CLINICAL TRIALS PROFILE FOR CILOSTAZOL

All Clinical Trials for cilostazol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00048763 ↗	Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon	Completed	Otsuka America Pharmaceutical	Phase 4	2001-10-01	Juvenile primary Raynaud's (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. When children with primary Raynaud's Phenomenon are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. Children with primary Raynaud's Phenomenon have no underlying systemic disease. The cause for their symptoms is unknown. The investigational drug, Pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. It has been used in a variety of other conditions in which blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of primary Raynaud's episodes in juvenile patients.
NCT00048776 ↗	Safety and Efficacy of Pletal (Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon	Completed	Otsuka America Pharmaceutical	Phase 4	2001-10-01	Juvenile secondary Raynaud's (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. Children with secondary Raynaud's Phenomenon have an underlying condition such as systemic lupus, scleroderma, or mixed connective tissue disease. When children with secondary Raynaud's are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. The investigational drug, Pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. It has been used in a variety of other conditions in which blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of secondary Raynaud's episodes in juvenile patients.
NCT00130039 ↗	Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II	Completed	Korea Otsuka International Asia Arab	Phase 4	2005-08-01	This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1 segment of Middle cerebral artery (MCA) or basilar artery). They will be randomly assigned into cilostazol group or clopidogrel group. Every patients will take 100mg of aspirin a day additionally. The primary outcome variable of this study is Progression rate of symptomatic intracranial stenosis on magnetic resonance angiogram (MRA).
NCT00130039 ↗	Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II	Completed	Asan Medical Center	Phase 4	2005-08-01	This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1 segment of Middle cerebral artery (MCA) or basilar artery). They will be randomly assigned into cilostazol group or clopidogrel group. Every patients will take 100mg of aspirin a day additionally. The primary outcome variable of this study is Progression rate of symptomatic intracranial stenosis on magnetic resonance angiogram (MRA).
NCT00132743 ↗	Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)	Unknown status	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	2007-02-01	The purpose of this study is to compare the effectiveness of aortic stent surgery versus exercise therapy in individuals with aortoiliac insufficiency.
NCT00132743 ↗	Claudication: Exercise Versus Endoluminal Revascularization (CLEVER)	Unknown status	Joselyn Cerezo, MD	Phase 3	2007-02-01	The purpose of this study is to compare the effectiveness of aortic stent surgery versus exercise therapy in individuals with aortoiliac insufficiency.

Clinical Trial Conditions for cilostazol

Condition Name

Condition Name for cilostazol
Intervention	Trials
Intermittent Claudication	11
Healthy	10
Peripheral Arterial Disease	9
Coronary Artery Disease	8

Condition MeSH

Condition MeSH for cilostazol
Intervention	Trials
Peripheral Arterial Disease	24
Peripheral Vascular Diseases	18
Intermittent Claudication	16
Cerebral Infarction	14

Clinical Trial Locations for cilostazol

Trials by Country

Trials by Country for cilostazol
Location	Trials
United States	82
Korea, Republic of	69
Russian Federation	30
China	19
Japan	13

Trials by US State

Trials by US State for cilostazol
Location	Trials
Missouri	8
California	5
Florida	4
Ohio	4
New York	4

Clinical Trial Progress for cilostazol

Clinical Trial Phase

Clinical Trial Phase for cilostazol
Clinical Trial Phase	Trials
Phase 4	59
Phase 3	13
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for cilostazol
Clinical Trial Phase	Trials
Completed	85
Unknown status	21
Recruiting	16

Clinical Trial Sponsors for cilostazol

Sponsor Name

Sponsor Name for cilostazol
Sponsor	Trials
Korea Otsuka Pharmaceutical Co., Ltd.	16
Danish Headache Center	7
Seoul National University Hospital	6

Sponsor Type

Sponsor Type for cilostazol
Sponsor	Trials
Other	165
Industry	66
NIH	4

Cilostazol Market Analysis and Financial Projection

Cilostazol: Clinical Trials, Market Analysis, and Projections

Introduction to Cilostazol

Cilostazol is a phosphodiesterase 3 inhibitor that has been widely used for the treatment of intermittent claudication, a symptom of peripheral artery disease (PAD), and more recently, for secondary stroke prevention. Here, we will delve into the latest clinical trials, market analysis, and projections for this versatile drug.

Clinical Trials and Efficacy

Intermittent Claudication

Clinical trials have consistently shown that cilostazol improves walking distance and reduces symptoms of claudication in patients with PAD. A meta-analysis of 14 clinical trials involving over 4,000 patients demonstrated that cilostazol significantly increased walking distance compared to placebo, with improvements ranging from 23 meters to 109 meters over baseline walking distance[3].

Secondary Stroke Prevention

Cilostazol has also been evaluated for its efficacy in secondary stroke prevention. A systematic review and meta-analysis of 18 randomized trials involving 11,429 participants showed that cilostazol significantly reduced the risk of recurrent ischemic stroke (RR=0.69, 95% CI 0.58 to 0.81) and any stroke recurrence (RR=0.64, 95% CI 0.54 to 0.74). It also reduced the risk of major adverse cardiovascular events and intracranial hemorrhage compared to traditional antiplatelet agents like aspirin and clopidogrel[4].

Lacunar Stroke and Cognitive Impairment

The LACI-2 trial explored the feasibility and safety of combining cilostazol with isosorbide mononitrate in patients with lacunar stroke. The trial found that this combination was well-tolerated and may reduce recurrent stroke, dependence, and cognitive impairment, suggesting potential benefits in cerebral small vessel disease (cSVD)[1].

Safety Profile

Cilostazol's safety profile is generally favorable, although it is associated with some adverse events. Common side effects include headaches, diarrhea, dizziness, palpitations, peripheral edema, and tachycardia. Despite its anti-platelet activity, cilostazol does not significantly increase the risk of bleeding, although it may cause more serious cardiac arrhythmias in some patients[3][4].

Market Analysis

Current Market Size and Growth

The global cilostazol market was valued at USD 1.2 billion in 2022 and is projected to reach USD 1.7 billion by 2030, growing at a CAGR of 4.5% from 2024 to 2030. This growth is driven by the increasing prevalence of PAD, the expanding aging population, and the rising adoption of cilostazol for treating intermittent claudication and other vascular disorders[2].

Key Drivers and Trends

Several factors are driving the growth of the cilostazol market:

• Increasing Prevalence of PAD: The rising incidence of peripheral artery disease is a significant driver.
• Aging Population: The expanding aging population, particularly in developed regions, contributes to a higher incidence of vascular diseases.
• Advancements in Drug Formulations: Improvements in drug formulations and better patient awareness are also contributing factors.
• Expanding Healthcare Infrastructure: Improvements in healthcare infrastructure and access to medicines in emerging markets are expected to broaden cilostazol's market potential[2][5].

Market Projections

Regional and Country-Level Forecasts

The cilostazol market is expected to grow across various regions, with significant contributions from developed and emerging economies. The market size and forecasts by region and country indicate a steady growth trajectory, driven by increasing demand and improving healthcare access[5].

Type and Application Forecasts

The market is segmented by type and application, with forecasts indicating continued demand for cilostazol in treating intermittent claudication and secondary stroke prevention. New indications and ongoing clinical research are expected to further expand its market scope[5].

Competitive Landscape

The cilostazol market is competitive, with several key players dominating the market. Company profiles and market share estimates highlight the competitive dynamics, with a focus on sales quantity, revenue, and average selling prices. The competitive situation is analyzed emphatically by landscape contrast, providing insights into the market's competitive factors[5].

Future Scope and Trends

Ongoing Research and New Indications

Ongoing clinical research and the potential use of cilostazol in other vascular disorders beyond its traditional applications are expected to fuel further market growth. The drug's efficacy in improving quality of life and reducing adverse outcomes in various vascular conditions makes it a promising candidate for expanded use[2][4].

Sustainability and Legislative Backing

Rising disposable incomes, urbanization, sustainability trends, and legislative backing are expected to drive the market forward. These factors will make the cilostazol market a top priority for investors and industry participants in the coming years[2].

Key Takeaways

• Clinical Efficacy: Cilostazol has shown significant efficacy in treating intermittent claudication and secondary stroke prevention.
• Safety Profile: The drug has a generally favorable safety profile, although it is associated with some adverse events.
• Market Growth: The global cilostazol market is projected to grow at a CAGR of 4.5% from 2024 to 2030.
• Key Drivers: Increasing prevalence of PAD, expanding aging population, and advancements in drug formulations are key drivers.
• Future Scope: Ongoing research and potential new indications are expected to further expand the market.

FAQs

Q: What is cilostazol primarily used for?

A: Cilostazol is primarily used for the treatment of intermittent claudication, a symptom of peripheral artery disease (PAD), and for secondary stroke prevention.

Q: What are the common side effects of cilostazol?

A: Common side effects include headaches, diarrhea, dizziness, palpitations, peripheral edema, and tachycardia.

Q: How does cilostazol compare to traditional antiplatelet agents in stroke prevention?

A: Cilostazol has demonstrated superior efficacy and safety profiles compared to traditional antiplatelet agents like aspirin and clopidogrel for secondary stroke prevention[4].

Q: What is the projected market size of cilostazol by 2030?

A: The global cilostazol market is projected to reach USD 1.7 billion by 2030, growing at a CAGR of 4.5% from 2024 to 2030[2].

Q: What are the key drivers of the cilostazol market growth?

A: Key drivers include the increasing prevalence of PAD, the expanding aging population, advancements in drug formulations, and improving healthcare infrastructure in emerging markets[2][5].

Sources

1. LACI-2 Trial: "Isosorbide Mononitrate and Cilostazol Treatment in Patients With Lacunar Stroke" - JAMA Network[1].
2. Cilostazol Market Report: "Cilostazol Market Key Drivers and Forecast 2025-2032" - GitHub[2].
3. EMA Opinion: "Cilostazol Art 31 - CHMP Opinion (positive)" - European Medicines Agency[3].
4. Systematic Review: "Cilostazol for secondary stroke prevention: systematic review and meta-analysis" - BMJ[4].
5. Global Cilostazol Market Report: "Global Cilostazol Market 2025 by Manufacturers, Regions, Type and Application, Forecast to 2031" - Global Info Research[5].