Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
Also used as a comparator or background therapy in 54 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 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 1/22 trials | ||||||
| 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 |
| Phase 24 trials | ||||||
| Phase 2 | NCT05836766 Comparator | Jun 2023 → Jul 2024 | cerebral artery occlusion, ischemic stroke | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03855332 Comparator | Jul 2019 → Dec 2022 | cerebrovascular disorder | University of Oxford | Completed | No outcome recorded |
| Phase 2 | NCT00783081 Comparator | Nov 2008 → Jul 2010 | intermittent vascular claudication | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00443287 Comparator | Feb 2007 → Oct 2008 | intermittent vascular claudication | Sanofi | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06117436 Comparator | Oct 2023 → Dec 2024 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 2/3 | NCT03451591 Comparator | Jan 2018 → May 2022 | stroke disorder | University of Edinburgh | Completed | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT06561867 Comparator | Aug 2024 → Nov 2025 overdue | ischemic stroke | Kafrelsheikh University | Recruiting | No outcome recorded |
| Phase 3 | NCT06591377 Comparator | Aug 2024 → Sep 2025 overdue | ischemic stroke | Kafrelsheikh University | Recruiting | No outcome recorded |
| Phase 3 | NCT06202755 Comparator | Mar 2024 → Jun 2025 overdue | ischemic stroke | Kafrelsheikh University | Recruiting | No outcome recorded |
| Phase 3 | NCT06196047 Comparator | Dec 2023 → Dec 2024 overdue | ischemic stroke | Kafrelsheikh University | Recruiting | No outcome recorded |
| Phase 3 | NCT06242145 Comparator | Jan 2023 → Jul 2024 | ischemic stroke | Kafrelsheikh University | Completed | No outcome recorded |
| Phase 3 | NCT05594680 Comparator | Oct 2022 → Nov 2024 | rheumatoid arthritis | Tanta University | Unknown | No outcome recorded |
| Phase 3 | NCT06242132 Comparator | Jun 2022 → Jul 2024 | ischemic stroke | Kafrelsheikh University | Completed | No outcome recorded |
| Phase 3 | NCT06591312 Comparator | May 2022 → Sep 2024 overdue | ischemic stroke | Kafrelsheikh University | Recruiting | No outcome recorded |
| Phase 3 | NCT06591351 Comparator | May 2022 → Sep 2024 overdue | ischemic stroke | Kafrelsheikh University | Recruiting | No outcome recorded |
| Phase 3 | NCT06591299 Comparator | Apr 2022 → Sep 2024 overdue | ischemic stroke | Kafrelsheikh University | Recruiting | No outcome recorded |
| Phase 3 | NCT06591390 Comparator | Feb 2022 → Sep 2024 overdue | ischemic stroke | Kafrelsheikh University | Recruiting | No outcome recorded |
| Phase 3 | NCT01895400 Comparator | Jul 2013 → Dec 2015 | vestibular disorder | Jong Woo Chung | Terminated | No outcome recorded |
| Phase 3 | NCT00891670 Comparator | May → Jun 2009 | coronary stenosis, platelet aggregation, spontaneous | Gyeongsang National University Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT00132743 Comparator | Feb 2007 → Jul 2013 | atherosclerosis, peripheral vascular disease | Joselyn Cerezo, MD | Unknown | No outcome recorded |
| Phase 421 trials | ||||||
| Phase 4 | NCT06402747 Comparator | Apr 2024 → Dec 2026 expected | atherosclerosis, type 2 diabetes mellitus | Seoul National University Bundang Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT03062319 Comparator | Apr 2017 → Jul 2023 | atherosclerosis, atrial fibrillation, ischemic stroke | National Hospital Organization Osaka National Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT02983214 Comparator | Nov 2016 → Oct 2019 | ischemic stroke, peripheral arterial disease, type 2 diabetes mellitus | University of Ioannina | Completed | No outcome recorded |
| Phase 4 | NCT02374957 Comparator | Feb 2015 → Jun 2017 | intermittent vascular claudication, peripheral arterial disease | Wake Forest University Health Sciences | Terminated | No outcome recorded |
| Phase 4 | NCT02174939 Comparator | Feb 2014 → Oct 2017 | coronary artery disorder | National Cheng-Kung University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02098460 Comparator | Oct 2013 → Mar 2016 | hyperlipidemia | Otsuka Beijing Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02194686 Comparator | Jan 2013 → Mar 2014 | cardiovascular disorder | National Cheng-Kung University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01952756 Comparator | Jan 2012 → Sep 2013 | peripheral arterial disease | National Cheng-Kung University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01291641 Comparator | Mar 2011 → Dec 2016 | hyperlipidemia | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01188824 Comparator | Sep 2010 → Jul 2013 | ischemic stroke | China Medical University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01192724 Comparator | Mar 2010 → Dec 2012 | coronary artery disorder | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT01252056 Comparator | Mar 2010 → Dec 2012 | diabetic kidney disease | Otsuka Beijing Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT01031667 Background | Nov 2009 → Jun 2011 | — | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT01328470 Comparator | Sep 2009 → Aug 2010 | Prinzmetal angina, chronic kidney disease | Kyunghee University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00915733 Comparator | May → Oct 2009 | myocardial infarction | Gyeongsang National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00886574 Comparator | Apr 2009 → Feb 2011 | type 2 diabetes mellitus | Hanyang University | Unknown | No outcome recorded |
| Phase 4 | NCT00822172 Comparator | Sep 2008 → Nov 2010 | intermittent vascular claudication, peripheral arterial disease | Colorado Prevention Center | Completed | No outcome recorded |
| Phase 4 | NCT01012193 Comparator | Jan 2008 → Jul 2009 | coronary artery disorder | Gyeongsang National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00776828 Comparator | Nov 2006 → Jan 2010 | coronary artery disorder | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00741286 Comparator | Nov 2006 → Oct 2008 | cerebral infarction | Inje University | Completed | No outcome recorded |
| Phase 4 | NCT00272831 Comparator | Dec 2005 → Dec 2007 | type 2 diabetes mellitus | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT07495969 Background | Apr 2026 → Dec 2027 expected | cerebral artery occlusion, ischemic stroke | Feng Gao | Not yet recruiting | No outcome recorded |
| — | NCT04452929 Comparator | Jul 2020 → Feb 2022 | migraine with aura, migraine without aura | Danish Headache Center | Unknown | No outcome recorded |
| — | NCT03422796 Comparator | Nov 2017 → Sep 2018 | migraine disorder | Danish Headache Center | Completed | No outcome recorded |
| — | NCT02486276 Comparator | Jun 2015 → Jun 2016 | migraine disorder | Danish Headache Center | Completed | No outcome recorded |
| — | NCT01841827 Comparator | Apr → Jun 2013 | migraine disorder | Danish Headache Center | Completed | No outcome recorded |
| — | NCT01779401 Comparator | Sep 2012 → Sep 2016 | coronary artery disorder | Chinese Academy of Medical Sciences, Fuwai Hospital | Completed | No outcome recorded |
| — | NCT01482117 Comparator | Nov 2011 → Jan 2012 | — | Inje University | Completed | No outcome recorded |
| — | NCT01359423 Comparator | Sep 2011 → Aug 2017 | intermittent vascular claudication | Yonsei University | Completed | No outcome recorded |
Press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-10-01 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Receives the 2013 Good Design Award for the Antiplatelet Drug "Pletaal OD Tablets"® otsuka.co.jp ↗ |
| 2010-09-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | 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 ↗ |
| 2010-04-23 | Otsuka Pharmaceutical Development & Commercialization, Inc. | First Antithrombotic Orally Disintegrating Tablets Antiplatelet Agent "Pletaal OD Tablets" Launched on April 26 ® otsuka.co.jp ↗ |
| 2010-03-01 | Otsuka Pharmaceutical Development & Commercialization, Inc. | 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 ↗ |
| 2008-04-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | The first drug to be approved in Sweden for intermittent claudication: Pletal is reimbursed® otsuka.co.jp ↗ |
| 2007-01-05 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Europe and Schwarz Pharma Deutschland to Co-promote Antiplatelet Agent Pletal in Germany® otsuka.co.jp ↗ |
| 2006-12-12 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Antiplatelet Agent “Pletaal” Co-Promotion Agreement between Otsuka Pharmaceutical and Chugai Pharmaceutical® otsuka.co.jp ↗ |
| 2004-11-24 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Cilostazol Tablets tevapharm.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 162 sources stand behind the page.
| Field | Value | Cited 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 2025157“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 ↗ “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 “Y-6 sublingual tablets (each tablet contains 25 mg cilostazol and 6 mg dexborneol) Manufacturer: Nanjing Neurodawn Pharmaceutical Co., Ltd.” NCT05836766 ↗ “Arm A had 30 participants receiving 200 mg cilostazol daily and arm B had 27 participants receiving 20 mg rosuvastatin daily for 7 days.” PMID 39487337 ↗ Nov 2024 “180mg loading dose of cilostazol during the first 24 hours of stroke onset, followed by 90mg once daily from the 2nd day to the 90th day” NCT06591312 ↗ “Cilostazol is an anti-PDE3 type antiplatelet agent with the function of preventing peripheral arterial occlusion disease and stroke.” NCT06504576 ↗ “each tablet of Y-6 contained 6 mg of dexborneol and 25 mg of cilostazol; Both groups took one tablet q12h for 28 days.” NCT07040085 ↗ “Patients administrate SID142 (Cilostazol 200mg, Ginkgo biloba leaf extract 160mg) once a day for 12 weeks” NCT03318276 ↗ “75 mg clopidogrel per day (or ticagrelor or cilostazol) for the initial 90 days after randomization” NCT07495969 ↗ “Comparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea” NCT03524963 ↗ “For ischemic-type moyamoya disease, antiplatelet monotherapy with cilostazol is administered” NCT07286110 ↗ “The investigational drug, Pletal(cilostazol), which has been approved for other conditions” NCT00048776 ↗ “* Maintenance: cilostazol 100mg bid+ aspirin 200mg/d+ clopidogrel 75mg/d for 1 month” NCT01354808 ↗ “100mg Aspirin QD + 75mg Clopidogrel QD + 100mg Cilostazol BID for 1 month” NCT01267734 ↗ “Cilostazol 100mg/ginko biloba leaf extract 80mg, Immediate release, bid” NCT02625714 ↗ “Cilostazol 100mg twice a day plus placebo of clopidogrel once a day” NCT00130039 ↗ “Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.” NCT03471169 ↗ “clopidogrel 75 mg once daily plus cilostazol 100 mg twice daily” PMID 34611892 ↗ Oct 2021 “aspirin, clopidogrel, prasugrel, ticlopidine, or cilostazol” NCT03062319 ↗ |
| 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 20251“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 ↗ |
| 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 ↗ |