NDAINTRAVENOUSSOLUTION
Approved
Feb 2026
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
FAVLYXA (fluorouracil) by Viatris (2) is nucleic acid synthesis inhibitors [moa]. Approved for colorectal cancer, breast cancer. First approved in 2026.
Drug data last refreshed 20h ago
Mechanism of Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Class:
Nucleoside Metabolic Inhibitor
Indications (2)
Clinical Trials (20)
A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination With Fluorouracil, Folinic Acid, and Oxaliplatin (FOLFOX) Compared to Standard of Care in Adult Participants With First-Line Metastatic Pancreatic Ductal Adenocarcinoma
Started Jun 2026
900 enrolled
Metastatic Pancreatic Ductal AdenocarcinomaPDAC
A Study of BL-B01D1 in Combination With Tislelizumab ±5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02)
Started Apr 2026
90 enrolled
Esophageal Squamous Cell Carcinoma
Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer
Started Jan 2026
50 enrolled
Metastatic Colorectal Cancer (CRC)
Study of 5-fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer
Started Sep 2025
0Metastatic Colorectal Cancer
Effectiveness of Micro-needling With 5 Fluorouracil Versus Potent Topical Steroids in the Treatment of Limited Vitiligo
Started Aug 2025
40 enrolled
Vitiligo
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.