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AboutPricing
Drug ReportsTipiracil
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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Financial
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YTD
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
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
LONSURFTaiho OncologyN-207981 RX2015-09-22
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
lonsurfNew Drug Application2024-12-10
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
TIPIRACIL HYDROCHLORIDE / TRIFLURIDINE, LONSURF, TAIHO ONCOLOGY
2026-02-22ODE-229
Patent Expiration
Patent
Expires
Flag
FDA Information
Tipiracil Hydrochloride / Trifluridine, Lonsurf, Taiho Oncology
104563992037-02-03U-3657, U-3658
109600042037-02-03U-3657, U-3658
99435372034-09-05U-3659
95278332034-06-17DS, DP
104576662034-06-17DS, DP
RE462842029-09-22U-1751, U-2503, U-3656
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
118 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——224513—1081
AdenocarcinomaD000230——8152—123
NeoplasmsD009369—C80952—113
CarcinomaD002277—C80.0251——8
SarcomaD012509————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rectal neoplasmsD012004——57———11
Colonic neoplasmsD003110—C1846———10
Renal cell carcinomaD002292EFO_0000376—34———7
Stomach neoplasmsD013274EFO_0003897C1625———5
CholangiocarcinomaD018281—C22.115———5
Esophageal neoplasmsD004938—C1513———4
Breast neoplasmsD001943EFO_0003869C5023———4
Drug therapyD004358——13———3
RecurrenceD012008——11———2
Bile duct neoplasmsD001650———2———2
Show 21 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gastrointestinal microbiomeD000069196——————11
CardiotoxicityD066126EFO_1001482—————11
Urinary incontinenceD014549—R32————11
Alcoholic intoxicationD000435——————11
Alcohol abstinenceD064829——————11
PainD010146EFO_0003843R52————11
Rheumatoid arthritisD001172EFO_0000685M06.9————11
Systemic lupus erythematosusD008180EFO_0002690M32————11
Respiratory aspirationD053120EFO_1001839—————11
Healthy volunteers/patients———————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTipiracil
INNtipiracil
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 classuracil type antineoplastics
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Structure (InChI/SMILES or Protein Sequence)
N=C1CCCN1Cc1[nH]c(=O)[nH]c(=O)c1Cl
Identifiers
PDB—
CAS-ID183204-74-2
RxCUI—
ChEMBL IDCHEMBL235668
ChEBI ID—
PubChem CID6323266
DrugBankDB09343
UNII IDNGO10K751P (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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11,136 adverse events reported
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