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5-Fluouracil
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, Breast cancer, Gastric cancer.
At a glance
| Generic name | 5-Fluouracil |
|---|---|
| Sponsor | Hoffmann-La Roche |
| Drug class | Antimetabolite |
| 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 DNA replication. It also incorporates into RNA, disrupting protein synthesis. This dual mechanism makes it effective against rapidly dividing cancer cells.
Approved indications
- Colorectal cancer
- Breast cancer
- Gastric cancer
- Pancreatic cancer
- Head and neck cancer
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia)
- Mucositis
- Diarrhea
- Nausea and vomiting
- Hand-foot syndrome
- Alopecia
- Cardiotoxicity
Key clinical trials
- Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (PHASE2)
- A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial (PHASE2)
- Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer (PHASE3)
- Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies (PHASE1)
- Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations (PHASE3)
- Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial (PHASE2)
- Adjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE) (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-Fluouracil CI brief — competitive landscape report
- 5-Fluouracil updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI