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, Tipiracil trifluridine
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
162 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 | 17 | 3 | — | 2 | 28 |
| 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 | 6 | 8 | — | — | — | 14 |
| Rectal neoplasms | D012004 | — | — | 6 | 7 | — | — | — | 12 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 3 | 3 | — | — | — | 6 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 2 | 5 | — | — | — | 6 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 3 | — | — | — | 6 |
| 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 |
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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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Financial
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Trends
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Safety
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No Black-box warning
Adverse Events
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10,463 adverse events reported
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