Lonsurf(tipiracil)
Lonsurf (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
Trade Name
FDA
EMA
Combinations
Lonsurf
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 | 2020-01-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| colorectal neoplasms | — | D015179 | — |
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
106 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 | 17 | 31 | 15 | — | 3 | 58 | ||
| Neoplasms | D009369 | C80 | 9 | 1 | 1 | — | — | 10 | |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | 5 | 1 | — | — | 6 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | 3 | 8 | — | — | 1 | 11 | ||
| Colonic neoplasms | D003110 | C18 | 2 | 6 | — | — | — | 8 | |
| Rectal neoplasms | D012004 | 4 | 4 | — | — | — | 8 | ||
| Renal cell carcinoma | D002292 | 3 | 3 | — | — | — | 6 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 4 | — | — | — | 5 |
| Cholangiocarcinoma | D018281 | C22.1 | — | 3 | — | — | — | 3 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | — | — | — | 3 |
| Bile duct neoplasms | D001650 | — | 2 | — | — | — | 2 | ||
| Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | — | 2 | — | — | — | 2 |
| Small cell lung carcinoma | D055752 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 1 | — | — | — | — | 1 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 1 | — | — | — | — | 1 |
| Pancreatic ductal carcinoma | D021441 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
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 | 1670304 |
| ChEMBL ID | CHEMBL235668 |
| ChEBI ID | — |
| PubChem CID | 6323266 |
| DrugBank | DB09343 |
| UNII ID | NGO10K751P (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
No data
Variants
Clinical Variant
No data
Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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16,275 adverse events reported
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