Drugs / TAS-102
TAS-102
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | colorectal cancer | 2014-12-19 | “Taiho Oncology submitted the final portion of the rolling NDA for U.S. marketing approval of TAS-102 on December 19, 2014.” taihooncology.com ↗ |
Trials 58
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 115 trials | ||||||
| Phase 1 | NCT07649655 | Jul 2026 → Mar 2028 expected | colorectal cancer | Shanghai EpimAb Biotherapeutics Co., Ltd. | Not yet 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 | 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 Stop: Enrollment |
| Phase 1 | NCT03305913 | Jul 2017 → Oct 2018 | colorectal cancer | AIO-Studien-gGmbH | Completed | No outcome recorded |
| Phase 1 | NCT02602327 | Jan 2017 → May 2021 | colon carcinoma, metastasis from malignant tumor of colon, rectal carcinoma | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1 | NCT02301117 | Jan 2015 → Jun 2019 | cancer | Taiho Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02301104 | Jan 2015 → Jun 2016 | cancer | Taiho Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02261532 | Sep 2014 → Oct 2015 | — | Taiho Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01916447 | Sep 2013 → Sep 2017 | — | Taiho Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01867879 | Jun 2013 → Aug 2014 | — | Taiho Oncology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01867866 | May → Oct 2013 | cancer | Taiho Oncology, Inc. | Completed | No outcome recorded |
| Phase 1/26 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 | NCT05482893 | Mar 2023 → Dec 2027 expected | biliary tract cancer, colorectal cancer, gastroesophageal adenocarcinoma, pancreatic ductal adenocarcinoma | Phanes Therapeutics | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03223779 | Oct 2017 → Feb 2025 | colorectal cancer | Massachusetts General Hospital | Completed | 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 229 trials · 3 met primary · 2 missed | ||||||
| Phase 2 | NCT07116577 | Aug 2025 → Aug 2027 expected | colorectal cancer | Jinan Central Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07212933 | Jul 2025 → Dec 2027 expected | gastric cancer | Chinese PLA General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07090031 | Jul 2025 → Dec 2027 expected | — | Qingdao Central Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06856187 | Feb 2025 → Jun 2026 overdue | colorectal cancer | Fudan University | 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 2 | NCT05854498 | Oct 2023 → Sep 2028 expected | colorectal cancer | University of Wisconsin, Madison | Recruiting | No outcome recorded |
| Phase 2 | NCT05806931 | May 2023 → May 2026 overdue | colon carcinoma, rectal carcinoma | Rutgers, The State University of New Jersey | Recruiting | No outcome recorded |
| Phase 2 | NCT05481463 | Jan 2023 → Mar 2025 | malignant pancreatic neoplasm | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 2 | NCT04417699 | Jul 2022 → Dec 2023 | rectal cancer | Providence Health & Services | Completed | No outcome recorded |
| Phase 2 | NCT05364489 | Jun 2022 → Jun 2025 overdue | colorectal cancer | The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05343013 | Jun 2022 → May 2027 expected | colorectal cancer | M.D. Anderson Cancer Center | Active not recruiting | Met primary |
| Phase 2 | NCT05314101 | Apr 2022 → Feb 2023 | colorectal cancer | Fujian Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05004831 | Mar 2022 → Sep 2023 | colorectal cancer | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT04808791 | Oct 2021 → Jul 2023 | gastric carcinoma, gastroesophageal junction adenocarcinoma | AHS Cancer Control Alberta | Completed | No outcome recorded |
| Phase 2 | NCT05266820 | Oct 2021 → Dec 2022 | colorectal cancer | Fujian Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05029102 | Sep 2021 → Dec 2024 | gastric cancer | Zhejiang University | Unknown | No outcome recorded |
| Phase 2 | NCT04701476 | May 2021 → Mar 2027 expected | colorectal cancer | Teclison Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT04923529 | Mar 2021 → Mar 2024 | malignant pancreatic neoplasm | The University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT04683965 | Jan 2021 → Jan 2024 | colorectal neoplasm | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT04627961 | Aug 2020 → Oct 2024 | nasopharyngeal carcinoma | National University Hospital, Singapore | Unknown | No outcome recorded |
| Phase 2 | NCT04109924 | Dec 2019 → Sep 2024 | colon adenocarcinoma, rectum adenocarcinoma | Roswell Park Cancer Institute | Completed | Met primary |
| Phase 2 | NCT03762161 | Jan 2019 → Jul 2023 | urinary bladder cancer | Rahul Parikh | Unknown | No outcome recorded |
| Phase 2 | NCT03686488 | Dec 2018 → Jan 2022 | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | Missed primary |
| Phase 2 | NCT02921737 | Nov 2017 → Jul 2020 | malignant pancreatic neoplasm | University of Florida | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03251612 | Sep 2017 → Aug 2021 | colorectal cancer | Vejle Hospital | Completed | Met primary |
| Phase 2 | NCT02920476 | Jul 2017 → Dec 2018 | squamous cell lung carcinoma | University of Florida | Completed | No outcome recorded |
| Phase 2 | NCT02860546 | Aug 2016 → Aug 2017 | colorectal cancer | Taiho Oncology, Inc. | Completed | Missed primary |
| Phase 2 | NCT02654639 | Feb 2016 → Nov 2017 | colorectal cancer | Georgetown University | Terminated | No outcome recorded |
| Phase 35 trials · 2 met primary | ||||||
| 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 | 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 | Met primary |
| Phase 3 | NCT01955837 | Sep 2013 → Feb 2016 | colorectal cancer | Taiho Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase not applicable2 trials · 1 met primary | ||||||
| — | 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 | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT02286492 | — | colorectal cancer | Taiho Oncology, Inc. | Approved for marketing | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| 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 1/2 | NCT01896856 Comparator | Oct 2013 → Aug 2019 | — | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2/3 | NCT03909724 Comparator | Oct 2019 → Jul 2021 | colorectal cancer, metastatic neoplasm | Amsterdam UMC, location VUmc | Unknown | Missed primary |
| Phase 3 | NCT07384377 Comparator | Feb 2026 → Nov 2027 expected | carcinoma | Shanghai JMT-Bio Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06346392 Comparator | Mar 2024 → May 2026 overdue | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | AstraZeneca | Active not recruiting | Mixed |
| Phase 3 | NCT05600309 Comparator | Jun 2022 → Aug 2024 | colorectal cancer | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 3 | NCT05328908 Comparator | Apr 2022 → Jul 2025 | colorectal neoplasm | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 3 | NCT05064059 Comparator | Nov 2021 → Aug 2024 | colorectal cancer | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 3 | NCT04776148 Comparator | Mar 2021 → Sep 2024 | colorectal neoplasm | Merck Sharp & Dohme LLC | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 37
| Date | Issuer | Release |
|---|---|---|
| 2026-06-17 | UCB Pharma | Results UCB Announces Publication of Data in Brain Communications Demonstrating Positive Impact of KYGEVVI[®]▼ (doxecitine and doxribtimine) in Patients with Thymidine Kinase 2 Deficiency (TK2d) ucb.com ↗
Data indicate that KYGEVVI therapy improved survival and functional outcomes in people with TK2d. |
| 2026-03-31 | UCB Pharma | Regulatory European Commission approves KYGEVVI[®]▼ (doxecitine and doxribtimine) as first and only treatment for Thymidine Kinase 2 Deficiency (TK2d) ucb.com ↗
It is the first and only approved treatment for TK2d. |
| 2026-01-30 | UCB Pharma | Regulatory KYGEVVI[®] (doxecitine and doxribtimine) recommended for approval in the European Union as treatment for Thymidine Kinase 2 Deficiency (TK2d) ucb.com ↗
“This positive CHMP opinion marks a turning point in the treatment of TK2d, offering a new chapter of hope and a meaningful step forward for patients, families, and clinicians alike,” said Donatello Crocetta, Chief Medical Officer at UCB. |
