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TS-1 (S-1)
TS-1 (S-1) is a Fluoropyrimidine antimetabolite Small molecule drug developed by National Cancer Center, Korea. It is currently in Phase 3 development for Gastric cancer, Colorectal cancer, Pancreatic cancer. Also known as: S-1.
TS-1 (S-1) is an oral fluoropyrimidine combination that inhibits thymidylate synthase and other enzymes in the pyrimidine synthesis pathway to suppress tumor cell DNA synthesis.
TS-1 is a medication used to treat Recurrent or Metastatic Gastric Cancer, Gastric Cancer, Advanced Non-Small Cell Lung Cancer, and Biliary Tract Neoplasm. It is administered as part of treatment regimens including SP, FL/Tax, and FL/Doc.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | TS-1 (S-1) |
|---|---|
| Also known as | S-1 |
| Sponsor | National Cancer Center, Korea |
| Drug class | Fluoropyrimidine antimetabolite |
| Target | Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
S-1 is a fixed-dose combination of tegafur (a prodrug of 5-fluorouracil), gimeracil (a dihydropyrimidine dehydrogenase inhibitor), and oteracil (a orotate phosphoribosyltransferase inhibitor). This combination enhances 5-FU bioavailability and reduces gastrointestinal toxicity by modulating fluoropyrimidine metabolism. It acts as an antimetabolite, primarily targeting thymidylate synthase to disrupt DNA synthesis in rapidly dividing cancer cells.
Approved indications
- Gastric cancer
- Colorectal cancer
- Pancreatic cancer
- Biliary tract cancer
Common side effects
- Nausea and vomiting
- Diarrhea
- Anorexia
- Bone marrow suppression (leukopenia, thrombocytopenia)
- Stomatitis
- Hand-foot syndrome
Key clinical trials
- Hypofractionated Radiotherapy Plus Immunochemotherapy for Neoadjuvant Treatment of Gastroesophageal Junction Adenocarcinoma (PHASE1, PHASE2)
- NGS as the First-line Treatment in Advanced Biliary Tract Cancer (PHASE2)
- Neoadjuvant Combination Chemotherapy of DCS and DCF in Patients With Locally Advanced Gastric Adenocarcinoma (PHASE2)
- Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma (PHASE2)
- Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial (PHASE3)
- Combined S-1 With DC+CIK As Maintenance Therapy For Advanced Pancreatic Ductal Adenocarcinoma (PHASE2, PHASE3)
- Perioperative Leucovorin, Oxaliplatin, Docetaxel and S-1 (LOTS) For Locally Advanced Gastric or Gastroesophageal Junction Cancer (PHASE2)
- Study of Irinotecan,Oxaliplatin, and S1 in Patients With Advanced Pancreatic Cancer (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TS-1 (S-1) CI brief — competitive landscape report
- TS-1 (S-1) updates RSS · CI watch RSS
- National Cancer Center, Korea portfolio CI
Frequently asked questions about TS-1 (S-1)
What is TS-1 (S-1)?
How does TS-1 (S-1) work?
What is TS-1 (S-1) used for?
Who makes TS-1 (S-1)?
Is TS-1 (S-1) also known as anything else?
What drug class is TS-1 (S-1) in?
What development phase is TS-1 (S-1) in?
What are the side effects of TS-1 (S-1)?
What does TS-1 (S-1) target?
Related
- Drug class: All Fluoropyrimidine antimetabolite drugs
- Target: All drugs targeting Thymidylate synthase
- Manufacturer: National Cancer Center, Korea — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Gastric cancer
- Indication: Drugs for Colorectal cancer
- Indication: Drugs for Pancreatic cancer
- Also known as: S-1
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing