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.
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 |
|---|---|---|---|---|---|
2025/06/10 | Phase 1 | Recruiting | Sun Yat-sen University | ||
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 | |||
2024/07/26 | Phase 2 | Recruiting | |||
2024/02/05 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Taiho Pharmaceutical Co., Ltd. | 64842-1025 | ORAL | 6.14 mg in 1 1 | 8/8/2023 | |
| Taiho Pharmaceutical Co., Ltd. | 64842-1020 | ORAL | 8.19 mg in 1 1 | 8/8/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/25/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| LONSURF FILM-COATED TABLET 15MG/6.14MG | SIN15491P | TABLET, FILM COATED | 6.14mg | 5/24/2018 | |
| LONSURF FILM-COATED TABLET 20MG/8.19MG | SIN15494P | TABLET, FILM COATED | 8.19mg | 5/24/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ORCANTAS 15/6.14 trifluridine 15 mg/ tipiracil hydrochloride 7.065 mg (equivalent to tipiracil 6.14 mg) film-coated tablet blister pack | 273237 | Medicine | A | 5/23/2017 | |
| LONSURF 15/6.14 trifluridine 15 mg/ tipiracil hydrochloride 7.065 mg (equivalent to tipiracil 6.14 mg) film-coated tablet blister pack | 273239 | Medicine | A | 5/23/2017 | |
| ORCANTAS 20/8.19 trifluridine 20 mg/ tipiracil hydrochloride 9.420 mg (equivalent to tipiracil 8.19 mg) film-coated tablet blister pack | 273240 | Medicine | A | 5/23/2017 | |
| LONSURF 20/8.19 trifluridine 20 mg/ tipiracil hydrochloride 9.420 mg (equivalent to tipiracil 8.19 mg) film-coated tablet blister pack | 273238 | Medicine | A | 5/23/2017 |
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