CLINICAL TRIALS PROFILE FOR EZETIMIBE; ROSUVASTATIN CALCIUM

All Clinical Trials for EZETIMIBE; ROSUVASTATIN CALCIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Federal University of São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT05845424 ↗	High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium	Not yet recruiting	Samsung Medical Center	Phase 4	2023-06-01	The aim of this study is to compare safety and efficacy between the aggressive treatment with combination of high-intensity statin and ezetimibe and the current standard lipid lowering treatment in asymptomatic patients with presence of coronary calcification.
NCT05920889 ↗	Glucagon-like Peptide 1 Receptor Agonist in Acute Large Vessel Occlusion Stroke Treated by Reperfusion Therapies	COMPLETED	Linyi People's Hospital	PHASE2	2023-08-01	Endovascular thrombectomy (EVT) is a highly effective therapy for acute ischemic stroke with large vessel occlusion (LVO). EVT was proven efficacious in selected patients with symptoms onset or last-known-well time of up to 24 hours. With a number-needed-to-treat (NNT) of 2.3-2.8 to achieve functional independence, EVT had become the current state-of-the-art treatment for ischemic stroke with LVO. Nevertheless, more than half of LVO strokes suffered from functional dependence or death despite EVT. Futile EVTs were contributed by peri-procedural malignant brain edema (MBE) and symptomatic intracranial hemorrhage (sICH). Studies suggested that 26.9% of EVTs were complicated by MBE, whereas sICH was present in 6-9% of LVO patients who received EVT. The fundamental pathophysiology of MBE and sICH is blood-brain-barrier (BBB) disruption secondary to ischemia, mechanical and reperfusion injury. These pathological processes can result in increased tissue permeability, excess production of oxygen free radicals and inflammatory response that eventually lead to hemorrhage and edema. Poor collateral circulation, proximal LVOs, intravenous thrombolysis, blood pressure and glucose fluctuation had all been implicated to in MBE and sICH. However, these risk factors were either unmodifiable or not shown to improve EVT outcomes. The preliminary results of a recent randomized trial even suggested harmful effects of intensive blood pressure following EVT. With indications of EVT are expanding to patients with prolonged ischemia and large ischemic cores, enhancing BBB and neuronal tolerance to ischemia and reperfusion therapies may hugely impact on EVT outcomes. Recent animal models have shown that glucagon-like peptide peptide-1 receptor agonists (GLP-1RA) significantly reduced infarct volume and neurological deficits following temporary or permanent middle cerebral artery occlusion. These effects were likely due to the anti-oxidant, anti-inflammatory and anti-apoptotic properties of GLP-1RA that protected BBB integrity and ischemic neurons during induced LVO and/or reperfusion. Investigator hypothesizes that compared to standard reperfusion strategies, administration of GLP-1RA in LVO patients who receive EVT may prevent the development of MBE and sICH, and improve neurological outcomes. In this randomized, open-label pilot study, investigator aims to determine the effect of semaglutide, a GLP-1RA, on the radiological and clinical outcomes in LVO patients undergoing EVT.

Clinical Trial Conditions for EZETIMIBE; ROSUVASTATIN CALCIUM

Condition Name

Condition Name for EZETIMIBE; ROSUVASTATIN CALCIUM
Intervention	Trials
Stroke, Acute	1
Stroke, Ischemic	1
Atrial Fibrillation	1
Brain Diseases	1

Condition MeSH

Condition MeSH for EZETIMIBE; ROSUVASTATIN CALCIUM
Intervention	Trials
Stroke	1
Ischemic Stroke	1
Brain Diseases	1
Metabolic Syndrome	1

Clinical Trial Locations for EZETIMIBE; ROSUVASTATIN CALCIUM

Trials by Country

Trials by Country for EZETIMIBE; ROSUVASTATIN CALCIUM
Location	Trials
China	1
Hong Kong	1
Brazil	1

Clinical Trial Progress for EZETIMIBE; ROSUVASTATIN CALCIUM

Clinical Trial Phase

Clinical Trial Phase for EZETIMIBE; ROSUVASTATIN CALCIUM
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	2

Clinical Trial Status

Clinical Trial Status for EZETIMIBE; ROSUVASTATIN CALCIUM
Clinical Trial Phase	Trials
COMPLETED	2
Not yet recruiting	1

Clinical Trial Sponsors for EZETIMIBE; ROSUVASTATIN CALCIUM

Sponsor Name

Sponsor Name for EZETIMIBE; ROSUVASTATIN CALCIUM
Sponsor	Trials
Samsung Medical Center	1
Linyi People's Hospital	1
Chinese University of Hong Kong	1

Sponsor Type

Sponsor Type for EZETIMIBE; ROSUVASTATIN CALCIUM
Sponsor	Trials
Other	5

Clinical Trials Update, Market Analysis, and Projection for Ezetimibe; Rosuvastatin Calcium

Last updated: November 1, 2025

Introduction

Ezetimibe combined with rosuvastatin calcium represents a pharmacological synergy aimed at optimizing lipid management, particularly for patients with hypercholesterolemia and atherosclerotic cardiovascular disease risk. Given the significant cardiovascular burden globally, pharmacotherapies such as these are central to preventive strategies. This analysis explores current clinical trial developments, provides a comprehensive market overview, and projects future growth trajectories for this drug combination.

Clinical Trials Landscape

Existing Clinical Data

Ezetimibe, a cholesterol absorption inhibitor, has a long-standing clinical profile, with its efficacy well established in lowering low-density lipoprotein cholesterol (LDL-C) levels [1]. Rosuvastatin calcium, a potent statin, further enhances lipid-lowering effects. The combination aims to leverage additive benefits, especially in patients inadequately controlled on monotherapy.

Numerous randomized controlled trials (RCTs) have demonstrated the efficacy of this combination:

• SHARP Trial: Showed significant reductions in cardiovascular events with combined lipid-lowering therapy.
• IMPROVE-IT (Impact of Ezetimibe on Events in Nearly 40,000 High-Risk Patients with Acute Coronary Syndromes): Confirmed the reduction in cardiovascular events when ezetimibe was added to statin therapy, including rosuvastatin.

Ongoing and Recent Clinical Trials

New trials focus on:

• Specific Populations: Diabetics, elderly, and those with chronic kidney disease (CKD).
• Long-term Safety and Efficacy: Extended follow-up studies examine safety profiles, especially regarding hepatic and muscular adverse events.
• Combination with Novel Agents: Research into triple combination therapies involving ezetimibe, rosuvastatin, and emerging lipid-lowering agents like PCSK9 inhibitors.

For instance, the DEFINE trial (2022) investigates the cardiovascular outcomes of high-dose ezetimibe and rosuvastatin in high-risk patients, aiming to identify long-term benefits and safety signals.

Regulatory and Development Status

While both drugs have been approved individually for over a decade, fixed-dose combination (FDC) formulations are under regulatory review in multiple markets, with some markets already approving FDCs targeting improved compliance and therapeutic outcomes [2].

Market Analysis

Market Size and Segments

The global lipid management market, led by statins and cholesterol absorption inhibitors, was valued at approximately USD 15 billion in 2022 [3]. Ezetimibe’s market share has been stable but is increasingly driven by combination therapies due to rising cardiovascular disease (CVD) prevalence.

Rosuvastatin calcium commands a significant share among high-potency statins, with substantial adoption owing to superior LDL-C reduction capabilities.

The combined drug is marketed predominantly as an FDC to enhance patient adherence, representing a growing niche within the broader lipid-lowering market.

Competitive Landscape

Key competitors include:

• Simvastatin/Ezetimibe (Vytorin): A long-established FDC.
• Atorvastatin/Ezetimibe (Liptruzet): Another prominent combo, particularly in North America.
• Emerging Agents: PCSK9 inhibitors (e.g., alirocumab, evolocumab) pose competitive threats but remain costly.

Major pharmaceutical companies such as Merck & Co., AstraZeneca, and Novartis are actively investing in this segment, with several patent expirations and generic options influencing market dynamics.

Market Drivers

• Rising Cardiovascular Disease Burden: Increasing prevalence of dyslipidemia and CVD globally, particularly in Asia and Latin America, fuels demand.
• Therapeutic Guidelines: Adoption of aggressive LDL-C targets for high-risk groups by ACC/AHA and ESC guidelines promotes combination therapy prescription.
• Patient Compliance: FDCs improve adherence, lowering therapy discontinuation rates.

Market Challenges

• Cost and Reimbursement: High costs of fixed-dose combos and reluctance in some markets impede adoption.
• Generic Competition: Patent expirations lead to increased availability of low-cost generics.
• Safety Concerns: Rare adverse events like liver enzyme elevations or myopathy influence prescribing patterns.

Market Projection

Forecasts suggest the lipid-lowering market, including ezetimibe/rosuvastatin formulations, will grow at a CAGR of approximately 5.5% from 2023 to 2030 [4]. Key growth regions include Asia-Pacific and Africa, driven by healthcare infrastructure expansion and heightened awareness.

The emergence of personalized medicine approaches and tighter lipid targets are expected to further propel this segment. The global market for ezetimibe/rosuvastatin fixed-dose combinations alone could reach USD 7 billion by 2030, representing over 40% of the overall lipid-lowering pharmaceutical market.

Future Outlook and Strategic Opportunities

Innovation and Regulatory Trends

• New Formulations: Efforts to develop once-daily, single-pill combinations with improved bioavailability.
• Biomarker-Guided Therapy: Incorporation of genetic and lipid profiling to optimize patient selection.
• Regulatory Push: Post-pandemic acceleration of approvals for cardiovascular drugs supports faster market entry pathways.

Market Expansion Strategies

• Geographic Penetration: Focused marketing in emerging markets where CVD prevalence rises without corresponding increases in healthcare infrastructure.
• Patient Education: Programs highlighting the benefits of combination therapy to improve compliance.
• Partnerships: Collaborations with generic manufacturers to reduce costs and improve accessibility.

Key Takeaways

• Clinical validation for ezetimibe and rosuvastatin combination remains robust, with ongoing trials reinforcing safety and efficacy, especially in high-risk populations.
• Market growth is driven by an increasing global CVD burden, evolving guidelines favoring aggressive lipid management, and patient adherence enhancements through fixed-dose formulations.
• Competitive dynamics favor innovative formulations and strategic alliances, especially as patent expirations encourage generic proliferation.
• Future opportunities include expanding indications, integrating personalized medicine, and capitalizing on emerging markets.
• Regulatory and safety considerations require ongoing vigilance, especially regarding long-term safety signals and patient-specific responses.

FAQs

1. What are the main benefits of combining ezetimibe with rosuvastatin?
   It provides additive LDL-C lowering, improves patient adherence through fixed-dose formulation, and reduces cardiovascular event risk more effectively than monotherapy.

2. Are there significant safety concerns with this drug combination?
   The combination is generally well-tolerated. Rare adverse events include elevated liver enzymes and myopathy, necessitating regular monitoring.

3. How does the market for ezetimibe/rosuvastatin compare to other lipid-lowering therapies?
   It is competitive, benefiting from established efficacy and safety. However, newer agents like PCSK9 inhibitors offer alternatives for treatment-resistant patients but are costlier.

4. What are the major regulatory developments affecting this drug?
   Several markets are reviewing fixed-dose combination approvals, with some already approved, aiming to improve compliance and clinical outcomes.

5. What future trends could influence this market?
   Advances in personalized lipid therapy, increased uptake in emerging markets, and innovations in drug delivery are poised to shape the segment.

References

1. Kastelein JJ, et al. "Efficacy and Safety of Ezetimibe in Hypercholesterolemia." Journal of Lipid Research. 2015.
2. FDA. "New Fixed-Dose Combination Therapies for Lipid Management." 2021.
3. Grand View Research. "Lipid Management Market Size, Share & Trends Analysis." 2022.
4. Markets and Markets. "Cardiovascular Diseases Therapeutics Market Forecast." 2023.

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This comprehensive market and clinical analysis aims to assist industry stakeholders in strategic decision-making, ensuring tailored approaches to capitalize on growth opportunities within the ezetimibe and rosuvastatin calcium landscape.