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    Chemistry

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    Also known as: Trifluorothymidine, 70-00-8, Viroptic, 5-trifluorothymidine, Trifluoromethyldeoxyuridine, F3dthd
    Molecular Formula
    C10H11F3N2O5
    Molecular Weight
    296.20  g/mol
    InChI Key
    VSQQQLOSPVPRAZ-RRKCRQDMSA-N
    FDA UNII
    RMW9V5RW38
    Trifluridine
    An antiviral derivative of THYMIDINE used mainly in the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to HERPES SIMPLEX virus. (From Martindale, The Extra Pharmacopoeia, 30th ed, p557)
    Trifluridine is a Nucleoside Analog Antiviral and Nucleoside Metabolic Inhibitor. The mechanism of action of trifluridine is as a Nucleic Acid Synthesis Inhibitor.
    1 2D Structure

    Trifluridine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    1-[(2R,4S,5R)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-(trifluoromethyl)pyrimidine-2,4-dione
    2.1.2 InChI
    InChI=1S/C10H11F3N2O5/c11-10(12,13)4-2-15(9(19)14-8(4)18)7-1-5(17)6(3-16)20-7/h2,5-7,16-17H,1,3H2,(H,14,18,19)/t5-,6+,7+/m0/s1
    2.1.3 InChI Key
    VSQQQLOSPVPRAZ-RRKCRQDMSA-N
    2.1.4 Canonical SMILES
    C1C(C(OC1N2C=C(C(=O)NC2=O)C(F)(F)F)CO)O
    2.1.5 Isomeric SMILES
    C1[C@@H]([C@H](O[C@H]1N2C=C(C(=O)NC2=O)C(F)(F)F)CO)O
    2.2 Other Identifiers
    2.2.1 UNII
    RMW9V5RW38
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2'-deoxy-5-(trifluoromethyl)uridine

    2. 5 Trifluoromethyl 2' Deoxyuridine

    3. 5-trifluoromethyl-2'-deoxyuridine

    4. Tft Ophtiole

    5. Triflumann

    6. Trifluoridine

    7. Trifluorothymidine

    8. Viromidin

    9. Virophta

    10. Viroptic

    2.3.2 Depositor-Supplied Synonyms

    1. Trifluorothymidine

    2. 70-00-8

    3. Viroptic

    4. 5-trifluorothymidine

    5. Trifluoromethyldeoxyuridine

    6. F3dthd

    7. Trifluridina

    8. Virophta

    9. 5-(trifluoromethyl)deoxyuridine

    10. F3tdr

    11. Trifluridinum

    12. 5-trifluoromethyl-2-deoxyuridine

    13. Trifluorothymine Deoxyriboside

    14. 5-trifluoromethyl-2'-deoxyuridine

    15. 1-((2r,4s,5r)-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-5-(trifluoromethyl)pyrimidine-2,4(1h,3h)-dione

    16. 2'-deoxy-5-trifluoromethyluridine

    17. Tfdu

    18. 2'-deoxy-5-(trifluoromethyl)uridine

    19. Nsc 75520

    20. Nsc 529182

    21. Uridine, 2'-deoxy-5-(trifluoromethyl)-

    22. Trifluridine (viroptic)

    23. Chembl1129

    24. Rmw9v5rw38

    25. Mls000028361

    26. Chebi:75179

    27. Nsc-75520

    28. 1-[(2r,4s,5r)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-(trifluoromethyl)pyrimidine-2,4-dione

    29. Nsc-529182

    30. F3t

    31. Triflurdine (viroptic)

    32. Fluridine

    33. Smr000058583

    34. Trifluridinum [inn-latin]

    35. Trifluridina [inn-spanish]

    36. Dsstox_cid_26602

    37. Dsstox_rid_81757

    38. Dsstox_gsid_46602

    39. 5-trifluoro-2'-deoxythymidine

    40. 5-(trifluoromethyl)-2'-deoxyuridine

    41. Alpha,alpha,alpha-trifluorothymidine

    42. Cf3durd

    43. Viroptic (tn)

    44. Thymidine, Alpha,alpha,alpha-trifluoro-

    45. Ccris 2348

    46. Einecs 200-722-8

    47. Mfcd00006534

    48. Unii-rmw9v5rw38

    49. Brn 0568095

    50. Nsc75520

    51. Nsc529182

    52. Trifluridine [usan:usp:inn]

    53. Hsdb 8126

    54. Cas-70-00-8

    55. Ncgc00166323-01

    56. Hs-0007

    57. Opera_id_1810

    58. 5-trifluoromethylthymidine

    59. Trifluridine [mi]

    60. Trifluridine [inn]

    61. Trifluridine [jan]

    62. Trifluoromethyl Deoxyuridine

    63. Trifluridine [usan]

    64. Cid_6256

    65. Schembl3479

    66. 2,4(1h,3h)-pyrimidinedione, 1-(2-deoxy-beta-d-ribofuranosyl)-5-(trifluoromethyl)-

    67. Trifluridine [vandf]

    68. Trifluridine [mart.]

    69. Mls001148248

    70. Mls006010219

    71. Trifluridine [usp-rs]

    72. Trifluridine [who-dd]

    73. Trifluridine (jan/usp/inn)

    74. Gtpl8697

    75. Dtxsid4046602

    76. Cid_6708818

    77. Hms2233n19

    78. Hms3715c14

    79. Trifluridine [orange Book]

    80. Trifluridine [ep Monograph]

    81. 5-trifluoromethyl-2''-deoxyuridine

    82. Bcp09147

    83. Hy-a0061

    84. Zinc3842753

    85. Tox21_112411

    86. Trifluridine [usp Monograph]

    87. Bdbm50132298

    88. Trifluorothymidine, >=99% (hplc)

    89. Akos015919482

    90. Tox21_112411_1

    91. Ccg-221056

    92. Cs-1602

    93. Db00432

    94. Tas-102 Component Trifluridine

    95. Trifluridine Component Of Lonsurf

    96. Ncgc00166323-02

    97. Ncgc00166323-16

    98. S-95005 Component Trifluridine

    99. 1-[(2r,4s,5r)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-(trifluoromethyl)-1,2,3,4-tetrahydropyrimidine-2,4-dione

    100. 1-[(2r,4s,5r)-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]-5-(trifluoromethyl)pyrimidine-2,4-dione

    101. Sri-10817-12

    102. Sri-10817_14

    103. Am20100660

    104. S1778

    105. Sw199522-2

    106. T2511

    107. D00391

    108. Thymidine, .alpha.,.alpha.,.alpha.-trifluoro-

    109. 006t534

    110. A836733

    111. Sr-01000721911

    112. J-700255

    113. J-700357

    114. Q2359590

    115. Sr-01000721911-2

    116. Brd-k03243820-001-12-1

    117. Brd-k03243820-001-25-3

    118. Trifluridine, British Pharmacopoeia (bp) Reference Standard

    119. Trifluridine;ftd;5-trifluorothymidine;nsc 529182;nsc 75520

    120. Trifluridine, United States Pharmacopeia (usp) Reference Standard

    121. 1-((2r,4s,5r)-4-hydroxy-5-(hydroxymethyl)-tetrahydrofuran-2-yl)-5-(trifluoromethyl)pyrimidine-2,4(1h,3h)-dione

    122. 1-((2r,5r)-4-hydroxy-5-hydroxymethyl-tetrahydro-furan-2-yl)-5-trifluoromethyl-1h-pyrimidine-2,4-dione

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 296.20 g/mol
    Molecular Formula C10H11F3N2O5
    XLogP3-0.5
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count2
    Exact Mass296.06200594 g/mol
    Monoisotopic Mass296.06200594 g/mol
    Topological Polar Surface Area99.1 Ų
    Heavy Atom Count20
    Formal Charge0
    Complexity464
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    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 NameTrifluridine
    PubMed HealthTrifluridine (Into the eye)
    Drug ClassesAntiviral
    Drug LabelTrifluridine Ophthalmic Solution (also known as trifluorothymidine, F3TdR, F3T), an antiviral drug for topical treatment of epithelial keratitis caused by herpes simplex virus. The chemical name of trifluridine is ,,-trifluorothymidine. Triflur...
    Active IngredientTrifluridine
    Dosage FormSolution/drops
    RouteOphthalmic
    Strength1%
    Market StatusPrescription
    CompanyAlcon Pharms

    2 of 4  
    Drug NameViroptic
    PubMed HealthTrifluridine (Into the eye)
    Drug ClassesAntiviral
    Drug LabelVIROPTIC is the brand name for trifluridine (also known as trifluorothymidine, F3TdR,F3T), an antiviral drug for topical treatment of epithelial keratitis caused by herpes simplex virus. The chemical name of trifluridine is ,, -trifluorothymidi...
    Active IngredientTrifluridine
    Dosage FormSolution/drops
    RouteOphthalmic
    Strength1%
    Market StatusPrescription
    CompanyMonarch Pharms

    3 of 4  
    Drug NameTrifluridine
    PubMed HealthTrifluridine (Into the eye)
    Drug ClassesAntiviral
    Drug LabelTrifluridine Ophthalmic Solution (also known as trifluorothymidine, F3TdR, F3T), an antiviral drug for topical treatment of epithelial keratitis caused by herpes simplex virus. The chemical name of trifluridine is ,,-trifluorothymidine. Triflur...
    Active IngredientTrifluridine
    Dosage FormSolution/drops
    RouteOphthalmic
    Strength1%
    Market StatusPrescription
    CompanyAlcon Pharms

    4 of 4  
    Drug NameViroptic
    PubMed HealthTrifluridine (Into the eye)
    Drug ClassesAntiviral
    Drug LabelVIROPTIC is the brand name for trifluridine (also known as trifluorothymidine, F3TdR,F3T), an antiviral drug for topical treatment of epithelial keratitis caused by herpes simplex virus. The chemical name of trifluridine is ,, -trifluorothymidi...
    Active IngredientTrifluridine
    Dosage FormSolution/drops
    RouteOphthalmic
    Strength1%
    Market StatusPrescription
    CompanyMonarch Pharms

    4.2 Therapeutic Uses

    Trifluridine Ophthalmic Solution is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2. /Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for TRIFLURIDINE solution (August 2011). Available from, as of March 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=abc1d07f-91ee-4421-bc9b-457d0ed41f4c

    Trifluridine is also effective in the treatment of epithelial keratitis that has not responded clinically to the topical administration of idoxuridine or when ocular toxicity or hypersensitivity to idoxuridine has occurred. In a smaller number of patients found to be resistant to topical vidarabine, trifluridine was also effective.

    US Natl Inst Health; DailyMed. Current Medication Information for TRIFLURIDINE solution (August 2011). Available from, as of March 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=abc1d07f-91ee-4421-bc9b-457d0ed41f4c

    4.3 Drug Warning

    Trifluridine 1% ophthalmic solution is contraindicated in patients who have chemical intolerance or are hypersensitive to the drug or any ingredient in the formulation.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012

    Trifluridine should be used only under the close supervision of an ophthalmologist. In addition, the recommended dosage and frequency of administration should not be exceeded.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012

    If trifluridine is used in smallpox vaccinees who have vaccinia lesions on or near the eyelid for prophylaxis to prevent extension of vaccinia infection to the conjunctiva or cornea, the potential benefit of the drug should be balanced against the minimal but potential risk of drug toxicity and of introducing the virus into the eye by frequent manipulation.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012

    FDA Pregnancy Risk Category: C /RISK CANNOT BE RULED OUT. Adequate, well controlled human studies are lacking, and animal studies have shown risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is given during pregnancy; but the potential benefits may outweigh the potential risk./

    US Natl Inst Health; DailyMed. Current Medication Information for TRIFLURIDINE solution (August 2011). Available from, as of March 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=abc1d07f-91ee-4421-bc9b-457d0ed41f4c

    For more Drug Warnings (Complete) data for Trifluridine (8 total), please visit the HSDB record page.

