Last reviewed · How we verify
5-Flurouracil
5-Fluorouracil is a pyrimidine analog that inhibits thymidylate synthase and gets incorporated into RNA and DNA, disrupting nucleotide synthesis and causing cell death.
5-Fluorouracil is a pyrimidine analog that inhibits thymidylate synthase and gets incorporated into RNA and DNA, disrupting nucleotide synthesis and causing cell death. Used for Colorectal cancer, Breast cancer, Gastric cancer.
At a glance
| Generic name | 5-Flurouracil |
|---|---|
| Also known as | 5FU |
| Sponsor | Janssen Research & Development, LLC |
| Drug class | Antimetabolite |
| Target | Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
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
Key clinical trials
- A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer (PHASE3)
- A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment (PHASE3)
- A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer (PHASE3)
- Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis (PHASE1)
- Trial of ProAgio in Advanced/Metastatic Colorectal Cancer (PHASE1)
- Microneedling Alone Versus Microneedling Coupled With Either Bleomycin or 5flourouracil in the Treatment of Plantar Warts (NA)
- A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer (PHASE3)
- Hyperthermia With Chemoradiotherapy in Rectal Cancer (NA)
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-Flurouracil CI brief — competitive landscape report
- 5-Flurouracil updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI