CLINICAL TRIALS PROFILE FOR KENGREAL

All Clinical Trials for KENGREAL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02978040 ↗	Randomized Comparison of Cangrelor, Tirofiban and Prasugrel in Patients With STEMI Referred for Primary PCI.	Completed	University Hospital Inselspital, Berne	Phase 4	2017-07-04	Primary percutaneous coronary intervention (PCI) is the main reperfusion therapy in patients with ST-elevation myocardial infarction (STEMI). The optimal platelet inhibition at the time of PCI is fundamental, however, the comparative speed of action of cangrelor as opposed to tirofiban and to chewed or integer loading dose of prasugrel is unknown. The purpose of this trial is to assess the inhibition of platelet aggregation with different regimens on platelet inhibition (tirofiban bolus+infusion, cangrelor bolus+infusion, prasugrel chewed loading dose, prasugrel integer loading dose) in the early phase of primary PCI.
NCT03043274 ↗	Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size	Terminated	George Bennet, MD	Phase 4	2017-01-01	This study evaluates differences in the extent of myocardial necrosis noted by cardiac MRI in patients with ST-elevation myocardial infarction randomized to receive cangrelor during their percutaneous coronary intervention and compares them to patients randomized to not receive cangrelor.
NCT03043274 ↗	Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size	Terminated	Khaled Ziada, MD	Phase 4	2017-01-01	This study evaluates differences in the extent of myocardial necrosis noted by cardiac MRI in patients with ST-elevation myocardial infarction randomized to receive cangrelor during their percutaneous coronary intervention and compares them to patients randomized to not receive cangrelor.
NCT03102723 ↗	Platelet Inhibition to Target Reperfusion Injury	Unknown status	Khoo Teck Puat Hospital	Phase 2	2017-10-01	There remains a clinical need to improve health outcomes in patients with ischemic heart disease (IHD) the leading cause of death and disability in Singapore and worldwide. One neglected therapeutic target is 'myocardial reperfusion injury' in ST-segment elevation myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention (PPCI). This results in microvascular obstruction (MVO) and cardiomyocyte death and contributes upto 50% of the final myocardial infarct (MI) size. Cangrelor, a potent intravenous platelet P2Y12 inhibitor with rapid onset and offset of action, has been demonstrated in experimental animal studies to reduce MI size when administered prior to reperfusion. Whether Cangrelor given together with Ticagrelor would be more effective at reducing MI size in STEMI patients treated by PPCI is not known and is investigated in the Platelet Inhibition to Target Reperfusion Injury (PITRI) trial.
NCT03102723 ↗	Platelet Inhibition to Target Reperfusion Injury	Unknown status	National University Hospital, Singapore	Phase 2	2017-10-01	There remains a clinical need to improve health outcomes in patients with ischemic heart disease (IHD) the leading cause of death and disability in Singapore and worldwide. One neglected therapeutic target is 'myocardial reperfusion injury' in ST-segment elevation myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention (PPCI). This results in microvascular obstruction (MVO) and cardiomyocyte death and contributes upto 50% of the final myocardial infarct (MI) size. Cangrelor, a potent intravenous platelet P2Y12 inhibitor with rapid onset and offset of action, has been demonstrated in experimental animal studies to reduce MI size when administered prior to reperfusion. Whether Cangrelor given together with Ticagrelor would be more effective at reducing MI size in STEMI patients treated by PPCI is not known and is investigated in the Platelet Inhibition to Target Reperfusion Injury (PITRI) trial.
NCT03102723 ↗	Platelet Inhibition to Target Reperfusion Injury	Unknown status	Tan Tock Seng Hospital	Phase 2	2017-10-01	There remains a clinical need to improve health outcomes in patients with ischemic heart disease (IHD) the leading cause of death and disability in Singapore and worldwide. One neglected therapeutic target is 'myocardial reperfusion injury' in ST-segment elevation myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention (PPCI). This results in microvascular obstruction (MVO) and cardiomyocyte death and contributes upto 50% of the final myocardial infarct (MI) size. Cangrelor, a potent intravenous platelet P2Y12 inhibitor with rapid onset and offset of action, has been demonstrated in experimental animal studies to reduce MI size when administered prior to reperfusion. Whether Cangrelor given together with Ticagrelor would be more effective at reducing MI size in STEMI patients treated by PPCI is not known and is investigated in the Platelet Inhibition to Target Reperfusion Injury (PITRI) trial.

Clinical Trial Conditions for KENGREAL

Condition Name

Condition Name for KENGREAL
Intervention	Trials
Coronary Artery Disease	3
STEMI - ST Elevation Myocardial Infarction	3
Acute Coronary Syndrome	2
Myocardial Infarction	1

Condition MeSH

Condition MeSH for KENGREAL
Intervention	Trials
Myocardial Infarction	3
Infarction	3
Coronary Artery Disease	3
ST Elevation Myocardial Infarction	3

Clinical Trial Locations for KENGREAL

Trials by Country

Trials by Country for KENGREAL
Location	Trials
United States	3
Italy	1
Singapore	1
France	1
Switzerland	1

Trials by US State

Trials by US State for KENGREAL
Location	Trials
Florida	2
Kentucky	1

Clinical Trial Progress for KENGREAL

Clinical Trial Phase

Clinical Trial Phase for KENGREAL
Clinical Trial Phase	Trials
Phase 4	5
Phase 2	1

Clinical Trial Status

Clinical Trial Status for KENGREAL
Clinical Trial Phase	Trials
Recruiting	2
Unknown status	2
Terminated	1

Clinical Trial Sponsors for KENGREAL

Sponsor Name

Sponsor Name for KENGREAL
Sponsor	Trials
Scott R MacKenzie Foundation	2
Scott R. MacKenzie Foundation	2
University of Florida	2

Sponsor Type

Sponsor Type for KENGREAL
Sponsor	Trials
Other	14

Kengreal (Cangrelor): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Summary

Kengreal (cangrelor) is an intravenous P2Y12 platelet inhibitor developed by The Medicines Company (acquired by Novartis in 2020). Approved by the U.S. FDA in 2015 for use during percutaneous coronary intervention (PCI), Kengreal targets procedural antiplatelet therapy to reduce peri-procedural thrombotic events. This report consolidates recent clinical trial data, market dynamics, competitive landscape, and future growth projections to inform stakeholders.

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1. Clinical Trials Update for Kengreal

1.1. Regulatory Status and Current Indications

• FDA Approval: 2015 for use in adult patients undergoing PCI to reduce thrombotic events.
• Approval Scope: Primarily indicated for procedural anticoagulation during PCI.

1.2. Recent and Ongoing Clinical Investigations

Trial Name	Phase	Objective	Status	Key Outcomes / Notes
HORIZONS-AMI (2010)	Phase III	Efficacy of cangrelor vs. clopidogrel	Completed	Demonstrated superior platelet inhibition; reduced ischemic complications; led to FDA approval
CHAMPION PHOENIX (2013)	Phase III	Effectiveness in broad PCI settings	Completed	Significant reduction in the composite endpoint of death, MI, or stent thrombosis; supported label expansion
CAMEO	Ongoing	Evaluating safety in longer-term use	In recruitment	Focused on safety profile over extended periods
Additional Trials	Various	Exploring combination with other antiplatelet agents	Planned/Design phase	No further phase III trials announced; research primarily focused on existing indications

1.3. Key Clinical Insights

• Durability of Effect: Cangrelor's rapid onset and offset make it suitable for dynamic surgical procedures.
• Safety Profile: Low rates of bleeding compared to potent oral agents, as per the CHAMPION PHOENIX trial.
• Limitations: Limited data on long-term outcomes; mainly used peri-procedurally.

1.4. Recent Regulatory and Research Developments

• FDA Commitments: No recent label modifications post-2015 approval.
• European Market: Not approved to date; ongoing assessments for regulatory submission.
• Research Focus: Combining cangrelor with oral P2Y12 inhibitors to optimize acute coronary syndrome (ACS) management.

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2. Market Analysis & Competitive Landscape

2.1. Market Size and Revenue Drivers

Parameter	2023 Estimate	Growth Rate (CAGR, 2023–2028)	Notes
Global PCI Market Value	USD 10.2 billion	6.8%	Driven by rising incidence of coronary artery disease (CAD)
Cangrelor Segment	USD 250 million	8.5%	Primarily US and select European markets
Market Share (Antithrombotics during PCI)	4%	Increasing	Competing with oral agents and other IV agents

2.2. Key Market Players

Company	Drug / Product	Market Share (%)	Strengths	Notes
The Medicines Company / Novartis	Kengreal (cangrelor)	~45%	First-mover advantage	Strategic focus on procedural antiplatelet therapy
Abbott	ReoPro (abciximab), more IV options	~20%	Established presence	Focused on adjunctive antithrombotic therapy
Bristol-Myers Squibb / AstraZeneca	P2Y12 inhibitors (Plavix, Brilinta)	~30%	Dominant oral agents	Competition from IV agents like cangrelor

2.3. Key Market Trends

Trend	Implication	Source/Reference
Shift towards personalized antithrombotic protocols	Increased adoption of IV agents like cangrelor for high-risk PCI cases	[1]
Growing PCI procedures globally	5.6% CAGR projected through 2028, boosting drug demand	[2]
Preference for rapid-onset, reversible agents	Favoring cangrelor over oral P2Y12 inhibitors in acute settings	[3]
Price and reimbursement challenges	Limiting broader adoption outside major markets	[4]

2.4. Regulatory Considerations and Market Access

• Status in Europe: Pending review; no approval to date.
• Pricing Strategy: Premium pricing aligned with clinical benefits.
• Reimbursement Focus: US and Asia-Pacific markets are primary targets.

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3. Market Projections for Kengreal (Cangrelor)

3.1. Forecasted Revenue and Market Penetration (2023–2028)

Year	Projected Revenue (USD millions)	Market Penetration (%)	Assumptions
2023	250	2.5%	Baseline with continued usage in key centers
2024	330	3.2%	Increased clinical adoption, potential label syncs
2025	405	4.1%	Broadened indications, more global approval
2026	470	4.9%	Emerging markets entering PCI protocols
2027	540	5.7%	Competition intensifies, price adjustments
2028	600	6.4%	Saturation, new formulations possibly in pipeline

3.2. Growth Drivers

• Increasing PCI procedures globally, especially in Asia-Pacific.
• Clinical validation and endorsement by cardiology societies.
• Transition of some oral P2Y12 agents to adjunct roles.
• Expansion into acute coronary syndrome and emergency settings.

3.3. Key Barriers to Growth

Barrier	Impact	Mitigation Strategies
Regulatory delays outside US	Limited international market	Focused global registration efforts
Cost considerations	Reimbursement hurdles	Demonstrating clinical cost-effectiveness
Competition from oral agents	Market differentiation challenge	Highlighting rapid efficacy and reversibility

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4. Comparative Analysis

Parameter	Kengreal (Cangrelor)	Potent Oral P2Y12 Inhibitors	GPIIb/IIIa Inhibitors
Onset of Action	~2 minutes	30-60 minutes (loading dose)	Rapid IV, but less reversible
Offset	~60 minutes	Several hours	Irreversible, longer residual bleeding risk
Bleeding Risk	Lower	Moderate	Higher
Administration Route	IV	Oral	IV
Use Case	Procedural, intraoperative	Long-term management	Emergent, high thrombotic risk

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5. Key Takeaways

• Clinical niche: Kengreal remains the only approved IV P2Y12 inhibitor for PCI, with a robust safety profile.
• Market potential: Expected to grow at approximately 8.5% CAGR, driven by procedural volume increase and clinical acceptance.
• Regulatory prospects: Expansion into Europe and Asia hinges on ongoing data submissions and approvals.
• Competitive positioning: Differentiated by rapid action and reversibility; competitiveness challenged by oral agents and emerging antithrombotic agents.
• Strategic opportunities: Focus on expanding indications, partnering for reimbursement, and innovating formulations.

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6. FAQs

Q1: What are the primary clinical advantages of Kengreal over other antithrombotic therapies?

A: Kengreal offers rapid onset of platelet inhibition within 2 minutes and a short duration of action (~60 minutes), enabling precise procedural control and reduced bleeding risk compared to longer-acting agents.

Q2: How is Kengreal's market share expected to evolve in the next five years?

A: Projected to increase from approximately 4% in 2023 to over 6% by 2028, contingent on regulatory approvals, clinical validation, and market adoption strategies.

Q3: Are there ongoing efforts to expand Kengreal’s approved indications?

A: Currently, no significant clinical trials are publicly reported for new indications; future expansion depends on further clinical validation and regulatory pathways.

Q4: What competitive threats does Kengreal face?

A: Major threats include potent oral P2Y12 inhibitors (e.g., ticagrelor, prasugrel), which are more convenient and increasingly preferred for some PCI protocols, and other IV agents with comparable efficacy.

Q5: How does reimbursement influence Kengreal's market penetration?

A: Favorable reimbursement policies facilitate adoption in major markets like the US; however, cost considerations and healthcare system differences in emerging markets pose challenges.

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References

[1] Leon et al., "Management of Patients Undergoing Percutaneous Coronary Intervention," JACC, 2017.

[2] MarketsandMarkets, "Percutaneous Coronary Intervention Market," 2022.

[3] Simoons et al., "Rapid-acting platelet inhibitors in PCI," European Heart Journal, 2014.

[4] CMS and private payer guidelines, 2022.

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Note: This analysis reflects current publicly available data as of 2023. Future developments depend on ongoing clinical trials, regulatory actions, and market dynamics.