Drugs / Teysuno
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 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05396326 | Jun → Dec 2022 | gastric cancer | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT02867397 | Jan 2012 → Aug 2015 | — | Disphar International B.V. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05346874 | Jun 2022 → Jun 2023 | gastric cancer | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT01918852 | Dec 2013 → Dec 2015 | colorectal cancer, metastatic neoplasm | Dutch Colorectal Cancer Group | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT06158919 | Nov 2023 → Nov 2024 overdue | gastroesophageal junction adenocarcinoma | Fudan University | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT01845337 Comparator | Feb 2014 → Mar 2020 | bile duct neoplasm, cancer of unknown primary site, malignant pancreatic neoplasm | University of Edinburgh | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-01-26 | Nordic Pharma SAS | European Commission approves Teysuno in metastatic colorectal cancer nordicpharma.com ↗ |
| 2022-01-03 | Nordic Pharma SAS | Positive EMA opinion for the use of Teysuno in metastatic colorectal cancer nordicpharma.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Teysuno | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06158919 ↗ |
| Known as | S-1 | “S-1 (Teysuno®) is an oral fluoropyrimidine that has shown comparable efficacy to 5FU and capecitabine in gastrointestinal cancers but is associated with a much lower incidence of HFS.” NCT01918852 ↗1“Orally Administered Teysuno (S-1) in Combination With Epirubicin and Oxaliplatin” NCT02867397 ↗ |
| Action | Inhibit | “It is a combination of tegafur (5-FU prodrug), gimeracil (dihydropyrimidine dehydrogenase (DPD) inhibitor) and oteracil (phosphorylation inhibitor).” NCT01845337 ↗ |
| Modality | Small molecule | “S-1 (Teysuno®) is an oral fluoropyrimidine that has shown comparable efficacy to 5FU and capecitabine in gastrointestinal cancers but is associated with a much lower incidence of HFS.” NCT01918852 ↗ |
| Route | Oral | “Teysuno is an oral fluoropyrimidine that has recently obtained a European licence.” NCT01845337 ↗ |