Drugs / Gimeracil

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Teysuno 2011-03-14 europa.eu

Trials 4 · a red edge is where a trial was stopped

201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT02454062 Mar 2013 → Dec 2016 neoplasm Taiho Oncology, Inc. Completed No outcome recorded
Phase 22 trials
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 31 trial
Phase 3 NCT03448549 Jan 2018 → Jan 2021 colorectal cancer Peking University Cancer Hospital & Institute Unknown No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT04571489 Comparator Dec 2020 → Dec 2021 malignant pancreatic neoplasm Lee's Pharmaceutical Limited 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
Phase 41 trial
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

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as Gimeracil “After enrolling in the study, the subjects receive Sintilimab combined with oxaliplatin+Tegafur, Gimeracil and Oteracil Potassium Capsules (SOX) or oxaliplatin+Capecitabine (XELOX)” NCT06761846
6

“S-1 is an oral antimetabolite; a combination of three pharmacological compounds: tegafur (FT), gimeracil (CDHP), and oteracil (Oxo)” NCT02454062

“Tegafur,Gimeracil and Oteracil Porassium Capsules” NCT06992362

NCT05498766

NCT02749526

NCT04571489

NCT03448549

Known as CDHP “S-1 is an oral antimetabolite; a combination of three pharmacological compounds: tegafur (FT), gimeracil (CDHP), and oteracil (Oxo)” NCT02454062
Known as Gimeracil component of teysuno ChEMBL registry synonym — accepted as the source's own label CHEMBL1730601
Known as Gimeracilo ChEMBL registry synonym — accepted as the source's own label CHEMBL1730601
Known as Gimestat ChEMBL registry synonym — accepted as the source's own label CHEMBL1730601
Action Inhibit “Gimeracil, as a potent and reversible inhibitor of dihydropyrimidine dehydrogenase (DPD enzyme)” NCT03448549
1

“Dihydropyrimidine dehydrogenase inhibitor” CHEMBL1730601

Modality Small molecule CHEMBL1730601
Route Oral “Patients will receive tegafur, gimeracil and oteracil potassium orally at 40 or 60mg twice daily on days 1 to 14 every 3 weeks.” NCT04571489
Target DPYD “Dihydropyrimidine dehydrogenase inhibitor” CHEMBL1730601