| 2025-11-06 | Treos Bio Zrt | Results TREOS Bio Announces Publication of Phase 1b Clinical Trial Results of PolyPEPI1018 Plus TAS-102 in Refractory MSS mCRC in JCO Oncology Advances treostherapeutics.com ↗
The combination achieved a 53.3% disease control rate (DCR) ; median progression-free survival (mPFS) was 4.0 months and median overall survival (mOS) was 8.7 months , representing promising improvements versus historical TAS-102 monotherapy . |
| 2025-11-03 | UCB Pharma | Regulatory U.S. FDA approves KYGEVVI[™] (doxecitine and doxribtimine), the first and only treatment for adults and children living with thymidine kinase 2 deficiency (TK2d) ucb.com ↗
UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that KYGEVVI™ has been granted approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults and pediatric patients living with thymidine kinase 2 deficiency (TK2d), with an age of symptom onset on or before 12 years. |
| 2025-10-13 | UCB Pharma | Results Results published in Neurology highlight a 95% reduction in risk of death with pyrimidine nucleos(t)ide therapy in patients with thymidine kinase 2 deficiency (TK2d) ucb.com ↗
The results indicated that pyrimidine nucleoside and/or nucleotide therapy may reduce risk of death and can impact functional outcomes in patients with TK2d. |
| 2025-03-19 | UCB Pharma | Results New data on investigational therapy for thymidine kinase 2 deficiency presented at Muscular Dystrophy Association (MDA) 2025 Conference ucb.com ↗
Clinical data highlight survival benefits and improvement in functional motor outcomes associated with treatment with doxecitine (dC) and doxribtimine (dT) - an investigational pyrimidine nucleoside therapy - in people living with thymidine kinase 2 deficiency (TK2d). |
| 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. |
| 2024-07-03 | TTY Biopharm | Regulatory 接軌國際最新治療趨勢 台灣東洋腸癌新雞尾酒療法獲准藥證 com.tw ↗
食藥署基於歐美核准證明以及臨床試驗報告，亦於3日審核通過Trifluridine/Tipiracil (FTD/TPI)複方口服化療癌藥併用Bevacizumab的「腸癌雞尾酒療法」。 |
| 2023-10-23 | Oncolytics Biotech | Results Oncolytics Achieves Success Criteria for Efficacy in the Third-Line Colorectal Cancer Cohort of the GOBLET Study oncolyticsbiotech.com ↗
The results presented at ESMO met the criteria to advance the study to the next stage, with 4 of 14 enrolled patients demonstrating stable disease at week 16. |
| 2023-10-16 | Oncolytics Biotech | Results Oncolytics Biotech® To Present Two Posters on the Pelareorep-Based GOBLET Study at ESMO 2023 oncolyticsbiotech.com ↗
Results from pelareorep combination in mCRC met the Stage 1 success criteria |
| 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 ↗ |
| 2023-06-05 | Treos Bio Zrt | Results Treos Bio Announces Presentation of Final Results from Phase 1b Study of PolyPEPI1018 Immunotherapy for Late-Stage Metastatic Colorectal Cancer at 2023 ASCO Annual Meeting treostherapeutics.com ↗
Final results from the study, conducted by Mayo Clinic in Minnesota, demonstrate that PolyPEPI1018 in combination with TAS-102 improved progression free-survival (PFS) and overall survival (OS) compared to historical data for standard of care TAS-102 alone. |
| 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. |
| 2023-04-18 | Taiho Oncology, Inc. | Regulatory U.S. Food and Drug Administration Accepts for Priority Review Taiho Oncology’s Supplemental New Drug Application for the Use of Trifluridine/Tipiracil (LONSURF®) in Combination With Bevacizumab for Refractory Metastatic Colorectal Cancer taihooncology.com ↗ |
| 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. |
| 2022-01-28 | PharmaEngine | Results PharmaEngine, Inc. Announces First Results for ONIVYDE® in Combination with LONSURF® in Refractory Solid Tumors at 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI 2022) pharmaengine.com ↗
The data from dose-finding phase showed that the recommended phase II dose (RP2D) of the combination was ONIVYDE® 80 mg/m2 plus LONSURF® 30 mg/m2. |
| 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. |
