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.
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.
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.
Title | Posted | Study ID | Phase | Status | Sponsor |
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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 |
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 |
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 |
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 |
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
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No NMPA products found for this drug
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No PPB products found for this drug
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
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273237 | Active | 2017/05/23 | tipiracil hydrochloride | ||
273239 | Active | 2017/05/23 | tipiracil hydrochloride | ||
273240 | Active | 2017/05/23 | tipiracil hydrochloride | ||
273238 | Active | 2017/05/23 | tipiracil hydrochloride |