Trifluridine

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
Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer	2025/06/09	NCT07011550	Phase 2	Recruiting	M.D. Anderson Cancer Center
Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer	2024/01/09	NCT06197425	Phase 3	Not yet recruiting	Centre Hospitalier Universitaire Dijon
Phase II Randomized Study Evaluating the Efficacy of Panitumumab (VEctibix ) and Trifluridine-Tipiracil (LOnsurf) in Pretreated RAS Wild Type Metastatic Colorectal Cancer Patients: the VELO Trial	2022/07/21	NCT05468892	Phase 2	Completed	University of Campania "Luigi Vanvitelli"
Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation	2022/01/20	NCT05198934	Phase 3	Active, not recruiting	Amgen
A Study of ASP1570 Alone or in Combination with Pembrolizumab or Standard Therapies in Adults with Solid Tumors	2021/10/19	2023-505084-37-00	Phase 1/2	Recruiting	Astellas Pharma Global Development Inc.
A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations	2021/04/22	NCT04854434	Phase 2	Terminated	Karyopharm Therapeutics Inc
Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection	2020/07/07	NCT04457297	Phase 3	Recruiting	National Cancer Center Hospital East
Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients	2019/06/05	NCT03974594	Phase 1	Completed	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone	2013/06/04	NCT01867866	Phase 1	Completed	Taiho Oncology, Inc.
Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine	2001/08/31	NCT00000635	Not Applicable	Completed	National Institute of Allergy and Infectious Diseases (NIAID)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Trifluridine	Sandoz Inc	61314-044	OPHTHALMIC	10 mg in 1 mL	8/1/2011
LONSURF	Taiho Pharmaceutical Co., Ltd.	64842-1025	ORAL	15 mg in 1 1	8/8/2023
LONSURF	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
Lonsurf	Les Laboratoires Servier,50 rue Carnot,92284 Suresnes cedex,France	Authorised	4/25/2016

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
LONSURF FILM-COATED TABLET 20MG/8.19MG	Taiho Pharmaceutical Co., Ltd. Kitajima Plant	SIN15494P	TABLET, FILM COATED	20mg	5/24/2018
LONSURF FILM-COATED TABLET 15MG/6.14MG	Taiho Pharmaceutical Co., Ltd. Kitajima Plant	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	Servier Laboratories (Aust) Pty Ltd	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	Servier Laboratories (Aust) Pty Ltd	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	Servier Laboratories (Aust) Pty Ltd	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	Servier Laboratories (Aust) Pty Ltd	Medicine	A	5/23/2017

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
APO-TRIFLURIDINE OPHTHALMIC SOLUTION	Apotex Inc	02248119	Solution - Ophthalmic	1 %	N/A
SANDOZ TRIFLURIDINE	Sandoz Canada, Inc.	02248529	Solution - Ophthalmic	1 %	1/23/2004
LONSURF	taiho pharma canada, inc.	02472104	Tablet - Oral	15 MG	3/22/2018
VIROPTIC	bausch & lomb inc	00687456	Solution - Ophthalmic	1 %	12/31/1987
LONSURF	taiho pharma canada, inc.	02472112	Tablet - Oral	20 MG	3/22/2018

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
LONSURF 20 MG/8,19 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Les Laboratoires Servier	1161096004	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
LONSURF 15 MG/6,14 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Les Laboratoires Servier	1161096003	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
LONSURF 15 MG/6,14 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Les Laboratoires Servier	1161096001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
LONSURF 20 MG/8,19 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Les Laboratoires Servier	1161096006	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
LONSURF 15 MG/6,14 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Les Laboratoires Servier	1161096003IP	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized
LONSURF 15 MG/6,14 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Les Laboratoires Servier	1161096001IP	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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