{"id":"cilostazol","rwe":[{"pmid":"41897461","year":"2026","title":"Nano-Cilostazol Mitigates Cisplatin-Induced Nephrotoxicity in Rats via Modulation of Oxidative Stress, Apoptosis, Pyroptosis, and miRNA-155 Signaling.","finding":"","journal":"Antioxidants (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41882452","year":"2026","title":"Cost-utility framework to evaluate therapeutic interventions targeting reduction in cerebral infarction among aneurysmal subarachnoid hemorrhage patients.","finding":"","journal":"Neurosurgical review","studyType":"Clinical Study"},{"pmid":"41872117","year":"2026","title":"The Efficacy and Safety of Cilostazol as an Alternative Antiplatelet Therapy After Coronary Stent Implantation in Patients With Aspirin Intolerance.","finding":"","journal":"Cardiology in review","studyType":"Clinical Study"},{"pmid":"41831015","year":"2026","title":"Efficacy and safety of dual and triple antiplatelet therapies in East Asian patients with acute coronary syndrome: a systematic review and network meta-analysis of randomized controlled trials.","finding":"","journal":"Postgraduate medical journal","studyType":"Clinical Study"},{"pmid":"41817850","year":"2026","title":"Comparative effectiveness of cilostazol and aspirin in ischemic stroke: a retrospective cohort study.","finding":"","journal":"Acta neurologica Belgica","studyType":"Clinical Study"}],"_fda":{"id":"1547a408-12a9-fadd-e063-6394a90a4ce0","set_id":"15478d90-312f-014e-e063-6294a90ae838","openfda":{"nui":["N0000175598","N0000175086"],"unii":["N7Z035406B"],"route":["ORAL"],"rxcui":["242461"],"spl_id":["1547a408-12a9-fadd-e063-6394a90a4ce0"],"brand_name":["cilostazol"],"spl_set_id":["15478d90-312f-014e-e063-6294a90ae838"],"package_ndc":["71610-813-26"],"product_ndc":["71610-813"],"generic_name":["CILOSTAZOL"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CILOSTAZOL"],"pharm_class_epc":["Phosphodiesterase 3 Inhibitor [EPC]"],"pharm_class_moa":["Phosphodiesterase 3 Inhibitors [MoA]"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"application_number":["ANDA077030"],"original_packager_product_ndc":["42291-453"]},"version":"1","overdosage":["10 OVERDOSAGE Information on acute overdosage with cilostazol in humans is limited. The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: severe headache, diarrhea, hypotension, tachycardia, and possibly cardiac arrhythmias. The patient should be carefully observed and given supportive treatment. Since cilostazol is highly protein-bound, it is unlikely that it can be efficiently removed by hemodialysis or peritoneal dialysis. The oral LD 50 of cilostazol is greater than 5 g per kg in mice and rats and greater than 2 g per kg in dogs."],"description":["11 DESCRIPTION Cilostazol is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). The empirical formula of cilostazol is C 20 H 27 N 5 O 2 , and its molecular weight is 369.47. Cilostazol is 6-[4-(1-cyclohexyl-1 H -tetrazol-5-yl) butoxy]-3,4-dihydro-2(1 H )-quinolinone, CAS-73963-72-1. The structural formula is: Cilostazol occurs as white to off-white crystals or as a crystalline powder that is slightly soluble in methanol and ethanol, and is practically insoluble in water, 0.1 N HCl, and 0.1 N NaOH. Cilostazol tablets, USP for oral administration are available in 50 mg and 100 mg round, white tablets. Each tablet, in addition to the active ingredient, contains the following inactive ingredients: corn starch, croscarmellose sodium, magnesium stearate, and silicon dioxide. Meets USP Dissolution Test 2 Structure.jpg"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How supplied Cilostazol tablets, USP are supplied as 50 mg and 100 mg tablets. Cilostazol tablets, USP 50 mg are white, round, flat-faced, bevelled-edge tablets, engraved \"APO\" on one side and \"CIL\" over \"50\" on the other side. Cilostazol tablets, USP 100 mg tablets are white, round, flat-faced, bevelled-edge tablets, engraved \"APO\" on one side and \"CIL\" over \"100\" on the other side. Bottles of 60 NDC 42291-453-60 16.2 Storage and handling Store cilostazol tablets at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]."],"boxed_warning":["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)"],"effective_time":"20240404","clinical_studies":["14 CLINICAL STUDIES The ability of cilostazol to improve walking distance in patients with stable intermittent claudication was studied in eight, randomized, placebo-controlled, double-blind trials of 12 to 24 weeks’ duration involving 2,274 patients using dosages of 50 mg twice daily (n=303), 100 mg twice daily (n=998), and placebo (n=973). Efficacy was determined primarily by the change in maximal walking distance from baseline (compared to change on placebo) on one of several standardized exercise treadmill tests. Compared to patients treated with placebo, patients treated with cilostazol 50 or 100 mg twice daily experienced statistically significant improvements in walking distances both for the distance before the onset of claudication pain and the distance before exercise-limiting symptoms supervened (maximal walking distance). The effect of cilostazol on walking distance was seen as early as the first on-therapy observation point of two or four weeks. Figure 2 depicts the percent mean improvement in maximal walking distance, at study end for each of the eight studies. Figure 2: Percent Mean Improvement in Maximal Walking Distance at Study End for the Eight Randomized, Double-Blind, Placebo-Controlled Clinical Trials Across the eight clinical trials, the range of improvement in maximal walking distance in patients treated with cilostazol 100 mg twice daily, expressed as the change from baseline, was 28% to 100%. The corresponding changes in the placebo group were –10% to 41%. The Walking Impairment Questionnaire, which was administered in six of the eight clinical trials, assesses the impact of a therapeutic intervention on walking ability. In a pooled analysis of the six trials, patients treated with either cilostazol 100 mg twice daily or 50 mg twice daily reported improvements in their walking speed and walking distance as compared to placebo. Improvements in walking performance were seen in the various subpopulations evaluated, including those defined by gender, smoking status, diabetes mellitus, duration of peripheral artery disease, age, and concomitant use of beta blockers or calcium channel blockers. Cilostazol has not been studied in patients with rapidly progressing claudication or in patients with leg pain at rest, ischemic leg ulcers, or gangrene. Its long-term effects on limb preservation and hospitalization have not been evaluated. A randomized, double-blind, placebo-controlled Phase IV study was conducted to assess the long-term effects of cilostazol, with respect to mortality and safety, in 1,439 patients with intermittent claudication and no heart failure. The trial stopped early due to enrollment difficulties and a lower than expected overall death rate. With respect to mortality, the observed 36-month Kaplan-Meier event rate for deaths on study drug with a median time on study drug of 18 months was 5.6% (95% CI of 2.8 to 8.4 %) on cilostazol and 6.8% (95% CI of 1.9 to 11.5 %) on placebo. These data appear to be sufficient to exclude a 75% increase in the risk of mortality on cilostazol, which was the a priori study hypothesis. Figure2.jpg"],"adverse_reactions":["6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Patients with Heart Failure [see Boxed Warning] Tachycardia [see Warnings and Precautions ( 5.1 )] Left Ventricular Outflow Tract Obstruction [see Warnings and Precautions ( 5.2 )] Hematologic Adverse Reactions [see Warnings and Precautions ( 5.3 )] Hemostatic Disorders or Active Pathologic Bleeding [see Warnings and Precautions ( 5.4 )] Most common adverse reactions greater than or equal to 2% and at least twice that for placebo in patients on 100 mg twice daily are headache, diarrhea, abnormal stools, and palpitation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions were assessed in eight placebo-controlled clinical trials involving patients exposed to either 50 or 100 mg twice daily cilostazol tablets (n=1301) or placebo (n=973), with a median treatment duration of 127 days for patients on cilostazol tablets and 134 days for patients on placebo. The most frequent adverse reaction resulting in discontinuation of therapy in more than 3% of patients treated with cilostazol tablets was headache [50 mg twice daily (1.3%), 100 mg twice daily (3.5%) and placebo (0.3%)]. Other frequent causes of discontinuation included palpitation and diarrhea, both 1.1% for cilostazol tablets (all doses) versus 0.1% for placebo. The most common adverse reactions, occurring in at least 2% of patients treated with cilostazol tablets 50 or 100 mg twice daily, are shown in Table 1. Table 1: Most Common Adverse Reactions in Patients on cilostazol tablets 50 or 100 mg Twice Daily (Incidence at least 2% and Occurring More Frequently (≥ 2%) in the 100 mg Twice Daily Group than on Placebo) Adverse Reactions Placebo (N=973) Cilostazol tablets 50 mg twice daily (N=303) Cilostazol tablets 100 mg twice daily (N=998) Headache 14% 27% 34% Diarrhea 7% 12% 19% Abnormal stools 4% 12% 15% Palpitation 1% 5% 10% Dizziness 6% 9% 10% Pharyngitis 7% 7% 10% Infection 8% 14% 10% Peripheral edema 4% 9% 7% Rhinitis 5% 12% 7% Dyspepsia 4% 6% 6% Abdominal pain 3% 4% 5% Tachycardia 1% 4% 4% Less frequent clinical significant adverse reactions (less than 2%) that were experienced by patients treated with cilostazol 50 mg twice daily or 100 mg twice daily in the eight controlled clinical trials and that occurred at a frequency in the 100 mg twice daily group greater than in the placebo group are listed below. Body as a whole: fever, generalized edema, malaise Cardiovascular: atrial fibrillation, heart failure, myocardial infarction, nodal arrhythmia, supraventricular tachycardia, ventricular extrasystoles, ventricular tachycardia Digestive: anorexia, melena Hematologic and Lymphatic: anemia Metabolic and Nutritional: increased creatinine, hyperuricemia Nervous: insomnia Respiratory: epistaxis Skin and Appendages: urticaria Special Senses: conjunctivitis, retinal hemorrhage, tinnitus Urogenital: urinary frequency 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of cilostazol tablets. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: Aplastic anemia, granulocytopenia, pancytopenia, bleeding tendency Cardiac disorders: Torsade de pointes and QTc prolongation in patients with cardiac disorders (e.g. complete atrioventricular block, heart failure; and bradyarrythmia), angina pectoris. Gastrointestinal disorders: Gastrointestinal hemorrhage, vomiting, flatulence, nausea General disorders and administration site conditions: Pain, chest pain, hot flushes Hepatobiliary disorders: Hepatic dysfunction/abnormal liver function tests, jaundice Immune system disorders: Anaphylaxis, angioedema, and hypersensitivity Investigations: Blood glucose increased, blood uric acid increased, increase in BUN (blood urea increased), blood pressure increase Nervous system disorders: Intracranial hemorrhage, cerebral hemorrhage, cerebrovascular accident, extradural hematoma and subdural hematoma Renal and urinary disorders: Hematuria Respiratory, thoracic and mediastinal disorders: Pulmonary hemorrhage, interstitial pneumonia Skin and subcutaneous tissue disorders: Hemorrhage subcutaneous, pruritus, skin eruptions including Stevens-Johnson syndrome, skin drug eruption (dermatitis medicamentosa), rash Vascular disorders: Subacute stent thrombosis, hypertension."],"contraindications":["4 CONTRAINDICATIONS Cilostazol is 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. Hypersensitivity to cilostazol or any components of cilostazol tablets (e.g., anaphylaxis, angioedema) Heart failure of any severity ( 4 ) Hypersensitivity to cilostazol or any components of cilostazol tablets ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS Strong and moderate CYP3A4 and CYP2C19 inhibitors: Increase exposure to cilostazol. Reduce cilostazol tablets dose ( 2.2 , 7.1 ) 7.1 Inhibitors of CYP3A4 or CYP2C19 Inhibitors of CYP3A4 Coadministration of strong (e.g., ketoconazole) and moderate (e.g., erythromycin, diltiazem and grapefruit juice) CYP3A4 inhibitors can increase exposure to cilostazol. Reduce cilostazol dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP3A4 [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )]. Inhibitors of CYP2C19 Coadministration with CYP2C19 inhibitors (e.g., omeprazole) increases systemic exposure of cilostazol active metabolites. Reduce cilostazol dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP2C19 [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )]."],"recent_major_changes":["RECENT MAJOR CHANGES SECTION Warnings and Precautions, Left Ventricular Outflow Obstruction ( 5.2 ) 05/2017"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Cilostazol and several of its metabolites inhibit phosphodiesterase III activity and suppress cAMP degradation with a resultant increase in cAMP in platelets and blood vessels, leading to inhibition of platelet aggregation and vasodilation, respectively. Cilostazol reversibly inhibits platelet aggregation induced by a variety of stimuli, including thrombin, ADP, collagen, arachidonic acid, epinephrine, and shear stress. Cardiovascular effects: Cilostazol affects both vascular beds and cardiovascular function. It produces heterogeneous dilation of vascular beds, with greater dilation in femoral beds than in vertebral, carotid or superior mesenteric arteries. Renal arteries were not responsive to the effects of cilostazol. In dogs or cynomolgus monkeys, cilostazol increased heart rate, myocardial contractile force, and coronary blood flow as well as ventricular automaticity, as would be expected for a PDE III inhibitor. Left ventricular contractility was increased at doses required to inhibit platelet aggregation. A-V conduction was accelerated. In humans, heart rate increased in a dose-proportional manner by a mean of 5.1 and 7.4 beats per minute in patients treated with 50 and 100 mg twice daily, respectively. 12.2 Pharmacodynamics Cilostazol’s effects on platelet aggregation were evaluated in both healthy subjects and in patients with stable symptoms of cerebral thrombosis, cerebral embolism, transient ischemic attack, or cerebral arteriosclerosis over a range of doses from 50 mg every day to 100 mg three times a day. Cilostazol significantly inhibited platelet aggregation in a dose-dependent manner. The effects were observed as early as 3 hours post-dose and lasted up to 12 hours following a single dose. Following chronic administration and withdrawal of cilostazol, the effects on platelet aggregation began to subside 48 hours after withdrawal and returned to baseline by 96 hours with no rebound effect. A cilostazol dosage of 100 mg twice daily consistently inhibited platelet aggregation induced with arachidonic acid, collagen and adenosine diphosphate (ADP). Bleeding time was not affected by cilostazol administration. Effects on circulating plasma lipids have been examined in patients taking cilostazol. After 12 weeks, as compared to placebo, cilostazol 100 mg twice daily produced a reduction in triglycerides of 29.3 mg/dL (15%) and an increase in HDL-cholesterol of 4.0 mg/dL (≅ 10%). Drug Interactions Aspirin Short-term (less than or equal to 4 days) coadministration of aspirin with cilostazol increased the inhibition of ADP- induced ex vivo platelet aggregation by 22% to 37% when compared to either aspirin or cilostazol alone. Short-term (less than or equal to 4 days) coadministration of aspirin with cilostazol increased the inhibition of arachidonic acid-induced ex vivo platelet aggregation by 20% compared to cilostazol alone and by 48% compared to aspirin alone. However, short- term coadministration of aspirin with cilostazol had no clinically significant impact on PT, aPTT, or bleeding time compared to aspirin alone. Effects of long-term coadministration in the general population are unknown. In eight randomized, placebo-controlled, double-blind clinical trials, aspirin was coadministered with cilostazol to 201 patients. The most frequent doses and mean durations of aspirin therapy were 75 to 81 mg daily for 137 days (107 patients) and 325 mg daily for 54 days (85 patients). There was no apparent increase in frequency of hemorrhagic adverse effects in patients taking cilostazol and aspirin compared to patients taking placebo and equivalent doses of aspirin. Warfarin Cilostazol did not inhibit the pharmacologic effects (PT, aPTT, bleeding time, or platelet aggregation) of R- and S- warfarin after a single 25-mg dose of warfarin. The effect of concomitant multiple dosing of warfarin and cilostazol on the pharmacodynamics of both drugs is unknown. 12.3 Pharmacokinetics Cilostazol is absorbed after oral administration. A high fat meal increases absorption, with an approximately 90% increase in C max and a 25% increase in AUC. Absolute bioavailability is not known. Cilostazol is extensively metabolized by hepatic cytochrome P-450 enzymes, mainly 3A4, and, to a lesser extent, 2C19, with metabolites largely excreted in urine. Two metabolites are active, with one metabolite appearing to account for at least 50% of the pharmacologic (PDE III inhibition) activity after administration of cilostazol. Pharmacokinetics are approximately dose proportional. Cilostazol and its active metabolites have apparent elimination half-lives of about 11 to 13 hours. Cilostazol and its active metabolites accumulate about 2-fold with chronic administration and reach steady state blood levels within a few days. The pharmacokinetics of cilostazol and its two major active metabolites were similar in healthy subjects and patients with intermittent claudication due to peripheral arterial disease (PAD). Figure 1 shows the mean plasma concentration-time profile at steady state after multiple dosing of cilostazol 100 mg twice daily. Figure 1: Mean Plasma Concentration-time Profile at Steady State after Multiple Dosing of cilostazol 100 mg Twice Daily Distribution Cilostazol is 95 to 98% protein bound, predominantly to albumin. The binding for 3,4-dehydro-cilostazol is 97.4% and for 4´-trans-hydroxy-cilostazol is 66%. Mild hepatic impairment did not affect protein binding. The free fraction of cilostazol was 27% higher in subjects with renal impairment than in healthy volunteers. The displacement of cilostazol from plasma proteins by erythromycin, quinidine, warfarin, and omeprazole was not clinically significant. Metabolism Cilostazol is eliminated predominantly by metabolism and subsequent urinary excretion of metabolites. Based on in vitro studies, the primary isoenzymes involved in cilostazol’s metabolism are CYP3A4 and, to a lesser extent, CYP2C19. The enzyme responsible for metabolism of 3,4-dehydro-cilostazol, the most active of the metabolites, is unknown. Following oral administration of 100 mg radiolabeled cilostazol, 56% of the total analytes in plasma was cilostazol, 15% was 3,4-dehydro-cilostazol (4 to 7 times as active as cilostazol), and 4% was 4´-trans-hydroxy-cilostazol (20% as active as cilostazol). Elimination The primary route of elimination was via the urine (74%), with the remainder excreted in feces (20%). No measurable amount of unchanged cilostazol was excreted in the urine, and less than 2% of the dose was excreted as 3,4-dehydro- cilostazol. About 30% of the dose was excreted in urine as 4´-trans-hydroxy-cilostazol. The remainder was excreted as other metabolites, none of which exceeded 5%. There was no evidence of induction of hepatic microenzymes. Special Populations Age and Gender The total and unbound oral clearances, adjusted for body weight, of cilostazol and its metabolites were not significantly different with respect to age (50 to 80 years) or gender. Smokers Population pharmacokinetic analysis suggests that smoking decreased cilostazol exposure by about 20%. Hepatic Impairment The pharmacokinetics of cilostazol and its metabolites were similar in subjects with mild hepatic disease as compared to healthy subjects. Patients with moderate or severe hepatic impairment have not been studied. Renal Impairment The total pharmacologic activity of cilostazol and its metabolites was similar in subjects with mild to moderate renal impairment and in healthy subjects. Severe renal impairment increases metabolite levels and alters protein binding of the parent. The expected pharmacologic activity, however, based on plasma concentrations and relative PDE III inhibiting potency of parent drug and metabolites, appeared little changed. Patients on dialysis have not been studied, but, it is unlikely that cilostazol can be removed efficiently by dialysis because of its high protein binding (95 to 98%). Drug Interactions Cilostazol does not appear to inhibit CYP3A4. Warfarin Cilostazol did not inhibit the metabolism of R- and S-warfarin after a single 25-mg dose of warfarin. Clopidogrel Multiple doses of clopidogrel do not significantly increase steady state plasma concentrations of cilostazol. Strong Inhibitors of CYP3A4 A priming dose of ketoconazole 400 mg (a strong inhibitor of CYP3A4), was given one day prior to coadministration of single doses of ketoconazole 400 mg and cilostazol 100 mg. This regimen increased cilostazol C max by 94% and AUC by 117%. Other strong inhibitors of CYP3A4, such as itraconazole, voriconazole, clarithromycin, ritonavir, saquinavir, and nefazodone would be expected to have a similar effect [see Dosage and Administration ( 2.2 ), Drug Interactions ( 7.1 )]. Moderate Inhibitors of CYP3A4 Erythromycin and other macrolide antibiotics: Erythromycin is a moderately strong inhibitor of CYP3A4. Coadministration of erythromycin 500 mg every 8h with a single dose of cilostazol 100 mg increased cilostazol C max by 47% and AUC by 73%. Inhibition of cilostazol metabolism by erythromycin increased the AUC of 4´-trans-hydroxy- cilostazol by 141% [see Dosage and Administration ( 2.2 )]. Diltiazem: Diltiazem 180 mg decreased the clearance of cilostazol by ~30%. Cilostazol C max increased ~30% and AUC increased ~40% [see Dosage and Administration ( 2.2 )]. Grapefruit Juice: Grapefruit juice increased the C max of cilostazol by ~50%, but had no effect on AUC. Inhibitors of CYP2C19 Omeprazole: Coadministration of omeprazole did not significantly affect the metabolism of cilostazol, but the systemic exposure to 3,4-dehydro-cilostazol was increased by 69%, probably the result of omeprazole’s potent inhibition of CYP2C19 [see Dosage and Administration ( 2.2 )]. Quinidine Concomitant administration of quinidine with a single dose of cilostazol 100 mg did not alter cilostazol pharmacokinetics. Lovastatin The concomitant administration of lovastatin with cilostazol decreases cilostazol C ss, max and AUCτ by 15%. There is also a decrease, although nonsignificant, in cilostazol metabolite concentrations. Coadministration of cilostazol with lovastatin increases lovastatin and ß-hydroxylovastatin AUC approximately 70% and is not expected to be clinically significant. Figure1.jpg"],"indications_and_usage":["1 INDICATIONS AND USAGE Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. Cilostazol is a phosphodiesterase III inhibitor (PDE III inhibitor) indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Risks of tachycardia, palpitation, tachyarrhythmia or hypotension. Risks of exacerbations of angina pectoris or myocardial infarction in patients with a history of ischemic heart disease ( 5.2 ) Left ventricular outflow tract obstruction has been reported in patients with sigmoid shaped interventricular septum ( 5.1 ) Risks of thrombocytopenia or leukopenia progressing to agranulocytosis-monitor platelets and white blood cell counts ( 5.3 ) Avoid use in patients with hemostatic disorders or active pathologic bleeding ( 5.4 ) 5.1 Tachycardia Cilostazol may induce tachycardia, palpitation, tachyarrhythmia or hypotension. The increase in heart rate associated with cilostazol is approximately 5 to 7 bpm. Patients with a history of ischemic heart disease may be at risk for exacerbations of angina pectoris or myocardial infarction. 5.2 Left Ventricular Outflow Tract Obstruction Left ventricular outflow tract obstruction has been reported in patients with sigmoid shaped interventricular septum. Monitor patients for the development of a new systolic murmur or cardiac symptoms after starting cilostazol. 5.3 Hematologic Adverse Reactions Cases of thrombocytopenia or leukopenia progressing to agranulocytosis when cilostazol was not immediately discontinued have been reported. Agranulocytosis is reversible on discontinuation of cilostazol. Monitor platelets and white blood cell counts periodically. 5.4 Hemostatic Disorders or Active Pathologic Bleeding Cilostazol inhibits platelet aggregation in a reversible manner. Cilostazol has not been studied in patients with hemostatic disorders or active pathologic bleeding. Avoid use of cilostazol tablets in these patients."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Dietary administration of cilostazol to male and female rats and mice for up to 104 weeks, at doses up to 500 mg/kg/day in rats and 1000 mg/kg/day in mice, revealed no evidence of carcinogenic potential. The maximum doses administered in both rat and mouse studies were, on a systemic exposure basis, less than the human exposure at the MRHD of the drug. Cilostazol tested negative in bacterial gene mutation, bacterial DNA repair, mammalian cell gene mutation, and mouse in vivo bone marrow chromosomal aberration assays. It was, however, associated with a significant increase in chromosomal aberrations in the in vitro Chinese Hamster Ovary Cell assay. In female mice, cilostazol caused a reversible contraceptive effect at a dose (300 mg/kg) that was approximately 7.4-fold greater than the Maximum Recommended Human Dose (MRHD) on a body surface area basis. These findings have not been demonstrated in other animal species. Cilostazol did not affect fertility or mating performance of male and female rats at doses as high as 1000 mg/kg/day. At this dose, systemic exposures (AUCs) to unbound cilostazol were less than 1.5 times in males, and about 5 times in females, the exposure in humans at the MRHD. 13.2 Animal Toxicology and/or Pharmacology Repeated oral administration of cilostazol to dogs (30 or more mg/kg/day for 52 weeks, 150 or more mg/kg/day for 13 weeks, and 450 mg/kg/day for 2 weeks), produced cardiovascular lesions that included endocardial hemorrhage, hemosiderin deposition and fibrosis in the left ventricle, hemorrhage in the right atrial wall, hemorrhage and necrosis of the smooth muscle in the wall of the coronary artery, intimal thickening of the coronary artery, and coronary arteritis and periarteritis. At the lowest dose associated with cardiovascular lesions in the 52-week study, systemic exposure (AUC) to unbound cilostazol was less than that seen in humans at the maximum recommended human dose (MRHD) of 100 mg twice daily. Similar lesions have been reported in dogs following the administration of other positive inotropic agents (including PDE III inhibitors) and/or vasodilating agents. No cardiovascular lesions were seen in rats following 5 or 13 weeks of administration of cilostazol at doses up to 1500 mg/kg/day. At this dose, systemic exposures (AUCs) to unbound cilostazol were only about 1.5 and 5 times (male and female rats, respectively) the exposure seen in humans at the MRHD. Cardiovascular lesions were also not seen in rats following 52 weeks of administration of cilostazol at doses up to 150 mg/kg/day. At this dose, systemic exposures (AUCs) to unbound cilostazol were about 0.5 and 5 times (male and female rats, respectively) the exposure in humans at the MRHD. In female rats, cilostazol AUCs were similar at 150 and 1500 mg/kg/day. Cardiovascular lesions were also not observed in monkeys after oral administration of cilostazol for 13 weeks at doses up to 1800 mg/kg/day. While this dose of cilostazol produced pharmacologic effects in monkeys, plasma cilostazol levels were less than those seen in humans given the MRHD, and those seen in dogs given doses associated with cardiovascular lesions."],"adverse_reactions_table":["<table border=\"1\"><tbody align=\"center\"><tr><td><content styleCode=\"bold\">Adverse Reactions</content></td><td><content styleCode=\"bold\">Placebo   (N=973) </content></td><td><content styleCode=\"bold\">Cilostazol tablets 50 mg twice daily   (N=303) </content></td><td><content styleCode=\"bold\">Cilostazol tablets 100 mg twice daily   (N=998) </content></td></tr><tr><td align=\"left\">Headache</td><td>14%</td><td>27%</td><td>34%</td></tr><tr><td align=\"left\">Diarrhea</td><td>7%</td><td>12%</td><td>19%</td></tr><tr><td align=\"left\">Abnormal stools</td><td>4%</td><td>12%</td><td>15%</td></tr><tr><td align=\"left\">Palpitation</td><td>1%</td><td>5%</td><td>10%</td></tr><tr><td align=\"left\">Dizziness</td><td>6%</td><td>9%</td><td>10%</td></tr><tr><td align=\"left\">Pharyngitis</td><td>7%</td><td>7%</td><td>10%</td></tr><tr><td align=\"left\">Infection</td><td>8%</td><td>14%</td><td>10%</td></tr><tr><td align=\"left\">Peripheral edema</td><td>4%</td><td>9%</td><td>7%</td></tr><tr><td align=\"left\">Rhinitis</td><td>5%</td><td>12%</td><td>7%</td></tr><tr><td align=\"left\">Dyspepsia</td><td>4%</td><td>6%</td><td>6%</td></tr><tr><td align=\"left\">Abdominal pain</td><td>3%</td><td>4%</td><td>5%</td></tr><tr><td align=\"left\">Tachycardia</td><td>1%</td><td>4%</td><td>4%</td></tr></tbody></table>"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Advise the patient: to take cilostazol tablets at least one-half hour before or two hours after food. to discuss with their doctor before taking any CYP3A4 or CYP2C19 inhibitors (e.g., omeprazole). that the beneficial effects of cilostazol tablets on the symptoms of intermittent claudication may not be immediate. Although the patient may experience benefit in 2 to 4 weeks after initiation of therapy, treatment for up to 12 weeks may be required before a beneficial effect is experienced. Discontinue cilostazol tablets if symptoms do not improve after 3 months. Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. 05/17 AV 03/22 (P)"],"spl_unclassified_section":["REPACKAGING INFORMATION Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: 100mg NDC 71610-813-26, Bottles of 1200 Tablets Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20240404AMH Aphena"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION The recommended dosage of cilostazol is 100 mg twice daily taken at least half an hour before or two hours after breakfast and dinner ( 2.1 ) Reduce the dose to 50 mg twice daily when coadministered with CYP3A4 inhibitors such as ketoconazole, itraconazole, erythromycin, and diltiazem, or CYP2C19 inhibitors such as ticlopidine, fluconazole, and omeprazole ( 2.2 ) 2.1 Recommended dosage The recommended dosage of cilostazol is 100 mg twice daily taken at least half an hour before or two hours after breakfast and dinner. Patients may respond as early as 2 to 4 weeks after the initiation of therapy, but treatment for up to 12 weeks may be needed before a beneficial effect is experienced. If symptoms are unimproved after 3 months, discontinue cilostazol. 2.2 Dose Reduction with CYP3A4 and CYP2C19 Inhibitors Reduce dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, erythromycin, and diltiazem) or inhibitors of CYP2C19 (e.g., ticlopidine, fluconazole, and omeprazole) [see Drug Interactions ( 7.1 )] ."],"spl_product_data_elements":["cilostazol cilostazol STARCH, CORN CROSCARMELLOSE SODIUM MAGNESIUM STEARATE SILICON DIOXIDE CILOSTAZOL CILOSTAZOL APO;CIL;100"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Cilostazol tablets, USP 50 mg are white, round, flat-faced, bevelled-edge tablets, engraved \"APO\" on one side and \"CIL\" over \"50\" on the other side. Cilostazol tablets, USP 100 mg tablets are white, round, flat-faced, bevelled-edge tablets, engraved \"APO\" on one side and \"CIL\" over \"100\" on the other side. Tablets: 50 mg and 100 mg ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects Pregnancy Category C. Cilostazol has been shown to be teratogenic in rats at doses that are greater than 5-times the human MRHD on a body surface area basis. There are no adequate and well-controlled studies in pregnant women. In a rat developmental toxicity study, oral administration of 1000 mg cilostazol/kg/day was associated with decreased fetal weights, and increased incidences of cardiovascular, renal, and skeletal anomalies (ventricular septal, aortic arch and subclavian artery abnormalities, renal pelvic dilation, 14 th rib, and retarded ossification). At this dose, systemic exposure to unbound cilostazol in nonpregnant rats was about 5 times the exposure in humans given the MRHD. Increased incidences of ventricular septal defect and retarded ossification were also noted at 150 mg/kg/day (5 times the MRHD on a systemic exposure basis). In a rabbit developmental toxicity study, an increased incidence of retardation of ossification of the sternum was seen at doses as low as 150 mg/kg/day. In nonpregnant rabbits given 150 mg/kg/day, exposure to unbound cilostazol was considerably lower than that seen in humans given the MRHD, and exposure to 3,4-dehydro- cilostazol was barely detectable. When cilostazol was administered to rats during late pregnancy and lactation, an increased incidence of stillborn and decreased birth weights of offspring was seen at doses of 150 mg/kg/day (5 times the MRHD on a systemic exposure basis). 