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Also known as: 73963-72-1, Pletal, Cilostazole, Pletaal, Opc-13013, Cilostazolum

Molecular Formula

C₂₀H₂₇N₅O₂

Molecular Weight

369.5 g/mol

InChI Key

RRGUKTPIGVIEKM-UHFFFAOYSA-N

FDA UNII

N7Z035406B

A quinoline and tetrazole derivative that acts as a phosphodiesterase type 3 inhibitor, with anti-platelet and vasodilating activity. It is used in the treatment of PERIPHERAL VASCULAR DISEASES; ISCHEMIC HEART DISEASE; and in the prevention of stroke.

Cilostazol is a Phosphodiesterase 3 Inhibitor. The mechanism of action of cilostazol is as a Phosphodiesterase 3 Inhibitor.

1 2D Structure

Cilostazol

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

6-[4-(1-cyclohexyltetrazol-5-yl)butoxy]-3,4-dihydro-1H-quinolin-2-one

2.1.2 InChI

InChI=1S/C20H27N5O2/c26-20-12-9-15-14-17(10-11-18(15)21-20)27-13-5-4-8-19-22-23-24-25(19)16-6-2-1-3-7-16/h10-11,14,16H,1-9,12-13H2,(H,21,26)

2.1.3 InChI Key

RRGUKTPIGVIEKM-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1CCC(CC1)N2C(=NN=N2)CCCCOC3=CC4=C(C=C3)NC(=O)CC4

2.2 Other Identifiers

2.2.1 UNII

N7Z035406B

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-3,4-dihydro-2(1h)-quinolinone

2. Opc 13013

3. Opc-13013

4. Pletal

2.3.2 Depositor-Supplied Synonyms

1. 73963-72-1

2. Pletal

3. Cilostazole

4. Pletaal

5. Opc-13013

6. Cilostazolum

7. Opc-21

8. Cilostazolum [inn-latin]

9. Opc 13013

10. Opc 21

11. 6-[4-(1-cyclohexyltetrazol-5-yl)butoxy]-3,4-dihydro-1h-quinolin-2-one

12. 6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-3,4-dihydro-2(1h)-quinolinone

13. 6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-3,4-dihydroquinolin-2(1h)-one

14. Chebi:31401

15. 6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-3,4-dihydrocarbostyril

16. 3,4-dihydro-6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-2(1h)-quinolinone

17. Nsc-758936

18. 6-[4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy]-3,4-dihydroquinolin-2(1h)-one

19. Mls000028470

20. 6-[4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy]-3,4-dihydro-2(1h)-quinolinone

21. 6-[4-(1-cyclohexyl-1h-1,2,3,4-tetrazol-5-yl)butoxy]-1,2,3,4-tetrahydroquinolin-2-one

22. N7z035406b

23. Ncgc00015207-07

24. Smr000058428

25. Dsstox_cid_25132

26. Dsstox_rid_80693

27. Dsstox_gsid_45132

28. 2(1h)-quinolinone, 6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-3,4-dihydro-

29. Cas-73963-72-1

30. Pletal (tn)

31. Sr-01000003107

32. Brn 3632107

33. Unii-n7z035406b

34. 2(1h)-quinolinone, 6-[4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy]-3,4-dihydro-

35. Cilostazol,(s)

36. Cilostazol-[d11]

37. Mfcd00866780

38. Cilostazol [usan:usp:inn:ban:jan]

39. Tocris-1692

40. Cilostazol [mi]

41. Opera_id_488

42. Cilostazol [inn]

43. Cilostazol [jan]

44. Spectrum2_001118

45. Spectrum3_001170

46. Spectrum4_000772

47. Spectrum5_001762

48. Cilostazol [usan]

49. Lopac-c-0737

50. Cilostazol [vandf]

51. Chembl799

52. 6-[4-(1-cyclohexyl-1h-tetrazol-5-yl)-butoxy]-3,4-dihydro-2(1h)-quinolinone

53. C 0737

54. Cilostazol [mart.]

55. Cilostazol [usp-rs]

56. Cilostazol [who-dd]

57. Lopac0_000218

58. Regid_for_cid_2754

59. Schembl16128

60. Bspbio_002759

61. Kbiogr_001184

62. Mls000758281

63. Mls000759507

64. Mls001076067

65. Mls002153891

66. Spectrum1505230

67. Spbio_001256

68. Cilostazol (jp17/usp/inn)

69. Gtpl7148

70. Cilostazol [orange Book]

71. Dtxsid9045132

72. Hsdb 8312

73. Kbio3_002259

74. Bcpp000279

75. Cilostazol [usp Monograph]

76. Hms1922n15

77. Hms2093m14

78. Hms2096f16

79. Hms2234c06

80. Hms3260l17

81. Hms3268o09

82. Hms3412b18

83. Hms3654j13

84. Hms3676b18

85. Hms3713f16

86. Pharmakon1600-01505230

87. Act02663

88. Bcp03724

89. Zinc1552174

90. Tox21_110098

91. Tox21_500218

92. Bdbm50225508

93. Ccg-39646

94. Nsc758936

95. S1294

96. Akos015855512

97. Cilostazol, >=98% (hplc), Powder

98. Opc 13013; Opc 21; Pletaal

99. Tox21_110098_1

100. Ac-4334

101. Am90304

102. Bcp9000530

103. Cs-1759

104. Db01166

105. Ks-5154

106. Lp00218

107. Nsc 758936

108. Sdccgsbi-0050206.p003

109. 2(1h)-quinolinone, 3,4-dihydro-6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-

110. 2(1h)-quionlinone, 6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)-3,4-dihydro-

111. Ncgc00015207-01

112. Ncgc00015207-02

113. Ncgc00015207-03

114. Ncgc00015207-04

115. Ncgc00015207-05

116. Ncgc00015207-06

117. Ncgc00015207-08

118. Ncgc00015207-09

119. Ncgc00015207-10

120. Ncgc00015207-11

121. Ncgc00015207-12

122. Ncgc00015207-25

123. Ncgc00022153-02

124. Ncgc00022153-04

125. Ncgc00022153-05

126. Ncgc00022153-06

127. Ncgc00022153-07

128. Ncgc00260903-01

129. Hy-17464

130. Bcp0726000145

131. Retal;pletal;opc 21;pletaal;cilostal

132. Sbi-0050206.p002

133. Eu-0100218

134. Ft-0602474

135. Ft-0645036

136. Ft-0665038

137. Sw199053-2

138. D01896

139. F20538

140. Ab00382988-14

141. Ab00382988_15

142. Ab00382988_16

143. 963c721

144. A837982

145. Q258591

146. Q-200854

147. Sr-01000003107-2

148. Sr-01000003107-4

149. Sr-01000003107-7

150. Brd-k67017579-001-04-2

151. Brd-k67017579-001-05-9

152. Brd-k67017579-001-07-5

153. Brd-k67017579-001-13-3

154. Brd-k67017579-001-17-4

155. Sr-01000003107-10

156. Cilastatin Sodium, Antibiotic For Culture Media Use Only

157. Cilostazol, United States Pharmacopeia (usp) Reference Standard

158. 6-[4-(1-cyclohexyl-1,2,3,4-tetrazol-5-yl)butoxy]-3,4-dihydrocarbostyril

159. 6-[4-(l-cyclohexyl-1,2,3,4-tetrazol-5-yl)butoxyl]-3,4-dihydrocarbostyril

160. Cilostazol, Pharmaceutical Secondary Standard; Certified Reference Material

161. 6-(4-(1-cyclohexyl-1h-tetrazol-5-yl)butoxy)quinoline-2,3(1h,4h)-dione

162. 6-[4-(1-cyclohexyl-1h-tetrazol-5-yl)-butoxy]-3,4-dihydro-1h-quinolin-2-one

163. 89332-50-3

2.4 Create Date

2005-03-25

3 Chemical and Physical Properties

Molecular Formula	C₂₀H₂₇N₅O₂
Molecular Weight	369.5 g/mol
XLogP3	3.1
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	7
Exact Mass	369.21647512 g/mol
Monoisotopic Mass	369.21647512 g/mol
Topological Polar Surface Area	81.9 Å²
Heavy Atom Count	27
Formal Charge	0
Complexity	485
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Cilostazol
PubMed Health	Cilostazol (By mouth)
Drug Classes	Platelet Aggregation Inhibitor
Drug Label	Cilostazol is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). The empirical formula of cilostazol is C20H27N5O2, and its molecular weight is 369.46. Cilostazol is 6-[4-(1-cyclohexyl-1H-tetr...
Active Ingredient	Cilostazol
Dosage Form	Tablet
Route	oral; Oral
Strength	100mg; 50mg
Market Status	Prescription
Company	Mylan Pharms; Actavis Elizabeth; Breckenridge Pharm; Teva; Apotex; Pliva Hrvatska Doo; Biokey; Sandoz; Mylan; Roxane

2 of 4
Drug Name	Pletal
PubMed Health	Cilostazol (By mouth)
Drug Classes	Platelet Aggregation Inhibitor
Drug Label	PLETAL (cilostazol) is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). The empirical formula of cilostazol is C20H27N5O2, and its molecular weight is 369.46. Cilostazol is 6-[4-(1-cyclohexy...
Active Ingredient	Cilostazol
Dosage Form	Tablet
Route	Oral
Strength	100mg; 50mg
Market Status	Prescription
Company	Otsuka

3 of 4
Drug Name	Cilostazol
PubMed Health	Cilostazol (By mouth)
Drug Classes	Platelet Aggregation Inhibitor
Drug Label	Cilostazol is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). The empirical formula of cilostazol is C20H27N5O2, and its molecular weight is 369.46. Cilostazol is 6-[4-(1-cyclohexyl-1H-tetr...
Active Ingredient	Cilostazol
Dosage Form	Tablet
Route	oral; Oral
Strength	100mg; 50mg
Market Status	Prescription
Company	Mylan Pharms; Actavis Elizabeth; Breckenridge Pharm; Teva; Apotex; Pliva Hrvatska Doo; Biokey; Sandoz; Mylan; Roxane

4 of 4
Drug Name	Pletal
PubMed Health	Cilostazol (By mouth)
Drug Classes	Platelet Aggregation Inhibitor
Drug Label	PLETAL (cilostazol) is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). The empirical formula of cilostazol is C20H27N5O2, and its molecular weight is 369.46. Cilostazol is 6-[4-(1-cyclohexy...
Active Ingredient	Cilostazol
Dosage Form	Tablet
Route	Oral
Strength	100mg; 50mg
Market Status	Prescription
Company	Otsuka

4.2 Therapeutic Uses

/CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Cilostazol is included in the database.

NIH/NLM; ClinicalTrials.Gov. Available from, as of March 17, 2016: https://clinicaltrials.gov/ct2/results?term=cilostazol&Search=Search

Pletal is indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. /Included in US product label/

NIH; DailyMed. Current Medication Information for Pletal (Cilostazol) Tablet (Updated: July 2015). Available from, as of January 20, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24d75b58-bafb-4440-b8d7-4f4079c08b0b

Because of its antiplatelet activity, cilostazol has been used alone or in combination with other antiplatelet agents (e.g., aspirin, clopidogrel) to prevent thrombosis and restenosis following coronary angioplasty/stent implantation. /NOT included in US product label/

American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 1528

Cilostazol has been used for the secondary prevention of stroke in patients with a history of noncardioembolic stroke or transient ischemic attacks (TIAs). /NOT included in US product label/

American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 1528

/EXPL THER/ We conducted a randomized, double blind, placebo controlled trial to assess the efficacy and safety of cilostazol, a selective inhibitor of phosphodiesterase 3, in patients with vasospastic angina (VSA). Cilostazol has been shown to induce vascular dilatation, but its efficacy in patients with VSA is unknown. Between October 2011 and July 2012, 50 patients with confirmed VSA who had >/= 1 angina episodes/week despite amlodipine therapy (5 mg/day) were randomly assigned to receive either cilostazol (up to 200 mg/day) or placebo for 4 weeks. All patients were given diaries to record the frequency and severity of chest pain (0-10 grading). The primary endpoint was the relative reduction of the weekly incidence of chest pain. Baseline characteristics were similar between the two groups. Among 49 evaluable patients (25 in the cilostazol group, 24 in the placebo group), the primary endpoint was significantly greater in the cilostazol group compared with the placebo group (-66.5 +/- 88.6% vs -17.6 +/- 140.1%, respectively, p=0.009). The secondary endpoints, including a change in the frequency of chest pain (-3.7 +/- 0.5 vs -1.9 +/- 0.6, respectively, p=0.029), a change in the chest pain severity scale (-2.8 +/- 0.4 vs -1.1 +/- 0.4, respectively, p=0.003), and the proportion of chest pain-free patients (76.0% vs 33.3%, respectively, p=0.003) also significantly favoured cilostazol. Headache was the most common adverse event in both groups (40.0% vs 20.8%, respectively, p=0.217). Cilostazol is an effective therapy for patients with VSA uncontrolled by conventional amlodipine therapy, and has no serious side effects.

PMID:24934484 Shin ES et al; Heart 100 (19): 1531-6 (2014)

4.3 Drug Warning

/BOXED WARNING/ WARNING: CONTRAINDICATED IN HEART FAILURE PATIENTS. Pletal is contraindicated in patients with heart failure of any severity. Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class III-IV heart failure.

Rare cases of thrombocytopenia or leukopenia progressing to agranulocytosis have been reported when cilostazol was not immediately discontinued; agranulocytosis was reversible with discontinuance of cilostazol.

American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 1529

Information is limited regarding the safety and efficacy of concurrent use of cilostazol and clopidogrel. Currently it is unknown whether concurrent therapy with cilostazol and clopidogrel has additive effects on bleeding time. Caution should be used and bleeding times monitored during such concurrent therapy.

American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 1529

Cilostazol may induce tachycardia, palpitation, tachyarrhythmia or hypotension. The increase in heart rate associated with cilostazol is approximately 5 to 7 bpm. Patients with a history of ischemic heart disease may be at risk for exacerbations of angina pectoris or myocardial infarction.

For more Drug Warnings (Complete) data for Cilostazol (10 total), please visit the HSDB record page.

4.4 Drug Indication

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

5 Pharmacology and Biochemistry

5.1 Pharmacology

Cilostazol reduces the symptoms of intermittent claudication, as indicated by an increased walking distance. Intermittent claudication is pain in the legs that occurs with walking and disappears with rest. The pain occurs due to reduced blood flow to the legs.

5.2 MeSH Pharmacological Classification

Fibrinolytic Agents

Fibrinolysin or agents that convert plasminogen to FIBRINOLYSIN. (See all compounds classified as Fibrinolytic Agents.)

Neuroprotective Agents

Drugs intended to prevent damage to the brain or spinal cord from ischemia, stroke, convulsions, or trauma. Some must be administered before the event, but others may be effective for some time after. They act by a variety of mechanisms, but often directly or indirectly minimize the damage produced by endogenous excitatory amino acids. (See all compounds classified as Neuroprotective Agents.)

Vasodilator Agents

Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)

Bronchodilator Agents

Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)

Platelet Aggregation Inhibitors

Drugs or agents which antagonize or impair any mechanism leading to blood platelet aggregation, whether during the phases of activation and shape change or following the dense-granule release reaction and stimulation of the prostaglandin-thromboxane system. (See all compounds classified as Platelet Aggregation Inhibitors.)

Phosphodiesterase 3 Inhibitors

Compounds that specifically inhibit PHOSPHODIESTERASE 3. (See all compounds classified as Phosphodiesterase 3 Inhibitors.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

CILOSTAZOL

5.3.2 FDA UNII

N7Z035406B

5.3.3 Pharmacological Classes

Phosphodiesterase 3 Inhibitors [MoA]; Phosphodiesterase 3 Inhibitor [EPC]

5.4 ATC Code

B - Blood and blood forming organs

B01 - Antithrombotic agents

B01A - Antithrombotic agents

B01AC - Platelet aggregation inhibitors excl. heparin

B01AC23 - Cilostazol

5.5 Absorption, Distribution and Excretion

Absorption

Cilostazol is absorbed after oral administration. A high fat meal increases absorption, with an approximately 90% increase in C_max and a 25% increase in AUC. Absolute bioavailability is not known.

Route of Elimination

Cilostazol is extensively metabolized by hepatic cytochrome P-450 enzymes, mainly 3A4, and, to a lesser extent, 2C19, with metabolites largely excreted in urine. Cilostazol is eliminated predominately by metabolism and subsequent urinary excretion of metabolites. The primary route of elimination was via the urine (74%), with the remainder excreted in feces (20%). No measurable amount of unchanged cilostazol was excreted in the urine, and less than 2% of the dose was excreted as 3,4-dehydro-cilostazol. About 30% of the dose was excreted in urine as 4'-trans-hydroxy-cilostazol.

/MILK/ Transfer of cilostazol into milk has been reported in rats.

Following oral administration of a single 100-mg dose of cilostazol with a high-fat meal, peak plasma cilostazol concentrations and area under the plasma concentration-time curve (AUC) increased by approximately 90 and 25%, respectively.

American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 1529

Pletal is absorbed after oral administration. A high fat meal increases absorption, with an approximately 90% increase in Cmax and a 25% increase in AUC. Absolute bioavailability is not known.

NIH; DailyMed. Current Medication Information for Pletal (Cilostazol) Tablet (Updated: July 2015). Available from, as of January 25, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24d75b58-bafb-4440-b8d7-4f4079c08b0b

The primary route of elimination was via the urine (74%), with the remainder excreted in feces (20%). No measurable amount of unchanged cilostazol was excreted in the urine, and less than 2% of the dose was excreted as 3,4-dehydro-cilostazol. About 30% of the dose was excreted in urine as 4'-trans-hydroxy-cilostazol. The remainder was excreted as other metabolites, none of which exceeded 5%. There was no evidence of induction of /microsomal enzymes/.

For more Absorption, Distribution and Excretion (Complete) data for Cilostazol (7 total), please visit the HSDB record page.

5.6 Metabolism/Metabolites

Hepatic. Cilostazol is extensively metabolized by hepatic cytochrome P-450 enzymes, mainly 3A4, and, to a lesser extent, 2C19, with metabolites largely excreted in urine. Two metabolites are active, with one metabolite appearing to account for at least 50% of the pharmacologic (PDE III inhibition) activity after administration of cilostazol.

Following oral administration of 100 mg radiolabeled cilostazol, 56% of the total analytes in plasma was cilostazol, 15% was 3,4-dehydro-cilostazol (4-7 times as active as cilostazol), and 4% was 4'-trans-hydroxy-cilostazol (20% as active as cilostazol).

Cilostazol is eliminated predominantly by metabolism and subsequent urinary excretion of metabolites. Based on in vitro studies, the primary isoenzymes involved in cilostazol's metabolism are CYP3A4 and, to a lesser extent, CYP2C19. The enzyme responsible for metabolism of 3,4-dehydro-cilostazol, the most active of the metabolites, is unknown.

