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Gemcitabine + S-1
Gemcitabine + S-1 is a Cytotoxic chemotherapy combination Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Pancreatic cancer, Biliary tract cancer, Gastric cancer. Also known as: Background Gemcitabine-based Chemotherapy Regimen, This regimen is not allowed for countries in the European Union., gemzar, TS-1.
Gemcitabine and S-1 are cytotoxic chemotherapy agents that work synergistically to inhibit DNA synthesis and cell division in cancer cells.
Gemcitabine and S-1 are cytotoxic chemotherapy agents that work synergistically to inhibit DNA synthesis and cell division in cancer cells. Used for Pancreatic cancer, Biliary tract cancer, Gastric cancer.
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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. -
Big-pharma sponsor
+3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Gemcitabine + S-1 |
|---|---|
| Also known as | Background Gemcitabine-based Chemotherapy Regimen, This regimen is not allowed for countries in the European Union., gemzar, TS-1 |
| Sponsor | AstraZeneca |
| Drug class | Cytotoxic chemotherapy combination |
| Target | Ribonucleotide reductase, DNA polymerase, thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Gemcitabine is a nucleoside analog that inhibits ribonucleotide reductase and DNA polymerase, leading to DNA strand breaks and apoptosis. S-1 is an oral fluoropyrimidine prodrug that inhibits thymidylate synthase and incorporates into DNA/RNA, enhancing the cytotoxic effects when combined with gemcitabine. This combination leverages complementary mechanisms to improve efficacy in solid tumors.
Approved indications
- Pancreatic cancer
- Biliary tract cancer
- Gastric cancer
Common side effects
- Neutropenia
- Anemia
- Thrombocytopenia
- Nausea and vomiting
- Diarrhea
- Fatigue
- Hand-foot syndrome
Key clinical trials
- HAIC Plus Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer (NA)
- 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)
- Camrelizumab Plus Apatinib in Combination With GEMOX (Gemcitabine and Oxaliplatin ) in Patients With Locally Advanced Biliary Tract Cancer (PHASE2)
- Metastasis-directed Therapy for Oligometastases of Breast Cancer (PHASE3)
- A Study to Evaluate Safety, Pharmacokinetics, & Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors; Urothelial Carcinoma Substudy in Association With RO7496353 Study GO44010 (PHASE1)
- A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer (PHASE2)
- SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic 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:
- Gemcitabine + S-1 CI brief — competitive landscape report
- Gemcitabine + S-1 updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Gemcitabine + S-1
What is Gemcitabine + S-1?
How does Gemcitabine + S-1 work?
What is Gemcitabine + S-1 used for?
Who makes Gemcitabine + S-1?
Is Gemcitabine + S-1 also known as anything else?
What drug class is Gemcitabine + S-1 in?
What development phase is Gemcitabine + S-1 in?
What are the side effects of Gemcitabine + S-1?
What does Gemcitabine + S-1 target?
Related
- Drug class: All Cytotoxic chemotherapy combination drugs
- Target: All drugs targeting Ribonucleotide reductase, DNA polymerase, thymidylate synthase
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Pancreatic cancer
- Indication: Drugs for Biliary tract cancer
- Indication: Drugs for Gastric cancer
- Also known as: Background Gemcitabine-based Chemotherapy Regimen, This regimen is not allowed for countries in the European Union., gemzar, TS-1
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing