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Placebo plus S1
Placebo plus S1 is a Fluoropyrimidine antimetabolite Small molecule drug developed by Chinese PLA General Hospital. It is currently FDA-approved for Gastric cancer, Colorectal cancer, Breast cancer. Also known as: Tegafur Gimeracil Oteracil Potassium Capsule.
S1 is a combination chemotherapy agent that inhibits thymidylate synthase and dihydropyrimidine dehydrogenase to disrupt DNA synthesis and cell division.
S1 is a combination chemotherapy agent that inhibits thymidylate synthase and dihydropyrimidine dehydrogenase to disrupt DNA synthesis and cell division. Used for Gastric cancer, Colorectal cancer, Breast cancer.
At a glance
| Generic name | Placebo plus S1 |
|---|---|
| Also known as | Tegafur Gimeracil Oteracil Potassium Capsule |
| Sponsor | Chinese PLA General Hospital |
| Drug class | Fluoropyrimidine antimetabolite |
| Target | Thymidylate synthase, dihydropyrimidine dehydrogenase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
S1 (tegafur/gimeracil/oteracil potassium) is an oral fluoropyrimidine combination that acts as a prodrug, converting to fluorouracil in tumor cells. The gimeracil component inhibits dihydropyrimidine dehydrogenase to enhance fluorouracil bioavailability, while oteracil protects normal tissues from toxicity. This combination enhances antitumor activity while reducing gastrointestinal side effects compared to 5-FU monotherapy.
Approved indications
- Gastric cancer
- Colorectal cancer
- Breast cancer
- Pancreatic cancer
Common side effects
- Nausea and vomiting
- Diarrhea
- Anorexia
- Leukopenia
- Thrombocytopenia
- Stomatitis
- Hand-foot syndrome
Key clinical trials
- First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics (PHASE1)
- A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer) (PHASE2)
- Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01) (PHASE3)
- Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction (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)
- The Effect of Oral Probiotics on Oral Hygiene and Halitosis in Orthodontic Patients. (NA)
- Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib (PHASE3)
- To Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia (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:
- Placebo plus S1 CI brief — competitive landscape report
- Placebo plus S1 updates RSS · CI watch RSS
- Chinese PLA General Hospital portfolio CI
Frequently asked questions about Placebo plus S1
What is Placebo plus S1?
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Is Placebo plus S1 also known as anything else?
What drug class is Placebo plus S1 in?
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What does Placebo plus S1 target?
Related
- Drug class: All Fluoropyrimidine antimetabolite drugs
- Target: All drugs targeting Thymidylate synthase, dihydropyrimidine dehydrogenase
- Manufacturer: Chinese PLA General Hospital — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Gastric cancer
- Indication: Drugs for Colorectal cancer
- Indication: Drugs for Breast cancer
- Also known as: Tegafur Gimeracil Oteracil Potassium Capsule
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing