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5-Fluorouracile
5-Fluorouracil is a pyrimidine analog that inhibits thymidylate synthase and gets incorporated into RNA and DNA, disrupting nucleotide synthesis and causing cancer cell death.
5-Fluorouracil is a pyrimidine analog that inhibits thymidylate synthase and gets incorporated into RNA and DNA, disrupting nucleotide synthesis and causing cancer cell death. Used for Colorectal cancer, Gastric cancer, Breast cancer.
At a glance
| Generic name | 5-Fluorouracile |
|---|---|
| Also known as | 5FU |
| Sponsor | Groupe Oncologie Radiotherapie Tete et Cou |
| Drug class | Antimetabolite; pyrimidine analog |
| Target | Thymidylate synthase; RNA and DNA incorporation |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
5-FU is converted intracellularly to active metabolites that inhibit thymidylate synthase, blocking dTMP synthesis and thus DNA replication. Additionally, the drug is incorporated into both RNA and DNA, causing direct damage and triggering apoptosis in rapidly dividing cells. This multi-target mechanism makes it effective against a broad range of solid tumors.
Approved indications
- Colorectal cancer
- Breast cancer
- Gastric cancer
- Head and neck cancer
- Pancreatic cancer
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia)
- Mucositis
- Diarrhea
- Nausea and vomiting
- Hand-foot syndrome
- Alopecia
Key clinical trials
- Evaluation of the Efficacy and the Safety of FOLFIRINOX3 Bevacizumab Treatment in Patients With Colorectal Cancer (FOLFIRINOX 3) (PHASE1, PHASE2)
- Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients (PHASE2)
- Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer (PHASE2)
- De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer (PHASE2)
- TWICE-IRI: Optimization of Second-line Therapy With Aflibercept, Irinotecan (Day 1 or Day 1,3), 5-Fluorouracile and Folinic Acid in Patients With Metastatic Colorectal Cancer. A Randomized Phase III Study. (PHASE3)
- Pharmacokinetics and Pharmacogenetics-based Adaptive Dosing of 5-fu (5-Fluorouracile) in Head & Neck Cancer Patient Undergoing Docetaxel, Cisplatin, 5-Fluorouracile (=TPF) Therapy (PHASE4)
- Platinum-Cetuximab Combined With Docetaxel or With 5FU in Patients With Recurrent/Metastatic HNSCC (PHASE2)
- Efficacy and Tolerance Evaluation in FOLFIRINOX Dose Adjusted in Elderly Patients With a 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:
- 5-Fluorouracile CI brief — competitive landscape report
- 5-Fluorouracile updates RSS · CI watch RSS
- Groupe Oncologie Radiotherapie Tete et Cou portfolio CI