| 2019-10-14 | Taiho Oncology, Inc. | Results Analysis of Patients with Prior Gastrectomy Treated with LONSURF® (trifluridine and tipiracil) Published in JAMA Oncology taihooncology.com ↗
The safety profile of LONSURF was consistent with studies of the drug in metastatic colorectal cancer (mCRC), and no new safety concerns were reported. |
| 2019-06-03 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier Present LONSURF® (trifluridine and tipiracil) Data at the 2019 ASCO Annual Meeting taihooncology.com ↗
A subgroup analysis from the Phase 3 TAGS trial demonstrates a manageable safety profile and consistent efficacy in patients with previously treated mGEJC. |
| 2019-02-25 | Taiho Oncology, Inc. | Regulatory FDA Approves Taiho Oncology’s LONSURF® (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma taihooncology.com ↗ |
| 2019-01-17 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier Present Data on LONSURF® (trifluridine/tipiracil) at ASCO 2019 Gastrointestinal Cancers Symposium (ASCO GI) taihooncology.com ↗
The results confirmed that LONSURF prolonged survival versus placebo regardless of prior gastrectomy. |
| 2018-10-25 | Taiho Oncology, Inc. | Regulatory FDA Accepts Supplemental New Drug Application for LONSURF® (trifluridine/tipiracil) for the Treatment of Metastatic Gastric/Gastroesophageal Junction (GEJ) Adenocarcinoma; Grants Priority Review taihooncology.com ↗ |
| 2018-10-21 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier Announce Positive Results from LONSURF® (trifluridine/tipiracil) Study Presented at ESMO 2018 Congress and Published in The Lancet Oncology taihooncology.com ↗
The trial met its primary endpoint of prolonged overall survival (OS) and secondary endpoint measures of progression-free survival (PFS), as well as continued to demonstrate LONSURF’s predictable safety and tolerability profile. |
| 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. |
| 2018-06-14 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier to Present Data on LONSURF® (trifluridine and tipiracil) and Key Investigational Compound TAS-120 at ESMO 20th World Congress on Gastrointestinal Cancer 2018 taihooncology.com ↗
A pivotal Phase III trial (TAGS) evaluating LONSURF® plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer refractory to standard therapies met its primary endpoint of prolonged overall survival (OS) (Abstract LBA-002). |
| 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 ↗ |
| 2018-04-13 | Taiho Oncology, Inc. | Results Taiho Oncology Presents Data on LONSURF® (trifluridine and tipiracil) and Key Investigational Compounds at the 109th Annual Meeting of the American Association for Cancer Research taihooncology.com ↗
The safety findings of LONSURF in combination with irinotecan were consistent with the existing safety profiles of each drug, and recommended dosing of LONSURF and irinotecan was identified for further study. |
| 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 46 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 74 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TAS-102 | “randomized for treatment with TAS-102 (standard-arm) or High Dose Intermittent Sunitinib (700 mg once every 2 weeks)” NCT03909724 ↗69“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 ↗ |
| 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 20242“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 |
| 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 20182“Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®)” NCT03810742 ↗ “TAS-102 (trifluridine and tipiracil, Lonsurf®)” NCT07212933 ↗ |
| Known as | Suyuan | “Tas-102(Suyuan) combined with bevacizumab” NCT06092242 ↗ |
| 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 | “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 20247“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 ↗ “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 “the cytotoxic drug TAS-102 (Trifluridine/Tipiracil) in mPC patients” PMID 41039600 ↗ Oct 2025 “TAS-102 (trifluridine/tipiracil)” PMID 37455496 ↗ Jul 2023 “Trifluridine/Tipiracil (TAS-102)” NCT07116577 ↗ |
| 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 | Oral | “35 mg/m2/dose, orally” NCT01867866 ↗ |