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5Fluorouracil
5Fluorouracil is a Antimetabolite Small molecule drug developed by University of Nebraska. It is currently FDA-approved for Colorectal cancer, Breast cancer, Gastric cancer. Also known as: Adrucil, 5-FU, Efudix, 5Fu.
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 medication used to treat various types of cancer, including neoplasms, esophageal cancer, pancreatic cancer, colon cancer, and cholangiocarcinoma. It is often used in combination with other treatments, such as neoadjuvant chemoradiotherapy or chemotherapy, and is also studied alongside other medications like capecitabine.
At a glance
| Generic name | 5Fluorouracil |
|---|---|
| Also known as | Adrucil, 5-FU, Efudix, 5Fu, Adrucil® |
| Sponsor | University of Nebraska |
| Drug class | Antimetabolite |
| Target | Thymidylate synthase |
| 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
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)
- Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44) (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)
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:
- 5Fluorouracil CI brief — competitive landscape report
- 5Fluorouracil updates RSS · CI watch RSS
- University of Nebraska portfolio CI
Frequently asked questions about 5Fluorouracil
What is 5Fluorouracil?
How does 5Fluorouracil work?
What is 5Fluorouracil used for?
Who makes 5Fluorouracil?
Is 5Fluorouracil also known as anything else?
What drug class is 5Fluorouracil in?
What development phase is 5Fluorouracil in?
What are the side effects of 5Fluorouracil?
What does 5Fluorouracil target?
Related
- Drug class: All Antimetabolite drugs
- Target: All drugs targeting Thymidylate synthase
- Manufacturer: University of Nebraska — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Colorectal cancer
- Indication: Drugs for Breast cancer
- Indication: Drugs for Gastric cancer
- Also known as: Adrucil, 5-FU, Efudix, 5Fu, Adrucil®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing