Viroptic, Lonsurf(trifluridine)
Lonsurf, Viroptic (trifluridine) is a small molecule pharmaceutical. Trifluridine was first approved as Viroptic on 1982-01-01. It is used to treat herpetic keratitis, infectious keratoconjunctivitis, and virus diseases in the USA. It has been approved in Europe to treat colorectal neoplasms.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Viroptic (generic drugs available since 1995-10-06)
CombinationsLonsurf (generic drugs available since 1995-10-06)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tipiracil hydrochloride
+
Trifluridine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LONSURF | Taiho Oncology | N-207981 RX | 2015-09-22 | 2 products, RLD, RS |
Trifluridine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VIROPTIC | Monarch Pharmaceuticals | N-018299 RX | 1982-01-01 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lonsurf | New Drug Application | 2023-08-08 |
| trifluridine | ANDA | 2021-08-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| virus diseases | — | D014777 | B34 |
| herpetic keratitis | EFO_0007308 | D016849 | — |
| infectious keratoconjunctivitis | — | D007639 | — |
| colorectal neoplasms | — | D015179 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TIPIRACIL HYDROCHLORIDE / TRIFLURIDINE, LONSURF, TAIHO ONCOLOGY | |||
| 2026-02-22 | ODE-229 | ||
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01B: Antimetabolites
— L01BC: Pyrimidine analogues, antineoplastic antimetabolites
— L01BC59: Trifluridine, combinations
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AD: Antivirals, ophthalmologic
— S01AD02: Trifluridine
HCPCS
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Clinical
Clinical Trials
157 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 25 | 56 | 19 | — | 15 | 103 |
| Adenocarcinoma | D000230 | — | — | 9 | 16 | 3 | — | 2 | 27 |
| Neoplasms | D009369 | — | C80 | 16 | 3 | 2 | — | 1 | 20 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 4 | 7 | 2 | — | 1 | 11 |
| Carcinoma | D002277 | — | C80.0 | 2 | 7 | 1 | — | — | 10 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 1 | 1 | — | — | 2 |
| Sarcoma | D012509 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colonic neoplasms | D003110 | — | C18 | 5 | 8 | — | — | — | 13 |
| Rectal neoplasms | D012004 | — | — | 6 | 7 | — | — | — | 12 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 3 | 3 | — | — | — | 6 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 3 | — | — | — | 6 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 1 | 5 | — | — | — | 5 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 4 | — | — | — | 5 |
| Esophageal neoplasms | D004938 | — | C15 | 2 | 3 | — | — | — | 5 |
| Recurrence | D012008 | — | — | 1 | 2 | — | — | — | 3 |
| Triple negative breast neoplasms | D064726 | — | — | 2 | 2 | — | — | — | 3 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 1 | 2 | — | — | — | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal neoplasms | D005770 | — | C26.9 | 1 | — | — | — | 1 | 2 |
| Digestive system neoplasms | D004067 | — | — | 1 | — | — | — | 1 | 2 |
| Pancreatic ductal carcinoma | D021441 | — | — | 2 | — | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | — | — | — | — | 2 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 1 | — | — | — | — | 1 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 1 | — | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | — | — | — | 1 |
| Alveolar soft part sarcoma | D018234 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 2 | 2 |
| Gastrointestinal microbiome | D000069196 | — | — | — | — | — | — | 1 | 1 |
| Cardiotoxicity | D066126 | EFO_1001482 | — | — | — | — | — | 1 | 1 |
| Herpes simplex | D006561 | — | B00 | — | — | — | — | 1 | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 1 | 1 |
| Mycobacterium avium-intracellulare infection | D015270 | EFO_0007386 | — | — | — | — | — | 1 | 1 |
| Mycobacterium infections | D009164 | — | A31.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Trifluridine |
| INN | trifluridine |
| Description | Trifluridine is a pyrimidine 2'-deoxyribonucleoside compound having 5-trifluoromethyluracil as the nucleobase. An antiviral drug used mainly in the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis. It has a role as an antiviral drug, an antimetabolite, an EC 2.1.1.45 (thymidylate synthase) inhibitor and an antineoplastic agent. It is a nucleoside analogue, an organofluorine compound and a pyrimidine 2'-deoxyribonucleoside. |
| Classification | Small molecule |
| Drug class | antivirals; antineoplastics (uridine derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=c1[nH]c(=O)n([C@H]2C[C@H](O)[C@@H](CO)O2)cc1C(F)(F)F |
Identifiers
| PDB | — |
| CAS-ID | 70-00-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1129 |
| ChEBI ID | 75179 |
| PubChem CID | 6256 |
| DrugBank | DB00432 |
| UNII ID | RMW9V5RW38 (ChemIDplus, GSRS) |
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Estimated US medical usage
Trifluridine
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Safety
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Adverse Events
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9,437 adverse events reported
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