Drugs / Trifluridine
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Trifluridine

Small molecule

Developed for
colorectal cancer · gastric adenocarcinoma · cholangiocarcinoma · colon carcinoma · colorectal adenocarcinoma · colorectal carcinoma · gastroesophageal junction adenocarcinoma · rectum adenocarcinoma
+12 more · carcinoma · colon adenocarcinoma · colorectal neoplasm · gallbladder carcinoma · gastric cancer · gastroesophageal adenocarcinoma · herpes simplex infectious disease · neuroendocrine neoplasm · pancreatic adenocarcinoma · rectal carcinoma · small cell lung carcinoma · gastroesophageal cancer
Investigated by
National Cancer Institute (NCI) · Taiho Oncology, Inc. · Academic and Community Cancer Research United · ADIR, a Servier Group company · Chang Gung Memorial Hospital · M.D. Anderson Cancer Center
+35 more · Servier · Taiho Pharmaceutical Co., Ltd. · AbbVie · Alpha-A, Inc. · Anhui Provincial Cancer Hospital · Baylor Research Institute · Case Comprehensive Cancer Center · Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · China Medical University Hospital · City of Hope Medical Center · Clinical Trial Center North (CTC North GmbH & Co. KG) · Emory University · First Affiliated Hospital of Wenzhou Medical University · Glaxo Wellcome · Holy Stone Healthcare Co., Ltd · Innovent Biologics (Suzhou) Co. Ltd. · Ipsen · Kaohsiung Medical University Chung-Ho Memorial Hospital · LIN YANG · National Cancer Center Hospital East · National Cheng-Kung University Hospital · National Comprehensive Cancer Network · National Health Research Institutes, Taiwan · National Institute of Allergy and Infectious Diseases (NIAID) · OHSU Knight Cancer Institute · Oregon Health and Science University · Pfizer · Roswell Park Cancer Institute · Rutgers, The State University of New Jersey · Servier · Shanghai Zhongshan Hospital · Strategic Alliance · Sunnybrook Health Sciences Centre · Taipei Veterans General Hospital, Taiwan · University Medical Center Hamburg-Eppendorf

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Lonsurf 2016-04-25 europa.eu
Approved US (FDA) VIROPTIC 1980-04-10 fda.gov

Trials 30 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT04511039 Jun 2021 → Sep 2028 expected colorectal adenocarcinoma, gastroesophageal junction adenocarcinoma Roswell Park Cancer Institute Recruiting No outcome recorded
Phase 1 NCT04104139 Dec 2019 → Sep 2024 overdue rectum adenocarcinoma OHSU Knight Cancer Institute Active not recruiting No outcome recorded
Phase 1 NCT03616574 Apr 2019 → Feb 2022 colorectal cancer Holy Stone Healthcare Co., Ltd Completed No outcome recorded
Phase 1 NCT03317119 Apr 2018 → Jul 2023 colon carcinoma, rectal carcinoma City of Hope Medical Center Completed No outcome recorded
Phase 1 NCT01867866 May → Oct 2013 cancer Taiho Oncology, Inc. Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT05927857 Apr 2024 → Dec 2027 expected gastric adenocarcinoma National Health Research Institutes, Taiwan Recruiting No outcome recorded
Phase 1/2 NCT04177602 Nov 2019 → Sep 2022 University Medical Center Hamburg-Eppendorf Terminated No outcome recorded
Phase 1/2 NCT03368963 Jan 2018 → Jun 2025 overdue cholangiocarcinoma, colorectal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma Emory University Active not recruiting No outcome recorded
Phase 214 trials
Phase 2 NCT07535632 Jun 2026 → Jun 2028 expected colorectal neoplasm Shanghai Zhongshan Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07146646 Dec 2025 → Feb 2027 expected cholangiocarcinoma, gallbladder carcinoma Case Comprehensive Cancer Center Recruiting No outcome recorded
Phase 2 NCT07011550 Aug 2025 → Jul 2028 colorectal cancer M.D. Anderson Cancer Center Suspended No outcome recorded
Phase 2 NCT06711471 Nov 2024 → Nov 2026 expected gastric adenocarcinoma LIN YANG Recruiting No outcome recorded
Phase 2 NCT06485713 Mar 2024 → Jun 2026 overdue colorectal cancer First Affiliated Hospital of Wenzhou Medical University Recruiting No outcome recorded
Phase 2 NCT05356897 Oct 2023 → Sep 2024 colon adenocarcinoma, rectum adenocarcinoma Academic and Community Cancer Research United Withdrawn No outcome recorded
Phase 2 NCT04660760 Jun 2021 → Jul 2024 gastric adenocarcinoma, gastroesophageal adenocarcinoma, gastroesophageal junction adenocarcinoma Academic and Community Cancer Research United Unknown No outcome recorded
Phase 2 NCT04076761 Dec 2019 → Sep 2022 cholangiocarcinoma Sunnybrook Health Sciences Centre Terminated No outcome recorded
Phase 2 NCT03981614 Oct 2019 → Aug 2021 colorectal carcinoma Academic and Community Cancer Research United Completed No outcome recorded
Phase 2 NCT04042714 Aug 2019 → Sep 2025 neuroendocrine neoplasm Baylor Research Institute Terminated No outcome recorded
Phase 35 trials
Phase 3 NCT07525206 May 2026 → May 2029 expected colorectal cancer AbbVie Recruiting No outcome recorded
Phase 3 NCT07483684 Mar 2026 → Aug 2027 expected carcinoma Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT04457297 Jul 2020 → Jul 2024 colorectal cancer National Cancer Center Hospital East Completed No outcome recorded
Phase 3 NCT03306394 Oct 2016 → Nov 2020 colorectal cancer Servier Completed No outcome recorded
Phase 3 NCT01607957 Jun 2012 → Jan 2014 colorectal cancer Taiho Oncology, Inc. Completed No outcome recorded
Phase not applicable3 trials
NCT07371871 Jan 2026 → Dec 2027 expected gastric cancer Anhui Provincial Cancer Hospital Not yet recruiting No outcome recorded
NCT06495463 Mar 2022 → Aug 2024 colorectal cancer Chang Gung Memorial Hospital Unknown No outcome recorded
NCT00000635 ? → Apr 1992 HIV infectious disease, herpes simplex infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Also used as a comparator or background therapy in 19 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07318389 Background Jun 2026 → Nov 2027 expected colorectal cancer M.D. Anderson Cancer Center Not yet recruiting No outcome recorded
Phase 12 trials
Phase 1 NCT05130060 Background Jan 2022 → Jun 2023 colon adenocarcinoma, metastatic malignant neoplasm in the colon, rectum adenocarcinoma Mayo Clinic Completed No outcome recorded
Phase 1 NCT03715933 Background Oct 2018 → Dec 2028 expected Ewing sarcoma, colorectal adenocarcinoma Inhibrx Biosciences, Inc Recruiting No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT05405595 Background Jun 2022 → Oct 2026 expected Adagene Inc Recruiting No outcome recorded
Phase 1/2 NCT05083481 Background Oct 2021 → May 2026 Astellas Pharma Global Development, Inc. Terminated No outcome recorded
Phase 1/2 NCT04393298 Background Jul 2020 → Apr 2024 cancer UCB Biopharma SRL Completed No outcome recorded
Phase 28 trials
Phase 2 NCT07353268 Comparator Jan 2026 → Aug 2027 expected colorectal cancer Tao Zhang Not yet recruiting No outcome recorded
Phase 2 NCT07387081 Background Dec 2025 → May 2028 expected LaNova Medicines Limited Recruiting No outcome recorded
Phase 2 NCT06856837 Comparator Oct 2025 → Dec 2029 expected colorectal cancer Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Recruiting No outcome recorded
Phase 2 NCT06680622 Background Mar 2025 → Sep 2027 expected gastroesophageal adenocarcinoma Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Active not recruiting No outcome recorded
Phase 2 NCT06039202 Background Jan 2024 → Feb 2025 colorectal cancer Holy Stone Healthcare Co., Ltd Unknown No outcome recorded
Phase 34 trials
Phase 3 NCT06992648 Comparator Apr 2025 → Dec 2027 expected colorectal cancer Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting No outcome recorded
Phase 3 NCT05198934 Comparator Apr 2022 → Jul 2025 colorectal cancer Amgen Completed No outcome recorded
Phase 3 NCT04879368 Comparator May 2021 → Jan 2025 gastroesophageal cancer Australasian Gastro-Intestinal Trials Group Completed No outcome recorded
Phase 3 NCT03717038 Comparator Feb 2019 → Dec 2023 colorectal carcinoma Symphogen A/S Withdrawn No outcome recorded
Phase not applicable1 trial
NCT00002037 Background HIV infectious disease, Mycobacterium avium complex disease Amgen Completed No outcome recorded

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 51 sources stand behind the page.

FieldValueCited text
Known as trifluridine “Film-coated tablet containing 15 mg of trifluridine and 7.065 mg of tipiracil hydrochloride, or 20 mg of trifluridine and 9.42 mg of tipiracil hydrochloride (with a molar ratio...” NCT03274882
48

“TAS-102 is a novel combination medicinal product consisting of a thymidine-based nucleoside analogue (trifluridine; FTD) as the active component and the thymidine phosphorylase...” NCT04042714

“OBJECTIVES: TAS-102 is an oral combination treatment comprised of an antimetabolite, trifluridine, a thymidine-based nucleoside analog, and tipiracil hydrochloride, at a molar...” PMID 27597276 Jun 2016

“LONSURF is a cytotoxic combination treatment of 2 new drugs: trifluridine, a thymidine-based nucleoside analog, and tipiracil, an inhibitor of thymidine phosphorylase.” NCT03616574

“TAS-102 is a cytotoxic combination treatment of 2 drugs: trifluridine, a thymidine-based nucleoside analogue, and tipiracil an inhibitor of thymidine phosphorylase.” NCT06039202

“TAS-102 is a combination of trifluridine, a thymidine-based nucleic acid analogue, and tipiracil, a thymidine phosphorylase inhibitor.” NCT03717038

“TAS-102 is a combination of the thymidine-based nucleoside analog trifluridine and the thymidine phosphorylase inhibitor tipiracil.” PMID 27443414 Jul 2016

“Regorafenib. Fruquintinib. Trifluridine/Tipiracil (TAS-102) with or without Bevacizumab.” NCT07353268

“Drug:Trifluridine and Tipiracil Hydrochloride Tablets BID,Oral Administration” NCT07387081

“Regorafenib or trifluridine and tipiracil.” NCT05608044

NCT04076761

NCT03981614

NCT06711471

NCT06485713

NCT04104139

NCT06856837

NCT07318389

NCT03306394

NCT06992648

NCT04511039

NCT05356897

NCT07483684

NCT04457297

NCT05405595

NCT00002037

NCT07146646

NCT06495463

NCT03317119

NCT03992456

NCT03715933

NCT05198934

NCT07011550

NCT04879368

NCT03368963

NCT00000635

NCT04854434

NCT07371871

NCT04294264

NCT04660760

NCT07535632

NCT05083481

NCT05130060

NCT06680622

NCT04393298

NCT07525206

NCT05927857

NCT04177602

NCT01867866

NCT03844620

Known as F3dthd ChEMBL registry synonym — accepted as the source's own label CHEMBL1129
Known as FTD “TAS-102 is a novel combination medicinal product consisting of a thymidine-based nucleoside analogue (trifluridine; FTD) as the active component and the thymidine phosphorylase...” NCT04042714
2

“The phase II J003 (N = 169) and phase III RECOURSE (N = 800) trials demonstrated a significant improvement in survival with trifluridine (FTD)/tipiracil (TPI) versus placebo in...” PMID 31912801 Jan 2020

FTD (Trifluridine)” NCT01867866

Known as NSC-529182 ChEMBL registry synonym — accepted as the source's own label CHEMBL1129
Known as NSC-75520 ChEMBL registry synonym — accepted as the source's own label CHEMBL1129
Known as Trifluridina ChEMBL registry synonym — accepted as the source's own label CHEMBL1129
Known as Trifluridine component of lonsurf ChEMBL registry synonym — accepted as the source's own label CHEMBL1129
Known as Trifluridine component of s-95005 ChEMBL registry synonym — accepted as the source's own label CHEMBL1129
Known as Trifluridine component of tas-102 ChEMBL registry synonym — accepted as the source's own label CHEMBL1129
Known as Triherpine ChEMBL registry synonym — accepted as the source's own label CHEMBL1129
Known as Viroptic ChEMBL registry synonym — accepted as the source's own label CHEMBL1129
Action Inhibit “Trifluridine is incorporated into DNA during DNA synthesis and inhibits tumor cell growth.” NCT04879368
Modality Small molecule “the thymidine-based nucleoside analog trifluridine” PMID 27443414 Jul 2016
Route Topical “Patients receive at least 10 days (and up to 42 days) of treatment with topical trifluridine.” NCT00000635