Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Teysuno | — | 2011-03-14 | europa.eu ↗ |
Trials 35
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07453875 | May 2026 → Nov 2027 expected | peritoneal carcinomatosis | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT02454062 | Mar 2013 → Dec 2016 | neoplasm | Taiho Oncology, Inc. | Completed | No outcome recorded |
| Phase 223 trials · 1 met primary · 2 missed | ||||||
| Phase 2 | NCT07165847 | Jul 2025 → Sep 2028 expected | gastric cancer | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06992362 | May 2025 → Dec 2026 expected | hepatoid adenocarcinoma | Peking University Cancer Hospital & Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06761846 | Jan 2025 → Dec 2027 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT06739252 | Dec 2024 → Dec 2025 | hilar cholangiocarcinoma | Peking University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06396585 | Aug 2024 → Aug 2025 overdue | gastroesophageal cancer | Fujian Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06439550 | Jul 2024 → Dec 2026 expected | — | The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06461910 | Jun 2024 → Jan 2026 overdue | gastric cancer, gastroesophageal junction adenocarcinoma | Zekuan Xu | Recruiting | No outcome recorded |
| Phase 2 | NCT06354140 | May 2024 → May 2027 expected | esophageal squamous cell carcinoma | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06383078 | Apr 2024 → Mar 2027 expected | — | The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06283121 | Apr 2024 → Nov 2027 expected | gastric cancer | China Medical University, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06339619 | Mar 2024 → Mar 2028 expected | esophageal squamous cell carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT05451290 | Nov 2022 → Dec 2024 overdue | biliary tract cancer | First Affiliated Hospital of Zhejiang University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05594381 | Oct 2022 → Sep 2023 | gastric cancer | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT05170503 | Dec 2021 → Jan 2026 overdue | gastroesophageal junction adenocarcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT05223088 | Oct 2021 → Apr 2023 | gastric cancer | Fujian Cancer Hospital | Completed | No outcome recorded |
| Phase 2 | NCT05070598 | Sep 2021 → Sep 2023 | — | Shengjing Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04216758 | Jan → Jul 2020 | pancreatic adenocarcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT03406299 | Apr 2018 → Dec 2024 | biliary tract neoplasm | National Health Research Institutes, Taiwan | Completed | No outcome recorded |
| Phase 2 | NCT03154983 | May 2017 → Dec 2020 | gastric cancer | Zhou Fuxiang | Unknown | No outcome recorded |
| Phase 2 | NCT03204019 | Oct 2016 → Oct 2017 | pancreatic neuroendocrine tumor | Chinese Academy of Medical Sciences | Unknown | Missed primary |
| Phase 2 | NCT03204032 | Oct 2016 → Oct 2017 | neuroendocrine neoplasm | Chinese Academy of Medical Sciences | Unknown | Missed primary |
| Phase 2 | NCT00439517 | Feb 2007 → Jun 2009 | — | Merck KGaA, Darmstadt, Germany | Completed | Met primary |
| Phase 2 | NCT00197431 | Jan 2004 → ? | colon carcinoma, esophageal cancer, gastric cancer, malignant pancreatic neoplasm | Hamamatsu University | Unknown | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05955157 | Jan 2023 → Dec 2024 | pancreatic ductal adenocarcinoma | University of Malaya | Unknown | No outcome recorded |
| Phase 2/3 | NCT05325528 | Apr 2022 → Aug 2025 | — | Zhejiang University | Unknown | No outcome recorded |
| Phase 2/3 | NCT02817425 | May 2013 → Apr 2018 | gastric cancer | LanZhou University | Unknown | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT04135781 | Mar 2020 → Oct 2024 | gastric cancer | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03448549 | Jan 2018 → Jan 2021 | colorectal cancer | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 3 | NCT00207831 | Jul 2004 → Jun 2007 | rectal cancer | Institut Cancerologie de l'Ouest | Terminated | No outcome recorded |
| Phase 3 | NCT00378716 | Feb 1997 → May 2006 | colorectal cancer | NSABP Foundation Inc | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07092449 | Aug 2025 → Dec 2027 expected | gastroesophageal adenocarcinoma, gastroesophageal junction adenocarcinoma | Tang-Du Hospital | Not yet recruiting | No outcome recorded |
| — | NCT05050760 | Sep 2021 → Dec 2023 | esophageal squamous cell carcinoma | Xijing Hospital | Unknown | No outcome recorded |
| — | NCT04198051 | Dec 2019 → Dec 2020 | colon carcinoma, gastric cancer | The First Affiliated Hospital of Dalian Medical University | Unknown | No outcome recorded |
| Comparator or background therapy17 trials | ||||||
| Phase 0 | NCT06525714 Background | Aug 2024 → Jul 2029 expected | gastric cancer | The First Hospital of Jilin University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT03175705 Background | May 2017 → Dec 2018 | hepatocellular carcinoma | Beijing YouAn Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT03175679 Background | Apr 2017 → Dec 2018 | hepatocellular carcinoma | Beijing YouAn Hospital | Completed | No outcome recorded |
| Phase 2 | NCT07530549 Background | Apr 2026 → Dec 2027 expected | esophageal cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06196697 Background | Apr 2024 → Jan 2027 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Harbin Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06988956 Background | Mar 2024 → Apr 2027 expected | esophageal squamous cell carcinoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT04571489 Comparator | Dec 2020 → Dec 2021 | malignant pancreatic neoplasm | Lee's Pharmaceutical Limited | Unknown | No outcome recorded |
| Phase 2 | NCT03702491 Comparator | Aug 2018 → Aug 2020 | gallbladder carcinoma | Eastern Hepatobiliary Surgery Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02749526 Background | Apr 2016 → Dec 2018 | esophageal cancer | The First Affiliated Hospital with Nanjing Medical University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT05817201 Comparator | Jul 2022 → Dec 2023 | esophageal cancer | Taizhou Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT06939439 Comparator | Dec 2024 → Dec 2026 expected | gastric cancer | The First Affiliated Hospital with Nanjing Medical University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05914610 Background | Sep 2023 → Jul 2025 overdue | gastric cancer | Fujian Medical University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04415853 Comparator | Jan 2021 → Aug 2026 overdue | esophageal cancer | Sunshine Lake Pharma Co., Ltd. | Recruiting | No outcome recorded |
| Phase 4 | NCT05498766 Comparator | Jul 2024 → Jul 2029 expected | gastric cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| — | NCT06603974 Background | Oct 2024 → Jul 2026 overdue | gastric cancer | Xijing Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06361316 Background | Apr 2024 → Mar 2025 overdue | malignant pancreatic neoplasm | Kuirong Jiang | Recruiting | No outcome recorded |
| — | NCT05800080 Background | Apr 2023 → Feb 2024 | gastric cancer | Xijing Hospital | Unknown | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2007-07-23 | Jeil Pharmaceutical Co., Ltd. | 항암제 "TS-1" 위암 사망 32% 감소 jeilpharm.co.kr ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 52 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tegafur | “Tegafur: It needs to be administered according to the patient's body surface area\< 40 mg/time at 1.25 m2; ≥ 50 mg/time when 1.25m2 and\<1.5 m2; ≥ 60 mg/time at 1.5 m2; Take...” NCT05800080 ↗51“Neoadjuvant treatment method: Sintilimab 200 mg, i.v., d1 + oxaliplatin 130 mg/m2, d1, i.v., + Tegafur 40 mg po, bid, d1-14; 3-week course; Neoadjuvant therapy: 3 courses of...” NCT05594381 ↗ “adjuvant therapy includes two cycles of HAIC combined with atezolizumab and bevacizumab (atezo/bev), along with additional capecitabine or tegafur as auxiliary maintenance...” NCT06739252 ↗ “After enrolling in the study, the subjects receive Sintilimab combined with oxaliplatin+Tegafur, Gimeracil and Oteracil Potassium Capsules (SOX) or oxaliplatin+Capecitabine (XELOX)” NCT06761846 ↗ “and tegafur, with the dose of tegafur determined based on body surface area and administered orally twice daily for 14 days every 3 weeks” NCT06939439 ↗ “S-1 is an oral antimetabolite; a combination of three pharmacological compounds: tegafur (FT), gimeracil (CDHP), and oteracil (Oxo)” NCT02454062 ↗ “S-1 is a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug of 5-fluorouracil (5-FU);” NCT00197431 ↗ “oxaliplatin + tegafur regimen,oxaliplatin 130mg/m2 intravenous infusion, the 1st day; tegafur 80mg/ m2/d orally Bid” NCT04198051 ↗ “UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules)” NCT00439517 ↗ “Pucotenlimab combined with chemotherapy (Nab-Paclitaxel + Tegafur + Carboplatin)” NCT07092449 ↗ “Tegafur: 40-60 mg/m² twice daily (d1-14) every 3 weeks for 2 cycles” NCT07530549 ↗ |
| Known as | S-1 | “Tegafur (S-1) 80mg/100mg/120mg Q3W (discontinued at the third week) + tislelizumab 200 mg Q3W, treatment for 1 year.” NCT06354140 ↗ |
| Known as | TS-1 | “Tegafur (TS-1) will be administrated alone as maintenance treatment to control group as standard of care” NCT05955157 ↗ |
| Route | Oral | “oral uracil/tegafur” NCT00378716 ↗ |