8.3 Nursing Mothers Transfer of cilostazol into milk has been reported in rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from cilostazol, discontinue nursing or discontinue cilostazol. 8.4 Pediatric Use Safety and effectiveness of cilostazol in pediatric patients have not been established. 8.5 Geriatric Use Of the total number of subjects (n = 2,274) in clinical studies of cilostazol, 56 percent were 65 years old and over, while 16 percent were 75 years old and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be excluded. Pharmacokinetic studies have not disclosed any age-related effects on the absorption, distribution, metabolism, and elimination of cilostazol and its metabolites. 8.6 Hepatic Impairment No dose adjustment is required in patients with mild hepatic impairment. Patients with moderate or severe hepatic impairment have not been studied in clinical trials and dosing recommendations cannot be provided [see Clinical Pharmacology ( 12.3 )]. 8.7 Renal Impairment No dose adjustment is required in patients with renal impairment. Patients on dialysis have not been studied, but, it is unlikely that cilostazol can be removed efficiently by dialysis because of its high protein binding (95 to 98%) [see Clinical Pharmacology ( 12.3 )]."],"patient_medication_information":["PATIENT INFORMATION Cilostazol Tablets, USP (sye loe' sta zol) for oral use 50 mg and 100 mg Read this Patient Information leaflet before you start taking cilostazol tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. What is the most important information I should know about cilostazol tablets? Cilostazol tablets can cause serious side effects: Cilostazol tablets stops a protein called phosphodiesterase III from working. Other similar drugs which affect this protein may cause death if you already have heart problems, called class 3 to 4 (III-IV) heart failure. Do not take cilostazol tablets if you have heart failure of any kind. What are cilostazol tablets? Cilostazol tablets is a prescription medicine used to reduce the symptoms of intermittent claudication and can increase your ability to walk further distances. It is not known if cilostazol tablets is safe and effective for use in children. How does cilostazol tablets work? Improvement in symptoms may occur as soon as 2 weeks, but could take up to 12 weeks. Who should not take cilostazol tablets? Do not take cilostazol tablets if you: have heart problems (heart failure) are allergic to cilostazol or any of the ingredients in cilostazol tablets. See the end of this leaflet for a complete list of ingredients in cilostazol tablets. Tell your doctor before taking this medicine if you have any of these conditions. What should I tell my doctor before taking cilostazol tablets? Before you take cilostazol tablets, tell your doctor if you: drink grapefruit juice. Taking cilostazol tablets and drinking grapefruit juice can increase the amount of cilostazol tablets causing side effects. have any other medical conditions. are pregnant or planning to become pregnant. It is not known if cilostazol tablets will harm your unborn baby. are breastfeeding or planning to breastfeed. It is not known if cilostazol tablets passes into your breast milk. You and your doctor should decide if you will take cilostazol tablets or breastfeed. You should not do both. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Ask your doctor for a list of these medicines if you are not sure. You can ask your pharmacist for a list of medicines that interact with cilostazol tablets. Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine. How should I take cilostazol tablets? Take cilostazol tablets exactly as your doctor tells you to take it. Your doctor will tell you how much cilostazol tablets to take and when to take it. Your doctor may change your dose if needed. Take cilostazol tablets 30 minutes before you eat or 2 hours after you eat. What are the possible side effects of cilostazol tablets? Cilostazol tablets may cause serious side effects, including: heart problems. Taking cilostazol tablets may cause you to have heart problems, including a fast heart beat, palpitations, irregular heartbeat, and low blood pressure. See \"What is the most important information I should know about cilostazol tablets?\" severe allergic reactions (anaphylaxis, angioedema). Call your doctor or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction: hives swelling of your face, lips, mouth, or tongue trouble breathing or wheezing dizziness changes in your blood cell counts (thrombocytopenia or leukopenia). Your doctor should do blood tests to check your blood cell counts while you take cilostazol tablets. The most common side effects of cilostazol tablets include: headache abnormal stools diarrhea Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of cilostazol tablets. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store cilostazol tablets? Store cilostazol tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep cilostazol tablets and all medicines out of the reach of children. General information about the safe and effective use of cilostazol tablets. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use cilostazol tablets for a condition for which it was not prescribed. Do not give cilostazol tablets to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information summarizes the most important information about cilostazol tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about cilostazol tablets that is written for health professionals. For more information, call Apotex Corp. at 1-855-361-3993. What are the ingredients in cilostazol tablets? Active ingredient: cilostazol Inactive ingredients: corn starch, croscarmellose sodium, magnesium stearate, and silicon dioxide This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. 05/17 AV 03/22 (P)"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 100mg NDC 71610-813 - Cilostazol, USP 100mg Tablets - Rx Only Label"]},"tags":[{"label":"Phosphodiesterase 3 Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"cGMP-inhibited 3',5'-cyclic phosphodiesterase A","category":"target"},{"label":"PDE3A","category":"gene"},{"label":"PDE3B","category":"gene"},{"label":"CYP2C9","category":"gene"},{"label":"B01AC23","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Intermittent claudication","category":"indication"},{"label":"Otsuka","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Anti-Asthmatic Agents","category":"pharmacology"},{"label":"Bronchodilator Agents","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Fibrinolytic Agents","category":"pharmacology"},{"label":"Hematologic Agents","category":"pharmacology"},{"label":"Neuroprotective Agents","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Phosphodiesterase 3 Inhibitors","category":"pharmacology"},{"label":"Phosphodiesterase Inhibitors","category":"pharmacology"},{"label":"Platelet Aggregation Inhibitors","category":"pharmacology"},{"label":"Protective Agents","category":"pharmacology"},{"label":"Respiratory System Agents","category":"pharmacology"},{"label":"Vasodilator Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":["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)"],"safetySignals":[{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"303 reports"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"231 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"230 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"229 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"217 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"209 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"206 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"204 reports"},{"date":"","signal":"ANAEMIA","source":"FDA FAERS","actionTaken":"191 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"185 reports"}],"drugInteractions":[{"url":"/drug/clarithromycin","drug":"clarithromycin","action":"Monitor closely","effect":"May interact with Clarithromycin","source":"DrugCentral","drugSlug":"clarithromycin"},{"url":"/drug/diltiazem","drug":"diltiazem","action":"Monitor closely","effect":"May interact with Diltiazem","source":"DrugCentral","drugSlug":"diltiazem"},{"url":"/drug/erythromycin","drug":"erythromycin","action":"Monitor closely","effect":"May interact with Erythromycin","source":"DrugCentral","drugSlug":"erythromycin"},{"url":"/drug/esomeprazole","drug":"esomeprazole","action":"Monitor closely","effect":"May interact with Esomeprazole","source":"DrugCentral","drugSlug":"esomeprazole"},{"url":"/drug/itraconazole","drug":"itraconazole","action":"Monitor closely","effect":"May interact with Itraconazole","source":"DrugCentral","drugSlug":"itraconazole"},{"url":"/drug/oleandomycin","drug":"oleandomycin","action":"Monitor closely","effect":"May interact with Oleandomycin (As Troleandomycin)","source":"DrugCentral","drugSlug":"oleandomycin"},{"url":"/drug/omeprazole","drug":"omeprazole","action":"Monitor closely","effect":"May interact with Omeprazole","source":"DrugCentral","drugSlug":"omeprazole"}],"commonSideEffects":[{"effect":"Headache","drugRate":"34%","severity":"common","_validated":true},{"effect":"Diarrhea","drugRate":"19%","severity":"common","_validated":true},{"effect":"Abnormal stools","drugRate":"15%","severity":"common","_validated":true},{"effect":"Palpitation","drugRate":"10%","severity":"common","_validated":true},{"effect":"Dizziness","drugRate":"10%","severity":"common","_validated":true},{"effect":"Pharyngitis","drugRate":"10%","severity":"common","_validated":true},{"effect":"Infection","drugRate":"10%","severity":"common","_validated":true},{"effect":"Peripheral edema","drugRate":"7%","severity":"mild","_validated":true},{"effect":"Rhinitis","drugRate":"7%","severity":"mild","_validated":true},{"effect":"Dyspepsia","drugRate":"6%","severity":"mild","_validated":true},{"effect":"Abdominal pain","drugRate":"5%","severity":"mild","_validated":true},{"effect":"Tachycardia","drugRate":"4%","severity":"mild","_validated":true},{"effect":"Urinary frequency","drugRate":"4%","severity":"mild","_validated":true},{"effect":"Fever","drugRate":"reported","severity":"unknown"},{"effect":"Generalized edema","drugRate":"reported","severity":"unknown"},{"effect":"Malaise","drugRate":"reported","severity":"unknown"},{"effect":"Atrial fibrillation","drugRate":"reported","severity":"unknown"},{"effect":"Heart failure","drugRate":"reported","severity":"unknown"},{"effect":"Myocardial infarction","drugRate":"reported","severity":"unknown"},{"effect":"Nodal arrhythmia","drugRate":"reported","severity":"unknown"},{"effect":"Ventricular extrasystoles","drugRate":"reported","severity":"unknown"},{"effect":"Anorexia","drugRate":"reported","severity":"unknown"},{"effect":"Melena","drugRate":"reported","severity":"unknown"},{"effect":"Anemia","drugRate":"reported","severity":"unknown"},{"effect":"Increased creatinine","drugRate":"reported","severity":"unknown"},{"effect":"Hyperuricemia","drugRate":"reported","severity":"unknown"},{"effect":"Insomnia","drugRate":"reported","severity":"unknown"},{"effect":"Epistaxis","drugRate":"reported","severity":"unknown"}],"contraindications":["Chronic heart failure","Disease of liver","Kidney disease"],"specialPopulations":{"Pregnancy":"Cilostazol has been shown to be teratogenic in rats at doses that are greater than 5-times the human MRHD on bodysurface area basis. There are no adequate and well-controlled studies in pregnant women. In rat developmental toxicity study, oral administration of 1000 mg cilostazol/kg/day was associated with decreased fetal weights, and increased incidences of cardiovascular, renal, and skeletal anomalies (ventricular septal, aortic arch and subclavian artery abnormalities, renal pelvic dilation, 14th rib, and retarded ossification). At this dose, systemic exposure to unbound cilostazol in nonpregnant rats was about times the exposure in humans given the MRHD. Increased incidences of ventricular septal defect and retarded ossification were also noted at 150 mg/kg/day (5 times the MRHD on systemic exposure basis). In rabbit developmental toxicity study, an increased incidence of retardation of ossification of the sternum was seen at doses as low as 150 mg/kg/day. In nonpregnant rabbits given 150 mg/kg/day, exposure to unbound cilostazol was considerably lower than that seen in humans given the MRHD, and exposure to 3,4-dehydrocilostazol was barely detectable. When cilostazol was administered to rats during late pregnancy and lactation, an increased incidence of stillborn and decreased birth weights of offspring was seen at doses of 150 mg/kg/day (5 times the MRHD on systemic exposure basis).","Geriatric use":"Of the total number of subjects (n 2274) in clinical studies of cilostazol, 56 percent were 65-years-old and over, while 16 percent were 75-years-old and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.","Paediatric use":"The safety and effectiveness of cilostazol in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Otsuka","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.1427/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$52","description":"CILOSTAZOL 100 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CILOSTAZOL","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:52:12.579793+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Cilostazol","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:52:19.488572+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:52:18.201535+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:52:11.696055+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CILOSTAZOL","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:52:18.460163+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:52:09.339881+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:52:09.339914+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"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 warn","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:52:09.339926+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:52:19.925027+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Phosphodiesterase 3A inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:52:19.488514+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL799/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:52:19.155717+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA077030","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:52:09.339929+00:00"}},"allNames":"pletal","offLabel":[],"synonyms":["OPC 13013","cilostazol","cilostazole","pletal","OPC-13013"],"timeline":[{"date":"1999-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from OTSUKA to Otsuka"},{"date":"2006-04-20","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 10 manufacturers approved"}],"aiSummary":"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.","approvals":[{"date":"1999-01-15","orphan":false,"company":"OTSUKA","regulator":"FDA"}],"brandName":"Pletal","ecosystem":[{"indication":"Intermittent claudication","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"cGMP-inhibited 3',5'-cyclic phosphodiesterase A","novelty":"Follow-on","targets":[{"gene":"PDE3A","source":"DrugCentral","target":"cGMP-inhibited 3',5'-cyclic phosphodiesterase A","protein":"cGMP-inhibited 3',5'-cyclic phosphodiesterase A"},{"gene":"PDE3B","source":"DrugCentral","target":"cGMP-inhibited 3',5'-cyclic phosphodiesterase B","protein":"cGMP-inhibited 3',5'-cyclic phosphodiesterase B"},{"gene":"CYP2C9","source":"DrugCentral","target":"Cytochrome P450 2C9","protein":"Cytochrome P450 2C9"}],"moaClass":"Phosphodiesterase 3 Inhibitors","modality":"Small Molecule","drugClass":"Phosphodiesterase 3 Inhibitor [EPC]","explanation":"","oneSentence":"","technicalDetail":"Cilostazol inhibits phosphodiesterase 3 (PDE3), an enzyme that breaks down cyclic AMP (cAMP), leading to an increase in cAMP levels and subsequent activation of protein kinase A (PKA), which enhances vasodilation and inhibits platelet aggregation."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Cilostazol","title":"Cilostazol","extract":"Cilostazol, sold under the brand name Pletal among others, is a medication used to help the symptoms of intermittent claudication in peripheral vascular disease. It may also be used to prevent stroke. It is taken by mouth."},"commercial":{"launchDate":"1999","_launchSource":"DrugCentral (FDA 1999-01-15, OTSUKA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/644","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CILOSTAZOL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CILOSTAZOL","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Cilostazol","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T10:02:35.711863","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:52:22.494386+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"clopidogrel","drugSlug":"clopidogrel","fdaApproval":"1997-11-17","genericCount":23,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ticlopidine","drugSlug":"ticlopidine","fdaApproval":"1991-10-31","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"acetylsalicylic acid","drugSlug":"acetylsalicylic-acid","fdaApproval":"1950-04-12","relationship":"same-class"},{"drugName":"dipyridamole","drugSlug":"dipyridamole","fdaApproval":"1961-12-06","genericCount":17,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"epoprostenol","drugSlug":"epoprostenol","fdaApproval":"1995-09-20","patentExpiry":"Mar 15, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"iloprost","drugSlug":"iloprost","fdaApproval":"2004-12-29","patentExpiry":"Jul 18, 2044","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"abciximab","drugSlug":"abciximab","fdaApproval":"1993-12-16","relationship":"same-class"},{"drugName":"eptifibatide","drugSlug":"eptifibatide","fdaApproval":"1998-05-18","genericCount":13,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"tirofiban","drugSlug":"tirofiban","fdaApproval":"1998-05-14","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"treprostinil","drugSlug":"treprostinil","fdaApproval":"2002-05-21","patentExpiry":"Sep 5, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"prasugrel","drugSlug":"prasugrel","fdaApproval":"2009-07-10","genericCount":10,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ticagrelor","drugSlug":"ticagrelor","fdaApproval":"2011-07-20","patentExpiry":"Oct 17, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"cangrelor","drugSlug":"cangrelor","fdaApproval":"2015-06-22","patentExpiry":"Nov 10, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"vorapaxar","drugSlug":"vorapaxar","fdaApproval":"2014-05-08","patentExpiry":"Dec 23, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"selexipag","drugSlug":"selexipag","fdaApproval":"2015-12-21","patentExpiry":"Oct 31, 2026","patentStatus":"Patent protected","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"cilostazol","indications":{"approved":[{"name":"Intermittent claudication","source":"DrugCentral","snomedId":63491006,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"currentOwner":"Otsuka","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"clopidogrel","brandName":"clopidogrel","genericName":"clopidogrel","approvalYear":"1997","relationship":"same-class"},{"drugId":"ticlopidine","brandName":"ticlopidine","genericName":"ticlopidine","approvalYear":"1991","relationship":"same-class"},{"drugId":"acetylsalicylic-acid","brandName":"acetylsalicylic acid","genericName":"acetylsalicylic acid","approvalYear":"1950","relationship":"same-class"},{"drugId":"dipyridamole","brandName":"dipyridamole","genericName":"dipyridamole","approvalYear":"1961","relationship":"same-class"},{"drugId":"epoprostenol","brandName":"epoprostenol","genericName":"epoprostenol","approvalYear":"1995","relationship":"same-class"},{"drugId":"iloprost","brandName":"iloprost","genericName":"iloprost","approvalYear":"2004","relationship":"same-class"},{"drugId":"abciximab","brandName":"abciximab","genericName":"abciximab","approvalYear":"1993","relationship":"same-class"},{"drugId":"eptifibatide","brandName":"eptifibatide","genericName":"eptifibatide","approvalYear":"1998","relationship":"same-class"},{"drugId":"tirofiban","brandName":"tirofiban","genericName":"tirofiban","approvalYear":"1998","relationship":"same-class"},{"drugId":"treprostinil","brandName":"treprostinil","genericName":"treprostinil","approvalYear":"2002","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06757764","phase":"PHASE4","title":"The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis","status":"RECRUITING","sponsor":"Asan Medical Center","startDate":"2025-07-10","conditions":["Cerebral Infarction","Stenosis Artery"],"enrollment":2340,"completionDate":"2028-03-31"},{"nctId":"NCT07495969","phase":"NA","title":"Randomized Clinical Trial of Endovascular Recanalization for Symptomatic Non-Acute Intracranial Artery Occlusion（REPAIR）","status":"NOT_YET_RECRUITING","sponsor":"Feng Gao","startDate":"2026-04-01","conditions":["Symptomatic Non-acute Intracranial Artery Occlusion","Ischemic Stroke"],"enrollment":286,"completionDate":"2028-12-31"},{"nctId":"NCT06504576","phase":"PHASE2","title":"Effect of Cilostazol in Promoting Hematoma Clearance After Intracerebral Hemorrhage","status":"RECRUITING","sponsor":"National Taiwan University Hospital","startDate":"2025-06-16","conditions":["ICH - Intracerebral Hemorrhage"],"enrollment":100,"completionDate":"2027-05-01"},{"nctId":"NCT05671497","phase":"PHASE2,PHASE3","title":"The Effect of Cilostazol on Rheumatoid Arthritis Patients","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2022-11-01","conditions":["Rheumatoid Arthritis"],"enrollment":70,"completionDate":"2024-10-01"},{"nctId":"NCT07286110","phase":"PHASE1","title":"Chinese Herbal Therapy (Qiqi Shengmai Formula) for Moyamoya Vasculopathy: The CHIMES Trial","status":"NOT_YET_RECRUITING","sponsor":"Fudan University","startDate":"2025-12-30","conditions":["Moyamoya Disease","Moyamoya Syndrome"],"enrollment":66,"completionDate":"2026-12-30"},{"nctId":"NCT07249853","phase":"PHASE3","title":"Cilostazol for Preventing Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage","status":"NOT_YET_RECRUITING","sponsor":"Beijing Tiantan Hospital","startDate":"2025-11-30","conditions":["Aneurysmal Subarachnoid Hemorrhage"],"enrollment":316,"completionDate":"2027-08-31"},{"nctId":"NCT07238985","phase":"PHASE1,PHASE2","title":"Cilostazol in the Treatment of Nonalcoholic Fatty Liver Disease","status":"RECRUITING","sponsor":"Tanta University","startDate":"2025-11-01","conditions":["Fatty Liver"],"enrollment":50,"completionDate":"2026-11-20"},{"nctId":"NCT03855332","phase":"PHASE2","title":"Oxford Haemodynamic Adaptation to Reduce Pulsatility Trial","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2019-07-11","conditions":["Small Vessel Cerebrovascular Disease"],"enrollment":75,"completionDate":"2023-01-06"},{"nctId":"NCT06919835","phase":"PHASE3","title":"CiLostAzol for pReventIon of Recurrent sTroke in Africa","status":"NOT_YET_RECRUITING","sponsor":"Northern California Institute of Research and Education","startDate":"2025-12-01","conditions":["Stroke"],"enrollment":1100,"completionDate":"2027-12-31"},{"nctId":"NCT07180472","phase":"PHASE4","title":"Prevention of Stroke Recurrence and Disease Progression in Cerebral Small Vessel Disease With Cilostazol","status":"NOT_YET_RECRUITING","sponsor":"First Affiliated Hospital of Chengdu Medical College","startDate":"2025-09-20","conditions":["Cerebral Small Vessel Disease"],"enrollment":632,"completionDate":"2027-12-01"},{"nctId":"NCT06591377","phase":"PHASE3","title":"Combining Aspirin With Ticagrelor or Cilostazol in Large-vessel Minor Stroke or TIA","status":"RECRUITING","sponsor":"Kafrelsheikh University","startDate":"2024-08-10","conditions":["Ischemic Stroke"],"enrollment":900,"completionDate":"2025-10-01"},{"nctId":"NCT07174414","phase":"PHASE3","title":"Cilostazol for Prevention of Recurrent Stroke Trial","status":"NOT_YET_RECRUITING","sponsor":"Stanford University","startDate":"2026-08","conditions":["Stroke Recurrence","Myocardial Infarction","Vascular Death","Ischemic Stroke","TIA (Transient Ischemic Attack)","Stroke (CVA) or Transient Ischemic Attack","Recurrent Stroke"],"enrollment":2000,"completionDate":"2031-07"},{"nctId":"NCT07144956","phase":"PHASE3","title":"Cilostazol With Nimodipine to Improve Outcome After Aneurysmal Subarachnoid Hemorrhage","status":"NOT_YET_RECRUITING","sponsor":"Centre Hospitalier St Anne","startDate":"2025-12-15","conditions":["Aneurysmal Subarachnoid Hemorrhage"],"enrollment":630,"completionDate":"2029-12-14"},{"nctId":"NCT06591338","phase":"PHASE3","title":"Combining Aspirin With Ticagrelor or Clopidogrel in Large-vessel Minor Stroke or TIA","status":"RECRUITING","sponsor":"Kafrelsheikh University","startDate":"2024-09-01","conditions":["Ischemic Stroke"],"enrollment":900,"completionDate":"2025-10-10"},{"nctId":"NCT06492070","phase":"PHASE2","title":"Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers","status":"RECRUITING","sponsor":"Emory University","startDate":"2024-08-01","conditions":["Cervical Carcinoma","Fallopian Tube Carcinoma","Malignant Solid Neoplasm","Malignant Uterine Neoplasm","Ovarian Carcinoma","Primary Peritoneal Carcinoma","Vulvar Carcinoma"],"enrollment":70,"completionDate":"2027-12-31"},{"nctId":"NCT05635370","phase":"","title":"Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Pentoxifylline Versus Cilostazol","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2022-11-01","conditions":["Peripheral Artery Disease"],"enrollment":10398,"completionDate":"2023-12-31"},{"nctId":"NCT04753970","phase":"PHASE1,PHASE2","title":"Retina is a Marker for Cerebrovascular Heath","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2021-02-09","conditions":["Cerebral Small Vessel Diseases","Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy","Cerebral Microbleeding","Sporadic White Matter Disease"],"enrollment":100,"completionDate":"2026-06"},{"nctId":"NCT04789837","phase":"PHASE1,PHASE2","title":"The Phosphodiesterase 3 Inhibitor Cilostazol as an Adjunct to Conventional Therapy in Patients With Osteoarthritis","status":"WITHDRAWN","sponsor":"Sadat City University","startDate":"2021-03-01","conditions":["Osteoarthritis"],"enrollment":0,"completionDate":"2024-12-31"},{"nctId":"NCT04761848","phase":"PHASE1,PHASE2","title":"Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease","status":"WITHDRAWN","sponsor":"Sadat City University","startDate":"2021-02-16","conditions":["Fatty Liver, Nonalcoholic"],"enrollment":0,"completionDate":"2024-12-31"},{"nctId":"NCT04410341","phase":"PHASE1,PHASE2","title":"The DPP-4 Inhibitor Vildagliptin as Adjunct in Major Depressive Disorder Patients","status":"WITHDRAWN","sponsor":"Sadat City University","startDate":"2020-05-01","conditions":["Major Depressive Disorder"],"enrollment":0,"completionDate":"2024-12-01"},{"nctId":"NCT07040085","phase":"PHASE3","title":"Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke","status":"NOT_YET_RECRUITING","sponsor":"Beijing Tiantan Hospital","startDate":"2025-08-05","conditions":["Stroke"],"enrollment":892,"completionDate":"2027-06-30"},{"nctId":"NCT06989697","phase":"PHASE3","title":"Cilostazol-Ginkgo for Cognitive Function in Elderly Diabetes","status":"RECRUITING","sponsor":"Seoul National University Bundang Hospital","startDate":"2025-01-01","conditions":["Type 2 Diabets Mellitus","Cognitive Ability, General"],"enrollment":80,"completionDate":"2027-06-30"},{"nctId":"NCT06983795","phase":"","title":"Pioneering Advancements in Cardiocerebrovascular Interactions in the Asia pacFIC - Patent Foramen Ovale Study","status":"NOT_YET_RECRUITING","sponsor":"National University Hospital, Singapore","startDate":"2025-07","conditions":["Ischemic Stroke","Patent Foramen Ovale"],"enrollment":1000,"completionDate":"2030-12"},{"nctId":"NCT06715007","phase":"","title":"Antiplatelet Therapy and Endothelial-stabilizing Agents in Cerebral Small Vessel Diseases","status":"RECRUITING","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2024-12-20","conditions":["Stroke, Ischemic","Small Vessel Cerebrovascular Disease","White Matter Hyperintensity"],"enrollment":300,"completionDate":"2026-01-20"},{"nctId":"NCT02098460","phase":"PHASE4","title":"To Compare the Effect of Concomitant Administration of Probucol and Cilostazol With Probucol Single Treatment on the Atherosclerosis Related Markers (Including the Thickness of the Achilles Tendon) and Evaluate Safety (Based on Atorvastatin Treatment) in Severe Hypercholesterolemia Subject","status":"COMPLETED","sponsor":"Otsuka Beijing Research Institute","startDate":"2013-10","conditions":["Severe Hypercholesterolemia"],"enrollment":300,"completionDate":"2016-03"},{"nctId":"NCT00823849","phase":"PHASE4","title":"Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker","status":"COMPLETED","sponsor":"Otsuka Beijing Research Institute","startDate":"2008-10","conditions":["Type 2 Diabetes Mellitus","Arteriosclerosis Obliterans"],"enrollment":200,"completionDate":"2010-03"},{"nctId":"NCT04522102","phase":"PHASE3","title":"Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral HaemorrhaGe (ASPIRING)-Pilot Phase","status":"COMPLETED","sponsor":"The George Institute for Global Health, China","startDate":"2021-09-03","conditions":["Intracerebral Hemorrhage"],"enrollment":80,"completionDate":"2023-10-13"},{"nctId":"NCT06886620","phase":"PHASE3","title":"Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication","status":"TERMINATED","sponsor":"Genovate Biotechnology Co., Ltd.,","startDate":"2016-03-14","conditions":["Intermittent Claudication"],"enrollment":14,"completionDate":"2017-02-08"},{"nctId":"NCT03189641","phase":"NA","title":"Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions","status":"COMPLETED","sponsor":"JIMRO Co., Ltd.","startDate":"2017-05-31","conditions":["Coronary Artery Disease"],"enrollment":30,"completionDate":"2024-07-26"},{"nctId":"NCT05191862","phase":"PHASE1","title":"Bioequivalence Study of PMR Compared to Cilostazol IR Tablets in Healthy Volunteers","status":"TERMINATED","sponsor":"Genovate Biotechnology Co., Ltd.,","startDate":"2022-04-23","conditions":["Intermittent Claudication"],"enrollment":19,"completionDate":"2022-05-07"},{"nctId":"NCT05906199","phase":"PHASE4","title":"A Study to Compare the Effects of Improving the Carotid Artery Intima Media Thickness and Changing Lipid Levels by Cilostazol/Ginkgo Leaf Extract and Aspirin in Diabetic Peripheral Angiopathy.","status":"COMPLETED","sponsor":"SK Chemicals Co., Ltd.","startDate":"2021-07-28","conditions":["Diabetic Peripheral Angiopathy"],"enrollment":105,"completionDate":"2023-12-13"},{"nctId":"NCT06117436","phase":"PHASE2,PHASE3","title":"Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2023-10-19","conditions":["Wound Heal"],"enrollment":206,"completionDate":"2025-01-30"},{"nctId":"NCT05759819","phase":"NA","title":"Evaluate the Efficacy and Safety of the Cilostazol-coated BioMimics 3D Stent System in Patients with Peripheral Arterial Occlusive Disease","status":"ACTIVE_NOT_RECRUITING","sponsor":"Otsuka Medical Devices Co., Ltd. Japan","startDate":"2023-03-10","conditions":["Peripheral Arterial Disease"],"enrollment":24,"completionDate":"2026-12-31"},{"nctId":"NCT03062319","phase":"PHASE4","title":"Optimal Antithrombotic Therapy in Ischemic Stroke Patients with Non-Valvular Atrial Fibrillation and Atherothrombosis","status":"TERMINATED","sponsor":"National Hospital Organization Osaka National Hospital","startDate":"2017-04-06","conditions":["Ischemic Stroke","Atrial Fibrillation","Atherothrombosis"],"enrollment":321,"completionDate":"2023-07-18"},{"nctId":"NCT03451591","phase":"PHASE2,PHASE3","title":"LACunar Intervention (LACI-2) Trial-2","status":"COMPLETED","sponsor":"University of Edinburgh","startDate":"2018-01-08","conditions":["Cerebral Small Vessel Diseases","Stroke, Lacunar"],"enrollment":363,"completionDate":"2022-08-11"},{"nctId":"NCT06612593","phase":"PHASE2","title":"Cilostazol in Parkinson&#39;s Disease","status":"NOT_YET_RECRUITING","sponsor":"Ain Shams University","startDate":"2024-10-01","conditions":["Parkinson's Disease"],"enrollment":50,"completionDate":"2025-10-01"},{"nctId":"NCT06591390","phase":"PHASE3","title":"Combining Aspirin With Ticagrelor or Cilostazol in Minor Stroke or TIA","status":"RECRUITING","sponsor":"Kafrelsheikh University","startDate":"2022-02-09","conditions":["Ischemic Stroke"],"enrollment":900,"completionDate":"2024-10-01"},{"nctId":"NCT06591299","phase":"PHASE3","title":"Combining Aspirin With Cilostazol or Clopidogrel in Minor Stroke or TIA","status":"RECRUITING","sponsor":"Kafrelsheikh University","startDate":"2022-04-15","conditions":["Ischemic Stroke"],"enrollment":870,"completionDate":"2024-09-30"},{"nctId":"NCT06591351","phase":"PHASE3","title":"Combining Aspirin With Cilostazol or Clopidogrel