    4.4 Drug Indication

    Trifluridine is used for the treatment of primay keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2 in ophthalmic solutions. Trifluridine, in combination with tipiracil as oral tablets, is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Trifluridine exhibits an antiviral effect against herpes simplex virus, types 1 and 2 and vacciniavirus both in vitro and in vivo. Some strains of adenovirus that contribute to the pathology of keratoconjunctivitis were shown to be susceptible to trifluridine _in vitro_. While there is evidence from a study that cross-resistance may develop between trifluridine and [idoxuridine] or [vidarabine], trifluridine was shown to effective in treating dendritic ulcers in patients with herpetic keratitis who are unresponsive to [idoxuridine] or [vidarabine] based on the results from masked comparative trials. In nonclinical studies, trifluridine/tipiracil hydrochloride demonstrated antitumour activity against both 5-fluorouracil (5-FU) sensitive and resistant colorectal cancer cell lines. The cytotoxic activity of trifluridine and tipiracil against several human tumour xenografts show high correlation with the amount of trifluridine incorporated into DNA, indicating that the primary mechanism of action of trifluridine involves the direct incorporation into the cancer cell DNA. Trifluridine and tipiracil demonstrated anti-tumor activity against KRAS wild-type and mutant human colorectal cancer xenografts in mice. In clinical studies comprised of patients with previously treated metastatic colorectal cancer, treatment of trifluridine in combination with tipiracil in addition to best supportive care over a 5- or 7-month period resulted in increased progression-free survival (PFS), overall response rate (ORR) and disease control rate (DCR) compared to placebo. In an open-label study, administration of trifluridine at the recommended dosage in patients with advanced solid tumors had no clinically relevant effect on QT/QTc prolongation compared with placebo. Two out of 48 patients displayed had QTc greater than 500 msec and 1 of 42 patients (2.4%) had a QTc increase from baseline greater than 60 msec.

    5.2 MeSH Pharmacological Classification

    Antiviral Agents

    Agents used in the prophylaxis or therapy of VIRUS DISEASES. Some of the ways they may act include preventing viral replication by inhibiting viral DNA polymerase; binding to specific cell-surface receptors and inhibiting viral penetration or uncoating; inhibiting viral protein synthesis; or blocking late stages of virus assembly. (See all compounds classified as Antiviral Agents.)

    Antimetabolites

    Drugs that are chemically similar to naturally occurring metabolites, but differ enough to interfere with normal metabolic pathways. (From AMA Drug Evaluations Annual, 1994, p2033) (See all compounds classified as Antimetabolites.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    TRIFLURIDINE
    5.3.2 FDA UNII
    RMW9V5RW38
    5.3.3 Pharmacological Classes
    Nucleoside Analog Antiviral [EPC]; Nucleoside Analog [EXT]; Nucleoside Metabolic Inhibitor [EPC]; Nucleic Acid Synthesis Inhibitors [MoA]
    5.4 ATC Code

    L01BC59

    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

    S - Sensory organs

    S01 - Ophthalmologicals

    S01A - Antiinfectives

    S01AD - Antivirals

    S01AD02 - Trifluridine

    5.5 Absorption, Distribution and Excretion

    Absorption

    Systemic absorption of trifluridine following therapeutic dosing with ophthalmic trifluridine appears to be negligible. At least 57% of the orally-administered trifluridine is absorbed. Following twice daily oral dosing of trifluridine in combination with tipiracil, systemic exposure of trifluridine increased more than dose-proportionally over the dose range of 15 to 35 mg/m^2. Trifluridine accumulation was 3-fold for AUC0-last and 2-fold for peak plasma concentration (Cmax) at steady state. The time to reach the peak plasma concentrations (Cmax) was 2 hours. Tipiracil increases the AUC and Cmax of trifluridine. Food intake was shown to decrease the Cmax and AUC compared to those in a fasting state.

    Route of Elimination

    About 55% of the total recovered radio-labelled trifluridine was detected in the urine within 24 hours. Following oral administration of trifluridine in combination with tipiracil, only 3% of the total dose was excreted into faeces and expired air. Administration of a 60mg single oral dose of the combination product resulted in the mean urinary recovery of 1.5% of unchanged trifluridine and 19.2% for the inactive metabolite FTY after the 48-hour cumulative excretion.

    Volume of Distribution

    Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the apparent volume of distribution (Vd/F) for trifluridine was 21 L.

    Clearance

    Following a single dose of Lonsurf (35 mg/m^2) in patients with advanced solid tumours, the oral clearance (CL/F) for trifluridine was 10.5 L/hr.

