Cilostazol Clinical Trials

Size	Price	Qty
25mg	USD 147
100mg	USD 297

Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4, alongside non-applicable phase designs, evaluate cilostazol primarily for arterial occlusive diseases, peripheral arterial disease with claudication, coronary artery disease, migraine, and chemotherapy-induced peripheral neuropathy. Sponsored by academic medical centers, government organizations, and pharmaceutical entities, these studies encompass various recruitment statuses—including active, recruiting, completed, and terminated—to investigate therapeutic vascular outcomes and headache mechanisms.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06530537	RECRUITING	Cerebral Microbleeds; Stroke	Zhejiang Provincial People's Hospital	2024-07-18	PHASE3
NCT07174414	NOT_YET_RECRUITING	Stroke Recurrence; Myocardial Infarction; Vascular Death; Ischemic Stroke; TIA (Transient Ischemic Attack); Stroke (CVA) or Transient Ischemic Attack; Recurrent Stroke	Stanford University	2026-08	PHASE3
NCT04753970	RECRUITING	Cerebral Small Vessel Diseases; Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy; Cerebral Microbleeding; Sporadic White Matter Disease	Mayo Clinic	2021-02-09	PHASE1; PHASE2
NCT07144956	NOT_YET_RECRUITING	Aneurysmal Subarachnoid Hemorrhage	Centre Hospitalier St Anne	2025-12-15	PHASE3
NCT06919835	NOT_YET_RECRUITING	Stroke	Northern California Institute of Research and Education	2026-08-01	PHASE3
NCT07719894	RECRUITING	Type 2 Diabetes Mellitus (T2DM); Atherosclerosis	Seoul National University Bundang Hospital	2026-05-06	PHASE4
NCT06757764	RECRUITING	Cerebral Infarction; Stenosis Artery	Asan Medical Center	2025-07-10	PHASE4
NCT07588932	RECRUITING	Stroke	Spaulding Rehabilitation Hospital	2026-05-18	EARLY_PHASE1
NCT07180472	NOT_YET_RECRUITING	Cerebral Small Vessel Disease	First Affiliated Hospital of Chengdu Medical College	2025-09-20	PHASE4
NCT07249853	NOT_YET_RECRUITING	Aneurysmal Subarachnoid Hemorrhage	Beijing Tiantan Hospital	2025-11-30	PHASE3
NCT06504576	RECRUITING	ICH - Intracerebral Hemorrhage	National Taiwan University Hospital	2025-06-16	PHASE2
NCT03109288	RECRUITING	Multiple Sclerosis	National Institute of Allergy and Infectious Diseases (NIAID)	2017-08-11	PHASE1; PHASE2
NCT06402747	RECRUITING	Type 2 Diabetes; Atherosclerosis	Seoul National University Bundang Hospital	2024-04-16	PHASE4
NCT06989697	RECRUITING	Type 2 Diabets Mellitus; Cognitive Ability, General	Seoul National University Bundang Hospital	2025-01-01	PHASE3
NCT06492070	RECRUITING	Cervical Carcinoma; Fallopian Tube Carcinoma; Malignant Solid Neoplasm; Malignant Uterine Neoplasm; Ovarian Carcinoma; Primary Peritoneal Carcinoma; Vulvar Carcinoma	Emory University	2024-08-01	PHASE2
NCT07238985	RECRUITING	Fatty Liver	Tanta University	2025-11-01	PHASE1; PHASE2
NCT06561867	UNKNOWN	Ischemic Stroke	Kafrelsheikh University	2024-08-30	PHASE3
NCT06053021	UNKNOWN	Acute Ischemic Stroke; Thrombocytopenia	Second Affiliated Hospital, Zhejiang University, School of Medicine	2023-09-15
NCT06612593	NOT_YET_RECRUITING	Parkinson's Disease	Ain Shams University	2024-10-01	PHASE2
NCT06591377	RECRUITING	Ischemic Stroke	Kafrelsheikh University	2024-08-10	PHASE3
NCT06202755	UNKNOWN	Ischemic Stroke	Kafrelsheikh University	2024-03-30	PHASE3
NCT06117436	COMPLETED	Wound Heal	Ain Shams University	2023-10-19	PHASE2; PHASE3
NCT04789837	WITHDRAWN	Osteoarthritis	Sadat City University	2021-03-01	PHASE1; PHASE2
NCT06196047	UNKNOWN	Ischemic Stroke	Kafrelsheikh University	2023-12-01	PHASE3
NCT05759819	ACTIVE_NOT_RECRUITING	Peripheral Arterial Disease	Otsuka Medical Devices Co., Ltd. Japan	2023-03-10
NCT05594680	UNKNOWN	Rheumatoid Arthritis	Tanta University	2022-10-01	PHASE3
NCT06138834	UNKNOWN	Acute Ischemic Stroke; Large Vessel Occlusion; Reperfusion	Beijing Tiantan Hospital	2023-11	PHASE2
NCT04761848	WITHDRAWN	Fatty Liver, Nonalcoholic	Sadat City University	2021-02-16	PHASE1; PHASE2
NCT05671497	COMPLETED	Rheumatoid Arthritis	Ain Shams University	2022-11-01	PHASE2; PHASE3
NCT06591351	RECRUITING	Ischemic Stroke	Kafrelsheikh University	2022-05-01	PHASE3
NCT06591390	RECRUITING	Ischemic Stroke	Kafrelsheikh University	2022-02-09	PHASE3
NCT06591299	RECRUITING	Ischemic Stroke	Kafrelsheikh University	2022-04-15	PHASE3
NCT06242132	COMPLETED	Ischemic Stroke	Kafrelsheikh University	2022-06-01	PHASE3
NCT06242145	COMPLETED	Ischemic Stroke	Kafrelsheikh University	2023-01-01	PHASE3
NCT05836766	UNKNOWN	Acute Ischemic Stroke; Reperfusion; Large Vessel Occlusion	Beijing Tiantan Hospital	2023-06-05	PHASE2
NCT06268470	UNKNOWN	Chronic Urticaria	Chulalongkorn University	2018-06-01	PHASE2
NCT05595993	UNKNOWN	Post-Traumatic Headache	Danish Headache Center	2022-10-25
NCT06167265	COMPLETED	Intermittent Claudication	Genovate Biotechnology Co., Ltd.,	2023-11-28	PHASE1
NCT05906199	COMPLETED	Diabetic Peripheral Angiopathy	SK Chemicals Co., Ltd.	2021-07-28	PHASE4
NCT04148105	TERMINATED	Aneurysmal Subarachnoid Hemorrhage	Henry Ford Health System	2019-11-01	PHASE4
NCT03855332	COMPLETED	Small Vessel Cerebrovascular Disease	University of Oxford	2019-07-11	PHASE2
NCT05298696	COMPLETED	Peripheral Neuropathy; Breast Cancer	Mansoura University	2022-03-28	PHASE1; PHASE2
NCT06522113	COMPLETED	Ischemic Stroke; TIA	Incheon St.Mary's Hospital	2019-07-18	PHASE4
NCT05466734	COMPLETED	Intermittent Claudication	Genovate Biotechnology Co., Ltd.,	2022-07-05	PHASE1
NCT05126836	COMPLETED	Heart Failure With Preserved Ejection Fraction	University of Minnesota	2021-09-01	PHASE2
NCT03451591	COMPLETED	Cerebral Small Vessel Diseases; Stroke, Lacunar	University of Edinburgh	2018-01-08	PHASE2; PHASE3
NCT05191862	TERMINATED	Intermittent Claudication	Genovate Biotechnology Co., Ltd.,	2022-04-23	PHASE1
NCT04452929	UNKNOWN	Migraine; Migraine Without Aura; Migraine With Aura	Danish Headache Center	2020-07-22
NCT04069819	COMPLETED	Major Depressive Disorder	Sadat City University	2019-08-01
NCT02770274	UNKNOWN	Peripheral Arterial Disease	Attikon Hospital	2016-12	PHASE3
NCT02829151	UNKNOWN	Critical Limb Ischemia	Yonsei University	2017-02-21	PHASE4
NCT03581409	COMPLETED	Aneurysm, Cerebral; Endovascular Procedures	Seoul National University Hospital	2018-10-24	PHASE4
NCT02491268	COMPLETED	Mild Cognitive Impairment	National Cerebral and Cardiovascular Center, Japan	2015-05-01	PHASE2
NCT03189641	COMPLETED	Coronary Artery Disease	JIMRO Co., Ltd.	2017-05-31
NCT01261832	UNKNOWN	Acute Myocardial Infarction	Korea University Guro Hospital	2011-07	PHASE4
NCT02983214	COMPLETED	Ischemic Stroke; Peripheral Artery Disease; Diabetes Mellitus, Type 2	University of Ioannina	2016-11	PHASE4
NCT01932203	UNKNOWN	Cerebral Small Vessel Disease	Inha University Hospital	2013-07-17	PHASE4
NCT03864666	COMPLETED	Intermittent Claudication	Genovate Biotechnology Co., Ltd.,	2019-02-11	PHASE1
NCT01261234	COMPLETED	In-stent Restenosis After Carotid Artery Stenting	Kobe City General Hospital	2010-12
NCT04407312	UNKNOWN	Myocardial Infarction, Acute	Gyeongsang National University Hospital	2016-01-01	PHASE4
NCT01995370	COMPLETED	Noncardioembolic Cerebral Infarction	Japan Cardiovascular Research Foundation	2013-12-13	PHASE4
NCT03248401	COMPLETED	Type 2 Diabetes Mellitus; Carotid Atherosclerosis	Seoul National University Bundang Hospital	2016-09-26	PHASE4
NCT03422796	COMPLETED	Migraine	Danish Headache Center	2017-11-01
NCT02549898	COMPLETED	Migraine Headache; Migraine Without Aura	Danish Headache Center	2015-08
NCT03480321	COMPLETED	Intermittent Claudication	Genovate Biotechnology Co., Ltd.,	2018-03-06	PHASE1
NCT02554721	COMPLETED	Healthy	Otsuka Pharmaceutical Co., Ltd.	2015-08	PHASE1
NCT03156920	COMPLETED	Migraine	Danish Headache Center	2017-05-23
NCT02174939	UNKNOWN	Coronary Artery Disease	National Cheng-Kung University Hospital	2014-02	PHASE4
NCT01359423	COMPLETED	Claudication	Yonsei University	2011-09-26
NCT02481323	COMPLETED	Cerebral Small Vessel Diseases; Cognitive Impairment; Stroke	University of Edinburgh	2016-03	PHASE2
NCT02374957	TERMINATED	Peripheral Arterial Disease; Claudication (Finding)	Wake Forest University Health Sciences	2015-02	PHASE4
NCT03156920	Completed	Migraine	Danish Headache Center	2017-05-23	Not Applicable
NCT06886620	TERMINATED	Intermittent Claudication	Genovate Biotechnology Co., Ltd.,	2016-03-14	PHASE3
NCT01955200	COMPLETED	Coronary Artery Disease	The First Affiliated Hospital with Nanjing Medical University	2013-10-05	PHASE4
NCT02933788	UNKNOWN	Type 2 Diabetes Mellitus	Kangbuk Samsung Hospital	2016-10	PHASE4
NCT01291641	COMPLETED	Hyperlipidemias	Seoul National University Hospital	2011-03	PHASE4
NCT02266030	COMPLETED	Coronary Artery Disease	Seoul National University Bundang Hospital	2011-02	PHASE3
NCT01013532	UNKNOWN	Brain Ischemia; Intracranial Hemorrhages	Asan Medical Center	2009-06	PHASE4
NCT02483169	UNKNOWN	Brain Ischemia; Intracranial Hemorrhages	Asan Medical Center	2009-06	PHASE4
NCT01779401	COMPLETED	Coronary Heart Disease	Chinese Academy of Medical Sciences, Fuwai Hospital	2012-09
NCT02486276	COMPLETED	Migraine	Danish Headache Center	2015-06
NCT02098460	COMPLETED	Severe Hypercholesterolemia	Otsuka Beijing Research Institute	2013-10	PHASE4
NCT02094469	COMPLETED	Vasospastic Angina	Korea Otsuka Pharmaceutical Co., Ltd.	2013-12	PHASE3
NCT01895400	TERMINATED	Recurrent Vestibulopathy	Jong Woo Chung	2013-07	PHASE3
NCT02253004	COMPLETED	Migraine With Aura; Stroke	Herlev Hospital	2014-09	EARLY_PHASE1
NCT02431013	UNKNOWN	Dyslipidemias; Peripheral Artery Disease	Ajou University School of Medicine	2015-04	PHASE1
NCT02087007	COMPLETED	Vasospastic Angina	Korea Otsuka Pharmaceutical Co., Ltd.	2013-11	PHASE3
NCT02625714	Completed	Arterial Occlusive Diseases	SK Chemicals Co. Ltd.	2015-06	Phase 1
NCT02374957	Terminated	Peripheral Arterial Disease\|Claudication (Finding)	Wake Forest University Health Sciences	2015-02	Phase 4
NCT01346865	TERMINATED	Coronary Artery Disease	Seung-Jung Park	2011-05	PHASE4
NCT03116269	COMPLETED	Ischemic Stroke; Endothelial Dysfunction	Ajou University School of Medicine	2012-03-01	PHASE4
NCT01915069	COMPLETED	Contraception	University of Southern California	2013-07	PHASE2
NCT01711333	COMPLETED	Chronic Occlusive Arterial Disease	Korea Otsuka Pharmaceutical Co., Ltd.	2012-10-26	PHASE4
NCT02194686	COMPLETED	Cardiovascular Diseases	National Cheng-Kung University Hospital	2013-01	PHASE4
NCT02098460	Unknown status	Severe Hypercholesterolemia	Otsuka Beijing Research Institute	2013-10	Phase 4
NCT01952756	COMPLETED	Peripheral Arterial Diseases	National Cheng-Kung University Hospital	2012-01	PHASE4
NCT01870466	COMPLETED	Healthy	Samsung Medical Center	2012-06	PHASE1
NCT00132743	UNKNOWN	Cardiovascular Diseases; Peripheral Vascular Diseases; Atherosclerosis	Joselyn Cerezo, MD	2007-02	PHASE3
NCT01188824	COMPLETED	Ischemic Stroke	China Medical University Hospital	2010-09	PHASE4
NCT01841827	COMPLETED	Migraine	Danish Headache Center	2013-04
NCT01378650	COMPLETED	Tinnitus	Jong Woo Chung	2011-07
NCT01841827	Completed	Migraine	Danish Headache Center	2013-04	Not Applicable
NCT01192724	COMPLETED	Coronary Artery Disease	Yonsei University	2010-03	PHASE4
NCT01252056	COMPLETED	Diabetic Nephropathy	Otsuka Beijing Research Institute	2010-03	PHASE4
NCT01142284	COMPLETED	Peripheral Artery Disease	Korea Otsuka Pharmaceutical Co., Ltd.	2010-05-19	PHASE2
NCT01872858	UNKNOWN	Mild Cognitive Impairment	Huashan Hospital	2010-11
NCT01354808	COMPLETED	Platelet Aggregation Inhibitors; Anti-inflammatory Agent; Myocardial Reperfusion Injury	Gyeongsang National University Hospital	2010-07	PHASE4
NCT01444885	COMPLETED	Variant Angina	Korea Otsuka Pharmaceutical Co., Ltd.	2011-10	PHASE2
NCT01409564	COMPLETED	Alzheimer's Dementia	Seoul National University Hospital	2010-05	PHASE4
NCT00912756	UNKNOWN	Arteriosclerosis Obliterans	Kansai Rosai Hospital	2009-03	PHASE4
NCT01094457	COMPLETED	Acute Coronary Syndromes; Percutaneous Coronary Intervention; Clopidogrel Low Responsiveness	Shenyang Northern Hospital	2009-03	PHASE4
NCT00333164	COMPLETED	Cerebrovascular Disease	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	2006-05	PHASE3
NCT01482117	COMPLETED	Interaction	Inje University	2011-11
NCT01383395	COMPLETED	Healthy	Samsung Medical Center	2011-06	PHASE1
NCT01031667	COMPLETED	Therapy	Yonsei University	2009-11	PHASE4
NCT00847860	COMPLETED	Vascular Dementia; Stroke	Peking University First Hospital	2008-03	PHASE4
NCT00886574	UNKNOWN	Type 2 Diabetes Mellitus	Hanyang University	2009-04	PHASE4
NCT00938522	UNKNOWN	Angioplasty, Transluminal, Percutaneous Coronary	Samsung Medical Center	2009-07	PHASE4
NCT00822172	COMPLETED	Peripheral Vascular Disease; Intermittent Claudication; Peripheral Arterial Disease	Colorado Prevention Center	2008-09	PHASE4
NCT01328470	COMPLETED	Chronic Kidney Disease; Stable Angina	Kyunghee University Medical Center	2009-09	PHASE4
NCT00783081	COMPLETED	Intermittent Claudication	Kowa Research Institute, Inc.	2008-11	PHASE2
NCT00776828	COMPLETED	Coronary Artery Disease	Seoul National University Hospital	2006-11	PHASE4
NCT00823875	COMPLETED	Atherosclerosis Cerebral Infarction	Otsuka Beijing Research Institute	2009-03	PHASE4
NCT00589927	COMPLETED	Coronary Artery Disease	CardioVascular Research Foundation, Korea	2007-12	PHASE4
NCT00915733	COMPLETED	Myocardial Infarction	Gyeongsang National University Hospital	2009-05	PHASE4
NCT01455558	COMPLETED	Healthy	Severance Hospital	2009-02	PHASE1
NCT00823849	COMPLETED	Type 2 Diabetes Mellitus; Arteriosclerosis Obliterans	Otsuka Beijing Research Institute	2008-10	PHASE4
NCT01012193	COMPLETED	Coronary Artery Disease; Percutaneous Coronary Intervention	Gyeongsang National University Hospital	2008-01	PHASE4
NCT00891670	UNKNOWN	Coronary Artery Stenosis; Maximal Platelet Aggregation; Late Platelet Aggregation; High Post-Treatment Platelet Reactivity	Gyeongsang National University Hospital	2009-05	PHASE3
NCT00773630	COMPLETED	Intermittent Claudication	Otsuka Frankfurt Research Institute GmbH	2008-12	PHASE1
NCT00130039	COMPLETED	Cerebral Infarction; Atherosclerosis	Asan Medical Center	2005-08	PHASE4
NCT00620646	COMPLETED	Clopidogrel Non-Responsiveness	Samsung Medical Center	2008-02
NCT00234065	COMPLETED	Cerebral Infarction	Otsuka Pharmaceutical Co., Ltd.	2003-12	PHASE4
NCT00741286	COMPLETED	Cerebral Infarction	Inje University	2006-11	PHASE4
NCT00443287	COMPLETED	Intermittent Claudication	Sanofi	2007-02	PHASE2
NCT00689858	COMPLETED	Healthy	SK Chemicals Co., Ltd.	2007-05	PHASE1
NCT00446641	COMPLETED	Cerebral Infarction	Asan Medical Center	2007-03	PHASE4
NCT00549978	COMPLETED	Healthy	Korea Otsuka Pharmaceutical Co., Ltd.	2007-10	PHASE4
NCT00431249	COMPLETED	Hemodialysis Patients; Peripheral Vascular Disease	Tungs' Taichung Metroharbour Hospital	2007-02	PHASE4
NCT00272831	COMPLETED	Diabetes Mellitus, Type 2; Diabetes Complications	Chinese University of Hong Kong	2005-12	PHASE4
NCT00300339	COMPLETED	Intermittent Claudication	Sanofi	2006-02	PHASE2
NCT00404781	COMPLETED	Ischemic Heart Disease; Acute Coronary Syndromes	Shenyang Northern Hospital	2006-06	PHASE4
NCT00685802	COMPLETED	Therapeutic Equivalency, Healthy	Mutual Pharmaceutical Company, Inc.	2004-06	PHASE1
NCT00648388	COMPLETED	Healthy	Mylan Pharmaceuticals Inc	2004-03	PHASE1
NCT00602407	COMPLETED	Intermittent Claudication	Roxane Laboratories	2004-02
NCT00684762	COMPLETED	Therapeutic Equivalency	Mutual Pharmaceutical Company, Inc.	2004-03	PHASE1
NCT00839930	COMPLETED	Healthy	Teva Pharmaceuticals USA	2004-02	PHASE1
NCT00881231	COMPLETED	Pain	Sandoz	2004-01	PHASE1
NCT00838630	COMPLETED	Healthy	Teva Pharmaceuticals USA	2003-11	PHASE1
NCT00602173	COMPLETED	Intermittent Claudication	Roxane Laboratories	2003-05
NCT00766545	COMPLETED	Cerebral Infarction	Otsuka Pharmaceutical Co., Ltd.	1992-04	PHASE3
NCT00048776	COMPLETED	Raynaud's Disease	Otsuka America Pharmaceutical	2001-10	PHASE4
NCT00573950	UNKNOWN	Diabetes Mellitus, Type 2; Metabolic Syndrome X	Korea University Anam Hospital	2007-12	PHASE4
NCT00048763	COMPLETED	Raynaud's Disease	Otsuka America Pharmaceutical	2001-10	PHASE4
NCT00272454	COMPLETED	Cerebral Infarction	Korea Otsuka Pharmaceutical Co., Ltd.	2006-01	PHASE4
NCT00202020	COMPLETED	Cerebral Infarction	Otsuka Beijing Research Institute	2004-05	PHASE3
NCT01076478	COMPLETED	Polyneuropathy	Otsuka Pharmaceutical, Inc., Philippines	2004-03	PHASE4
NCT00404716	COMPLETED	Acute Coronary Syndrome	Shenyang Northern Hospital	2004-12	PHASE4

(data from https://clinicaltrials.gov, updated on 2024-07-31)

Check the Cilostazol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cilostazol selectively inhibits cyclic nucleotide phosphodiesterase type 3 (PDE3), thereby suppressing the degradation of intracellular cyclic adenosine monophosphate (cAMP) and inhibiting cellular adenosine uptake. The resulting elevation in intracellular cAMP levels suppresses platelet activation and relaxes vascular smooth muscle, inducing potent arterial vasodilation and antiplatelet aggregation that directly alleviates symptoms of intermittent claudication in peripheral arterial disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).