Cilostazol

Sold as Pletal. Every FDA application for this active ingredient: 1 branded and 15 generic.

As of Nov 15, 2026, FDA lists 16 applications for Cilostazol (sold as Pletal), first approved Jan 15, 1999, with 1 new use approved and 0 published complete response letters.

First approved: Jan 15, 1999
Applications: 16
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $17.6M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Cilostazol	Part D	$17.6M	+2%	198,336

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

CILOSTAZOL 100 MG TABLET: $0.125 per unitGeneric · -1% in a year
CILOSTAZOL 50 MG TABLET: $0.122 per unitGeneric · +10% in a year

Clinical Trials

28 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Long-Term Sequential Dual Antiplatelet Therapy Based on Cilostazol in Symptomatic Intracranial Arterial Stenosis: A Real-World Cohort StudyIschemic Stroke, Symptomatic Intracranial Atherosclerotic Stenosis · Second Affiliated Hospital of Soochow University	—	Recruiting	Nov 13, 2026
Long-Term Sequential Dual Antiplatelet Therapy Based on Cilostazol in Symptomatic Intracranial Arterial StenosisIschemic Stroke, Symptomatic Intracranial Atherosclerotic Stenosis · Second Affiliated Hospital of Soochow University	Phase 4	Recruiting	Nov 12, 2026
Study on Anti-Thrombotic Regimens for Secondary Prevention in Ischemic Stroke Patients With Possible Benefit From Anticoagulation TherapyStroke, Acute Ischemic Stroke · Second Affiliated Hospital, Zhejiang University, School of Medicine	Phase 3	Not yet recruiting	Aug 5, 2026
Cilostazol and Aspirin for Cardiovascular Event Prevention in Patients With Type 2 DiabetesType 2 Diabetes Mellitus (T2DM), Atherosclerosis · Seoul National University Bundang Hospital	Phase 4	Recruiting	Jul 22, 2026
Efficacy and Safety of Indobufen, Aspirin, Cilostazol and Clopidogrel in the Treatment of Ischemic StrokeAcute Ischemic Stroke · Nanfang Hospital, Southern Medical University	—	Not yet recruiting	May 22, 2026
Relying on Pharmacotherapy to Improve Motor Gains in Chronic Stroke SurvivorsStroke · Spaulding Rehabilitation Hospital	Early phase 1	Recruiting	May 15, 2026
Randomized Clinical Trial of Endovascular Recanalization for Symptomatic Non-Acute Intracranial Artery Occlusion（REPAIR）Symptomatic Non-acute Intracranial Artery Occlusion, Ischemic Stroke · Feng Gao	Not applicable	Not yet recruiting	Mar 27, 2026
Chinese Herbal Therapy (Qiqi Shengmai Formula) for Moyamoya Vasculopathy: The CHIMES TrialMoyamoya Disease, Moyamoya Syndrome · Fudan University	Phase 1	Not yet recruiting	Dec 16, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jan 15, 1999	PletalNDA 20863 · New molecular entity	Otsuka	14	Discontinued
Nov 23, 2004	CilostazolANDA 77019	Aurobindo Pharma USA	2	Marketed
Nov 23, 2004	CilostazolANDA 77021	Chartwell Rx	3	Discontinued
Nov 23, 2004	CilostazolANDA 77022	Epic Pharma LLC	6	Marketed
Nov 24, 2004	CilostazolANDA 77027	Teva	10	Marketed
Nov 26, 2004	CilostazolANDA 77028	Actavis Elizabeth	1	Marketed
Dec 10, 2004	CilostazolANDA 77030	Apotex	5	Marketed
Mar 1, 2005	CilostazolANDA 77020	Ivax Sub Teva Pharms	0	Discontinued
May 17, 2005	CilostazolANDA 77024	Hikma	4	Discontinued
Nov 8, 2005	CilostazolANDA 77310	Chartwell Rx	3	Discontinued
Mar 29, 2006	CilostazolANDA 77208	Slate Run Pharma	0	Marketed
Apr 20, 2006	CilostazolANDA 77323	Rising	4	Discontinued
Oct 29, 2007	CilostazolANDA 77898	Pliva Hrvatska Doo	0	Discontinued
Sep 28, 2009	CilostazolANDA 77708	Sankalp Lifecare	3	Discontinued
Sep 24, 2012	CilostazolANDA 77722	Chartwell Rx	1	Marketed
Sep 24, 2012	CilostazolANDA 77831	Chartwell Rx	1	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA