Drugs / Trifluridine
Trifluridine
also known as
FTD · F3dthd · NSC-529182 · NSC-75520 · Trifluridina · Trifluridine component of lonsurf · Trifluridine component of s-95005 · Trifluridine component of tas-102 · +2 more
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed colorectal cancer 1 milestone | |||||
| Filed | US (FDA) | LONSURF | colorectal cancer | 2023-04-18 | “FDA has accepted for Priority Review the supplemental new drug application (sNDA) for trifluridine/tipiracil (LONSURF®)” taihooncology.com ↗ |
| Filed refractory malignant neoplasm 1 milestone | |||||
| Filed | US (FDA) | — | refractory malignant neoplasm | 2014-12-22 | “the New Drug Application (NDA) for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), has been accepted for review by the U.S. Food and Drug Administration (FDA).” taihooncology.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Filed | Other | — | — | 2017-10-20 | “today announced that Health Canada accepted for review Taiho’s New Drug Submission (NDS) for trifluridine (FTD) and tipiracil (TPI)” taihooncology.com ↗ |
| Approved | EU (EMA) | Lonsurf | — | 2016-04-25 | europa.eu ↗ |
| Approved | US (FDA) | VIROPTIC | — | 1980-04-10 | fda.gov ↗ |
Trials 30
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 Stop: Business |
| 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 Stop: Business |
| 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 Stop: Enrollment |
| Phase 2 | NCT04294264 | Feb 2019 → Mar 2024 overdue | colon carcinoma | Rutgers, The State University of New Jersey | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03844620 | Jan 2019 → Aug 2026 overdue | colorectal carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03274882 | Mar → Dec 2017 | colorectal cancer | Servier | Completed | No outcome recorded |
| Phase 2 | NCT01904253 | Jul 2013 → Jun 2014 | small cell lung carcinoma | Taiho Oncology, Inc. | Terminated | No outcome recorded |
| Phase 35 trials · 1 met primary · 1 missed | ||||||
| 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 | Missed primary |
| 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 | Met primary |
| 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 → Dec 2024 | colorectal cancer | Chang Gung Memorial Hospital | Completed | 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 |
| Comparator or background therapy20 trials | ||||||
| Phase 0 | NCT07318389 Background | Jun 2026 → Nov 2027 expected | colorectal cancer | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| 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 1/2 | NCT05405595 Background | Jun 2022 → Oct 2026 expected | — | Adagene Inc | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05438459 Comparator | Jun 2022 → Mar 2032 expected | gastric cancer, malignant pancreatic neoplasm | Kyushu University | 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 2 | NCT06039202 Background | Dec 2027 → Oct 2030 | colorectal cancer | Holy Stone Healthcare Co., Ltd | Suspended | No outcome recorded Stop: Business |
| 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 | NCT05608044 Comparator | Nov 2022 → Sep 2027 expected | colorectal cancer | Agenus Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04854434 Comparator | Jun 2021 → Jun 2022 | colorectal cancer | Karyopharm Therapeutics Inc | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03992456 Comparator | Apr 2020 → Dec 2023 | colon adenocarcinoma, rectum adenocarcinoma | Academic and Community Cancer Research United | Unknown | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT04879368 Comparator | May 2021 → Jan 2025 | gastroesophageal cancer | Australasian Gastro-Intestinal Trials Group | Completed | Missed primary |
| Phase 3 | NCT03717038 Comparator | Feb 2019 → Dec 2023 | colorectal carcinoma | Symphogen A/S | Withdrawn | No outcome recorded |
| — | NCT00002037 Background | — | HIV infectious disease, Mycobacterium avium complex disease | Amgen | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2025-10-13 | AbbVie | Results AbbVie to Present New Data at ESMO 2025 Reinforcing Leadership in Advancing Targeted Therapies for Solid Tumors abbvie.com ↗
Grade ≥3 treatment emergent adverse events (TEAEs) occurred in 67% and 65% of patients, respectively. |
| 2025-01-24 | Taiho Oncology, Inc. | Results Taiho Oncology Presents Real-World Findings for LONSURF® at the ASCO Gastrointestinal Cancers Symposium taihooncology.com ↗
In two abstracts, Taiho will present findings from real-world retrospective studies demonstrating that pairing LONSURF with bevacizumab, rather than administering LONSURF alone, improves clinical outcomes for the mCRC patient population, including Black patients. |
| 2025-01-22 | Agenus Inc. | Results Agenus Presents Data at ASCO GI Demonstrating Impact of BOT/BAL in Colorectal Cancer Across Neoadjuvant and Advanced Disease agenusbio.com ↗
Standard of care had no responses. |
| 2023-08-02 | Taiho Oncology, Inc. | Regulatory FDA Approves LONSURF® (trifluridine/tipiracil) in Combination With Bevacizumab for Adult Patients With Metastatic Colorectal Cancer (mCRC) taihooncology.com ↗ |
| 2023-05-03 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier Announce Publication in the New England Journal of Medicine of Pivotal Phase 3 Data for Trifluridine/Tipiracil (LONSURF®) in Combination With Bevacizumab in Patients With Refractory Metastatic Colorectal Cancer taihooncology.com ↗
In addition, the median time to worsening of ECOG (Eastern Cooperative Oncology Group) performance-status score was significantly delayed in patients receiving the investigational combination of trifluridine/tipiracil and bevacizumab. |
| 2023-01-17 | Taiho Oncology, Inc. | Results Servier and Taiho Oncology Present Overall Survival Data for Trifluridine/Tipiracil (LONSURF®) In Combination With Bevacizumab in Patients With Refractory Metastatic Colorectal Cancer at 2023 ASCO Gastrointestinal Cancers Symposium taihooncology.com ↗
This improvement in OS represents a 39% reduction in the risk of death in patients with refractory mCRC. |
| 2022-09-12 | Taiho Oncology, Inc. | Results Drug Combination Meets Survival Endpoint in Phase III Pivotal Trial Involving Participants With Refractory Metastatic Colorectal Cancer taihooncology.com ↗
Combining trifluridine/tipiracil with bevacizumab demonstrated the potential to extend survival in these patients who have limited therapeutic options. |
| 2020-01-25 | Taiho Oncology, Inc. | Results Taiho Oncology Presents Data on LONSURF® (trifluridine and tipiracil) and Futibatinib (TAS-120) at ASCO 2020 Gastrointestinal Cancers Symposium (ASCO GI) taihooncology.com ↗
hematologic adverse events with LONSURF in subgroups of patients with mild to moderate renal impairment and mild hepatic impairment were manageable and similar to those in the overall patient population. |
| 2018-09-28 | Taiho Oncology, Inc. | Results Taiho Oncology Presents Real-World Adherence Data for LONSURF® (trifluridine and tipiracil) in Metastatic Colorectal Cancer at ASCO Quality of Care Symposium taihooncology.com ↗
Treatment with LONSURF was associated with significantly higher medication adherence and longer time to discontinuation compared to treatment with regorafenib. |
| 2018-06-21 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier to Present Data on LONSURF® (trifluridine and tipiracil) at ESMO 20th World Congress on Gastrointestinal Cancer 2018 taihooncology.com ↗
This trial met its primary endpoint of overall survival (OS) and secondary endpoint measures of progression-free survival (PFS), and safety and tolerability, as well as quality of life. |
| 2018-05-09 | Taiho Oncology, Inc. | Results Taiho Oncology Announces Positive Topline Results from Pivotal Phase 3 Trial of LONSURF® (trifluridine/tipiracil) in Metastatic Gastric Cancer taihooncology.com ↗ |
| 2018-01-20 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier Present LONSURF® (trifluridine and tipiracil) Metastatic Colorectal Cancer (mCRC) Data at ASCO 2018 Gastrointestinal Cancers Symposium taihooncology.com ↗
Taiho Oncology, Inc. and Servier today announced clinical data for LONSURF® (trifluridine and tipiracil) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild type, an anti-EGFR therapy. |
| 2017-10-20 | Taiho Oncology, Inc. | Regulatory Health Canada Grants Priority Review Status to trifluridine and tipiracil for Refractory Metastatic Colorectal Cancer taihooncology.com ↗ |
| 2015-09-22 | Taiho Oncology, Inc. | Regulatory Taiho Oncology, Inc. Announces FDA Approval of LONSURF® (trifluridine and tipiracil) for Refractory Metastatic Colorectal Cancer (mCRC) taihooncology.com ↗
today announced that the U.S. Food and Drug Administration (FDA) approved LONSURF® (trifluridine and tipiracil), formerly known as TAS-102 |
| 2015-02-23 | Taiho Oncology, Inc. | Regulatory Taiho Oncology, Inc. Announces TAS-102 New Drug Application for Refractory Metastatic Colorectal Cancer Accepted for Review by FDA taihooncology.com ↗
Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced the New Drug Application (NDA) for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), has been accepted for review by the U.S. Food and Drug Administration (FDA). |
| 2014-12-22 | Taiho Oncology, Inc. | Regulatory Taiho Oncology Completes Submission of TAS-102 New Drug Application to the US Food and Drug Administration for the Treatment of Refractory Metastatic Colorectal Cancer taihooncology.com ↗
Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), announced that it has completed its rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride). |
| 2014-10-20 | Taiho Oncology, Inc. | Regulatory Taiho Oncology, Inc. Receives FDA Fast Track Designation for TAS-102 as a Potential Treatment for Refractory Metastatic Colorectal Cancer taihooncology.com ↗
“We are pleased that TAS-102 has been granted Fast Track designation" said Fabio Benedetti, Senior Vice President and Chief Medical Officer at Taiho Oncology. |
| 2014-06-28 | Taiho Oncology, Inc. | Results Taiho Oncology, Inc. Announces Results from TAS-102 Global Phase III RECOURSE Trial in Refractory Metastatic Colorectal Cancer taihooncology.com ↗
TAS-102 achieved statistically significant improvements in overall survival (OS) and progression-free survival (PFS) in patients with refractory metastatic colorectal cancer (mCRC) whose disease had progressed after or who were intolerant to standard therapies. |
All press releases naming this drug 34 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 52 sources stand behind the page.
| Field | Value | Cited 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 ↗49“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 ↗ |
| 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 ↗ |