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cilostazol

Trade name: pletal

Small moleculeapproved

Approved

Jan 15, 1999

Cilostazol is a PDE3 inhibitor which is used for the treatment of intermittent claudication. The drug positively affects the platelet aggregation and may be used off-label as a measure to prevent coronary thrombosis/restenosis and stroke recurrence. — NCATS

Clinical trial activity

150 trials · 144 clinical orgs · 19 marketing orgs

Phase 1
25
Phase 2
48
Phase 3
33
Phase 4
61

Earliest trial started Apr 1, 1992 (NCT00766545)

Timeline

1990s

  1. Jan 1, 1992

    Otsuka — Earliest Phase 3 Sponsor(trial)

  2. Jan 15, 1999

    Otsuka — Earliest FDA Approval

  3. Jan 15, 1999

    Otsuka — NDA Organization

2000s

  1. Jan 1, 2003

    Teva — Earliest Phase 1 Sponsor(trial)

  2. Nov 23, 2004

    CASI Pharmaceuticals, Inc. — Marketing Organization

  3. Nov 23, 2004

    Epic Pharma Llc — Marketing Organization

  4. Nov 23, 2004

    Aurobindo Pharma — Marketing Organization

  5. Nov 26, 2004

    Actavis — Marketing Organization

  6. Dec 10, 2004

    Apotex — Marketing Organization

  7. Mar 1, 2005

    Teva — Marketing Organization

  8. May 17, 2005

    West-Ward Pharmaceutical — Marketing Organization

  9. May 17, 2005

    Hikma — Marketing Organization

  10. Mar 29, 2006

    Frontida BioPharm — Marketing Organization

  11. Mar 29, 2006

    Slate Pharmaceuticals — Marketing Organization

  12. Mar 29, 2006

    SLATE RUN PHARMA — Marketing Organization

  13. Apr 20, 2006

    Mylan — Marketing Organization

  14. Apr 20, 2006

    Rising Pharmaceuticals — Marketing Organization

  15. Jan 1, 2007

    Earliest Phase 2 Sponsor(trial)

  16. Oct 29, 2007

    Pliva — Marketing Organization

  17. Oct 29, 2007

    Barr Laboratories — Marketing Organization

  18. Sep 28, 2009

    Nostrum Laboratories — Marketing Organization

  19. Sep 28, 2009

    Esteve Labs — Marketing Organization

2010s

  1. Sep 24, 2012

    Chartwell Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJan 15, 1999

Chemistry & pharmacology

Loading structure…

SMILES

O=C1CCC2=C(N1)C=CC(OCCCCC3=NN=NN3C4CCCCC4)=C2
Mol. weight
369.4607 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 2(1h)-quinolinone, 6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-3,4-dihydro-
  • 3,4-dihydro-6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-2(1h)-quinolinone
  • 3,4-dihydro-6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-2(1h)-quinolinone
  • 6-[4-(1-cyclohexyl-1h-tetrazol-5-yl)-butoxy]-3,4-dihydro-1h-quinolin-2-one
  • 6-[4-(1-cyclohexyl-1h-tetrazol-5-yl)-butoxy]-3,4-dihydro-1h-quinolin-2-one
  • 6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-3,4-dihydro-2(1h)-quinolinone
  • 6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-3,4-dihydro-2(1h)-quinolinone
  • 6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-3,4-dihydro-2(1h)-quinolinone
  • 6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-3,4-dihydrocarbostyril
  • 6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-3,4-dihydrocarbostyril
  • cilostazol
  • cilostazol
  • cilostazol
  • cilostazol
  • cilostazol
  • cilostazol
  • cilostazol
  • cilostazol
  • cilostazol
  • cilostazol
  • cilostazole
  • cilostazole
  • cilostazole
  • cilostazole
  • cilostazolum
  • cilostazolum
  • cisostazol
  • opc 13013
  • opc 13013
  • opc 13013
  • opc 13013
  • opc 13013
  • opc 13013
  • opc-13013
  • opc-13013
  • opc-13013
  • opc-13013
  • opc-21
  • opc-21
  • pletal
  • pletal
  • pletal
  • pletal
  • pletal

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07174414Phase 3Aug 31, 2026Medical University of South Carolina, National Institute of Neurological Disorders and Stroke (NINDS), Stanford University, University of Cincinnati, Yale University
NCT07144956Phase 3Dec 15, 2025Centre Hospitalier St Anne
NCT06919835Phase 3Dec 1, 2025Northern California Institute of Research and Education
NCT07249853Phase 3Nov 30, 2025Capital Medical University
NCT07238985Phase 1/Phase 2 (Phase 2)Nov 1, 2025Tanta University
NCT07180472Phase 4Sep 20, 2025Sichuan University
NCT07040085Phase 3Aug 5, 2025Capital Medical University, NeuroDawn Pharmaceutical Co., Ltd.
NCT06757764Phase 4Mar 15, 2025Otsuka, University of Ulsan
NCT06702657N/AFeb 15, 2025Changhai Hospital, The First People's Hospital of Changzhou
NCT06989697Phase 3Jan 1, 2025Seoul National University, SK Chemicals
NCT06612593Phase 2Oct 1, 2024Ain Shams University
NCT06561867Phase 3Aug 30, 2024Kafrelsheikh University
NCT06504576Phase 2Aug 1, 2024National Taiwan University
NCT06492070Phase 2Aug 1, 2024Emory University, National Cancer Institute (NCI)
NCT06530537Phase 3Jul 18, 2024Zhejiang University
NCT06402747Phase 4Apr 16, 2024Samjin Pharmaceutical Co., Ltd., Seoul National University
NCT06202755Phase 3Mar 30, 2024Kafrelsheikh University
NCT05995600Phase 4Dec 31, 2023Samjin Pharmaceutical Co., Ltd., Seoul National University
NCT06196047Phase 3Dec 1, 2023Kafrelsheikh University
NCT06138834Phase 2Nov 30, 2023Capital Medical University, NeuroDawn Pharmaceutical Co., Ltd.
Showing 20 of 150 trials
Page 1 / 8

Organizations

Research & Development (144)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
OtsukaFor profit361851992
Seoul National UniversityAcademic/Hospital11922006
University of UlsanAcademic/Hospital10722005
Kafrelsheikh UniversityAcademic/Hospital9912022
University of CopenhagenAcademic/Hospital7722013
Peking UniversityAcademic/Hospital6132004
Yonsei UniversityAcademic/Hospital6542009
Gyeongsang UniversityAcademic/Hospital5522008
Inje UniversityAcademic/Hospital5232006
SK ChemicalsFor profit5432007
Sungkyunkwan UniversityAcademic/Hospital5432008
Capital Medical UniversityAcademic/Hospital4432017
China Medical UniversityAcademic/Hospital4412004
Genovate Biotechnology Co., Ltd.,For profit4422016
Government of TaiwanGovernment4012010
Korea UniversityAcademic/Hospital4212006
National Cheng Kung UniversityAcademic/Hospital4312010
Ain Shams UniversityAcademic/Hospital3322022
National Cerebral and Cardiovascular CenterGovernment3232013
National Taiwan UniversityAcademic/Hospital3132010
144 organizations
Page 1 / 8

Marketing (22)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGNov 26, 2004
ApotexFor profitMKTGDec 10, 2004
Aurobindo PharmaFor profitMKTGNov 23, 2004
Barr LaboratoriesFor profitMKTGOct 29, 2007
CASI Pharmaceuticals, Inc.For profitMKTGNov 23, 2004
Chartwell PharmaceuticalsFor profitMKTGSep 24, 2012
Epic Pharma LlcFor profitMKTGNov 23, 2004
Esteve LabsFor profitMKTGSep 28, 2009
Frontida BioPharmFor profitMKTGMar 29, 2006
HikmaFor profitMKTGMay 17, 2005
HikmaFor profitSYNMay 17, 2005
MylanFor profitMKTGApr 20, 2006
MylanFor profitSYNNov 23, 2004
Nostrum LaboratoriesFor profitMKTGSep 28, 2009
OtsukaFor profitNDAJan 15, 1999
PlivaFor profitMKTGOct 29, 2007
Rising PharmaceuticalsFor profitMKTGApr 20, 2006
SLATE RUN PHARMAFor profitMKTGMar 29, 2006
Slate PharmaceuticalsFor profitMKTGMar 29, 2006
TevaFor profitMKTGMar 1, 2005
TevaFor profitSYNNov 24, 2004
West-Ward PharmaceuticalFor profitMKTGMay 17, 2005