CLINICAL TRIALS PROFILE FOR PLETAL

All Clinical Trials for Pletal

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.
NCT00602173 ↗	Bioequivalency Study of 100 mg Cilostazol Tablets Under Fasting Conditions	Completed	Roxane Laboratories	N/A	2003-05-01	The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 100 mg, to PLETAL® Tablets, 100 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 3-treatment, 3-period, crossover design.
NCT00602407 ↗	Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions	Completed	Roxane Laboratories	N/A	2004-02-01	The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, crossover design.
NCT00648388 ↗	Fasting Study of Cilostazol Tablets 100 mg and Pletal® Tablets 100 mg	Completed	Mylan Pharmaceuticals	Phase 1	2004-03-01	The objective of this study was to investigate the bioequivalence of Mylan's cilostazol 100 mg tablets and Otsuka's Pletal® 100 mg tablets following a single, oral 100 mg(1 x 100 mg) dose administered under fasting conditions.

Clinical Trial Conditions for Pletal

Condition Name

Condition Name for Pletal
Intervention	Trials
Intermittent Claudication	4
Migraine	3
Peripheral Arterial Disease	2
Raynaud's Disease	2

Condition MeSH

Condition MeSH for Pletal
Intervention	Trials
Intermittent Claudication	5
Migraine Disorders	4
Headache	4
Peripheral Arterial Disease	2

Clinical Trial Locations for Pletal

Trials by Country

Trials by Country for Pletal
Location	Trials
United States	50
Denmark	5
Germany	1
United Kingdom	1

Trials by US State

Trials by US State for Pletal
Location	Trials
California	4
Ohio	3
New York	3
Missouri	3
Massachusetts	3

Clinical Trial Progress for Pletal

Clinical Trial Phase

Clinical Trial Phase for Pletal
Clinical Trial Phase	Trials
Phase 4	5
Phase 2	2
Phase 1	6

Clinical Trial Status

Clinical Trial Status for Pletal
Clinical Trial Phase	Trials
Completed	17
Unknown status	2
Terminated	1

Clinical Trial Sponsors for Pletal

Sponsor Name

Sponsor Name for Pletal
Sponsor	Trials
Danish Headache Center	4
Otsuka America Pharmaceutical	2
Roxane Laboratories	2

Sponsor Type

Sponsor Type for Pletal
Sponsor	Trials
Other	13
Industry	11

Pletal (Cilostazol): Clinical Trials Update, Market Analysis, and Projections

Introduction

Pletal, known generically as cilostazol, is a medication used primarily for the treatment of intermittent claudication, a symptom of peripheral arterial disease, and for the prevention of recurrence of cerebral infarction. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Development

Current Clinical Trials

Genovate Biotechnology Co., Ltd. is currently in the process of developing an extended-release formulation of cilostazol, known as PMR. This new formulation is designed to reduce the concentration-dependent side effects associated with the immediate-release (IR) tablet form of cilostazol. The key clinical study, GBL23-001, is a randomized, fully replicate crossover study aimed at evaluating the bioequivalence and within-subject variability between PMR 145 mg once daily and the immediate-release tablet of cilostazol 100 mg twice daily. This study is expected to be completed in mid-2024, with top-line results already indicating that the primary endpoints have been achieved[1].

Mechanism of Action and Previous Studies

Cilostazol is a specific phosphodiesterase III (PDE III) inhibitor that reduces platelet aggregation and increases vasodilation. Previous studies, such as the OPTIMUS-2 study, have assessed the impact of cilostazol on platelet function in patients with type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD). This study demonstrated that cilostazol can modulate P2Y12 signaling, thereby enhancing antiplatelet therapy[3].

Market Analysis

Current Market

The immediate-release formulation of cilostazol, marketed as Pletal in the US and Pletaal in other regions, has been available since its approval by the US FDA in 1999. It is a significant player in the treatment of intermittent claudication and the prevention of cerebral infarction recurrence. However, the market is evolving with the introduction of new formulations and competitors.

Market Projections

The submission of the New Drug Application (NDA) for PMR, the extended-release formulation of cilostazol, is planned for the second half of 2025. This new formulation is expected to capture a significant share of the market due to its once-daily dosing and reduced side effects compared to the immediate-release form. The market for peripheral arterial disease treatments is growing, driven by increasing prevalence and better diagnostic techniques.

Competitive Landscape

The cardiovascular and cerebrovascular disease treatment markets are highly competitive, with various drugs targeting different aspects of these conditions. The introduction of PMR will need to compete with existing treatments, including other antiplatelet agents and vasodilators. However, the unique profile of PMR, with its extended-release formulation and reduced side effects, positions it favorably in the market[1].

Market Growth Drivers

Increasing Prevalence of Peripheral Arterial Disease

The growing prevalence of peripheral arterial disease, particularly in aging populations, is a significant driver for the market. As the global population ages, the demand for effective treatments for intermittent claudication and related conditions is expected to increase.

Regulatory Pathway

The FDA's confirmation that the clinical studies conducted by Genovate are sufficient to support the submission of a marketing application under the 505(b)(2) regulatory pathway is a positive indicator for the drug's approval and subsequent market entry[1].

Improvements in Formulation and Manufacturing

Genovate's ongoing improvements in the PMR formulation and manufacturing processes address additional FDA comments, ensuring a smoother regulatory approval process and higher quality product[1].

Regional Market Analysis

Global Perspective

The global market for treatments of peripheral arterial disease and cerebrovascular conditions is diverse, with different regions having varying levels of demand and market penetration. The US and European markets are significant, but the Asia-Pacific region is also growing rapidly due to an aging population and increasing healthcare investments.

Asia-Pacific Market

The Asia-Pacific region, particularly countries like Taiwan and Japan, where cilostazol was first introduced, will be crucial for the market growth of PMR. The aging population in this region and government initiatives to improve healthcare infrastructure are expected to drive the demand for effective treatments like PMR[1].

Key Takeaways

• Clinical Trials: Genovate's PMR is in the final stages of clinical trials, with positive top-line results indicating bioequivalence and reduced side effects.
• Market Analysis: The market for peripheral arterial disease treatments is growing, driven by increasing prevalence and better diagnostic techniques.
• Competitive Landscape: PMR will compete with existing treatments but is positioned favorably due to its once-daily dosing and reduced side effects.
• Market Growth Drivers: Increasing prevalence of peripheral arterial disease, favorable regulatory pathway, and improvements in formulation and manufacturing.
• Regional Market Analysis: The Asia-Pacific region is expected to be a significant market due to an aging population and increasing healthcare investments.

FAQs

What is the primary use of Pletal (cilostazol)?

Pletal (cilostazol) is primarily used for the treatment of intermittent claudication, a symptom of peripheral arterial disease, and for the prevention of recurrence of cerebral infarction.

What is the new formulation of cilostazol being developed?

The new formulation, known as PMR, is an extended-release form of cilostazol designed to reduce concentration-dependent side effects associated with the immediate-release form.

When is the NDA submission for PMR expected?

The NDA submission for PMR is planned for the second half of 2025.

How does cilostazol work?

Cilostazol is a specific phosphodiesterase III (PDE III) inhibitor that reduces platelet aggregation and increases vasodilation.

What are the key drivers for the market growth of PMR?

The key drivers include the increasing prevalence of peripheral arterial disease, a favorable regulatory pathway, and improvements in the formulation and manufacturing processes.

Sources

1. Genovate Biotechnology Co., Ltd. - "Genovate Announces Plans to Submit a New Drug Application for PMR to the U.S. Food and Drug Administration in the Second Half of 2025" - PR Newswire.
2. GlobalData - "NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025" - Drug Development.
3. European Heart Journal - "A randomized study assessing the impact of cilostazol on platelet function in patients with type 2 diabetes mellitus and coronary artery disease" - Academic.oup.com.
4. PubMed - "2025 update on clinical trials in immune thrombocytopenia" - PubMed.
5. Research Nester - "Fentanyl Market Size | Growth Analysis 2025-2037" - Research Nester.