activity is focused on dose optimization, high-bleeding-risk subpopulations, real-world outcomes, and switching strategies rather than new pivotal registration programs. Commercially, the drug’s revenue is mature and driven by secondary prevention in ACS/PCI workflows and formulary positioning; growth is constrained by generic erosion in the US and broad international availability. The key forward-looking lever for market dynamics is uptake of the most preferred P2Y12 inhibitor options within hospital protocols and guideline-aligned selection in bleeding-risk cohorts.

What is the latest clinical trials landscape for prasugrel hydrochloride?

Featured-snippet answer: Current prasugrel research is largely non-pivotal and pragmatic, tracking efficacy-safety tradeoffs (ischemic vs bleeding) across ACS phenotypes, surgical timing, and de-escalation or switching approaches.

Which trial themes are most active?

Across the prasugrel clinical-trials ecosystem, updates tend to cluster in these areas:

• High-bleeding-risk (HBR) refinement: lower-dose regimens, patient stratification (age, body weight, renal function), and bleeding mitigation strategies.
• Switching and de-escalation: transition between P2Y12 inhibitors to balance bleeding and ischemic events after early stabilization.
• Perioperative management: washout timing before CABG or non-cardiac surgery, and bridging practices.
• Real-world effectiveness: adherence, event rates, and hospital pathway performance vs RCT baselines.
• Biomarker or platelet-function substudies: variability in clopidogrel and prasugrel response and whether tailoring improves outcomes.

Are there ongoing Phase 3 registration trials?

No broad, registration-changing Phase 3 program is consistently identifiable from public summaries as the dominant near-term driver of prasugrel’s label expansion. Most activity is positioned as evidence generation for clinical practice and subgroup guidance rather than a new indication filing.

Where does prasugrel fit in current ACS/PCI guideline practice?

Featured-snippet answer: Prasugrel is a preferred option in ACS patients undergoing PCI when bleeding risk is acceptable, and it is typically avoided or used with caution in patients with prior stroke/TIA and in certain bleeding-risk strata.

Patient selection factors that govern utilization

Utilization is sensitive to:

• History of stroke or TIA (generally contraindicated/avoided in standard guidance).
• Age and body weight (lower-dose regimens and caution are common in practice).
• Bleeding-risk score composition and concurrent anticoagulation.
• Anatomic and procedural factors in PCI complexity.

How does prasugrel compare with clopidogrel and ticagrelor in practice?

• Compared with clopidogrel: prasugrel generally offers lower ischemic events in ACS cohorts at the cost of higher bleeding, which drives selective use.
• Compared with ticagrelor: the choice often turns on bleeding profile, dyspnea intolerance, drug interactions, adherence, and formulary.

What is the current market size and revenue exposure for prasugrel hydrochloride?

Featured-snippet answer: Prasugrel is a mature, generic-dominated market in the US with revenue exposure concentrated in remaining branded/authorized generics where they persist via contracting, plus international markets where local exclusivity remnants can shape short-term share.

Market drivers

Key demand drivers:

• Stable ACS incidence and ongoing PCI throughput.
• Hospital formulary protocols and standardized order sets.
• Payer and PBM contracting dynamics.
• Uptake in STEMI/NSTEMI pathways and co-therapy patterns.

Primary headwinds

• US generic erosion and pricing pressure.
• Competitive displacement within P2Y12 class protocols.
• Formularies increasingly tuned to bleeding risk.

Commercial projection (directional)

• US: low-growth to declining branded revenue; total category demand remains resilient but value declines with generic pricing.
• International: slower erosion where local generic entry is later or more fragmented; overall category value still trends downward where generic penetration increases.

When does prasugrel lose exclusivity in key markets and what timelines matter?

Featured-snippet answer: In the US, prasugrel’s branded exclusivity era is largely past; market entry and share shifts now depend on patent estates tied to specific formulations, methods, or manufacturing processes, plus local regulatory exclusivity (notably for brand sponsors’ secondary patents in certain jurisdictions).

What does “exclusivity” mean for prasugrel now?

For an established small molecule:

• Brand exclusivity typically ends first via regulatory exclusivity periods.
• Patent-driven exclusivity follows through secondary patents (formulation, polymorph, manufacturing).
• Market access is then shaped by ANDA/authorized generic timing, Paragraph IV litigation, and settlement dates.

What patents protect prasugrel hydrochloride and its formulations?

Featured-snippet answer: The prasugrel estate historically includes patents spanning polymorph or solid-state form, formulation (including tablet compositions), and manufacturing process controls, plus any method-of-treatment claims associated with dosing regimens.

How to interpret “patent protection” for a mature drug

For investors and litigators, patent coverage is usually assessed by:

• Whether claims are directed to the active ingredient per se, a specific crystalline form, or tablet formulation parameters.
• Whether method-of-use claims are enforceable against direct infringement in the US context.
• Whether manufacturing process claims can be avoided by alternative routes.

How many patents usually matter for a small molecule like prasugrel?

For mature small molecules, the number of in-force, enforceable patents at any time often narrows to a handful tied to:

• Solid-state/formulation specifics.
• Narrow process steps.
• Method-of-use claims tied to clinical practice.

(A jurisdiction- and brand-specific Orange Book review is required to enumerate exact in-force listings and expiration dates; without a current Orange Book snapshot, enumeration would risk incorrect or incomplete mapping.)

What is the Orange Book status of prasugrel?

Featured-snippet answer: Prasugrel is an FDA-approved small molecule with multiple listed patents historically; current status is dominated by generic entries and patent lifetimes that affect which applicants launch and whether settlements apply.

How Orange Book listings affect generic entry risk

For each listed patent:

• If a patent is expired, generics can rely on “no patent” status.
• If a patent is active, an ANDA must either wait, challenge via Paragraph IV, or enter through a license/settlement.

Which companies are challenging prasugrel patents via Paragraph IV?

Featured-snippet answer: Patent challenges in an established small molecule segment typically involve generic manufacturers filing ANDAs with Paragraph IV certifications against active patents, with litigation or settlement determining launch timing.

Settlement-driven launch patterns

Common outcomes for brand-adjacent generic challengers:

• Early entry blocked unless settlement grants a launch date.
• Post-settlement launch with stipulated “at-risk” or limited launch carveouts.
• Some challengers exit litigation after non-infringement/invalidity concessions.

(A precise Paragraph IV challenger list and case mapping requires current FDA and litigation docket data. Without a verified docket and Orange Book crosswalk, listing specific company names would be unreliable.)

What prasugrel patent litigation affects market timing?

Featured-snippet answer: For established drugs, litigation affects timing primarily through negotiated settlement dates, not through a brand’s ability to block all generic entry indefinitely.

What to track in prasugrel-related cases

• Settlement effective dates and stipulated launch triggers.
• Carveouts tied to specific strengths, label claims, or formulation versions.
• Injunction posture and ongoing appeal outcomes.

What formulations are protected for prasugrel tablets?

Featured-snippet answer: Formulation and solid-state protections typically focus on tablet composition and manufacturing controls that maintain a defined dissolution profile and stability.

Why formulation patents matter for generics

Even when the active ingredient is off-patent, generics can be blocked if:

• Their proposed formulation falls within claim scope (composition parameters).
• Their manufacturing route does not design around process claims.
• Their solid-state form differs but still falls within dependent claims.

How do bioequivalence and clinical switching affect competitive positioning?

Featured-snippet answer: Bioequivalence compliance supports generic substitution, while clinical switching protocols determine whether prescribers remain on prasugrel versus switch to ticagrelor or clopidogrel in HBR or post-PCI settings.

Switching pathways that influence demand

• De-escalation after initial stabilization.
• Discontinuation timing in bleeding events.
• Transition for patients who develop intolerance or complicating comedications.

Commercial projection: base-case, bear-case, bull-case market scenarios

Featured-snippet answer: Total demand is likely stable, but value declines with generic penetration, discounting, and formulary pressure. Forecast dispersion depends on P2Y12 class competition and local reimbursement.

Base case (most likely)

• US branded value continues downward.
• Generic share stabilizes; category volume holds with ACS/PCI throughput.
• International trends down in value where generic penetration accelerates.

Bear case

• Faster substitution away from prasugrel to other P2Y12 inhibitors where protocols shift toward bleeding minimization.
• Greater payer push for lowest net cost generics.
• Fewer favorable formulary exceptions for branded or authorized generics.

Bull case

• Clinical pathways increase prasugrel preference in selected ACS cohorts based on updated real-world evidence.
• New secondary evidence broadens confidence in specific HBR segments.
• Strong hospital contract renewals preserve higher-margin supply for authorized generics/brand-equivalent SKUs.

Manufacturing and IP barriers that can delay generic competition

Featured-snippet answer: The highest barriers are often formulation and process patent claims tied to tablet performance characteristics, plus procedural or settlement constraints, rather than the active ingredient itself.

Where delays typically come from

• Design-around failure against formulation/composition claims.
• Process claims that are hard to replicate without triggering infringement.
• Settlement terms restricting launch timing for specific strengths.

Key Takeaways

• Prasugrel hydrochloride is a mature ACS/PCI antiplatelet with active research mainly in subgroups, perioperative timing, and de-escalation/switching strategies rather than label-expanding Phase 3 programs.
• Market value is constrained by generic penetration, formulary contracting, and P2Y12 class substitution dynamics; volume is more stable than revenue.
• Near-term commercial outcomes hinge on hospital pathway adherence and bleeding-risk selection rather than new clinical breakthroughs.
• Patent and Orange Book-driven entry risks typically now concentrate on remaining in-force formulation, solid-state, and process patents, with litigation and settlements shaping launch windows.

FAQs

1. What is prasugrel hydrochloride used for in acute coronary syndrome patients undergoing PCI?
2. How do age and body weight influence prasugrel dosing and bleeding risk in clinical practice?
3. Can patients switch from prasugrel to ticagrelor or clopidogrel after PCI, and what outcomes matter?
4. What types of patents typically remain relevant for generic competition to prasugrel tablets?
5. How does FDA ANDA Paragraph IV litigation usually affect prasugrel generic launch timing?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. ClinicalTrials.gov. Prasugrel search results. U.S. National Library of Medicine. https://clinicaltrials.gov/