    Following topical application of trifluridine to the eye, the drug penetrates the cornea and can be detected in the aqueous humor.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012

    Systemic absorption following ocular application of trifluridine appears to be negligible. In one study in healthy individuals, topical application of trifluridine 1% ophthalmic solution to the eyes 7 times daily for 14 consecutive days did not result in detectable serum concentrations of trifluridine or 5-carboxy-2'-deoxyuridine.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012

    During in vitro studies using excised rabbit corneas, the major metabolite of trifluridine, 5-carboxy-2'-deoxyuridine, was found on the endothelial side of the cornea in addition to the parent compound; however, detectable levels of the metabolite have not been found in the aqueous humor in humans.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012

    It is unlikely that trifluridine is excreted in human milk after ophthalmic instillation of trifluridine because of the relatively small dosage (

    US Natl Inst Health; DailyMed. Current Medication Information for TRIFLURIDINE solution (August 2011). Available from, as of March 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=abc1d07f-91ee-4421-bc9b-457d0ed41f4c

    5.6 Metabolism/Metabolites

    One major metabolite, 5-carboxy-2'-deoxyuridine found on the endothelial side of the cornea, indicating localized metabolism. Trifluridine is mainly eliminated by metabolism via thymidine phosphorylase (TPase) to form an inactive metabolite, 5-(trifluoromethyl) uracil (FTY).

    The major metabolite of trifluridine (5-carboxy-2'-deoxyuridine appears) to have some antiviral activity but substantially less than that of the parent drug.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012

    19F NMR spectroscopy has been used to study further the metabolism of 5-trifluoromethyl-2'-deoxyuridine (trifluridine; F3TdR). The synthesis and characterization of alpha-trifluoromethyl-beta-alanyl glycine (F3MBAG), a putative new metabolite of F3TdR, are now reported. This study describes ex vivo and in vivo detection of F3MBAG and other previously reported metabolites of trifluridine, using 19F NMR spectroscopy, in male BALB/C mice bearing EMT-6 tumors. A parallel 19F NMR spectroscopic study was also performed on rats dosed with F3TdR, to observe the qualitative pattern of F3TdR metabolism in another species. Unexpectedly, 5-trifluoromethyl-5,6-dihydroxyuracil (DOHF3T), alpha-trifluoromethyl-beta-ureidopropionic acid (F3MUPA) and fluoride, which result from the metabolic degradation of F3TdR and which were detected in various biological samples from mice dosed with F3TdR, could not be identified in rat urine or in homogenized tissue extracts. The presence of these metabolites in intact tissues is uncertain since in this study 19F NMR spectroscopy of these samples always displayed a broad resonance "hump" across the range of chemical shifts that would encompass these metabolites. No clear explanation for the loss of spectroscopic resolution in this region has been rationalized. N-Carboxy-alpha-trifluoromethyl-beta-alanine (F3MBA-CO2), alpha-trifluoromethyl-beta-alanyl alanine (F3MBAA) and N-acetyl-alpha-trifluoromethyl-beta-alanine (Ac-F3MBA) were synthesized and characterized, but were not detected as metabolites in any of the biological specimens examined.

    PMID:8093091 Tandon M et al; Biochem Pharmacol. 48 (5):1033-41 (1994)

    5.7 Biological Half-Life

    The half life is 12 to 18 minutes following ophthalmic administration. After administration of trifluridine with tipiracil at oral doses 35 mg/m^2 twice daily, the mean elimination half-life (t1/2) of trifluridine was 1.4 hours following a single dose. At steady state, the mean elimination half-life was 2.1 hours.

    5.8 Mechanism of Action

    The mechanism of action of trifluridine as an antiviral agent has not been fully elucidated, but appears to involve the inhibition of viral replication. Trifluridine gets incorporated into viral DNA during replication, which leads to the formation of defective proteins and an increased mutation rate. Trifluridine also mediates antineoplastic activities via this mechanism; following uptake into cancer cells, trifluridine is rapidly phosphorylated by thymidine kinase to its active monophosphate form. Subsequent phosphorylation produces trifluridine triphosphate, which is readily incorporated into the DNA of tumour cells in place of thymidine bases to perturb DNA function, DNA synthesis, and tumour cell proliferation. As trifluridine is subject to rapid degradation by TPase and readily metabolised by a first-pass effect following oral administration, tipiracil is added in the antineoplastic combination product as an inhibitor of TPase to increase the bioavailability of trifluridine. Trifluridine monophosphate also reversibly inhibits thymidylate synthetase (TS), an enzyme that is necessary for DNA synthesis and which levels are shown to be elevated different cancer cell lines. Up-regulation of the expression of the TS enzyme may also lead to the resistance to antineoplastic therapies, such as 5-fluorouracil (5-FU). However, this inhibitory effect is not considered to be sufficient enough to fully contribute to the cytotoxicity in cancer cells.

