Drugs / TAS-102
last change Jul 2026 re-read 2 minutes ago

TAS-102

Small molecule

Developed for
colorectal cancer · mitochondrial DNA depletion syndrome, myopathic form · cancer · gastric adenocarcinoma · gastroesophageal junction adenocarcinoma · malignant pancreatic neoplasm · rectum adenocarcinoma · colon adenocarcinoma
+29 more · colon carcinoma · colorectal adenocarcinoma · colorectal neoplasm · gastric cancer · rectal carcinoma · 5-nucleotidase syndrome · colorectal carcinoma · esophageal squamous cell carcinoma · gastric carcinoma · gastroesophageal adenocarcinoma · gastroesophageal cancer · Hoyeraal-Hreidarsson syndrome · inborn mitochondrial myopathy · malignant colon neoplasm · metastasis from malignant tumor of colon · metastatic malignant neoplasm · mitochondrial DNA depletion syndrome · mitochondrial encephalomyopathy · nasopharyngeal carcinoma · neuroendocrine neoplasm · pancreatic ductal adenocarcinoma · pulmonary fibrosis and/or bone marrow failure, telomere-related · rectal cancer · refractory malignant neoplasm · Revesz syndrome · squamous cell lung carcinoma · urinary bladder cancer · carcinoma · metastatic neoplasm
Investigated by
Taiho Oncology, Inc. · Taiho Pharmaceutical Co., Ltd. · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · University of California, Irvine · Fujian Cancer Hospital · National Cancer Institute (NCI)
+75 more · Sun Yat-sen University · UCB BIOSCIENCES, Inc. · University of Florida · University of Wisconsin, Madison · AHS Cancer Control Alberta · AIO-Studien-gGmbH · Bayer · Biomedical Research Networking Center (CIBER) · Centre Hospitalier Universitaire Dijon · Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Chinese PLA General Hospital · Columbia University · Cristina Domínguez González · Criterium, Inc. · Eli Lilly and Company · Fudan University · Georgetown University · Gilead Sciences · H. Lee Moffitt Cancer Center and Research Institute · Henan Cancer Hospital · Hospital Universitario 12 de Octubre · Hospitales Universitarios Virgen del Rocío · Huai'an First People's Hospital · Indiana University · Instituto de Salud Carlos III · Ipsen · Jiangsu Hansoh Pharmaceutical Co., Ltd. · Jinan Central Hospital · Kenneth Myers, MD · M.D. Anderson Cancer Center · Massachusetts General Hospital · Mayo Clinic · Medical Research Council Mitochondrial Biology Unit · Merck Sharp & Dohme LLC · Muscular Dystrophy Association · Natera, Inc. · National Center for Research Resources (NCRR) · National Comprehensive Cancer Network · National University Hospital, Singapore · Patrick Joseph Loehrer Sr. · PharmaEngine · Providence Health & Services · Qianfoshan Hospital · Qingdao Central Hospital · Rahul Parikh · Roswell Park Cancer Institute · Rutgers, The State University of New Jersey · Sapience Therapeutics · Servier · Shandong Cancer Hospital and Institute · Shanghai EpimAb Biotherapeutics Co., Ltd. · Sirtex Medical · Suneet Agarwal · Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Syndax Pharmaceuticals · Taiho · Takeda · Teclison Ltd. · The First Affiliated Hospital of Zhengzhou University · The First Affiliated Hospital with Nanjing Medical University · The Second Affiliated Hospital of Shandong First Medical University · The University of Hong Kong · Trium Analysis Online GmbH · UCB Pharma · UNICANCER · Universitat Autonoma de Barcelona · University of California, San Diego · University of California, San Francisco · University of Campania Luigi Vanvitelli · University of Seville · Vejle Hospital · Virginia Commonwealth University · Yale University · Zhejiang University · all 81 on the full record

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) LONSURF 2015-09-22 fda.gov

Trials 74 · started per year

today
US approved 2015
EU approved 2016
2
4
1
3
4
9
1
8
2
9
6
6
2
12
3
1995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 119 trials
Phase 1 NCT07649655 Jul 2026 → Mar 2028 expected colorectal cancer Shanghai EpimAb Biotherapeutics Co., Ltd. Not yet recruiting No outcome recorded
Phase 1 NCT06817590 Sep 2025 → Jun 2028 expected Hoyeraal-Hreidarsson syndrome, Revesz syndrome, pulmonary fibrosis and/or bone marrow failure, telomere-related Suneet Agarwal Recruiting No outcome recorded
Phase 1 NCT05848739 Jun 2023 → May 2026 overdue colorectal cancer Sapience Therapeutics Recruiting No outcome recorded
Phase 1 NCT04920032 Aug 2021 → Jan 2027 expected colon adenocarcinoma University of California, Irvine Recruiting No outcome recorded
Phase 1 NCT04868773 Jul 2021 → Aug 2023 colorectal carcinoma, metastatic malignant neoplasm University of California, Irvine Completed No outcome recorded
Phase 1 NCT04046887 Sep 2019 → May 2021 pancreatic ductal adenocarcinoma Patrick Joseph Loehrer Sr. Terminated No outcome recorded
Phase 1 NCT04074343 Aug 2019 → Jul 2021 gastric adenocarcinoma, gastroesophageal cancer University of California, Irvine Completed No outcome recorded
Phase 1 NCT03810742 Mar 2019 → May 2022 refractory malignant neoplasm PharmaEngine Completed No outcome recorded
Phase 1 NCT03297710 Dec 2017 → Mar 2020 rectum adenocarcinoma Mayo Clinic Completed No outcome recorded
Phase 1 NCT02943733 Aug 2017 → Nov 2020 cancer, neuroendocrine neoplasm University of Wisconsin, Madison Terminated No outcome recorded
Phase 1/27 trials
Phase 1/2 NCT07196345 Sep 2025 → Sep 2027 expected esophageal squamous cell carcinoma Qianfoshan Hospital Not yet recruiting No outcome recorded
Phase 1/2 NCT07044908 Jul 2025 → Jul 2026 overdue colorectal cancer Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT05731947 Apr 2023 → Jun 2025 colorectal cancer Syndax Pharmaceuticals Terminated No outcome recorded
Phase 1/2 NCT03223779 Oct 2017 → Feb 2025 colorectal cancer Massachusetts General Hospital Completed No outcome recorded
Phase 1/2 NCT03639701 May 2017 → Dec 2026 expected mitochondrial DNA depletion syndrome, myopathic form Columbia University Active not recruiting No outcome recorded
Phase 1/2 NCT02848079 Oct 2016 → Jun 2020 colorectal neoplasm Yale University Completed No outcome recorded
Phase 1/2 NCT02613221 Dec 2015 → Oct 2017 colorectal cancer Takeda Completed No outcome recorded
Phase 237 trials
Phase 2 NCT07527858 May 2026 → Dec 2028 expected colorectal cancer Gilead Sciences Recruiting No outcome recorded
Phase 2 NCT06992258 Oct 2025 → Dec 2027 expected colorectal cancer Criterium, Inc. Recruiting No outcome recorded
Phase 2 NCT07116577 Aug 2025 → Aug 2027 expected colorectal cancer Jinan Central Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07090031 Jul 2025 → Dec 2027 expected Qingdao Central Hospital Active not recruiting No outcome recorded
Phase 2 NCT07212933 Jul 2025 → Dec 2027 expected gastric cancer Chinese PLA General Hospital Recruiting No outcome recorded
Phase 2 NCT06245356 Mar 2025 → Oct 2026 expected colorectal cancer, dihydropyrimidine dehydrogenase deficiency, gastroesophageal adenocarcinoma UNICANCER Recruiting No outcome recorded
Phase 2 NCT06856187 Feb 2025 → Jun 2026 overdue colorectal cancer Fudan University Recruiting No outcome recorded
Phase 2 NCT06754098 Jan 2025 → Jan 2027 expected inborn mitochondrial myopathy, mitochondrial DNA depletion syndrome, myopathic form Cristina Domínguez González Recruiting No outcome recorded
Phase 2 NCT06293014 Feb 2024 → Oct 2025 overdue colorectal cancer Henan Cancer Hospital Recruiting No outcome recorded
Phase 2 NCT06092242 Oct 2023 → Oct 2025 overdue colorectal cancer The Second Affiliated Hospital of Shandong First Medical University Not yet recruiting No outcome recorded
Phase 37 trials
Phase 3 NCT06197425 May 2026 → May 2032 expected colorectal adenocarcinoma Centre Hospitalier Universitaire Dijon Recruiting No outcome recorded
Phase 3 NCT06850090 Jul 2025 → Jun 2027 expected rectum adenocarcinoma Shandong Cancer Hospital and Institute Recruiting No outcome recorded
Phase 3 NCT06199973 Mar 2024 → Apr 2026 overdue colorectal cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Active not recruiting No outcome recorded
Phase 3 NCT04581733 Sep 2022 → Mar 2025 mitochondrial DNA depletion syndrome, myopathic form Zogenix MDS, Inc. Withdrawn No outcome recorded
Phase 3 NCT03520946 Jan 2019 → Jul 2024 colorectal cancer Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Completed No outcome recorded
Phase 3 NCT02500043 Feb 2016 → Apr 2018 Taiho Oncology, Inc. Completed No outcome recorded
Phase 3 NCT01955837 Sep 2013 → Feb 2016 colorectal cancer Taiho Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase not applicable2 trials
NCT06936488 Mar 2025 → Oct 2026 expected colorectal adenocarcinoma Huai'an First People's Hospital Enrolling by invitation No outcome recorded
NCT04517747 Oct 2020 → Jan 2022 gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Completed No outcome recorded
Phase not stated2 trials
NCT06590493 mitochondrial DNA depletion syndrome, myopathic form UCB BIOSCIENCES, Inc. Available No outcome recorded
NCT02286492 colorectal cancer Taiho Oncology, Inc. Approved for marketing No outcome recorded
Also used as a comparator or background therapy in 15 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04999761 Background Jun 2021 → May 2026 overdue alveolar soft part sarcoma, biliary tract cancer, colorectal cancer, esophageal cancer +4 Taiho Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT04626635 Background Dec 2020 → Nov 2026 expected cancer Regeneron Pharmaceuticals Active not recruiting No outcome recorded
Phase 1/2 NCT01896856 Comparator Oct 2013 → Aug 2019 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
Phase 24 trials
Phase 2 NCT06607458 Background Aug 2025 → Dec 2026 expected colorectal cancer Delcath Systems Inc. Recruiting No outcome recorded
Phase 2 NCT06887218 Comparator May 2025 → Dec 2028 expected colorectal cancer The Methodist Hospital Research Institute Recruiting No outcome recorded
Phase 2 NCT06563986 Background Jun 2024 → Jan 2028 expected colorectal cancer UMC Utrecht Recruiting No outcome recorded
Phase 2 NCT05278351 Comparator Jul 2022 → Apr 2024 colorectal cancer Shanghai Zhongshan Hospital Unknown No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03909724 Comparator Oct 2019 → Jul 2021 colorectal cancer, metastatic neoplasm Amsterdam UMC, location VUmc Unknown No outcome recorded
Phase 37 trials
Phase 3 NCT07384377 Comparator Feb 2026 → Nov 2027 expected carcinoma Shanghai JMT-Bio Inc. Not yet recruiting No outcome recorded
Phase 3 NCT06356311 Comparator May 2024 → Jan 2027 expected gastroesophageal cancer Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 3 NCT06346392 Comparator Mar 2024 → May 2026 overdue gastric adenocarcinoma, gastroesophageal junction adenocarcinoma AstraZeneca Active not recruiting No outcome recorded
Phase 3 NCT05600309 Comparator Jun 2022 → Aug 2024 colorectal cancer Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT05328908 Comparator Apr 2022 → Jul 2025 colorectal neoplasm Bristol-Myers Squibb Terminated No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2005-02-28 Gilead Sciences 48-Week Data Comparing Viread Versus Abacavir as Replacement for Thymidine Analogue in Lipoatraphic HIV Patients Presented at the 12th Conference on Retroviruses and Opportunistic Infections gilead.com

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 96 sources stand behind the page.

FieldValueCited text
Known as TAS102 “randomized for treatment with TAS-102 (standard-arm) or High Dose Intermittent Sunitinib (700 mg once every 2 weeks)” NCT03909724
68

“trifluridine/tipiracil (also called TAS-102) are two drugs which are both used late in this sequence of treatments” PMID 33993741 May 2021

“TAS-102 is a novel oral antimetabolite with a distinct mechanism of action from fluoropyrimidines” PMID 39244627 Sep 2024

“Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®)” NCT03810742

“randomized 1:1 to receive either ramucirumab/TAS102 (arm A) or TAS102 (arm B)” NCT03520946

“TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma” NCT04923529

“* Tas-102” NCT03251612

NCT02860546

NCT04999761

NCT05806931

NCT03909724

NCT04776148

NCT05343013

NCT01916447

NCT07384377

NCT06092242

NCT05328908

NCT01955837

NCT02943733

NCT06856187

NCT04701476

NCT07044908

NCT04417699

NCT04074343

NCT07212933

NCT03762161

NCT02301104

NCT04923529

NCT05266820

NCT07196345

NCT05314101

NCT05004831

NCT06199973

NCT02500043

NCT05364489

NCT07090031

NCT06936488

NCT06346392

NCT01867879

NCT04683965

NCT03297710

NCT07649655

NCT01896856

NCT03223779

NCT04868773

NCT03520946

NCT02921737

NCT01867866

NCT03686488

NCT02654639

NCT07116577

NCT04627961

NCT05029102

NCT02602327

NCT02613221

NCT05854498

NCT02920476

NCT06850090

NCT02848079

NCT05481463

NCT02261532

NCT06293014

NCT05600309

NCT02301117

NCT04920032

NCT02286492

NCT05064059

NCT04517747

NCT04808791

Known as dCyt “open label deoxythymidine (dThd) and deoxycytidine (dCyt), which are nucleotide precursors” NCT03639701
Known as deoxycytidine “Treatment of TK2 Deficiency With Thymidine and DeoxycytidineNCT03639701
4

Deoxycytidine (dC) and deoxythymidine (dT)” NCT04581733

NCT06817590

NCT04802707

NCT00002818

Known as deoxythymidine “open label deoxythymidine (dThd) and deoxycytidine (dCyt), which are nucleotide precursors” NCT03639701
Known as doxecitine ClinicalTrials.gov intervention name — accepted as the source's own label NCT03845712
2

NCT06590493

NCT06754098

Known as dThd “open label deoxythymidine (dThd) and deoxycytidine (dCyt), which are nucleotide precursors” NCT03639701
Known as FTD/TPI “The aim of this study was to evaluate the cost-effectiveness of trifluridine/tipiracil (FTD/TPI) for heavily pretreated metastatic gastric cancer from the perspective of the...” PMID 39510786 Nov 2024
3

“Trifluridine/tipiracil (FTD/TPI) is approved in Japan, the United States (US), and Europe for metastatic colorectal cancer (mCRC) refractory to standard therapies.” PMID 32308505 Apr 2020

“Trifluridine/tipiracil (FTD/TPI; TAS-102, Lonsurf®), a novel form of chemotherapy for metastatic colorectal cancer (mCRC), has shown clinical benefit” PMID 30350179 Oct 2018

NCT06563986

Known as LONSURF “Trifluridine/tipiracil (FTD/TPI; TAS-102, Lonsurf®), a novel form of chemotherapy for metastatic colorectal cancer (mCRC), has shown clinical benefit” PMID 30350179 Oct 2018
7

“Either Lonsurf® or Stivarga® administered per the investigator's choice at the respective drug label's dose and schedule.” NCT05731947

“Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®)” NCT03810742

“TAS-102 (trifluridine and tipiracil, Lonsurf®)” NCT07212933

NCT04046887

NCT06992258

NCT06245356

NCT05848739

Known as Suyuan “Tas-102(Suyuan) combined with bevacizumab” NCT06092242
Known as TDR “uridine (UR) and thymidine (TDR) are added to the regimen” NCT00004658
Known as thymidine ClinicalTrials.gov intervention name — accepted as the source's own label NCT00004658
1

NCT03639701

Known as Triflridine/Tipiracil (FTD/TPI) “The purpose of this study is to evaluate the combination of panitumumab and Triflridine/Tipiracil (FTD/TPI; TAS-102) in patients with RAS wild-type metastatic colorectal cancer...” NCT02613221
Known as trifluridine and tipiracil Trifluridine and tipiracil (TAS-102) has overall survival benefit for patients with refractory mCRC and may be a radiosensitizer.” PMID 36514060 Dec 2022
Known as Trifluridine/Tipiracil “Trifluridine-Tipiracil will be administered at 35 mg per square meter orally twice daily, with a glass of water within 1 hour after completion of morning and evening meals, 5...” NCT05468892
17

“The aim of this study was to evaluate the cost-effectiveness of trifluridine/tipiracil (FTD/TPI) for heavily pretreated metastatic gastric cancer from the perspective of the...” PMID 39510786 Nov 2024

“This phase I trial studies the side effects and best dose of trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) when given together with radiation therapy” NCT03297710

“In the same patient population, trifluridine/tipiracil (FTD-TPI) and bevacizumab lead to disease control and overall survival benefit and may be a radiosensitizer.” NCT06563986

Trifluridine/tipiracil (FTD/TPI) is approved in Japan, the United States (US), and Europe for metastatic colorectal cancer (mCRC) refractory to standard therapies.” PMID 32308505 Apr 2020

Trifluridine/tipiracil (FTD/TPI; TAS-102, Lonsurf®), a novel form of chemotherapy for metastatic colorectal cancer (mCRC), has shown clinical benefit” PMID 30350179 Oct 2018

“Purpose Trifluridine/tipiracil (TAS-102) was effective in patients with metastatic colorectal cancer (mCRC) in a phase II Japanese trial.” PMID 29215955 Dec 2017

“Trifluridine tipiracil 35 mg/m2 bid during 5 days/w on week 1 and 2 every 4 weeks, for 6 months or until disease progression on imaging” NCT06197425

“the cytotoxic drug TAS-102 (Trifluridine/Tipiracil) in mPC patients” PMID 41039600 Oct 2025

“Trifluridine Tipiracil Tablets 35mg/m2 BID D1-D5, D8-D12 oral, Q4W” NCT05278351

Trifluridine/Tipiracil (TAS-102)” NCT07116577

“TAS-102 (trifluridine/tipiracil)” PMID 37455496 Jul 2023

NCT05468892

NCT04626635

NCT06607458

NCT07527858

NCT06887218

NCT06356311

Known as trifluridine/tipiracil hydrochloride “This phase I trial studies the side effects and best dose of trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) when given together with radiation therapy” NCT03297710
1

“TAS-102 (Trifluridine/Tipiracil Hydrochloride) will be administered orally at a dose of 35mg/m², twice daily, Days 1-5, with each cycle lasting 3 weeks.” NCT07212933

Known as Trifluridine/tipiracil hydrochloride mixture “alternative anti-metabolite Trifluridine/tipiracil hydrochloride mixture, TAS-102,(TAS-OX)” NCT05806931
Action Inhibit “thymidine phosphorylase inhibitor” NCT04808791
Modality Small molecule “Oral nucleoside antitumor agent consisting of α,α,α-trifluorothymidine (FTD) and 5-chloro-6-(2-iminopyrrolidin-1-yl) methyl-2,4 (1H,3H)-pyrimidinedione hydro chloride (TPI) at...” NCT02602327
Route Intravenous “Patients receive deoxycytidine IV over 120 hours” NCT00002818