Overview
Trifluridine is a fluorinated pyrimidine nucleoside that is structurally related to idoxuridine . It is an active antiviral agent in ophthalmic solutions used mainly in the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus. It displays effective antiviral activity against Herpes simplex virus type 1 and 2 . The combination product of trifluridine with tipiracil marketed as Lonsurf has been approved in Japan, the United States, and the European Union 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. In the anticancer therapy, trifluridine acts as a thymidine-based nucleoside metabolic inhibitor that gets incorporated into DNA of cancer cells following cell uptake to aberrate DNA function during cell replication .
Indication
用于Ⅰ及Ⅱ型单纯疱疹病毒、胞病毒、牛痘病毒、巨细胞病毒、带状疱疹病毒及耐阿昔洛韦的疱疹病毒的眼部感染。
Associated Conditions
- Metastatic Colorectal Cancer (CRC)
- Metastatic Gastric Cancers
- Metastatic Gastroesophageal Junction Adenocarcinoma
- Primary keratoconjunctivitis caused by herpes simplex virus type 2
- Recurrent epithelial keratitis caused by herpes simplex 2
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/09 | Phase 2 | Not yet recruiting | |||
2024/01/09 | Phase 3 | Not yet recruiting | |||
2022/07/21 | Phase 2 | Completed | |||
2022/01/20 | Phase 3 | Active, not recruiting | |||
2024/06/17 | Phase 1/2 | Recruiting | |||
2021/04/22 | Phase 2 | Terminated | |||
2020/07/07 | Phase 3 | Recruiting | |||
2019/06/05 | Phase 1 | Completed | |||
2013/06/04 | Phase 1 | Completed | |||
2001/08/31 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sandoz Inc | 61314-044 | OPHTHALMIC | 10 mg in 1 mL | 8/1/2011 | |
| Taiho Pharmaceutical Co., Ltd. | 64842-1025 | ORAL | 15 mg in 1 1 | 8/8/2023 | |
| Taiho Pharmaceutical Co., Ltd. | 64842-1020 | ORAL | 20 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 20MG/8.19MG | SIN15494P | TABLET, FILM COATED | 20mg | 5/24/2018 | |
| LONSURF FILM-COATED TABLET 15MG/6.14MG | SIN15491P | TABLET, FILM COATED | 15mg | 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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