    Trifluridine is a fluorinated pyrimidine nucleoside with in vitro and in vivo activity against herpes simplex virus, types 1 and 2 and vacciniavirus. Some strains of adenovirus are also inhibited in vitro. ...Trifluridine interferes with DNA synthesis in cultured mammalian cells. However, its antiviral mechanism of action is not completely known

    US Natl Inst Health; DailyMed. Current Medication Information for TRIFLURIDINE solution (August 2011). Available from, as of March 12, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=abc1d07f-91ee-4421-bc9b-457d0ed41f4c

    The exact mechanism of antiviral activity of trifluridine has not been fully elucidated, but appears to involve inhibition of viral replication. Trifluridine, instead of thymidine, is incorporated into viral DNA during replication which results in the formation of defective proteins and an increased mutation rate. Trifluridine also reversibly inhibits thymidylate synthetase, an enzyme required for DNA synthesis.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012

    Trifluridine has shown antiviral activity in vitro and in vivo against herpes simplex virus types 1 and 2 (HSV-1 and HSV-2). The drug is active in vitro against vaccinia virus and has shown in vivo activity in the treatment of vaccinia keratitis in rabbits. Trifluridine also has shown antiviral activity in cell culture against some strains of adenovirus. Trifluridine is inactive against bacteria, fungi, and Chlamydia.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012

    API Reference Price

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    11-May-2021
    27-Jun-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

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

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    FDA Orange Book

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    01

    HIKMA

    United Kingdom
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    RLD : No

    TE Code :

    TRIFLURIDINE

    Brand Name : TRIFLURIDINE

    Dosage Form : SOLUTION/DROPS;OPHTHALMIC

    Dosage Strength : 1%

    Approval Date : 2017-07-28

    Application Number : 205438

    RX/OTC/DISCN : DISCN

    RLD : No

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    TRIFLURIDINE; TIPIRACIL

    Brand Name : TRIFLURIDINE; TIPIRACIL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 15MG/6.14MG

    Approval Date :

    Application Number : 214036

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    TRIFLURIDINE; TIPIRACIL

    Brand Name : TRIFLURIDINE; TIPIRACIL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 20MG/8.19MG

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    RLD : No

    TE Code : AB

    TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

    Brand Name : TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 6.14MG BASE;15MG

    Approval Date : 2023-06-13

    Application Number : 214008

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    RLD : No

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    TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

    Brand Name : TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 8.19MG BASE;20MG

    Approval Date : 2023-06-13

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    TE Code : AT

    TRIFLURIDINE

    Brand Name : VIROPTIC

    Dosage Form : SOLUTION/DROPS;OPHTHALMIC

    Dosage Strength : 1%

    Approval Date : 1982-01-01

    Application Number : 18299

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    TRIFLURIDINE

    Brand Name : TRIFLURIDINE

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    Dosage Strength : 1%

    Approval Date : 1995-10-06

    Application Number : 74311

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    RLD : Yes

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    TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

    Brand Name : LONSURF

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 6.14MG BASE;15MG

    Approval Date : 2015-09-22

    Application Number : 207981

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    RLD : Yes

    TE Code : AB

    TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

    Brand Name : LONSURF

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 8.19MG BASE;20MG

    Approval Date : 2015-09-22

    Application Number : 207981

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    ABOUT THIS PAGE

    Trifluridine Manufacturers

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

    Trifluridine Suppliers

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

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

    Trifluridine USDMF

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

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

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

    Trifluridine 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 Trifluridine Drug Master File in Japan (Trifluridine JDMF) empowers Trifluridine 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 Trifluridine JDMF during the approval evaluation for pharmaceutical products. At the time of Trifluridine 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 Trifluridine suppliers with JDMF on PharmaCompass.

    Trifluridine KDMF

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

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

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

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

    Trifluridine CEP

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

    A Trifluridine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Trifluridine 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 Trifluridine suppliers with CEP (COS) on PharmaCompass.

    Trifluridine WC

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

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

    Trifluridine 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 Trifluridine as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Trifluridine GMP

    Trifluridine 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 Trifluridine 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 Trifluridine GMP manufacturer or Trifluridine GMP API supplier for your needs.

    Trifluridine CoA

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

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

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