Cilostazol

Overview

Cilostazol is a quinolinone derivative and antiplatelet agent with vasodilating properties that has been used in the symptomatic treatment of intermittent claudication in patients with peripheral ischaemia. It is marketed under the brand name Pletal by Otsuka Pharmaceutical Co.. Cilostazol works by inhibiting both primary and secondary aggregation and reducing calcium-induced contractions.

Indication

Indicated for the alleviation of symptoms of intermittent claudication (pain in the legs that occurs with walking and disappears with rest).

Associated Conditions

Intermittent Claudication

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
CiLostAzol for pReventIon of Recurrent sTroke in Africa	2025/04/09	NCT06919835	Phase 3	Not yet recruiting	Northern California Institute of Research and Education
Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication	2025/03/20	NCT06886620	Phase 3	Terminated	Genovate Biotechnology Co., Ltd.,
The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis	2025/01/03	NCT06757764	Phase 4	Recruiting	Asan Medical Center
Antiplatelet Therapy and Endothelial-stabilizing Agents in Cerebral Small Vessel Diseases	2024/12/04	NCT06715007	N/A	Recruiting	The First Affiliated Hospital with Nanjing Medical University
Cilostazol in Parkinson's Disease	2024/09/25	NCT06612593	Phase 2	Not yet recruiting	Ain Shams University
Combining Aspirin With Ticagrelor or Cilostazol in Large-vessel Minor Stroke or TIA	2024/09/19	NCT06591377	Phase 3	Recruiting	Kafrelsheikh University
Combining Aspirin With Ticagrelor or Cilostazol in Minor Stroke or TIA	2024/09/11	NCT06591390	Phase 3	Recruiting	Kafrelsheikh University
Combining Aspirin With Cilostazol or Clopidogrel in Minor Stroke or TIA	2024/09/11	NCT06591299	Phase 3	Recruiting	Kafrelsheikh University
Combining Aspirin With Cilostazol or Clopidogrel in Large-vessel Minor Stroke or TIA	2024/09/11	NCT06591351	Phase 3	Recruiting	Kafrelsheikh University
Ticagrelor Versus Cilostazol in Ischemic Stroke	2024/08/20	NCT06561867	Phase 3	Recruiting	Kafrelsheikh University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Cilostazol	REMEDYREPACK INC.	70518-2208	ORAL	50 mg in 1 1	2/27/2024
Cilostazol	A-S Medication Solutions	50090-5329	ORAL	50 mg in 1 1	7/26/2022
Cilostazol	Teva Pharmaceuticals USA, Inc.	0093-2064	ORAL	100 mg in 1 1	7/31/2022
Cilostazol	Aphena Pharma Solutions - Tennessee, LLC	71610-037	ORAL	100 mg in 1 1	2/2/2018
cilostazol	REMEDYREPACK INC.	70518-2714	ORAL	100 mg in 1 1	3/5/2024
cilostazol	Apotex Corp.	60505-2522	ORAL	100 mg in 1 1	12/13/2023
cilostazol	AvKARE	42291-453	ORAL	100 mg in 1 1	1/9/2024
Cilostazol	Carilion Materials Management	68151-4123	ORAL	100 mg in 1 1	7/6/2016
Cilostazol	Teva Pharmaceuticals USA, Inc.	0093-2065	ORAL	50 mg in 1 1	7/31/2022
Cilostazol	Slate Run Pharmaceuticals, LLC	70436-156	ORAL	50 mg in 1 1	4/16/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Cilostazol Tablets	宏越科技（湖州）有限公司	国药准字H20249441	化学药品	片剂	11/22/2024
Cilostazol Tablets	烟台万润药业有限公司	国药准字H20253783	化学药品	片剂	4/1/2025
Cilostazol Tablets	浙江迪耳药业有限公司	国药准字H20058053	化学药品	片剂	4/30/2020
Cilostazol Tablets	黑龙江乌苏里江制药有限公司哈尔滨分公司	国药准字H20057124	化学药品	片剂(素片)	7/30/2020
Cilostazol Tablets	江苏新海康制药有限公司	国药准字H20103401	化学药品	片剂	6/30/2020
Cilostazol Tablets	浙江永宁药业股份有限公司	国药准字H20057506	化学药品	片剂	7/31/2024
Cilostazol Tablets	浙江迪耳药业有限公司	国药准字H20058054	化学药品	片剂	4/30/2020
Cilostazol Tablets	江苏天士力帝益药业有限公司	国药准字H20057584	化学药品	片剂	6/23/2020
Cilostazol Tablets	深圳海王药业有限公司	国药准字H20055018	化学药品	片剂	8/5/2020
Cilostazol Tablets	成都倍特药业股份有限公司	国药准字H20243874	化学药品	片剂	6/4/2024

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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