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S-1 plus Cisplatin
S-1 plus Cisplatin is a Antineoplastic agents Small molecule drug developed by Taiho Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Advanced gastric cancer, Pancreatic cancer. Also known as: TS-1, cisplatin, Tegafur,Gimeracil and Oteracil Potassium Capsules.
S-1 is a fluoropyrimidine derivative that inhibits thymidylate synthase, while cisplatin is a platinum-based alkylating agent that cross-links DNA, thereby inhibiting DNA replication and transcription.
S-1 is a small molecule used in cancer treatment, and it is often combined with Cisplatin in clinical trials for various types of cancer, including Nasopharyngeal Carcinoma, Cervical Cancer, Esophageal Squamous Cell Carcinoma, Gastric Cancer, and Gastroesophageal Junction Cancer. The combination of S-1 and Cisplatin has been studied in clinical trials as a potential treatment for these cancers.
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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 | S-1 plus Cisplatin |
|---|---|
| Also known as | TS-1, cisplatin, Tegafur,Gimeracil and Oteracil Potassium Capsules |
| Sponsor | Taiho Pharmaceutical Co., Ltd. |
| Drug class | Antineoplastic agents |
| Target | Thymidylate synthase, DNA |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
S-1 works by inhibiting thymidylate synthase, which is essential for DNA synthesis and repair. Cisplatin, on the other hand, forms platinum-DNA adducts that interfere with DNA replication and transcription, ultimately leading to cell death. This combination of mechanisms allows S-1 plus cisplatin to target rapidly dividing cancer cells.
Approved indications
- Advanced gastric cancer
- Pancreatic cancer
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Fatigue
- Anemia
Key clinical trials
- Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs) (PHASE3)
- Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01) (PHASE3)
- Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma (PHASE2)
- Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811) (PHASE3)
- A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma (PHASE2)
- A Benefit Population Atlas of nICT Versus nCT for LAGC
- Watch-and-Wait After Immunochemotherapy in Locally Recurrent Nasopharyngeal Carcinoma
- Iparomlimab/Tuvorlimab (QL1706) and Modified TPF Regimen for Induction Therapy in LANPC (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:
- S-1 plus Cisplatin CI brief — competitive landscape report
- S-1 plus Cisplatin updates RSS · CI watch RSS
- Taiho Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about S-1 plus Cisplatin
What is S-1 plus Cisplatin?
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What is S-1 plus Cisplatin used for?
Who makes S-1 plus Cisplatin?
Is S-1 plus Cisplatin also known as anything else?
What drug class is S-1 plus Cisplatin in?
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What does S-1 plus Cisplatin target?
Related
- Drug class: All Antineoplastic agents drugs
- Target: All drugs targeting Thymidylate synthase, DNA
- Manufacturer: Taiho Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced gastric cancer
- Indication: Drugs for Pancreatic cancer
- Also known as: TS-1, cisplatin, Tegafur,Gimeracil and Oteracil Potassium Capsules
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing