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    Chemistry

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    Also known as: Trental, 6493-05-6, Oxpentifylline, Pentoxifyllin, Torental, Pentoxyphylline
    Molecular Formula
    C13H18N4O3
    Molecular Weight
    278.31  g/mol
    InChI Key
    BYPFEZZEUUWMEJ-UHFFFAOYSA-N
    FDA UNII
    SD6QCT3TSU
    Pentoxifylline
    A METHYLXANTHINE derivative that inhibits phosphodiesterase and affects blood rheology. It improves blood flow by increasing erythrocyte and leukocyte flexibility. It also inhibits platelet aggregation. Pentoxifylline modulates immunologic activity by stimulating cytokine production.
    Pentoxifylline is a Blood Viscosity Reducer. The physiologic effect of pentoxifylline is by means of Hematologic Activity Alteration.
    1 2D Structure

    Pentoxifylline

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    3,7-dimethyl-1-(5-oxohexyl)purine-2,6-dione
    2.1.2 InChI
    InChI=1S/C13H18N4O3/c1-9(18)6-4-5-7-17-12(19)10-11(14-8-15(10)2)16(3)13(17)20/h8H,4-7H2,1-3H3
    2.1.3 InChI Key
    BYPFEZZEUUWMEJ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(=O)CCCCN1C(=O)C2=C(N=CN2C)N(C1=O)C
    2.2 Other Identifiers
    2.2.1 UNII
    SD6QCT3TSU
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Agapurin

    2. Bl 191

    3. Bl-191

    4. Bl191

    5. Oxpentifylline

    6. Pentoxil

    7. Torental

    8. Trental

    2.3.2 Depositor-Supplied Synonyms

    1. Trental

    2. 6493-05-6

    3. Oxpentifylline

    4. Pentoxifyllin

    5. Torental

    6. Pentoxyphylline

    7. Dimethyloxohexylxanthine

    8. Pentoxiphyllium

    9. Vazofirin

    10. 3,7-dimethyl-1-(5-oxohexyl)xanthine

    11. Pentoxiphyllin

    12. Pentoxiphylline

    13. Rentylin

    14. 1-(5-oxohexyl)theobromine

    15. Bl 191

    16. Bl-191

    17. 1h-purine-2,6-dione, 3,7-dihydro-3,7-dimethyl-1-(5-oxohexyl)-

    18. 3,7-dimethyl-1-(5-oxohexyl)purine-2,6-dione

    19. Pentoxyphyllin

    20. 3,7-dihydro-3,7-dimethyl-1-(5-oxohexyl)-1h-purine-2,6-dione

    21. 3,7-dimethyl-1-(5-oxohexyl)-3,7-dihydro-1h-purine-2,6-dione

    22. Oxypentifylline

    23. Pentoxyfilline

    24. 1-(5-oxohexyl)-3,7-dimethylxanthine

    25. Theobromine, 1-(5-oxohexyl)-

    26. C04ad03

    27. Sd6qct3tsu

    28. 3,7-dimethyl-1-(5-oxohexyl)-1h-purine-2,6(3h,7h)-dione

    29. Nsc637086

    30. Chembl628

    31. Nsc 637086

    32. Nsc-637086

    33. Nsc-758481

    34. 3,7-dimethyl-1-(5-oxohexyl)-1h,3h-purin-2,6-dione

    35. Mls000079026

    36. Chebi:7986

    37. Pentoxyfylline

    38. Azupentat

    39. 1,2,3,6-tetrahydro-3,7-dimethyl-1-(5-oxohexyl)-2,6-purindion

    40. 3,7-dimethyl-1-(5-oxohexyl)-2,3,6,7-tetrahydro-1h-purine-2,6-dione

    41. Eht 0202

    42. Ncgc00015801-02

    43. Durapental

    44. Smr000035998

    45. Dsstox_cid_3437

    46. Dsstox_rid_77028

    47. Dsstox_gsid_23437

    48. Pnx

    49. Pentoxifyllinum

    50. Pentoxifilina

    51. Hemovas

    52. Ralofect

    53. Vasofirin

    54. Ikomio

    55. Agapurin Retard

    56. Pentoxifilina [inn-spanish]

    57. Pentoxifyllinum [inn-latin]

    58. Pentoxil (tn)

    59. Trental (tn)

    60. Cas-6493-05-6

    61. Eht0201

    62. Sr-01000075641

    63. Mfcd00063379

    64. 3,7-dimethyl-1-(5-oxohexyl)xantine

    65. 3,7-dimethyl-1-(5-oxohexyl) Xantine

    66. Pentoxyifylline

    67. Pentopak

    68. Ccris 6832

    69. Pentoxifylline (jan/usp/inn)

    70. 3arr

    71. 3aru

    72. 3tvx

    73. Eht-201

    74. Ptx;oxpentifylline

    75. Eht-0201

    76. Prestwick_608

    77. Einecs 229-374-5

    78. Pentoxifylline,(s)

    79. Brn 0558929

    80. Spectrum_001444

    81. 2a3c

    82. Unii-sd6qct3tsu

    83. Opera_id_1800

    84. Prestwick0_000196

    85. Prestwick1_000196

    86. Prestwick2_000196

    87. Prestwick3_000196

    88. Spectrum2_001181

    89. Spectrum3_001820

    90. Spectrum4_000227

    91. Spectrum5_001161

    92. Lopac-p-1784

    93. P 1784

    94. Pentoxifylline [mi]

    95. Pentoxifylline [inn]

    96. Pentoxifylline [jan]

    97. Lopac0_000936

    98. Schembl34039

    99. Bspbio_000151

    100. Bspbio_003439

    101. Kbiogr_000893

    102. Kbioss_001924

    103. Pentoxifylline [usan]

    104. Mls000758298

    105. Mls001201764

    106. Mls001424051

    107. Bidd:gt0174

    108. Divk1c_000729

    109. Pentoxifylline [vandf]

    110. Spectrum1503611

    111. Spbio_001221

    112. Spbio_002072

    113. Pentoxifylline [mart.]

    114. Bpbio1_000167

    115. Gtpl7095

    116. 1-(3-carboxypropyl)-3,7-

    117. Pentoxifylline [usp-rs]

    118. Pentoxifylline [who-dd]

    119. Dtxsid7023437

    120. Bdbm10850

    121. Hms502e11

    122. Kbio1_000729

    123. Kbio2_001924

    124. Kbio2_004492

    125. Kbio2_007060

    126. Kbio3_002942

    127. Ninds_000729

    128. Hms1568h13

    129. Hms1922e16

    130. Hms2051n06

    131. Hms2090h13

    132. Hms2093g21

    133. Hms2095h13

    134. Hms2235c16

    135. Hms3262l14

    136. Hms3370d09

    137. Hms3393n06

    138. Hms3712h13

    139. Pharmakon1600-01503611

    140. Bcp29306

    141. Hy-b0715

    142. Zinc1530776

    143. Pentoxifylline [orange Book]

    144. Tox21_110223

    145. Tox21_500936

    146. Bbl016497

    147. Ccg-36382

    148. Nsc758481

    149. Pdsp1_001015

    150. Pdsp2_000999

    151. Pentoxifylline [ep Monograph]

    152. Stk177321

    153. Pentoxifylline [usp Monograph]

    154. Akos000541484

    155. Tox21_110223_1

    156. Ac-8381

    157. Db00806

    158. Lp00936

    159. Nc00255

    160. Sdccgsbi-0050910.p004

    161. 3,7-dimethyl-1-(5-oxohexyl)-xanthine

    162. Cas-1677687

    163. Idi1_000729

    164. Ncgc00015801-01

    165. Ncgc00015801-03

    166. Ncgc00015801-04

    167. Ncgc00015801-05

    168. Ncgc00015801-06

    169. Ncgc00015801-07

    170. Ncgc00015801-08

    171. Ncgc00015801-09

    172. Ncgc00015801-10

    173. Ncgc00015801-12

    174. Ncgc00015801-17

    175. Ncgc00015801-21

    176. Ncgc00067069-02

    177. Ncgc00067069-03

    178. Ncgc00067069-04

    179. Ncgc00067069-05

    180. Ncgc00178062-01

    181. Ncgc00178062-02

    182. Ncgc00261621-01

    183. As-13662

    184. Pentoxifylline [usan:usp:inn:ban:jan]

    185. Sbi-0050910.p003

    186. 1-(5-oxohexyl)theobromine (pentoxifylline)

    187. Ab00052363

    188. Eu-0100936

    189. Ft-0603570

    190. Ft-0657886

    191. Ft-0673610

    192. P2050

    193. S4345

    194. Sw196777-4

    195. C07424

    196. D00501

    197. D70138

    198. Ab00052363-17

    199. Ab00052363_18

    200. Ab00052363_21

    201. 5-26-14-00081 (beilstein Handbook Reference)

    202. Q416331

    203. 3,7-dimethyl-1-(5-oxohexyl)-1h-purine-2,6-dione

    204. Ptx; Oxpentifylline; Bl191; Bl 191; Bl-191

    205. Sr-01000075641-1

    206. Sr-01000075641-4

    207. Sr-01000075641-7

    208. Sr-01000075641-9

    209. Brd-k57569181-001-05-1

    210. Brd-k57569181-001-16-8

    211. 3,7-dimethyl-1-(5-oxohexyl)-3,7-dihydropurine-2,6-dione

    212. 3,7-dimethyl-1-(5-oxohexyl)-3,7-dihydro-1h-purine-2,6-dione #

    213. Px

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 278.31 g/mol
    Molecular Formula C13H18N4O3
    XLogP30.3
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count5
    Exact Mass278.13789045 g/mol
    Monoisotopic Mass278.13789045 g/mol
    Topological Polar Surface Area75.5 Ų
    Heavy Atom Count20
    Formal Charge0
    Complexity426
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NamePentoxifylline
    PubMed HealthPentoxifylline (By mouth)
    Drug ClassesHemorheologic
    Drug LabelEach extended-release tablet, for oral administration, contains 400 mg of pentoxifylline and the following inactive ingredients: D&C Red #30 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hydroxyethyl cellulose, hypro
    Active IngredientPentoxifylline
    Dosage FormTablet, extended release
    RouteOral
    Strength400mg
    Market StatusPrescription
    CompanyApotex; Valeant Bermuda; Pliva; Mylan; Impax Labs

    2 of 4  
    Drug NamePentoxil
    Drug LabelPentoxil (Pentoxifylline Extended-release Tablets, USP) for oral administration contain 400 mg of the active drug and the following inactive ingredients: D&C Red No. 27 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, hypromellose USP, magnesium stea
    Active IngredientPentoxifylline
    Dosage FormTablet, extended release
    RouteOral
    Strength400mg
    Market StatusPrescription
    CompanyUpsher Smith

    3 of 4  
    Drug NamePentoxifylline
    PubMed HealthPentoxifylline (By mouth)
    Drug ClassesHemorheologic
    Drug LabelEach extended-release tablet, for oral administration, contains 400 mg of pentoxifylline and the following inactive ingredients: D&C Red #30 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hydroxyethyl cellulose, hypro
    Active IngredientPentoxifylline
    Dosage FormTablet, extended release
    RouteOral
    Strength400mg
    Market StatusPrescription
    CompanyApotex; Valeant Bermuda; Pliva; Mylan; Impax Labs

    4 of 4  
    Drug NamePentoxil
    Drug LabelPentoxil (Pentoxifylline Extended-release Tablets, USP) for oral administration contain 400 mg of the active drug and the following inactive ingredients: D&C Red No. 27 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, hypromellose USP, magnesium stea
    Active IngredientPentoxifylline
    Dosage FormTablet, extended release
    RouteOral
    Strength400mg
    Market StatusPrescription
    CompanyUpsher Smith

    4.2 Drug Indication

    Pentoxifylline is indicated for the treatment of intermittent claudication in patients with chronic occlusive arterial disease. Pentoxifylline may improve limb function and reduce symptoms but cannot replace other therapies such as surgical bypass or removal of vascular obstructions.

    FDA Label

    Investigated for use/treatment in alzheimer's disease and neurologic disorders.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Pentoxifylline, a synthetic dimethylxanthine derivative structurally related to [theophylline] and [caffeine], exhibits hemorheological, anti-oxidative, and anti-inflammatory properties and is traditionally indicated in the treatment of peripheral arterial disease (PAD). In PAD patients with concurrent cerebrovascular and coronary artery diseases, pentoxifylline treatment has occasionally been associated with angina, arrhythmia, and hypotension. Concurrent use with [warfarin] should be associated with more frequent monitoring of prothrombin times. Also, patients with risk factors complicated by hemorrhages, such as retinal bleeding, peptic ulceration, and recent surgery, should be monitored periodically for bleeding signs.

    5.2 MeSH Pharmacological Classification

    Phosphodiesterase Inhibitors

    Compounds which inhibit or antagonize the biosynthesis or actions of phosphodiesterases. (See all compounds classified as Phosphodiesterase Inhibitors.)

    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.)

    Free Radical Scavengers

    Substances that eliminate free radicals. Among other effects, they protect PANCREATIC ISLETS against damage by CYTOKINES and prevent myocardial and pulmonary REPERFUSION INJURY. (See all compounds classified as Free Radical Scavengers.)

    Vasodilator Agents

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

    Radiation-Protective Agents

    Drugs used to protect against ionizing radiation. They are usually of interest for use in radiation therapy but have been considered for other purposes, e.g. military. (See all compounds classified as Radiation-Protective Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    PENTOXIFYLLINE
    5.3.2 FDA UNII
    SD6QCT3TSU
    5.3.3 Pharmacological Classes
    Hematologic Activity Alteration [PE]; Blood Viscosity Reducer [EPC]
    5.4 ATC Code

    C04AD03

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    C - Cardiovascular system

    C04 - Peripheral vasodilators

    C04A - Peripheral vasodilators

    C04AD - Purine derivatives

    C04AD03 - Pentoxifylline

    5.5 Absorption, Distribution and Excretion

    Absorption

    Oral pentoxifylline (PTX) is almost completely absorbed but has low bioavailability of 20-30% due to extensive first-pass metabolism; three of the seven known metabolites, M1, M4, and M5 are present in plasma and appear soon after dosing. Single oral doses of 100, 200, and 400 mg of pentoxifylline in healthy males produced a mean tmax of 0.29-0.41 h, a mean Cmax of 272-1607 ng/mL, and a mean AUC0- of 193-1229 ng\*h/mL; corresponding ranges for metabolites 1, 4, and 5 were 0.72-1.15, 114-2753, and 189-7057. Single administration of a 400 mg extended-release tablet resulted in a heightened tmax of 2.08 1.16 h, lowered Cmax of 55.33 22.04 ng/mL, and a comparable AUC0-t of 516 165 ng\*h/mL; all these parameters were increased in cirrhotic patients. Smoking was associated with a decrease in the Cmax and AUCsteady-state of metabolite M1 but did not dramatically affect the pharmacokinetic parameters of pentoxifylline or other measured metabolites. Renal impairment increases the mean Cmax, AUC, and ratio to parent compound AUC of metabolites M4 and M5, but has no significant effect on PTX or M1 pharmacokinetics. Finally, similar to cirrhotic patients, the Cmax and tmax of PTX and its metabolites are increased in patients with varying degrees of chronic heart failure. Overall, metabolites M1 and M5 exhibit plasma concentrations roughly five and eight times greater than PTX, respectively. PTX and M1 pharmacokinetics are approximately dose-dependent, while those of M5 are not. Food intake before PTX ingestion delays time to peak plasma concentrations but not overall absorption. Extended-release forms of PTX extend the tmax to between two and four hours but also serves to ameliorate peaks and troughs in plasma concentration over time.

    Route of Elimination

    Pentoxifylline is eliminated almost entirely in the urine and predominantly as M5, which accounts for between 57 and 65 percent of the administered dose. Smaller amounts of M4 are recovered, while M1 and the parent compound account for less than 1% of the recovered dose. The fecal route accounts for less than 4% of the administered dose.

    Volume of Distribution

    Pentoxifylline has a volume of distribution of 4.15 0.85 following a single intravenous 100 mg dose in healthy subjects.

    Clearance

    Pentoxifylline given as a single 100 mg intravenous infusion has a clearance of 3.62 0.75 L/h/kg in healthy subjects, which decreased to 1.44 0.46 L/h/kg in cirrhotic patients. In another study, the apparent clearance of either 300 or 600 mg of pentoxifylline given intravenously (median and range) was 4.2 (2.8-6.3) and 4.1 (2.3-4.6) L/min, respectively. It is important to note that, due to the reversible extra-hepatic metabolism of the parent compound and metabolite 1, the true clearance of pentoxifylline may be even higher than the measured values.

    5.6 Metabolism/Metabolites

    Pentoxifylline (PTX) metabolism is incompletely understood. There are seven known metabolites (M1 through M7), although only M1, M4, and M5 are detected in plasma at appreciable levels, following the general pattern M5 > M1 > PTX > M4. As PTX apparent clearance is higher than hepatic blood flow and the AUC ratio of M1 to PTX is not appreciably different in cirrhotic patients, it is clear that erythrocytes are the main site of PTX-M1 interconversion. However, the reaction likely occurs in the liver as well. PTX is reduced in an NADPH-dependent manner by unknown an unidentified carbonyl reductase to form either [lisofylline] (the (R)-M1 enantiomer) or (S)-M1; the reaction is stereoselective, producing (S)-M1 exclusively in liver cytosol, 85% (S)-M1 in liver microsomes, and a ratio of 0.010-0.025 R:S-M1 after IV or oral dosing in humans. Although both (R)- and (S)-M1 can be oxidized back into PTX, (R)-M1 can also give rise to M2 and M3 in liver microsomes. _In vitro_ studies suggest that CYP1A2 is at least partly responsible for the conversion of [lisofylline] ((R)-M1) back into PTX. Unlike the reversible oxidation/reduction of PTX and its M1 metabolites, M4 and M5 are formed via irreversible oxidation of PTX in the liver. Studies in mice recapitulating the PTX-ciprofloxacin drug reaction suggest that CYP1A2 is responsible for the formation of M6 from PTX and of M7 from M1, both through de-methylation at position 7. In general, metabolites M2, M3, and M6 are formed at very low levels in mammals.

    Pentoxifylline is a known human metabolite of lisofylline.

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

    5.7 Biological Half-Life

    Overall, pentoxifylline has an elimination half-life of between 0.39 and 0.84 hours, while its primary metabolites have elimination half-lives of between 0.96 and 1.61 hours.

    5.8 Mechanism of Action

    Patients with peripheral arterial disease (PAD) may suffer from intermittent claudication, exertional leg pain that resolves upon rest, which is underscored by a complex etiology including vascular dysfunction (reduced limb perfusion, angiogenesis, and microcirculatory flow), systemic inflammation, and skeletal muscle dysfunction. Pentoxifylline (PTX), (3,7-dimethyl-1-(5-oxohexyl)-3,7-dihydro-1H-purine-2,6-dione) or 1-(5-oxohexyl)-3,7-dimethylxanthine, is a methyl-xanthine derivative that acts to lower blood viscosity by increasing erythrocyte flexibility, reducing plasma fibrinogen, inhibiting neutrophil activation, and suppressing erythrocyte/platelet aggregation; it also has antioxidant and anti-inflammatory effects. Although the precise mechanism of action has yet to be elucidated, numerous studies have suggested several effects of PTX. The classical interpretation of PTX's broad effects is due to its ability to act, _in vitro_, as a non-specific cyclic-3',5'-phosphodiesterase (PDE) inhibitor at millimolar concentrations; specifically, it has been proposed that inhibition of PDE type III and IV isozymes leads to elevated cyclic adenosine monophosphate (cAMP) levels, which mediate diverse downstream effects. This view has been challenged, specifically by observing those plasma concentrations of PTX in routine clinical use are typically only around 1M, far lower than those used to inhibit PDEs _in vitro_. Instead, several studies have suggested that PTX can modulate adenosine receptor function, specifically the G-coupled A2A receptor (A2AR). Whether PTX acts directly as an A2AR agonist is unclear, although it can clearly increase the response of A2AR to adenosine. A2AR activation activates adenylyl cyclase, which increases intracellular cAMP levels; this observation may explain PTX's ability to increase intracellular cAMP in a PDE-independent fashion. Elevated cAMP levels have numerous downstream effects. cAMP-mediated activation of protein kinase A (PKA) suppresses nuclear translocation of NF-B, which suppresses transcription of pro-inflammatory cytokines such as tumour necrosis factor (TNF-), interleukin-1 (IL-1), and IL-6 as well as TNF-induced molecules such as adhesion molecules (ICAM1 and VCAM1) and the C-reactive protein (CRP). PTX has also been shown to prevent the downstream phosphorylation of p38 MAPK and ERK, which are responsible for assembling the NADPH oxidase involved in the neutrophil oxidative burst. This effect is due to a PKA-independent decrease in Akt phosphorylation and a PKA-dependent decrease in phosphorylation of p38 MAPK and ERK. This transcriptional regulation at least partially explains the anti-inflammatory and anti-oxidative properties of PTX. Also, activated PKA can activate the cAMP response element-binding protein (CREB), which itself blocks SMAD-driven gene transcription, effectively disrupting transforming growth factor (TGF-1) signalling. This results in lower levels of fibrinogenic molecules such as collagens, fibronectin, connective tissue growth factor, and alpha-smooth muscle actin. Hence, disruption of TGF-1 signalling may explain the anti-fibrotic effects of PTX, including at least some of the decrease in blood viscosity. The picture is complicated by the observation that PTX metabolites M1, M4, and M5 have been shown to inhibit C5 Des Arg- and formyl-methionylleucylphenylalanine-induced superoxide production in neutrophils and M1 and M5 significantly contribute to PTX's observed hemorheological effects. Overall, PTX administration is associated with decreased pro-inflammatory molecules, an increase in anti-inflammatory molecules such as IL-10, and decreased production of fibrinogenic and cellular adhesion molecules.

    EHT 0202 was discovered to play a role in protecting neurons in pharmacological models of neuronal cell death. ExonHit identified RNA isoforms produced by alterations of splicing specifically taking place in neurodegenerative disease models. These isoforms were identified using DATAS(TM), ExonHit's proprietary gene profiling technology. DATAS(TM), stands for Differential Analysis of Transcripts with Alternative Splicing.

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    Drugs in Development

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    Pentoxifylline PKB171 Gel in Healthy Females Volunteers

    Details:

    PKB171 (Pentoxifylline) is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.


    Lead Product(s): Pentoxifylline,Inapplicable

    Therapeutic Area: Undisclosed Brand Name: PKB171

    Study Phase: Phase IProduct Type: Miscellaneous

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    Highest Development Status : Phase I

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    Pentoxifylline PKB171 Gel in Healthy Females Volunteers

    Details : PKB171 (Pentoxifylline) is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.

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    PKB171 Against Placebo in Couples with Asthenozoospermia Who Wish to Conceive

    Details:

    PKB171 (Pentoxifylline) is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Infertility, Male.


    Lead Product(s): Pentoxifylline,Inapplicable

    Therapeutic Area: Endocrinology Brand Name: PKB171

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 22, 2025

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    Prokrea BCN, S.L.

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    Therapeutic Area : Endocrinology

    Highest Development Status : Phase II

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    PKB171 Against Placebo in Couples with Asthenozoospermia Who Wish to Conceive

    Details : PKB171 (Pentoxifylline) is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Infertility, Male.

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    Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients Undergoing Chemoradiation

    Details:

    Pentoxifylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.


    Lead Product(s): Pentoxifylline,Vitamin E

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: AstraZeneca

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    Deal Type: Inapplicable October 09, 2024

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    University Health Network, Toronto

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    Therapeutic Area : Oncology

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    Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Ce...

    Details : Pentoxifylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.

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    Poolbeg Pharma PLC Announces Option Agreement to Acquire Orphan Drug Candidate

    Details:

    Through the agreement with Silk Road Therapeutics to acquire novel topical muco-adherent formulation of Trental (pentoxifylline), for oral ulcers in patients suffering from behcet's disease.


    Lead Product(s): Pentoxifylline,Inapplicable

    Therapeutic Area: Rare Diseases and Disorders Brand Name: Trental

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    Highest Development Status : Phase II

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    Poolbeg Pharma PLC Announces Option Agreement to Acquire Orphan Drug Candidate

    Details : Through the agreement with Silk Road Therapeutics to acquire novel topical muco-adherent formulation of Trental (pentoxifylline), for oral ulcers in patients suffering from behcet's disease.

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    ANI Pharmaceuticals Announces the Launch of Pentoxifylline Extended-Release Tablets, USP

    Details:

    Trental-Generic (pentoxifylline) is an oral small molecule drug. It is now approved for the treatment of chronic occlusive arterial disease of the limbs.


    Lead Product(s): Pentoxifylline,Inapplicable

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Trental-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

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    Deal Type: Inapplicable January 23, 2024

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    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

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    ANI Pharmaceuticals Announces the Launch of Pentoxifylline Extended-Release Tablets, USP

    Details : Trental-Generic (pentoxifylline) is an oral small molecule drug. It is now approved for the treatment of chronic occlusive arterial disease of the limbs.

    Product Name : Trental-Generic

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    Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible

    Details:

    Pentoxifylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Osteoradionecrosis.


    Lead Product(s): Pentoxifylline,Vitamin E,Clodronic Acid Disodium Salt

    Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 26, 2023

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    Sunnybrook Health Sciences Centre

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    Lead Product(s) : Pentoxifylline,Vitamin E,Clodronic Acid Disodium Salt

    Therapeutic Area : Trauma (Emergency, Injury, Surgery)

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

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    Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Man...

    Details : Pentoxifylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Osteoradionecrosis.

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    Soligenix Enters into Exclusive Option Agreement with Silk Road Therapeutics for Rights to Topical Pentoxifylline Designed to Treat Behçet's Disease

    Details:

    The option agreement grants Soligenix the right to acquire a novel topical formulation of SRT001 (pentoxifylline), a non-biological anti-TNF-alpha inhibitor, for the treatment of mucocutaneous ulcers in patient's suffering from Behçet's Disease (BD).


    Lead Product(s): Pentoxifylline,Inapplicable

    Therapeutic Area: Rare Diseases and Disorders Brand Name: Trental

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Soligenix

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement May 01, 2023

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    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Soligenix

    Deal Size : Undisclosed

    Deal Type : Agreement

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    Soligenix Enters into Exclusive Option Agreement with Silk Road Therapeutics for Rights to Topical...

    Details : The option agreement grants Soligenix the right to acquire a novel topical formulation of SRT001 (pentoxifylline), a non-biological anti-TNF-alpha inhibitor, for the treatment of mucocutaneous ulcers in patient's suffering from Behçet's Disease (BD).

    Product Name : Trental

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    May 01, 2023

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    Efficacy of Pentoxifylline on Cerebrovascular Function in Patients With Cerebral Small Vessel Disease(PERFORM)

    Details:

    Pentoxifylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Cerebral Small Vessel Diseases.


    Lead Product(s): Pentoxifylline,Inapplicable

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Miscellaneous

    Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 17, 2022

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    Beijing Tiantan Hospital

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    Lead Product(s) : Pentoxifylline,Inapplicable

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : CSPC Ouyi Pharmaceutical Co., Ltd

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Efficacy of Pentoxifylline on Cerebrovascular Function in Patients With Cerebral Small Vessel Dise...

    Details : Pentoxifylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Cerebral Small Vessel Diseases.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 17, 2022

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    Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers

    Details:

    Pentoxifylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Behcet Syndrome.


    Lead Product(s): Pentoxifylline,Inapplicable

    Therapeutic Area: Rare Diseases and Disorders Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 04, 2019

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    Silk Road Therapies

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    Lead Product(s) : Pentoxifylline,Inapplicable

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers

    Details : Pentoxifylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Behcet Syndrome.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 04, 2019

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    Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers

    Details:

    Pentoxifylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Behcet Syndrome.


    Lead Product(s): Pentoxifylline,Colchicine

    Therapeutic Area: Rare Diseases and Disorders Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Istanbul University - Cerrahpasa

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 25, 2019

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    10

    Ipekyolu Ilac

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    Ipekyolu Ilac

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    Lead Product(s) : Pentoxifylline,Colchicine

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Istanbul University - Cerrahpasa

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers

    Details : Pentoxifylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Behcet Syndrome.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    March 25, 2019

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    INTERMEDIATE SUPPLIERS

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    01

    Allchem Lifescience

    India
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    Allchem Lifescience

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    6-Chloro-2-hexanone

    CAS Number : 10226-30-9

    End Use API : Pentoxifylline

    About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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    02

    Ami Organics Private Limited

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    6-CHLORO 2-HEXANONE

    CAS Number : 10226-30-9

    End Use API : Pentoxifylline

    About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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    03

    Chemclone Industries

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    6-Chloro-2-hexanone

    CAS Number : 10226-30-9

    End Use API : Pentoxifylline

    About The Company : Chemclone Industries is India’s leading manufacturer of bromide derivatives, specialty chemicals, quaternary ammonium and phosphonium salts, APIs, and interme...

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    04

    Litmus Organics

    India
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    Litmus Organics

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    6-Chloro-2-Hexanone

    CAS Number : 10226-30-9

    End Use API : Pentoxifylline

    About The Company : Litmus Organics Pvt. Ltd., established in 2005, aims to be a leading chemical manufacturer in India. Equipped with the latest technology and testing facilities,...

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    05

    RR LIFESCIENCES

    India
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    RR LIFESCIENCES

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    6-Chloro-2-hexanone

    CAS Number : 10226-30-9

    End Use API : Pentoxifylline

    About The Company : RR LIFESCIENCES manufactures products purely by organic synthesis to offer its customers a choice of products in their areas. Our facilities are equipped with a...

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    06

    Shodhana Laboratories

    India
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    6-chlorohexan-2-one

    CAS Number : 10226-30-9

    End Use API : Pentoxifylline

    About The Company : Established in 2000, Shodhana Laboratories offers a wide range of APIs and intermediates and caters to the generic and custom requirements of some of the most p...

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    07

    SPC Lifesciences Pvt. Ltd

    India
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    SPC Lifesciences Pvt. Ltd

    India
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    3,7-Dihydro-3,7-Dimethyl-1H-purine-2,6-Dione or Th...

    CAS Number : 83-67-0

    End Use API : Pentoxifylline

    About The Company : Established in 2006, SPC Lifesciences is a truly knowledge driven and fully integrated pharmaceutical company creating global solutions. We are a dynamic chemic...

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    SPC Lifesciences Pvt. Ltd

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    6-Chloro-2-Hexanone

    CAS Number : 10226-30-9

    End Use API : Pentoxifylline

    About The Company : Established in 2006, SPC Lifesciences is a truly knowledge driven and fully integrated pharmaceutical company creating global solutions. We are a dynamic chemic...

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    ABOUT THIS PAGE

    Looking for 6493-05-6 / Pentoxifylline API manufacturers, exporters & distributors?

    Pentoxifylline manufacturers, exporters & distributors 1

    14

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

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pentoxifylline manufacturer or Pentoxifylline supplier.

    API | Excipient name

    Pentoxifylline

    Synonyms

    Trental, 6493-05-6, Oxpentifylline, Pentoxifyllin, Torental, Pentoxyphylline

    Cas Number

    6493-05-6

    Unique Ingredient Identifier (UNII)

    SD6QCT3TSU

    About Pentoxifylline

    A METHYLXANTHINE derivative that inhibits phosphodiesterase and affects blood rheology. It improves blood flow by increasing erythrocyte and leukocyte flexibility. It also inhibits platelet aggregation. Pentoxifylline modulates immunologic activity by stimulating cytokine production.

    Torental Manufacturers

    A Torental manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Torental, including repackagers and relabelers. The FDA regulates Torental manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Torental 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 Torental manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

    Torental Suppliers

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

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

    Torental USDMF

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

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

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

    Torental KDMF

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

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

    After submitting a Torental 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 Torental API can apply through the Korea Drug Master File (KDMF).

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

    Torental CEP

    A Torental CEP of the European Pharmacopoeia monograph is often referred to as a Torental Certificate of Suitability (COS). The purpose of a Torental CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Torental EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Torental to their clients by showing that a Torental CEP has been issued for it. The manufacturer submits a Torental CEP (COS) as part of the market authorization procedure, and it takes on the role of a Torental CEP holder for the record. Additionally, the data presented in the Torental CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Torental DMF.

    A Torental CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Torental CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Torental suppliers with CEP (COS) on PharmaCompass.

    Torental WC

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

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

    Torental 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 Torental as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Torental 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 Torental 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 Torental and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Torental NDC to their finished compounded human drug products, they may choose to do so.

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

    Torental GMP

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

    Torental CoA

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

    Torental CoA mostly includes findings from lab analyses of a specific batch. For each Torental 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.

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