Drugs / Cilostazol
last change Aug 2026 re-read 9 days ago

Cilostazol

also known as Pletal · Pletaal · PMR · CTZ · CLS · CSZ · NSC-758936 · OPC-13013 · +3 more

Small molecule targets PDE3A via inhibition

Developed for
cerebral infarction · stroke disorder · peripheral arterial disease · coronary artery disorder · ischemic stroke · type 2 diabetes mellitus · cerebrovascular disorder · intermittent vascular claudication
+49 more · acquired aneurysmal subarachnoid hemorrhage · acute coronary syndrome · intracerebral hemorrhage · acute myocardial infarction · arteriosclerosis obliterans · atherosclerosis · brain ischemia · carotid stenosis · cognitive impairment with or without cerebellar ataxia · coronary vasospasm · Raynaud disease · transient ischemic attack · Alzheimer disease · atrial fibrillation · brain aneurysm · cerebral artery stenosis · CGF1 · chronic urticaria · cognitive disorder · diabetic peripheral angiopathy · diastolic heart failure · intracranial arteriosclerosis · large artery stroke · limb ischemia · major depressive disorder · metabolic syndrome X · multiple sclerosis · myocardial infarction · myocardial stunning · NAFLD1 · osteoarthritis · Parkinson disease · peripheral arterial occlusive disease 1 · platelet aggregation, spontaneous · polyneuropathy · Prinzmetal angina · rheumatoid arthritis · tinnitus · vascular dementia · cardiovascular disorder · cerebral artery occlusion · chronic kidney disease · coronary stenosis · diabetic kidney disease · fatty liver disease · hyperlipidemia · peripheral neuropathy · peripheral vascular disease · vestibular disorder
Investigated by
Korea Otsuka Pharmaceutical Co., Ltd. · Asan Medical Center · SK Chemicals Co., Ltd. · Otsuka Pharmaceutical Co., Ltd. · Samsung Medical Center · Seoul National University Bundang Hospital
+98 more · Beijing Tiantan Hospital · Genovate Biotechnology Co., Ltd. · Otsuka Beijing Research Institute · Sadat City University · Seoul National University Hospital · Shenyang Northern Hospital · Ain Shams University · Danish Headache Center · Foundation for Biomedical Research and Innovation · Gyeongsang National University Hospital · Kobe City General Hospital · Korea Otsuka International Asia Arab · Korea United Pharm. Inc. · Mutual Pharmaceutical Company, Inc. · Neurodawn Pharmaceutical Co., Ltd. · Otsuka America Pharmaceutical · Otsuka Pharmaceutical Development & Commercialization, Inc. · Second Affiliated Hospital, School of Medicine, Zhejiang University · Teva Pharmaceuticals USA · Zhejiang Otsuka Pharmaceutical Co., Ltd. · Ajou University School of Medicine · Al-Azhar University · Association for Establishment of Ebvidence in Interventions · Attikon Hospital · Boston Scientific Corporation · Bundang CHA Hospital · CardioVascular Research Foundation · CardioVascular Research Foundation, Korea · Centre Hospitalier St Anne · Chiba University · China National Center for Cardiovascular Diseases · Chinese PLA General Hospital · Chulalongkorn University · Department of Neurology, Saiseikai Central Hospital · Emory University · First Affiliated Hospital of Chengdu Medical College · Fukuoka University · Henry Ford Health System · Herlev Hospital · Huashan Hospital · Incheon St.Mary's Hospital · Inha University Hospital · Inje University · Japan Cardiovascular Research Foundation · Jong Woo Chung · Kangbuk Samsung Hospital · Kansai Rosai Hospital · Kobe University · Korea OIAA · Korea University Anam Hospital · Korea University Guro Hospital · Kyoto University · Kyushu University · Mayo Clinic · Medical University of South Carolina · Mie University · Misr International University · Mylan Pharmaceuticals Inc · Nagasaki University · Nagoya University · National Cancer Institute (NCI) · National Cerebral and Cardiovascular Center, Japan · National Institute of Allergy and Infectious Diseases (NIAID) · National Institute of Neurological Disorders and Stroke (NINDS) · National Natural Science Foundation of China · National Taiwan University Hospital · Neuro-Innovators, Inc. · Neurology, Tokyo Women's Medical University, School of Medicine · Northern California Institute of Research and Education · Okayama University · Osaka University · Otsuka Frankfurt Research Institute GmbH · Otsuka Korea · Otsuka Pharmaceutical Co., Ltd. · all 104 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) PLETAL — 2007-01-18 fda.gov ↗
Approved US (FDA) PLETAL — 1999-01-15 fda.gov ↗

Trials 104 · started per year

today
US approved 1999
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1992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT07588932 May 2026 → Dec 2027 expected stroke disorder Spaulding Rehabilitation Hospital Recruiting No outcome recorded
Phase 0 NCT02253004 Sep 2014 → Aug 2015 migraine with aura, stroke disorder Herlev Hospital Completed No outcome recorded
Phase 118 trials · 1 met primary
Phase 1 NCT06167265 Nov → Dec 2023 intermittent vascular claudication Genovate Biotechnology Co., Ltd. Completed No outcome recorded
Phase 1 NCT05466734 Jul → Aug 2022 intermittent vascular claudication Genovate Biotechnology Co., Ltd. Completed No outcome recorded
Phase 1 NCT03524963 Aug 2017 → May 2018 peripheral arterial disease Bundang CHA Hospital Completed No outcome recorded
Phase 1 NCT03471169 Apr 2017 → Dec 2018 cerebrovascular disorder Xuanwu Hospital, Beijing Unknown No outcome recorded
Phase 1 NCT06568133 Mar → Jul 2017 — Korea United Pharm. Inc. Completed No outcome recorded
Phase 1 NCT02554721 Aug 2015 → Mar 2018 — Otsuka Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1 NCT02625714 Jun → Jul 2015 arterial occlusion SK Chemicals Co., Ltd. Completed No outcome recorded
Phase 1 NCT01870466 Jun 2012 → Sep 2013 — Samsung Medical Center Completed No outcome recorded
Phase 1 NCT01383395 Jun → Sep 2011 — Samsung Medical Center Completed No outcome recorded
Phase 1 NCT01455558 Feb → Aug 2009 — Severance Hospital Completed Mixed
Phase 1/24 trials
Phase 1/2 NCT04789837 Mar 2021 → Dec 2024 osteoarthritis Sadat City University Withdrawn No outcome recorded Stop: Business
Phase 1/2 NCT04761848 Feb 2021 → Oct 2024 NAFLD1 Sadat City University Withdrawn No outcome recorded Stop: Business
Phase 1/2 NCT04753970 Feb 2021 → Jun 2026 overdue cerebral arteriopathy, autosomal dominant, with subcortical infarcts and leukoencephalopathy, type 1, cerebrovascular disorder Mayo Clinic Recruiting No outcome recorded
Phase 1/2 NCT03109288 Aug 2017 → Jan 2027 expected multiple sclerosis National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase 211 trials · 2 met primary · 1 missed
Phase 2 NCT06504576 Jun 2025 → Jan 2027 expected intracerebral hemorrhage National Taiwan University Hospital Recruiting No outcome recorded
Phase 2 NCT06612593 Oct 2024 → Oct 2025 overdue Parkinson disease Ain Shams University Not yet recruiting No outcome recorded
Phase 2 NCT06492070 Aug 2024 → Dec 2026 expected cervical carcinoma, fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma +1 Emory University Recruiting No outcome recorded
Phase 2 NCT06138834 Nov 2023 → Nov 2024 ischemic stroke, large artery stroke Beijing Tiantan Hospital Unknown No outcome recorded
Phase 2 NCT05126836 Sep 2021 → Jun 2022 diastolic heart failure University of Minnesota Completed Met primary
Phase 2 NCT06268470 Jun 2018 → Mar 2024 chronic urticaria Chulalongkorn University Unknown No outcome recorded
Phase 2 NCT02481323 Mar 2016 → Aug 2017 cognitive disorder, stroke disorder University of Edinburgh Completed No outcome recorded
Phase 2 NCT02491268 May 2015 → Aug 2020 cognitive impairment with or without cerebellar ataxia National Cerebral and Cardiovascular Center, Japan Completed Missed primary
Phase 2 NCT01915069 Jul 2013 → Aug 2014 — University of Southern California Completed No outcome recorded
Phase 2 NCT01444885 Oct 2011 → Jul 2012 Prinzmetal angina Korea Otsuka Pharmaceutical Co., Ltd. Completed Met primary
Phase 2/31 trial
Phase 2/3 NCT05671497 Nov 2022 → Oct 2024 rheumatoid arthritis Ain Shams University Completed No outcome recorded
Phase 317 trials · 1 met primary · 1 missed
Phase 3 NCT06919835 Aug 2026 → Jul 2029 expected stroke disorder Northern California Institute of Research and Education Not yet recruiting No outcome recorded
Phase 3 NCT07174414 Aug 2026 → Jul 2031 expected myocardial infarction, transient ischemic attack Stanford University Not yet recruiting No outcome recorded
Phase 3 NCT07144956 Dec 2025 → Dec 2029 expected acquired aneurysmal subarachnoid hemorrhage Centre Hospitalier St Anne Not yet recruiting No outcome recorded
Phase 3 NCT07249853 Nov 2025 → May 2027 expected acquired aneurysmal subarachnoid hemorrhage Beijing Tiantan Hospital Not yet recruiting No outcome recorded
Phase 3 NCT07040085 Aug 2025 → Jun 2027 expected stroke disorder Beijing Tiantan Hospital Not yet recruiting No outcome recorded
Phase 3 NCT06989697 Jan 2025 → Dec 2026 expected CGF1, type 2 diabetes mellitus Seoul National University Bundang Hospital Recruiting No outcome recorded
Phase 3 NCT06530537 Jul 2024 → Aug 2031 expected stroke disorder Zhejiang Provincial People's Hospital Recruiting No outcome recorded
Phase 3 NCT07600385 Mar 2019 → May 2022 peripheral arterial disease Korea United Pharm. Inc. Completed No outcome recorded
Phase 3 NCT03318276 Feb 2017 → Oct 2018 peripheral arterial disease SK Chemicals Co., Ltd. Completed Met primary
Phase 3 NCT02770274 Dec 2016 → Dec 2021 peripheral arterial disease Attikon Hospital Unknown No outcome recorded
Phase 442 trials · 10 met primary · 4 missed
Phase 4 NCT07180472 Sep 2025 → Sep 2027 expected — First Affiliated Hospital of Chengdu Medical College Not yet recruiting No outcome recorded
Phase 4 NCT06757764 Jul 2025 → Mar 2028 expected cerebral artery stenosis, cerebral infarction Asan Medical Center Recruiting No outcome recorded
Phase 4 NCT05445895 Dec 2022 → Oct 2025 ischemic stroke SK Chemicals Co., Ltd. Completed No outcome recorded
Phase 4 NCT05906199 Jul 2021 → Jun 2023 diabetic peripheral angiopathy SK Chemicals Co., Ltd. Completed Met primary
Phase 4 NCT04148105 Nov 2019 → May 2023 acquired aneurysmal subarachnoid hemorrhage Henry Ford Health System Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT06522113 Jul 2019 → Oct 2022 transient ischemic attack Incheon St.Mary's Hospital Completed No outcome recorded
Phase 4 NCT03581409 Oct 2018 → Jan 2021 brain aneurysm Seoul National University Hospital Completed Met primary
Phase 4 NCT02829151 Feb 2017 → Oct 2021 limb ischemia Yonsei University Unknown No outcome recorded
Phase 4 NCT02933788 Oct → Dec 2016 type 2 diabetes mellitus Kangbuk Samsung Hospital Unknown Missed primary
Phase 4 NCT03248401 Sep 2016 → Oct 2018 atherosclerosis, type 2 diabetes mellitus Seoul National University Bundang Hospital Completed No outcome recorded
Phase not applicable9 trials · 1 met primary · 1 missed
— NCT06058130 Sep 2023 → Oct 2025 atrial fibrillation, carotid stenosis, intracranial arteriosclerosis, ischemic stroke Second Affiliated Hospital, School of Medicine, Zhejiang University Unknown No outcome recorded
— NCT06053021 Sep 2023 → Oct 2025 ischemic stroke, thrombocytopenia Second Affiliated Hospital, School of Medicine, Zhejiang University Unknown No outcome recorded
— NCT05595993 Oct 2022 → Dec 2023 — Danish Headache Center Unknown Met primary
— NCT04069819 Aug 2019 → Dec 2021 major depressive disorder Sadat City University Completed No outcome recorded
— NCT02549898 Aug 2015 → Jun 2018 migraine without aura Danish Headache Center Completed No outcome recorded
— NCT01378650 Jul 2011 → Jun 2013 tinnitus Jong Woo Chung Completed No outcome recorded
— NCT01261234 Dec 2010 → Mar 2019 carotid stenosis Kobe City General Hospital Completed Missed primary
— NCT01872858 Nov 2010 → Nov 2012 cognitive impairment with or without cerebellar ataxia Huashan Hospital Unknown No outcome recorded
— NCT00620646 Feb → Dec 2008 — Samsung Medical Center Completed No outcome recorded
Comparator or background therapy54 trials
Phase 1 NCT07286110 Background Dec 2025 → Nov 2026 expected Moyamoya disease Fudan University Not yet recruiting No outcome recorded
Phase 1 NCT03480321 Comparator Mar → Apr 2018 intermittent vascular claudication Genovate Biotechnology Co., Ltd. Completed No outcome recorded
Phase 1 NCT02431013 Background Apr → Aug 2015 hyperlipidemia, peripheral arterial disease Ajou University School of Medicine Unknown No outcome recorded
Phase 1/2 NCT07238985 Comparator Nov 2025 → Nov 2026 expected fatty liver disease Tanta University Recruiting No outcome recorded
Phase 1/2 NCT05298696 Comparator Mar → Oct 2022 breast cancer, peripheral neuropathy Mansoura University Completed No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2017-01-27 Otsuka Pharmaceutical Development & Commercialization, Inc. Regulatory Otsuka Files a Supplemental Application in Japan: A Plastic Case with Anti-Stroke Medicine for a Smart Medicine Container otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. today announced the filing of a supplemental application for a plastic case containing the anti-platelet drug Pletaal (cilostazol) OD tablets 100mg to the Japanese Ministry of Health, Labour and Welfare.
2010-09-13 Otsuka Pharmaceutical Development & Commercialization, Inc. Results The Antiplatelet Agent Pletaal (Nonproprietary Name: Cilostazol) The Results of CSPS 2, a Large-Scale Clinical Trial of Cilostazol in Preventing Recurrent Strokes, Posted on the Online Version of The Lancet Neurology® otsuka.co.jp ↗
Tokyo, Japan -- Otsuka Pharmaceutical Co., Ltd. today announced that the results of CSPS 2, a large-scale clinical trial of cilostazol (Product Name: Pletaal) in preventing recurrent strokes, were posted on the online version of The Lancet Neurology, a British major medical journal in neurology, on September 11, 2010.*
2010-03-01 Otsuka Pharmaceutical Development & Commercialization, Inc. Results The Results of CSPS II, a Large-scale Clinical Trial of Cilostazol in Preventing Recurrent Strokes, Presented at American Stroke Association's International Stroke Conference on February 26 otsuka.co.jp ↗
According to the report, patients taking cilostazol were less likely to suffer a stroke or develop bleeding requiring hospitalization compared to patients taking aspirin.
2004-11-24 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Approval Of Cilostazol Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Cilostazol Tablets, 50 mg and 100 mg.

All press releases naming this drug 10 releases

DateIssuerRelease

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 162 sources stand behind the page.

FieldValueCited text
Known as cilostazol “We conducted a prospective, randomized study to evaluate the combination of cilostazol (CTZ) and extract of Ginkgo biloba (EGb) and compare it with aspirin for the prevention...” PMID 40803668 ↗ Aug 2025
157

“Five hundred patients with non-cardioembolic AIS presenting within 72 h of symptom onset will be randomized to receive either aspirin 100 mg and cilostazol 200 mg plus EGb 761...” PMID 39528058 ↗ Nov 2024

“The investigational drug, Pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and...” NCT00048763 ↗

“Dual antiplatelet therapy is defined as combination therapy with aspirin and clopidogrel and triple antiplatelet therapy is defined as combination therapy with...” NCT01261832 ↗

“In part 1, each subject received a single dose of SR (200 mg × 1 tablet, once daily) and IR (100 mg × 2 tablets, BID) formulations of cilostazol orally 7 days apart in a fasted state.” PMID 22129569 ↗ Nov 2011

“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” NCT01711333 ↗

“dabigatran 110mg twice daily or 150mg twice daily+ aspirin 100mg once daily / clopidogrel 75mg once daily / ticagrelor 90mg twice daily / cilostazol 100mg twice daily” NCT06058130 ↗

“Pletaal (Cilostazol) is taken 100mg oral tablets two times a day (bid) during 2 weeks after dosing of Pletaal (Cilostazol) 50mg oral tablets bid during 2 weeks.” NCT01444885 ↗

“Efficacy and Safety of Combined Cilostazol and Rosuvastatin Therapy Versus Rosuvastatin Alone in Patients with Chronic Lower Extremity Peripheral Artery Disease” NCT07600385 ↗

“Y-6 sublingual tablets (each tablet contains 25 mg cilostazol and 6 mg dexborneol) Manufacturer: Nanjing Neurodawn Pharmaceutical Co., Ltd.” NCT05836766 ↗

“We aimed to test whether cilostazol has beneficial effects in the real-world patients treated with intracoronary drug-eluting stents (DES).” PMID 21232664 ↗ Jan 2011

Show 147 more sources

Known as CLS “Cilostazol (CLS) has shown antidepressant effect in cardiovascular patients, post-stroke depression, and animal models” PMID 34545997 ↗ Sep 2021
Known as CSZ “Cilostazol (CSZ), a 2-oxo-quinoline derivative, is a selective inhibitor of phosphodiesterase-3” NCT06612593 ↗
Known as CTZ “We conducted a prospective, randomized study to evaluate the combination of cilostazol (CTZ) and extract of Ginkgo biloba (EGb) and compare it with aspirin for the prevention...” PMID 40803668 ↗ Aug 2025
1

“Fifty patients with T2D and carotid atherosclerotic plaques were randomly assigned to either a 200 mg/d cilostazol (CTZ) group or a 100 mg/d aspirin (ASA) group for 6 months.” PMID 32700396 ↗ Sep 2020

Known as NSC-758936 ChEMBL registry synonym — accepted as the source's own label CHEMBL799 ↗
Known as OPC-13013 ChEMBL registry synonym — accepted as the source's own label CHEMBL799 ↗
Known as OPC-21 ChEMBL registry synonym — accepted as the source's own label CHEMBL799 ↗
Known as Pletaal “Pletaal (Cilostazol) is taken 100mg oral tablets two times a day (bid) during 2 weeks after dosing of Pletaal (Cilostazol) 50mg oral tablets bid during 2 weeks.” NCT01444885 ↗
2

“Pletaal(Cilostazol) is taken 100mg oral tablets bid during 2 weeks after dosing of Pletaal(Cilostazol) 50mg oral tablets bid during 2 weeks.” NCT02087007 ↗

“Pletaal® (Cilostazol) 100 mg, bid p.o.” NCT01188824 ↗

Known as Pletaal (Otsuka pharmaceutical) “Pletaal (Otsuka pharmaceutical)” NCT00776828 ↗
Known as Pletaal SR Capsule “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” NCT01711333 ↗
Known as Pletal “Pletal® 50 mg Tablet (reference) dosed in first period followed by Cilostazol 50 mg Tablet (test) dosed in second period.” NCT00839930 ↗
5

“Mylan's cilostazol 100 mg tablets and Otsuka's Pletal® 100 mg tablets” NCT00648388 ↗

“Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)” NCT00881231 ↗

“Cilostazol (Pletal®) 100 mg Tablets” NCT07144956 ↗

NCT00048776 ↗

NCT00048763 ↗

Known as PMR “The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered...” NCT05466734 ↗
2

“The study is designed to evaluate the bioequivalency between the test formulations of extended-release tablet of cilostazol (PMR) administered once-daily and the reference...” NCT03480321 ↗

“the test formulation of extended-release tablet of cilostazol (PMR) administered once daily” NCT06167265 ↗

Action Inhibit “inhibits the ability of one type of blood cell, platelets, to form blood clots” NCT00048776 ↗
1

“Phosphodiesterase 3A inhibitor” CHEMBL799 ↗

Modality Small molecule “Cilostazol is a quinoline derivative” NCT02983214 ↗
Route Oral “Cilostazol 200mg/day Oral” NCT00202020 ↗
Target PDE3A “Phosphodiesterase 3A inhibitor” CHEMBL799 ↗