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Pletal (CILOSTAZOL)
Pletal (Cilostazol) is a small molecule phosphodiesterase 3 inhibitor developed by Otsuka, targeting cGMP-inhibited 3',5'-cyclic phosphodiesterase A. It was FDA-approved in 1999 for the treatment of intermittent claudication. As an off-patent medication, Pletal is available from multiple generic manufacturers. Key considerations include its mechanism of action, which involves increasing cyclic AMP levels to improve blood flow and reduce platelet aggregation. Pletal's commercial status and availability make it a viable option for patients with intermittent claudication.
At a glance
| Generic name | CILOSTAZOL |
|---|---|
| Sponsor | Otsuka |
| Drug class | Phosphodiesterase 3 Inhibitor [EPC] |
| Target | cGMP-inhibited 3',5'-cyclic phosphodiesterase A |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1999 |
Approved indications
- Intermittent claudication
Boxed warnings
- WARNING: CONTRAINDICATED IN HEART FAILURE PATIENTS Cilostazol tablets are contraindicated in patients with heart failure of any severity. Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class III-IV heart failure [see Contraindications ( 4 )] . WARNING: CONTRAINDICATED IN HEART FAILURE PATIENTS See full prescribing information for complete boxed warning. Cilostazol tablets is contraindicated in patients with heart failure of any severity. Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with the pharmacologic effect have caused decreased survival compared to placebo patients with class III-IV heart failure. (4)
Common side effects
- Headache
- Diarrhea
- Abnormal stools
- Palpitation
- Dizziness
- Pharyngitis
- Infection
- Peripheral edema
- Rhinitis
- Dyspepsia
- Abdominal pain
- Tachycardia
Drug interactions
- clarithromycin
- diltiazem
- erythromycin
- esomeprazole
- itraconazole
- oleandomycin
- omeprazole
Key clinical trials
- The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis (PHASE4)
- Randomized Clinical Trial of Endovascular Recanalization for Symptomatic Non-Acute Intracranial Artery Occlusion（REPAIR） (NA)
- Effect of Cilostazol in Promoting Hematoma Clearance After Intracerebral Hemorrhage (PHASE2)
- The Effect of Cilostazol on Rheumatoid Arthritis Patients (PHASE2,PHASE3)
- Chinese Herbal Therapy (Qiqi Shengmai Formula) for Moyamoya Vasculopathy: The CHIMES Trial (PHASE1)
- Cilostazol for Preventing Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage (PHASE3)
- Cilostazol in the Treatment of Nonalcoholic Fatty Liver Disease (PHASE1,PHASE2)
- Oxford Haemodynamic Adaptation to Reduce Pulsatility Trial (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pletal CI brief — competitive landscape report
- Pletal updates RSS · CI watch RSS
- Otsuka portfolio CI