Lonsurf(tipiracil)
Lonsurf, Tipiracil / Trifluridine (tipiracil) is a small molecule pharmaceutical. Tipiracil was first approved as Lonsurf on 2015-09-22. It is used to treat colorectal neoplasms in the USA. It has been approved in Europe to treat colorectal neoplasms.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| digestive system diseases | D004066 |
Trade Name
FDA
EMA
Combinations
Lonsurf (generic drugs available since 2023-06-13)
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 |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lonsurf | New Drug Application | 2023-08-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| colorectal neoplasms | — | D015179 | — |
| virus diseases | — | D014777 | B34 |
| herpetic keratitis | EFO_0007308 | D016849 | — |
| infectious keratoconjunctivitis | — | D007639 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TIPIRACIL HYDROCHLORIDE / TRIFLURIDINE, LONSURF, TAIHO ONCOLOGY | |||
| 2026-02-22 | ODE-229 | ||
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
160 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 |
|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal microbiome | D000069196 | — | — | — | — | — | — | 1 | 1 |
| Cardiotoxicity | D066126 | EFO_1001482 | — | — | — | — | — | 1 | 1 |
| Urinary incontinence | D014549 | HP_0000020 | R32 | — | — | — | — | 1 | 1 |
| Alcoholic intoxication | D000435 | — | — | — | — | — | — | 1 | 1 |
| Alcohol abstinence | D064829 | — | — | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 1 | 1 |
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | — | — | — | — | 1 | 1 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | — | — | — | — | 1 | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tipiracil |
| INN | tipiracil |
| Description | Tipiracil is a member of the class of pyrimidones that is uracil substituted by chloro and (2-iminopyrrolidin-1-yl)methyl groups at positions 5 and 6 respectively. Used (as the hydrochloride salt) in combination with trifluridine, a nucleoside metabolic inhibitor, for treatment of advanced/relapsed unresectable colorectal cancer. It has a role as an antineoplastic agent and an EC 2.4.2.4 (thymidine phosphorylase) inhibitor. It is a pyrimidone, an organochlorine compound, a carboxamidine and a member of pyrrolidines. It is functionally related to a uracil. It is a conjugate base of a tipiracil(1+). |
| Classification | Small molecule |
| Drug class | uracil type antineoplastics |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | N=C1CCCN1Cc1[nH]c(=O)[nH]c(=O)c1Cl |
Identifiers
| PDB | — |
| CAS-ID | 183204-74-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL235668 |
| ChEBI ID | — |
| PubChem CID | 6323266 |
| DrugBank | DB09343 |
| UNII ID | NGO10K751P (ChemIDplus, GSRS) |
Target
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Variants
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Trends
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Safety
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Adverse Events
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10,463 adverse events reported
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