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Fluorouracil + folinic acid
Fluorouracil inhibits thymidylate synthase to block DNA synthesis, while folinic acid enhances its cytotoxic effect by providing reduced folate cofactors.
Fluorouracil inhibits thymidylate synthase to block DNA synthesis, while folinic acid enhances its cytotoxic effect by providing reduced folate cofactors. Used for Colorectal cancer, Gastric cancer, Breast cancer.
At a glance
| Generic name | Fluorouracil + folinic acid |
|---|---|
| Sponsor | Odense University Hospital |
| Drug class | Antimetabolite chemotherapy combination |
| Target | Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Fluorouracil is a pyrimidine antimetabolite that interferes with DNA and RNA synthesis by inhibiting thymidylate synthase, preventing the conversion of dUMP to dTMP. Folinic acid (leucovorin) is a reduced folate that stabilizes the fluorouracil-thymidylate synthase complex, increasing the drug's efficacy and duration of action. This combination is a classic chemotherapy regimen used to enhance cytotoxic activity against rapidly dividing cancer cells.
Approved indications
- Colorectal cancer
- Gastric cancer
- Breast cancer
- Pancreatic cancer
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia)
- Mucositis
- Diarrhea
- Nausea and vomiting
- Hand-foot syndrome
- Alopecia
Key clinical trials
- 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)
- Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations (PHASE3)
- Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study (PHASE3)
- Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial) (PHASE2)
- Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer (PHASE1)
- A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) ABBV-400 in Combination With IV Fluorouracil, Leucovorin, and Budigalimab in Adult Participants With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (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:
- Fluorouracil + folinic acid CI brief — competitive landscape report
- Fluorouracil + folinic acid updates RSS · CI watch RSS
- Odense University Hospital portfolio CI