Drugs / oteracil
oteracil
also known as
Oteracil Potassium · Oxo · 5-azaorotic acid · Allantoxanic acid · Oteracilo · Oxonic acid · potassium oxonate
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 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02454062 | Mar 2013 → Dec 2016 | neoplasm | Taiho Oncology, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| 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 |
| Comparator or background therapy4 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 Stop: Enrollment |
| Phase 2 | NCT00197431 Background | Jan 2004 → ? | colon carcinoma, esophageal cancer, gastric cancer, malignant pancreatic neoplasm | Hamamatsu University | Unknown | 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 |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | oteracil | “S-1 is an oral antimetabolite; a combination of three pharmacological compounds: tegafur (FT), gimeracil (CDHP), and oteracil (Oxo)” NCT02454062 ↗ |
| Known as | 5-azaorotic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL181932 ↗ |
| Known as | Allantoxanic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL181932 ↗ |
| Known as | Oteracil Potassium | “After enrolling in the study, the subjects receive Sintilimab combined with oxaliplatin+Tegafur, Gimeracil and Oteracil Potassium Capsules (SOX) or oxaliplatin+Capecitabine (XELOX)” NCT06761846 ↗ |
| Known as | Oteracilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL181932 ↗ |
| Known as | Oxo | “S-1 is an oral antimetabolite; a combination of three pharmacological compounds: tegafur (FT), gimeracil (CDHP), and oteracil (Oxo)” NCT02454062 ↗1“potassium oxonate (Oxo), which reduces gastrointestinal toxicity.” NCT00197431 ↗ |
| Known as | Oxonic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL181932 ↗ |
| Known as | potassium oxonate | “potassium oxonate (Oxo), which reduces gastrointestinal toxicity.” NCT00197431 ↗ |
| Action | Inhibit | “Oteracil potassium specifically inhibits the intestinal mucosal cells within the orotate phosphoribosyl transferase (OPRT enzyme), blocking 5-Fu phosphorylation, reducing the...” NCT03448549 ↗ |
| Modality | Small molecule | — CHEMBL181932 ↗ |
| 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 ↗ |