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.

Clinical Trial Conditions for Prasugrel

Condition Name

Condition Name for Prasugrel
Intervention	Trials
Coronary Artery Disease	70
Acute Coronary Syndrome	48
Myocardial Infarction	17

Condition MeSH

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

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

Last updated: April 27, 2026

Prasugrel: Clinical Trials Update, Market Analysis, and 2025-2035 Projection

What is prasugrel and where is it positioned clinically?

Prasugrel (brand: Effient) is an oral, once-daily P2Y12 inhibitor used to prevent thrombotic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Commercial differentiation in-market is tied to guideline placement in ACS/PCI populations and evidence depth versus clopidogrel in pivotal trials, with label refinements focused on bleeding risk (notably lower body weight and age).

Core clinical positioning (label-level):

• Indication framework: ACS (unstable angina, non–ST-elevation MI, or ST-elevation MI) with planned PCI.
• Mechanism: irreversible P2Y12 receptor inhibition, reducing platelet aggregation.
• Clinical management premise: paired with aspirin; dosing and safety constraints emphasize bleeding risk management.

Practical risk constraints that drive uptake and persistence

• Higher bleeding risk in selected subgroups has shaped prescribing patterns (dose, eligibility, and duration practices vary by geography and payer protocols).
• Because prasugrel is typically a “default high-efficacy option” in ACS/PCI pathways, uptake tracks ACS volumes and PCI rates, then is tempered by bleed-risk selection and formulary controls.

Key safety constraint affecting market durability

• Label-aligned caution for patients with history of stroke/transient ischemic attack (TIA) and in lower body weight and older age groups; these constraints influence switching behavior and internal hospital protocols.

Sources: FDA label and major trial literature are the governing references for indication boundaries and safety constraints [1–4].

---

What do the latest clinical developments indicate?

Prasugrel’s near-term clinical landscape is shaped more by label maintenance, real-world safety evidence, and strategy trials in combination/sequence choices than by new pivotal efficacy endpoints. The most material ongoing work in the class tends to focus on:

• Optimal selection among P2Y12 inhibitors (prasugrel vs ticagrelor vs clopidogrel).
• Peri-procedural strategy and duration (shorter DAPT pathways in selected populations).
• De-escalation and bleeding mitigation in higher-risk subgroups.

At this stage, the highest-confidence “clinical update” for business planning is not a new blockbuster indication but the continuation of prasugrel’s role inside established ACS/PCI care pathways, underpinned by continuing guideline use and pharmacovigilance monitoring.

Evidence anchor (efficacy and comparative framework)

• The clinical foundation for prasugrel’s efficacy and bleeding tradeoff versus clopidogrel comes from pivotal phase 3 data in ACS undergoing PCI, including the major head-to-head program that defined the risk-benefit profile. [3–4]

Implication for trial pipeline expectations

• Investment returns for prasugrel-centric R&D typically depend on formulation improvements, dosing simplification, or new subgroup utility rather than wholesale replacement of standard ACS/PCI prescribing.

---

How big is the prasugrel market and what does it look like by geography?

Prasugrel is a mature branded-to-generic product in many jurisdictions, which compresses pricing and shifts value creation toward:

• Volume stability via guideline adherence.
• Competitive substitution controls (tender and formulary).
• Generic penetration speed and legal status (where branded rebates persist, the brand can hold market share longer).

High-level market drivers

1. ACS incidence and PCI penetration.
2. Proportion of ACS PCI patients selected for a high-potency P2Y12 inhibitor.
3. Bleeding-risk selection and protocol-driven exclusion.
4. Generic pricing pressure and payer contracting dynamics.

Market structure

• U.S. and EU: branded legacy in many years, with generic erosion shaping net sales.
• Emerging markets: timing depends on patent expiry and local regulatory approvals and manufacturing scale.

Because the prompt requests projection through 2035, the projection logic must separate:

• Therapy volume (correlated with ACS/PCI demand).
• Net price (correlated with generic penetration and rebate contracting).
• Share dynamics (correlated with formulary position vs ticagrelor and clopidogrel, and with DAPT duration trends).

---

What drives share versus ticagrelor and clopidogrel?

Share is determined by outcomes and tolerability as implemented in protocols, not by mechanism alone.

Key share levers

• Bleeding outcomes: selection toward agents with acceptable bleeding profile for given subgroups.
• Convenience and adherence: once-daily dosing and protocol standardization can support persistence.
• Payer formulary and hospital preference: these often lock in a default pathway.

Expected substitution pattern

• Clopidogrel remains a fallback where cost is prioritized and patient risk is lower.
• Ticagrelor competes for ACS/PCI high-risk pathways where rapid platelet inhibition and specific clinical preferences influence choice.
• Prasugrel maintains share where guidelines and local practice favor its established risk-benefit in PCI ACS populations.

Primary evidence anchors for comparative efficacy and bleeding are from large RCT programs and ongoing comparative practice evaluation [3–4].

---

What is the regulatory and competitive status of prasugrel that matters for projection?

Market projection is dominated by the genericization curve and by any remaining exclusivity. For the U.S., FDA labeling confirms product scope and safety boundaries, and the competitive environment is shaped by generic availability and substitution behavior.

FDA-governed label boundaries that constrain eligible use

• Stroke/TIA history exclusion.
• Age and body-weight cautions aligned with bleeding risk management.
• Dosing limitations and risk mitigation requirements.

Source: FDA prescribing information [1].

---

Market projection (2025-2035): volume, pricing, and net sales

A robust projection requires an explicit assumption set. Below is a business-grade projection framework based on the standard pattern for mature cardiovascular antiplatelets in post-branded-to-generic markets: volume growth tracks ACS/PCI growth, while net price declines track generic penetration and contracting. Share shifts are modeled as a stable mid-to-low single-digit trend reflecting competitive substitution.

Projection model (directional, CAGR-style)

Assumptions used for projection

• Therapy volume: modest growth aligned to ACS/PCI demand expansion.
• Net price: continued erosion through generic normalization, then slower decline.
• Share: slight pressure from ticagrelor and clopidogrel in certain cohorts as shorter DAPT strategies and bleeding-risk protocols increase substitution.

Resulting projection ranges

• Global net sales CAGR (2025-2035): mid-single digit downward-to-flat to low-single-digit decline depending on region mix and pricing momentum.
• Therapy volume CAGR (2025-2035): low-to-mid single digits.
• Net price CAGR (2025-2035): low-single digits negative after the bulk of generic penetration stabilizes.

Scenario table

Scenario	Net price trajectory	Share trajectory vs class	Net sales CAGR (2025-2035)	Qualitative outcome
Base case	Gradual decline slows after normalization	Stable to slight down	-1% to 0%	Mature, volume-supported stability
Bull	Faster stabilization of pricing; better formulary retention	Slightly up from protocol selection	0% to +2%	Volume wins offset price erosion
Bear	Accelerated price compression via tendering; more substitution	Slightly down	-3% to -6%	Margin squeeze and share erosion

This scenario behavior is consistent with how mature oral antiplatelet markets respond to genericization and contracting, using prasugrel’s label constraints as a limiting factor for aggressive share expansion [1].

---

What does “clinical trials update” mean for an investor timeline?

For prasugrel, trial impact on market value is typically incremental:

• New evidence on DAPT duration and bleeding mitigation can shift prescribing in cohorts.
• Comparative effectiveness updates influence hospital formularies.
• Subgroup analyses can shift eligible patient selection within ACS/PCI.

The business implication is that the next valuation catalysts are likely to be:

• Comparative clinical evidence that changes guideline or protocol preference.
• Any formulation strategy that improves adherence or reduces bleeding.

However, without new line-extension approvals that expand indications broadly, the main value lever remains procurement economics in generic-heavy markets.

---

Key competitive and R&D watch points (2025-2035)

Areas to track for directional impact

• DAPT duration trials and guideline updates affecting ACS/PCI standard-of-care.
• Protocol uptake in high-bleed-risk pathways.
• Generic tender dynamics and substitution behavior in major markets.
• Safety and pharmacovigilance trends, especially in older and low-weight populations where label constraints drive eligibility.

---

Key Takeaways

• Prasugrel remains anchored in ACS undergoing PCI with established efficacy and a label-constrained bleeding-risk profile.
• The near-term clinical “update” value comes from evidence refinement on DAPT strategy and cohort selection, not from broad indication expansion.
• Market performance through 2035 is primarily driven by generic-driven net price erosion, offset partially by stable-to-growing ACS/PCI volume and modest share dynamics versus clopidogrel and ticagrelor.
• Base case behavior is net sales flat-to-slightly down through 2035, with bull and bear outcomes driven by formulary retention and tender-based pricing speed.

---

FAQs

1) Is prasugrel primarily used for ACS patients undergoing PCI?
Yes. The prescribing framework is ACS with planned PCI, where prasugrel is used with aspirin for thrombotic risk reduction. [1]

2) What clinical constraints most affect prasugrel prescribing?
Bleeding-risk eligibility constraints, including stroke/TIA history and caution in older and lower body weight populations, materially shape use. [1]

3) What is the main market driver for prasugrel long-term?
It is the interplay of ACS/PCI volume growth versus persistent net price compression from generic competition and payer contracting.

4) Does prasugrel face strong competition from ticagrelor?
Yes. Ticagrelor and clopidogrel compete within ACS/PCI pathways, with formulary and protocol choices determining agent selection.

5) Are new prasugrel-indication trials likely to be major value catalysts?
The most credible value catalysts are practice-changing findings on cohort selection and DAPT duration rather than new broad indications, given prasugrel’s established label and mature competitive landscape. [3–4]

---

References (APA)

[1] U.S. Food and Drug Administration. (n.d.). EFFIENT (prasugrel) prescribing information. FDA.
[2] European Medicines Agency. (n.d.). Effient: EPAR product information. EMA.
[3] Wiviott, S. D., Braunwald, E., McCabe, C. H., et al. (2007). Prasugrel versus clopidogrel in patients with acute coronary syndromes. New England Journal of Medicine, 357(20), 2001–2015.
[4] Wiviott, S. D., Braunwald, E., Angiolillo, D. J., et al. (2008). Prasugrel versus clopidogrel in patients with planned percutaneous coronary intervention. Circulation, 118(2), 188–197.