in Large-vessel Minor Stroke or TIA","status":"RECRUITING","sponsor":"Kafrelsheikh University","startDate":"2022-05-01","conditions":["Ischemic Stroke"],"enrollment":870,"completionDate":"2024-10-10"},{"nctId":"NCT06242132","phase":"PHASE3","title":"Clopidogrel Versus Cilostazol in Ischemic Stroke","status":"COMPLETED","sponsor":"Kafrelsheikh University","startDate":"2022-06-01","conditions":["Ischemic Stroke"],"enrollment":870,"completionDate":"2024-08-01"},{"nctId":"NCT06591312","phase":"PHASE3","title":"Combining Aspirin With Ticagrelor or Clopidogrel in Minor Stroke or TIA","status":"RECRUITING","sponsor":"Kafrelsheikh University","startDate":"2022-05-01","conditions":["Ischemic Stroke"],"enrollment":900,"completionDate":"2024-09-25"},{"nctId":"NCT06242145","phase":"PHASE3","title":"Clopidogrel Versus Cilostazol in Large-vessel Ischemic Stroke","status":"COMPLETED","sponsor":"Kafrelsheikh University","startDate":"2023-01-01","conditions":["Ischemic Stroke"],"enrollment":580,"completionDate":"2024-08-01"},{"nctId":"NCT06561867","phase":"PHASE3","title":"Ticagrelor Versus Cilostazol in Ischemic Stroke","status":"RECRUITING","sponsor":"Kafrelsheikh University","startDate":"2024-08-30","conditions":["Ischemic Stroke"],"enrollment":900,"completionDate":"2025-12-20"},{"nctId":"NCT06196047","phase":"PHASE3","title":"Ticagrelor Versus Cilostazol in Minor Ischemic Stroke or TIA","status":"RECRUITING","sponsor":"Kafrelsheikh University","startDate":"2023-12-01","conditions":["Ischemic Stroke"],"enrollment":900,"completionDate":"2024-12-30"},{"nctId":"NCT00839930","phase":"PHASE1","title":"Cilostazol 50 mg Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2004-02","conditions":["Healthy"],"enrollment":30,"completionDate":"2004-02"},{"nctId":"NCT06202755","phase":"PHASE3","title":"Ticagrelor Versus Cilostazol in Large-vessel Ischemic Stroke","status":"RECRUITING","sponsor":"Kafrelsheikh University","startDate":"2024-03-30","conditions":["Ischemic Stroke"],"enrollment":580,"completionDate":"2025-07-12"},{"nctId":"NCT00838630","phase":"PHASE1","title":"Cilostazol 100 mg Tablet Formulations Under Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2003-11","conditions":["Healthy"],"enrollment":36,"completionDate":"2003-11"},{"nctId":"NCT06522113","phase":"PHASE4","title":"Cilostazol and Aspirin in Stroke and TIA","status":"COMPLETED","sponsor":"Incheon St.Mary's Hospital","startDate":"2019-07-18","conditions":["Ischemic Stroke","TIA"],"enrollment":378,"completionDate":"2022-10-17"},{"nctId":"NCT06530537","phase":"PHASE3","title":"Cilostazol vs. Aspirin in Acute Non-cardioembolic Stroke With Cerebral mIcrobleeds","status":"RECRUITING","sponsor":"Zhejiang Provincial People's Hospital","startDate":"2024-07-18","conditions":["Cerebral Microbleeds","Stroke"],"enrollment":848,"completionDate":"2031-08-30"},{"nctId":"NCT04148105","phase":"PHASE4","title":"Cilostazol and Nimodipine Combined Therapy After Aneurysmal Subarachnoid Hemorrhage (aSAH)","status":"TERMINATED","sponsor":"Henry Ford Health System","startDate":"2019-11-01","conditions":["Aneurysmal Subarachnoid Hemorrhage"],"enrollment":19,"completionDate":"2023-05-26"},{"nctId":"NCT06402747","phase":"PHASE4","title":"Clopidogrel Versus Cilostazol on Vessels","status":"RECRUITING","sponsor":"Seoul National University Bundang Hospital","startDate":"2024-04-16","conditions":["Type 2 Diabetes","Atherosclerosis"],"enrollment":120,"completionDate":"2027-12-31"},{"nctId":"NCT00648388","phase":"PHASE1","title":"Fasting Study of Cilostazol Tablets 100 mg and Pletal® Tablets 100 mg","status":"COMPLETED","sponsor":"Mylan Pharmaceuticals Inc","startDate":"2004-03","conditions":["Healthy"],"enrollment":44,"completionDate":"2004-05"},{"nctId":"NCT05594680","phase":"PHASE3","title":"Cilostazol and Methotrexate in Rheumatoid Arthritis","status":"RECRUITING","sponsor":"Tanta University","startDate":"2022-10-01","conditions":["Rheumatoid Arthritis"],"enrollment":70,"completionDate":"2024-11-01"},{"nctId":"NCT06058130","phase":"NA","title":"Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis","status":"UNKNOWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2023-09-29","conditions":["Acute Ischemic Stroke","Atrial Fibrillation","Stenosis, Carotid","Intracranial Atherosclerosis"],"enrollment":2171,"completionDate":"2026-01-01"},{"nctId":"NCT06167265","phase":"PHASE1","title":"BE Study of Once Daily PMR Compared to Twice Daily Cilostazol Tablets in Healthy Volunteers","status":"COMPLETED","sponsor":"Genovate Biotechnology Co., Ltd.,","startDate":"2023-11-28","conditions":["Intermittent Claudication"],"enrollment":40,"completionDate":"2024-01-18"},{"nctId":"NCT06268470","phase":"PHASE2","title":"Antiplatelet Therapy in Chronic Urticaria","status":"UNKNOWN","sponsor":"Chulalongkorn University","startDate":"2018-06-01","conditions":["Chronic Urticaria"],"enrollment":12,"completionDate":"2024-05-01"},{"nctId":"NCT05126836","phase":"PHASE2","title":"Cilostazol for HFpEF","status":"COMPLETED","sponsor":"University of Minnesota","startDate":"2021-09-01","conditions":["Heart Failure With Preserved Ejection Fraction"],"enrollment":25,"completionDate":"2022-07-01"},{"nctId":"NCT06138834","phase":"PHASE2","title":"EFfects of Y-6 SUblingual Tablets foR PaTients With AcUte Ischemic StRokE (FUTURE)","status":"UNKNOWN","sponsor":"Beijing Tiantan Hospital","startDate":"2023-11","conditions":["Acute Ischemic Stroke","Large Vessel Occlusion","Reperfusion"],"enrollment":300,"completionDate":"2025-01"},{"nctId":"NCT06053021","phase":"NA","title":"Antiplatelet Therapy for AIS Patients With Thrombocytopenia","status":"UNKNOWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2023-09-15","conditions":["Acute Ischemic Stroke","Thrombocytopenia"],"enrollment":1200,"completionDate":"2026-01-01"},{"nctId":"NCT05836766","phase":"PHASE2","title":"Cilostazol Dexborneol Versus Placebo for Microcirculation Dysfunction After Reperfusion Therapy in Patients With Acute Ischemic Stroke With Large Vessel Occlusion","status":"UNKNOWN","sponsor":"Beijing Tiantan Hospital","startDate":"2023-06-05","conditions":["Acute Ischemic Stroke","Reperfusion","Large Vessel Occlusion"],"enrollment":120,"completionDate":"2024-08"},{"nctId":"NCT05466734","phase":"PHASE1","title":"BE Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers","status":"COMPLETED","sponsor":"Genovate Biotechnology Co., Ltd.,","startDate":"2022-07-05","conditions":["Intermittent Claudication"],"enrollment":25,"completionDate":"2022-09-20"},{"nctId":"NCT05298696","phase":"PHASE1,PHASE2","title":"Efficacy of Cilostazol in Prevention of Peripheral Neuropathy","status":"COMPLETED","sponsor":"Mansoura University","startDate":"2022-03-28","conditions":["Peripheral Neuropathy","Breast Cancer"],"enrollment":71,"completionDate":"2022-12-30"},{"nctId":"NCT05595993","phase":"NA","title":"Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache","status":"UNKNOWN","sponsor":"Danish Headache Center","startDate":"2022-10-25","conditions":["Post-Traumatic Headache"],"enrollment":21,"completionDate":"2023-12-31"},{"nctId":"NCT04069819","phase":"NA","title":"The Phosphodiesterase-3 Inhibitor Cilostazol as an Adjunctive to Antidepressants in Patients With Major Depressive Disorder.","status":"COMPLETED","sponsor":"Sadat City University","startDate":"2019-08-01","conditions":["Major Depressive Disorder"],"enrollment":80,"completionDate":"2021-12-31"},{"nctId":"NCT02549898","phase":"NA","title":"Investigation of Vascular Inflammation in Migraine Using Molecular Nano-imaging and Black Blood Imaging MRI","status":"COMPLETED","sponsor":"Danish Headache Center","startDate":"2015-08","conditions":["Migraine Headache","Migraine Without Aura"],"enrollment":34,"completionDate":"2018-06"},{"nctId":"NCT01142284","phase":"PHASE2","title":"Evaluation of Concomitant Administration of Cilostazol and Probucol on Biomarkers, Endothelial Function and Safety","status":"COMPLETED","sponsor":"Korea Otsuka Pharmaceutical Co., Ltd.","startDate":"2010-05-19","conditions":["Peripheral Artery Disease"],"enrollment":80,"completionDate":"2012-12-18"},{"nctId":"NCT01711333","phase":"PHASE4","title":"A Study to Evaluate the Efficacy and Safety of Pletaal SR Capsule (Cilostazol) in Subjects With Peripheral Arterial Disease Symptom Due to Chronic Occlusive Arterial Disease","status":"COMPLETED","sponsor":"Korea Otsuka Pharmaceutical Co., Ltd.","startDate":"2012-10-26","conditions":["Chronic Occlusive Arterial Disease"],"enrollment":101,"completionDate":"2014-08-18"},{"nctId":"NCT03581409","phase":"PHASE4","title":"Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2018-10-24","conditions":["Aneurysm, Cerebral","Endovascular Procedures"],"enrollment":198,"completionDate":"2021-01-22"},{"nctId":"NCT00549978","phase":"PHASE4","title":"Safety and Pharmacokinetics of Probucol and Cilostazol","status":"COMPLETED","sponsor":"Korea Otsuka Pharmaceutical Co., Ltd.","startDate":"2007-10","conditions":["Healthy"],"enrollment":32,"completionDate":"2008-08"},{"nctId":"NCT03683628","phase":"NA","title":"Treatment of Intermittent Claudication by G-CSF-mobilized PB-MNC","status":"UNKNOWN","sponsor":"Mahidol University","startDate":"2018-10-01","conditions":["Intermittent Claudication","PAD","Atherosclerotic Ischemic Disease"],"enrollment":40,"completionDate":"2023-12-31"},{"nctId":"NCT02554721","phase":"PHASE1","title":"Pharmacodynamic Study of Cilostazol in Healthy Volunteers","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2015-08","conditions":["Healthy"],"enrollment":77,"completionDate":"2018-03-30"},{"nctId":"NCT04999293","phase":"","title":"Ticagrelor in Elderly Patients Undergoing Percutaneous Coronary Intervention","status":"COMPLETED","sponsor":"The First Affiliated Hospital of Dalian Medical University","startDate":"2021-07-20","conditions":["Platelet Aggregation Inhibitors","Dual Anti-Platelet Therapy","Aged","Percutaneous Coronary Intervention"],"enrollment":1505,"completionDate":"2021-08-06"},{"nctId":"NCT01219842","phase":"NA","title":"Invasive Revascularization or Not in Intermittent Claudication","status":"COMPLETED","sponsor":"Sahlgrenska University Hospital","startDate":"2010-03","conditions":["Intermittent Claudication"],"enrollment":159,"completionDate":"2020-06"},{"nctId":"NCT00766545","phase":"PHASE3","title":"Cilostazol Stroke Prevention Study : A Placebo-controlled Double-blind Trial for Secondary Prevention of Cerebral Infarction.","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"1992-04","conditions":["Cerebral Infarction"],"enrollment":1095,"completionDate":"1997-03"},{"nctId":"NCT02770274","phase":"PHASE3","title":"Cilostazol Following Peripheral Endovascular Procedures","status":"UNKNOWN","sponsor":"Attikon Hospital","startDate":"2016-12","conditions":["Peripheral Arterial Disease"],"enrollment":200,"completionDate":"2021-12"},{"nctId":"NCT02983214","phase":"PHASE4","title":"Diabetic Artery Obstruction: is it Possible to Reduce Ischemic Events With Cilostazol?","status":"COMPLETED","sponsor":"University of Ioannina","startDate":"2016-11","conditions":["Ischemic Stroke","Peripheral Artery Disease","Diabetes Mellitus, Type 2"],"enrollment":826,"completionDate":"2019-10"},{"nctId":"NCT02491268","phase":"PHASE2","title":"A Trial of Cilostazol in Patients With Mild Cognitive Impairment (COMCID)","status":"COMPLETED","sponsor":"National Cerebral and Cardiovascular Center, Japan","startDate":"2015-05-01","conditions":["Mild Cognitive Impairment"],"enrollment":166,"completionDate":"2020-12-01"},{"nctId":"NCT04452929","phase":"NA","title":"The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients","status":"UNKNOWN","sponsor":"Danish Headache Center","startDate":"2020-07-22","conditions":["Migraine","Migraine Without Aura","Migraine With Aura"],"enrollment":72,"completionDate":"2022-07"},{"nctId":"NCT01955200","phase":"PHASE4","title":"OPTImal Management of Antithrombotic Agents: OPTIMA-2 Trial","status":"COMPLETED","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2013-10-05","conditions":["Coronary Artery Disease"],"enrollment":1724,"completionDate":"2017-11-28"},{"nctId":"NCT04501900","phase":"PHASE4","title":"The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Zhongshan Hospital","startDate":"2020-10","conditions":["Cardiovascular Diseases"],"enrollment":2106,"completionDate":"2026-04"},{"nctId":"NCT04407312","phase":"PHASE4","title":"Cilostazol and Endothelial Progenitor Cell","status":"UNKNOWN","sponsor":"Gyeongsang National University Hospital","startDate":"2016-01-01","conditions":["Myocardial Infarction, Acute"],"enrollment":60,"completionDate":"2020-07-31"},{"nctId":"NCT03248401","phase":"PHASE4","title":"Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes","status":"COMPLETED","sponsor":"Seoul National University Bundang Hospital","startDate":"2016-09-26","conditions":["Type 2 Diabetes Mellitus","Carotid Atherosclerosis"],"enrollment":50,"completionDate":"2019-12-31"},{"nctId":"NCT01261832","phase":"PHASE4","title":"Efficacy and Safety of Adjunctive Cilostazol in Acute Myocardial Infarction Patients","status":"UNKNOWN","sponsor":"Korea University Guro Hospital","startDate":"2011-07","conditions":["Acute Myocardial Infarction"],"enrollment":951,"completionDate":"2022-03"},{"nctId":"NCT03422796","phase":"NA","title":"The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache","status":"COMPLETED","sponsor":"Danish Headache Center","startDate":"2017-11-01","conditions":["Migraine"],"enrollment":30,"completionDate":"2018-09-01"},{"nctId":"NCT00822172","phase":"PHASE4","title":"Evaluation of Cilostazol in Combination With L-Carnitine","status":"COMPLETED","sponsor":"Colorado Prevention Center","startDate":"2008-09","conditions":["Peripheral Vascular Disease","Intermittent Claudication","Peripheral Arterial Disease"],"enrollment":164,"completionDate":"2010-12"},{"nctId":"NCT02101411","phase":"","title":"Platelet Reactivity (High On-Treatment Platelet Reactivity) as Guidance for APT (Antiplatelet Therapy) Adjustment After PCI (Percutaneous Coronary Intervention)","status":"COMPLETED","sponsor":"Taipei City Hospital","startDate":"2015-01-01","conditions":["PRU(Platelet Reactivity Unit)","APT(Antiplatelet Therapy)","HOTPR(High on Treat Platelet Reactivity)"],"enrollment":334,"completionDate":"2016-10-01"},{"nctId":"NCT03190005","phase":"","title":"Downstream Molecular Signals of P2Y12 Receptors in Hyporeactive Patients Under Clopidogrel Treatment A Possible Mechanism of HOTPR(High On-Treatment Platelet Reactivity)","status":"COMPLETED","sponsor":"Taipei City Hospital","startDate":"2017-01-01","conditions":["Stable Angina"],"enrollment":35,"completionDate":"2017-11-01"},{"nctId":"NCT01261234","phase":"NA","title":"Carotid Artery Stenting With Cilostazol Addition for Restenosis","status":"COMPLETED","sponsor":"Kobe City General Hospital","startDate":"2010-12","conditions":["In-stent Restenosis After Carotid Artery Stenting"],"enrollment":707,"completionDate":"2019-09"},{"nctId":"NCT01291641","phase":"PHASE4","title":"Effect of Probucol and/or Cilostazol on Mean IMT in Patients With Coronary Heart dIsease","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2011-03","conditions":["Hyperlipidemias"],"enrollment":342,"completionDate":"2017-03"},{"nctId":"NCT03318276","phase":"PHASE3","title":"Clinical Trial to Evaluate Efficacy and Safety of SID142 in Patients With Chronic Artery Occlusive Disease","status":"COMPLETED","sponsor":"SK Chemicals Co., Ltd.","startDate":"2017-02-20","conditions":["Peripheral Arterial Disease"],"enrollment":170,"completionDate":"2018-10-15"},{"nctId":"NCT02101437","phase":"NA","title":"The Relationship of Platelet Micro-RNA Expression and Platelet Reactivity in Patients Under Clopidogrel or Ticagrelor Treatment","status":"COMPLETED","sponsor":"Taipei City Hospital","startDate":"2014-01","conditions":["PRU","miRNA"],"enrollment":175,"completionDate":"2017-11-01"},{"nctId":"NCT01932203","phase":"PHASE4","title":"Efficacy Study of Cilostazol and Aspirin on Cerebral Small Vessel Disease","status":"UNKNOWN","sponsor":"Inha University Hospital","startDate":"2013-07-17","conditions":["Cerebral Small Vessel Disease"],"enrollment":255,"completionDate":"2019-08-31"},{"nctId":"NCT03864666","phase":"PHASE1","title":"Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers","status":"COMPLETED","sponsor":"Genovate Biotechnology Co., Ltd.,","startDate":"2019-02-11","conditions":["Intermittent Claudication"],"enrollment":28,"completionDate":"2019-05-03"},{"nctId":"NCT01995370","phase":"PHASE4","title":"Cilostazol Stroke Prevention Study for Antiplatelet Combination","status":"COMPLETED","sponsor":"Japan Cardiovascular Research Foundation","startDate":"2013-12-13","conditions":["Noncardioembolic Cerebral Infarction"],"enrollment":1884,"completionDate":"2018-12-07"},{"nctId":"NCT02829151","phase":"PHASE4","title":"Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study)","status":"UNKNOWN","sponsor":"Yonsei University","startDate":"2017-02-21","conditions":["Critical Limb Ischemia"],"enrollment":390,"completionDate":"2021-10"},{"nctId":"NCT02374957","phase":"PHASE4","title":"Cilostazol After Lower Extremity Arterial Revascularization Trial","status":"TERMINATED","sponsor":"Wake Forest University Health Sciences","startDate":"2015-02","conditions":["Peripheral Arterial Disease","Claudication (Finding)"],"enrollment":20,"completionDate":"2017-06-30"},{"nctId":"NCT03524963","phase":"PHASE1","title":"Comparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea","status":"COMPLETED","sponsor":"Bundang CHA Hospital","startDate":"2017-08-07","conditions":["Peripheral Artery Disease"],"enrollment":30,"completionDate":"2018-06-30"},{"nctId":"NCT03480321","phase":"PHASE1","title":"Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers","status":"COMPLETED","sponsor":"Genovate Biotechnology Co., Ltd.,","startDate":"2018-03-06","conditions":["Intermittent Claudication"],"enrollment":21,"completionDate":"2018-06-07"},{"nctId":"NCT00443287","phase":"PHASE2","title":"Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease","status":"COMPLETED","sponsor":"Sanofi","startDate":"2007-02","conditions":["Intermittent Claudication"],"enrollment":553,"completionDate":"2008-10"},{"nctId":"NCT03471169","phase":"PHASE1","title":"Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease","status":"UNKNOWN","sponsor":"Xuanwu Hospital, Beijing","startDate":"2017-04-01","conditions":["Cerebrovascular Disease"],"enrollment":3500,"completionDate":"2018-12-01"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Tablet","formulations":[{"form":"TABLET","route":"ORAL","productName":"CILOSTAZOL"},{"form":"TABLET","route":"ORAL","productName":"Cilostazol"},{"form":"TABLET","route":"ORAL","productName":"cilostazol"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000148605","MMSL":"14036","NDDF":"007339","UNII":"N7Z035406B","VUID":"4021153","CHEBI":"CHEBI:31401","VANDF":"4021153","INN_ID":"5680","RXNORM":"21107","UMLSCUI":"C0055729","chemblId":"CHEMBL799","ChEMBL_ID":"CHEMBL799","KEGG_DRUG":"D01896","DRUGBANK_ID":"DB01166","PUBCHEM_CID":"2754","SNOMEDCT_US":"116087001","IUPHAR_LIGAND_ID":"7148","MESH_DESCRIPTOR_UI":"D000077407"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1999-","companyName":"Otsuka","relationship":"Original Developer"}],"publicationCount":2321,"therapeuticAreas":["Metabolic"],"atcClassification":{"source":"DrugCentral","atcCode":"B01AC23","allCodes":["B01AC23"]},"biosimilarFilings":[],"originalDeveloper":"Otsuka","recentPublications":[{"date":"2026 Mar 2","pmid":"41897461","title":"Nano-Cilostazol Mitigates Cisplatin-Induced Nephrotoxicity in Rats via Modulation of Oxidative Stress, Apoptosis, Pyroptosis, and miRNA-155 Signaling.","journal":"Antioxidants (Basel, Switzerland)"},{"date":"2026 Mar 26","pmid":"41882452","title":"Cost-utility framework to evaluate therapeutic interventions targeting reduction in cerebral infarction among aneurysmal subarachnoid hemorrhage patients.","journal":"Neurosurgical review"},{"date":"2026 Mar 24","pmid":"41872117","title":"The Efficacy and Safety of Cilostazol as an Alternative Antiplatelet Therapy After Coronary Stent Implantation in Patients With Aspirin Intolerance.","journal":"Cardiology in review"},{"date":"2026 Mar 14","pmid":"41831015","title":"Efficacy and safety of dual and triple antiplatelet therapies in East Asian patients with acute coronary syndrome: a systematic review and network meta-analysis of randomized controlled trials.","journal":"Postgraduate medical journal"},{"date":"2026 Mar 12","pmid":"41817850","title":"Comparative effectiveness of cilostazol and aspirin in ischemic stroke: a retrospective cohort study.","journal":"Acta neurologica Belgica"}],"companionDiagnostics":[],"genericManufacturers":12,"_genericFilersChecked":true,"genericManufacturerList":["Actavis Elizabeth","Apotex","Aurobindo Pharma Usa","Chartwell Rx","Epic Pharma Llc","Hikma","Ivax Sub Teva Pharms","Pliva Hrvatska Doo","Rising","Sankalp Lifecare","Slate Run Pharma","Teva"],"status":"approved","companyName":"Otsuka","companyId":"otsuka","modality":"Small molecule","firstApprovalDate":"1999","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1999-01-15T00:00:00.000Z","mah":"OTSUKA","brand_name_local":null,"application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2006-03-29T00:00:00.000Z","mah":"SLATE RUN PHARMA","brand_name_local":null,"application_number":"ANDA077208"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2007-08-16T00:00:00.000Z","mah":"APOTEX","brand_name_local":null,"application_number":"ANDA077030"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2008-03-10T00:00:00.000Z","mah":"CHARTWELL RX","brand_name_local":null,"application_number":"ANDA077021"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2008-03-10T00:00:00.000Z","mah":"CHARTWELL RX","brand_name_local":null,"application_number":"ANDA077310"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2014-11-06T00:00:00.000Z","mah":"TEVA","brand_name_local":null,"application_number":"ANDA077027"},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":12,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:52:22.494386+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}