PLETAL
LOE ApproachingNDAORALTABLET
Approved
Jan 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
2/8 — Basic
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PLETAL is an oral tablet indicated for Raynaud's Disease, a vascular disorder characterized by episodic constriction of peripheral blood vessels. The mechanism of action is unknown based on available data. It is an NDA-approved small molecule developed by Otsuka Pharmaceutical.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), suggesting a defending brand team focused on market stabilization rather than expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
A Mono-center Study in Healthy Volunteers on the Comparative Bioavailability of Pletal 100 mg Tablets and a New Pletal 100 mg Orodispersible Tablet (ODT), This Latter in Fasting Conditions With and Without Water and Under Fed Conditions
Started Dec 2008
44 enrolled
Intermittent Claudication
Safety and Efficacy of Pletal (Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon
Started Oct 2001
75 enrolled
Raynaud's Disease
Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon
Started Oct 2001
75 enrolled
Raynaud's Disease
Career Relevance
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.