MedPath

Tipiracil

Generic Name
Tipiracil
Brand Names
Lonsurf
Drug Type
Small Molecule
Chemical Formula
C9H11ClN4O2
CAS Number
183204-74-2
Unique Ingredient Identifier
NGO10K751P

Overview

Tipiracil is a thymidine phosphorylase inhibitor. It is used in combination with trifluridine, in a ratio of 1:0.5, to form TAS-102. The main function of Tipiracil in TAS-102 is to increase trifluridine bioavailability by inhibiting its catabolism. TAS-102 is indicated for the treatment of metastatic colorectal cancer which has been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, or with an anti-VEGF or anti-EGFR therapy.

Background

Tipiracil is a thymidine phosphorylase inhibitor. It is used in combination with trifluridine, in a ratio of 1:0.5, to form TAS-102. The main function of Tipiracil in TAS-102 is to increase trifluridine bioavailability by inhibiting its catabolism. TAS-102 is indicated for the treatment of metastatic colorectal cancer which has been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, or with an anti-VEGF or anti-EGFR therapy.

Indication

Tipiracil is also available as a combination product with Trifluridine, which is indicated either alone or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. This combination product is also used for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma and were previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan and if appropriate, HER2/neu-targeted therapy.

Associated Conditions

  • Metastatic Colorectal Cancer (CRC)
  • Metastatic Gastroesophageal Junction Adenocarcinoma

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/03/12
Phase 2
Not yet recruiting
2025/03/04
Phase 2
Not yet recruiting
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
2024/09/26
Phase 3
Recruiting
2024/07/10
Not Applicable
Recruiting
Chang Gung Memorial Hospital
2024/07/03
Phase 2
Recruiting
2024/04/23
Phase 1
Recruiting
Wangxia LV
2024/04/02
Phase 3
Not yet recruiting
2024/02/07
Phase 2
Recruiting
2024/02/05
Phase 2
Recruiting
2024/01/08
N/A
Not yet recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University

FDA Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code
ORAL
6.14 mg in 1 1
2023/08/08
64842-1025
ORAL
8.19 mg in 1 1
2023/08/08
64842-1020

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision
EMEA/H/C/003897
France
N/A
Authorised
2016/04/25
2016/02/25
10

HSA Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.
TABLET, FILM COATED
6.14mg
2018/05/24
SIN15491P
TABLET, FILM COATED
8.19mg
2018/05/24
SIN15494P

NMPA Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import

No NMPA products found

No NMPA products found for this drug

PPB Approved Products

Product Name
Registration Code
Company
Category
Sale Type
Reg. Date

No PPB products found

No PPB products found for this drug

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