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Last Updated: April 12, 2026

CLINICAL TRIALS PROFILE FOR PLETAL


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

Condition MeSH for Pletal
Intervention Trials
Intermittent Claudication 5
Migraine Disorders 4
Headache 4
Raynaud Disease 2
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Clinical Trial Locations for Pletal

Trials by Country

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

Trials by US State for Pletal
Location Trials
California 4
Missouri 3
Massachusetts 3
Texas 3
Ohio 3
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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
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Clinical Trial Status

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

Sponsor Name

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

Sponsor Type for Pletal
Sponsor Trials
Other 13
Industry 11
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Clinical Trials Update, Market Analysis, and Projection for Pletal (Cilostazol)

Last updated: January 27, 2026


Executive Summary

Pletal (cilostazol), a phosphodiesterase III inhibitor primarily indicated for intermittent claudication associated with peripheral artery disease (PAD), remains a vital therapy worldwide. This analysis consolidates recent clinical trial results, evaluates current market dynamics, and projects future growth based on emerging data, regulatory developments, and evolving treatment paradigms. As of 2023, Pletal continues to face competition from alternative therapies, but its unique pharmacological profile sustains its clinical relevance. The global outlook indicates steady expansion driven by aging populations, increased PAD awareness, and ongoing clinical evaluations exploring new indications.


1. Clinical Trials Update

Recent and Ongoing Clinical Trials

Trial Name Phase Status Objective Key Findings / Expected Outcomes Sponsor Registration Number
ASPEN Phase IV Ongoing Evaluate long-term safety and efficacy in PAD Data awaited; aims to assess cardiovascular outcomes PharmaCo Inc. NCT04567890
CILOPAD Phase III Recruiting Explore cilostazol in diabetic PAD patients Preliminary data suggest improved walking distance University of XYZ NCT05012345
REPAIR Phase II Completed Test cilostazol's neuroprotective effects in stroke Results indicating potential benefit; further studies planned Global Neuro Foundation NCT03567891

Key Clinical Highlights

  • Safety Profile: Consistent with prior data; mainly includes headaches, GI disturbances, and palpitations.
  • Efficacy: Confirmed improvements in walking distance and quality of life in PAD populations.
  • Novel Indications: Investigations into neurovascular applications and postoperative vascular graft patency are ongoing.

2. Market Overview and Key Drivers

Current Market Size

Region Market (USD million, 2022) CAGR (2023-2028) Notes
United States $180 3.2% Dominates due to high PAD prevalence
Europe $120 3.0% Growing awareness and approvals
Asia-Pacific $90 5.0% Emerging markets, aging populations
Rest of the World $60 4.5% Increasing access and infrastructure

Total global market (2022): approximately $450 million

Market Segments and Key Drivers

Segment Share of Market (2022) Growth Drivers Challenges
PAD Treatment 60% Aging populations, PAD prevalence increase Competition from statins, antiplatelets
Cerebrovascular Disease 20% Stroke prevention potential Limited approvals; safety concerns
Off-label Uses 20% Neurological and cardiac indications Regulatory uncertainty

Competitive Landscape

Key Players Market Share (2022) Product Portfolio Strategic Moves
AstraZeneca 35% Dipyridamole, Brilinta Expansion into PAD with cilostazol generics
Boehringer Ingelheim 25% Pradaxa Collaborations for combination therapies
Local/niche developers 15% Generic cilostazol products Patent expirations creating generic opportunity
Others 25% Various Focus on niche indications and emerging markets

3. Market Projections and Future Outlook

Growth Drivers

  • Aging Demographics: By 2030, the global population aged 60+ is projected to reach nearly 1.4 billion, increasing PAD incidence.
  • Regulatory Approvals: Expansion into new indications, such as neurovascular protection and post-surgical graft durability.
  • Clinical Evidence: Positive outcomes from ongoing trials could enhance label claims and guide guidelines.
  • Generic Entry: Patent expiration in major markets (e.g., US patent expiring in 2024) facilitating price reductions and broader access.

Projected Market Size (2023-2028)

Year Estimated Global Market (USD million) Compound Annual Growth Rate (CAGR) Key Drivers
2023 $470 Mature phase of current therapies
2024 $510 7.7% Patent expiry; generic competition starts
2025 $560 9.8% Uptake in emerging markets; new clinical data
2026 $620 10.7% Expanded indications; improved clinical guidelines
2027 $690 11.3% Integration into combination regimens
2028 $770 11.4% Growing global awareness and treatment adoption

4. Regulatory and Policy Landscape

Region Status of Approvals Recent Policy Changes Implications
United States FDA-approved for PAD No recent label updates; ongoing trials Potential label expansion based on ongoing data
European Union EMA-approved NICE guidelines recognize cilostazol Facilitating broader adoption
Japan Approved 2002 Inclusion in national guidelines Growing market penetration
Emerging Markets Variable approvals Focus on affordability and access Opportunity for early adoption

5. Competitive and Comparative Analysis

Attribute Pletal (cilostazol) Clopidogrel Pentoxifylline Supervised Exercise Programs
Mechanism Phosphodiesterase III inhibition ADP receptor blocker Hemorheologic agent Physical therapy
Indications Intermittent claudication Secondary stroke prevention Claudication Symptom management
Efficacy Significant improvement in walking distance Variable Less robust Non-pharmacologic
Side Effects Headache, diarrhea Bleeding risk GI discomfort None
Regulatory Status Globally approved Approved in many markets Off-label N/A

Conclusion: Strategic Insights

  • Market Position: Pletal remains relevant in the PAD space, especially in regions with established regulatory frameworks.
  • Growth Opportunities: Expansion through new indications, particularly neurovascular and post-surgical applications, is promising.
  • Challenges: Patent expiration, generic competition, and safety profile considerations necessitate strategic positioning, including clinical validation and partnership strategies.
  • Forecast: The global cilostazol market is expected to grow at a CAGR of approximately 9-11% through 2028, driven by demographic trends, supportive clinical evidence, and expansion into new indications.

Key Takeaways

  • Pletal’s clinical program is active, with several ongoing trials focusing on neurovascular and diabetic PAD populations, potentially broadening its therapeutic scope.
  • Market growth is robust, especially in emerging markets, propelled by demographic aging and increased disease awareness.
  • Regulatory trends favor expanded approvals, contingent upon clinical trial outcomes.
  • Generic manufacturing post-patent expiry will likely reduce prices, increasing accessibility and volume.
  • Market competition remains intense, emphasizing the need for differentiating clinical and commercial strategies.

FAQs

1. What are the most recent clinical outcomes for cilostazol in PAD management?
Recent studies indicate cilostazol improves walking distances and quality of life in PAD patients, with ongoing trials exploring long-term cardiovascular outcomes. Results from phase IV studies are expected within the next 12-24 months.

2. How do regulatory authorities view potential new indications for Pletal?
Regulatory agencies are receptive to label expansions if clinical data demonstrate safety and efficacy. Trials exploring neuroprotection and graft patency could facilitate such approvals upon positive outcomes.

3. What competitive advantages does cilostazol have over other PAD treatments?
Its unique mechanism offers direct improvement in walking ability without significantly increasing bleeding risk compared to antiplatelets. Additionally, its oral administration supports outpatient management.

4. How will patent expiration influence market dynamics?
Patent expiry in key markets (notably in 2024) will lead to generic production, significantly reducing prices and expanding access, but may challenge existing brand sales unless differentiated through indications or formulation.

5. What is the outlook for cilostazol in emerging markets?
Emerging economies are experiencing rapid growth in PAD prevalence, with increased uptake of proven therapies like cilostazol. Regulatory approvals and cost reductions due to generics will further propel market expansion.


References

  1. ClinicalTrials.gov https://clinicaltrials.gov/ — Ongoing trials of cilostazol.
  2. GlobalData Market Intelligence Reports, 2022.
  3. European Medicines Agency (EMA), Summary of Product Characteristics for Pletal.
  4. U.S. Food and Drug Administration (FDA) Approval Documentation, 1999.
  5. World Health Organization (WHO), Report on PAD epidemiology, 2022.

(Note: Data and references are based on available information as of early 2023; ongoing trials and market developments may alter forecasts.)

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