Cilostazol is extensively metabolized by hepatic cytochrome P-450 enzymes, mainly 3A4, and, to a lesser extent, 2C19, with metabolites largely excreted in urine. Two metabolites are active, with one metabolite appearing to account for at least 50% of the pharmacologic (PDE III inhibition) activity after administration of Pletal.

The pharmacokinetics of cilostazol was investigated after oral and intravenous administration in both male and female rats. After oral administration, area under serum concentration-time curve (AUC) was about 35-fold higher in female rats than in male rats, and absolute bioavailability was about 5.8-fold higher in female rats than in male rats. Total body clearance (CL(total)) for female rats was around one-sixth of that for male rats. In vivo hepatic clearance (CL(h)) calculated based on isolated liver perfusion studies was even higher than or around 90% of the in vivo CL(total) of cilostazol for female and male rats, respectively, indicating that cilostazol is mainly eliminated by the liver in both male and female rats. In vitro metabolism studies utilizing hepatic microsomes and recombinant cytochrome (CYP) isoforms clearly indicated that major metabolites of cilostazol were generated extensively with hepatic microsomes of male rats and that male-predominant CYP3A2 and male-specific CYP2C11 were mainly responsible for the hepatic metabolism of cilostazol. Therefore, the great sex differences in the pharmacokinetics of cilostazol were mainly attributed to the large difference in hepatic metabolism. Our experimental results also suggested that the substantial metabolism of cilostazol in the small intestine and its possible saturation would be responsible for dose-dependent bioavailability in both male and female rats.

PMID:21718207 Kamada N et al; Xenobiotica 41 (10): 903-13 (2011)

Cilostazol has known human metabolites that include OPC-13217 and OPC-13326.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

5.7 Biological Half-Life

11-13 hours.

Cilostazol and its active metabolites have apparent elimination half-lives of about 11-13 hours.

5.8 Mechanism of Action

Cilostazol and several of its metabolites are cyclic AMP (cAMP) phosphodiesterase III inhibitors (PDE III inhibitors), inhibiting phosphodiesterase activity and suppressing cAMP degradation with a resultant increase in cAMP in platelets and blood vessels, leading to inhibition of platelet aggregation and vasodilation.

Cilostazol, a phosphodiesterase 3, has been widely used in patients with arterial disease and is known to have additional beneficial effects on dyslipidemia. However, the effect of cilostazol on hepatic steatosis has not been fully elucidated. We investigated the effect of cilostazol on hepatic ABCA1 expression and hepatic steatosis in diet-induced obesity mice model. Hepatic ABCA1 expression and lipid accumulation were analyzed in HepG2 cell lines treated with cilostazol. Male C57BL/6 mice were randomly divided into three groups: (1) fed normal chow diet with vehicle; (2) fed high-fat diet (HFD) with vehicle; (3) fed HFD with cilostazol. Cilostazol (30 mg/kg) was orally administered once daily for 9 weeks. Cilostazol significantly enhanced ABCA1 expression and restored ABCA1 expression reduced by palmitate in HepG2 cells. Cilostazol treatment ameliorated lipid accumulation induced by palmitate, and this effect was diminished when ABCA1 or LRP1 was silenced by small interference RNA. After silencing of LRP1, ABCA1 expression was decreased in HepG2 cells. Cilostazol significantly enhanced hepatic ABCA1 expression and decreased hepatic fat in HFD-fed mice. Hepatic expression of cleaved caspase-3 and PARP1 was also decreased in HFD-fed mice treated with cilostazol. Cilostazol ameliorated hepatic steatosis and increased ABCA1 expression in the hepatocytes. Enhancing ABCA1 expression with cilostazol represents a potential therapeutic avenue for treatment of hepatic steatosis.

PMID:26362727 Jeon BH et al; Metabolism 64 (11): 1444-53 (2015)

Cilostazol, a quinolinone-derivative selective phosphodiesterase (PDE) inhibitor, is a platelet-aggregation inhibitor and arterial vasodilator. Although the mechanism of action of cilostazol has not been fully elucidated, the drug appears to inhibit activation of cellular PDE type III (PDE III), resulting in suppressed degradation, and thus increased concentrations, of cyclic adenosine-3',5'-monophosphate (cAMP) in platelets and blood vessels. Increased cAMP concentrations are thought to result in arterial vasodilation and inhibition of platelet aggregation.

American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 1529

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SOLUTIONS","customerCountry":"INDIA","quantity":"10.50","actualQuantity":"10.5","unit":"KGS","unitRateFc":"350","totalValueFC":"3663.8","currency":"USD","unitRateINR":"26967.5","date":"13-May-2022","totalValueINR":"283158.75","totalValueInUsd":"3663.8","indian_port":"JNPT","hs_no":"29420090","bill_no":"8660919","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652380200,"product":"CILOSTAZOL (IP\/USP\/BP)","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,","city":"KURLA, MUMBAI","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"CHINA","foreign_port":"NA","customer":"PIRAMAL PHARMA 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SOLUTIONS","customerCountry":"INDIA","quantity":"260.00","actualQuantity":"260","unit":"KGS","unitRateFc":"350","totalValueFC":"90722.4","currency":"USD","unitRateINR":"26967.5","date":"13-May-2022","totalValueINR":"7011550","totalValueInUsd":"90722.4","indian_port":"JNPT","hs_no":"29420090","bill_no":"8660919","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652380200,"product":"CILOSTAZOL (IP\/USP\/BP)","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,","city":"KURLA, MUMBAI","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"CHINA","foreign_port":"NA","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"320.00","actualQuantity":"320","unit":"KGS","unitRateFc":"350","totalValueFC":"111658.4","currency":"USD","unitRateINR":"26967.5","date":"13-May-2022","totalValueINR":"8629600","totalValueInUsd":"111658.4","indian_port":"JNPT","hs_no":"29420090","bill_no":"8660919","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652380200,"product":"CILOSTAZOL (IP\/USP\/BP)","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,","city":"KURLA, MUMBAI","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"CHINA","foreign_port":"NA","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"360.00","actualQuantity":"360","unit":"KGS","unitRateFc":"350","totalValueFC":"125615.7","currency":"USD","unitRateINR":"26967.5","date":"13-May-2022","totalValueINR":"9708300","totalValueInUsd":"125615.7","indian_port":"JNPT","hs_no":"29420090","bill_no":"8660919","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654453800,"product":"CILOSTAZOL IP\/USP\/BP","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,","city":"KURLA, MUMBAI","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"CHINA","foreign_port":"NA","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"350","totalValueFC":"2113","currency":"USD","unitRateINR":"27475","date":"06-Jun-2022","totalValueINR":"164850","totalValueInUsd":"2113","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"8991991","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654453800,"product":"CILOSTAZOL IP\/USP\/BP","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,","city":"KURLA, MUMBAI","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"CHINA","foreign_port":"NA","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"350","totalValueFC":"70434.9","currency":"USD","unitRateINR":"27475","date":"06-Jun-2022","totalValueINR":"5495000","totalValueInUsd":"70434.9","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"8991991","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654453800,"product":"CILOSTAZOL IP\/USP\/BP","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,","city":"KURLA, MUMBAI","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"CHINA","foreign_port":"NA","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"340.00","actualQuantity":"340","unit":"KGS","unitRateFc":"350","totalValueFC":"119739.3","currency":"USD","unitRateINR":"27475","date":"06-Jun-2022","totalValueINR":"9341500","totalValueInUsd":"119739.3","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"8991991","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1656009000,"product":"CILOSTAZOL (IP\/USP\/BP)","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,","city":"KURLA, MUMBAI","supplier":"TEVA API","supplierCountry":"CHINA","foreign_port":"NA","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"1530.00","actualQuantity":"1530","unit":"KGS","unitRateFc":"350","totalValueFC":"541915.9","currency":"USD","unitRateINR":"27632.5","date":"24-Jun-2022","totalValueINR":"42277725","totalValueInUsd":"541915.9","indian_port":"JNPT","hs_no":"29420090","bill_no":"9261557","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1656009000,"product":"CILOSTAZOL (IP\/USP\/BP)","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,","city":"KURLA, MUMBAI","supplier":"TEVA API","supplierCountry":"CHINA","foreign_port":"NA","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"1870.00","actualQuantity":"1870","unit":"KGS","unitRateFc":"350","totalValueFC":"662341.6","currency":"USD","unitRateINR":"27632.5","date":"24-Jun-2022","totalValueINR":"51672775","totalValueInUsd":"662341.6","indian_port":"JNPT","hs_no":"29420090","bill_no":"9261557","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20863

DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20863

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ABOUT THIS PAGE

Cilostazol Manufacturers

A Cilostazol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cilostazol, including repackagers and relabelers. The FDA regulates Cilostazol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cilostazol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Cilostazol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Cilostazol Suppliers

A Cilostazol supplier is an individual or a company that provides Cilostazol active pharmaceutical ingredient (API) or Cilostazol finished formulations upon request. The Cilostazol suppliers may include Cilostazol API manufacturers, exporters, distributors and traders.

click here to find a list of Cilostazol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Cilostazol USDMF

A Cilostazol DMF (Drug Master File) is a document detailing the whole manufacturing process of Cilostazol active pharmaceutical ingredient (API) in detail. Different forms of Cilostazol DMFs exist exist since differing nations have different regulations, such as Cilostazol USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Cilostazol DMF submitted to regulatory agencies in the US is known as a USDMF. Cilostazol USDMF includes data on Cilostazol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cilostazol USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Cilostazol suppliers with USDMF on PharmaCompass.

Cilostazol JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Cilostazol Drug Master File in Japan (Cilostazol JDMF) empowers Cilostazol API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Cilostazol JDMF during the approval evaluation for pharmaceutical products. At the time of Cilostazol JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Cilostazol suppliers with JDMF on PharmaCompass.

Cilostazol KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Cilostazol Drug Master File in Korea (Cilostazol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cilostazol. The MFDS reviews the Cilostazol KDMF as part of the drug registration process and uses the information provided in the Cilostazol KDMF to evaluate the safety and efficacy of the drug.

After submitting a Cilostazol KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Cilostazol API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Cilostazol suppliers with KDMF on PharmaCompass.

Cilostazol WC

A Cilostazol written confirmation (Cilostazol WC) is an official document issued by a regulatory agency to a Cilostazol manufacturer, verifying that the manufacturing facility of a Cilostazol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cilostazol APIs or Cilostazol finished pharmaceutical products to another nation, regulatory agencies frequently require a Cilostazol WC (written confirmation) as part of the regulatory process.

click here to find a list of Cilostazol suppliers with Written Confirmation (WC) on PharmaCompass.

Cilostazol NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Cilostazol as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cilostazol API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Cilostazol as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Cilostazol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cilostazol NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Cilostazol suppliers with NDC on PharmaCompass.

Cilostazol GMP

Cilostazol Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Cilostazol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Cilostazol GMP manufacturer or Cilostazol GMP API supplier for your needs.

Cilostazol CoA

A Cilostazol CoA (Certificate of Analysis) is a formal document that attests to Cilostazol's compliance with Cilostazol specifications and serves as a tool for batch-level quality control.

Cilostazol CoA mostly includes findings from lab analyses of a specific batch. For each Cilostazol CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Cilostazol may be tested according to a variety of international standards, such as European Pharmacopoeia (Cilostazol EP), Cilostazol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cilostazol USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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10 Solubilizers

9 Taste Masking

9 Chewable & Orodispersible Aids

6 Film Formers & Plasticizers

5 Empty Capsules

5 API Stability Enhancers

4 Vegetarian Capsules

4 Emulsifying Agents

3 Parenteral

TABLET;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons