NDAINTRAVENOUSSOLUTION
Approved
Feb 2026
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
FAVLYXA (fluorouracil) by Viatris (2) is nucleic acid synthesis inhibitors [moa]. First approved in 2026.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FAVLYXA (fluorouracil) is a nucleoside metabolic inhibitor administered intravenously that works by inhibiting nucleic acid synthesis. It is indicated for oncology applications where it disrupts cancer cell proliferation by blocking DNA and RNA synthesis. The drug represents a generic formulation of a well-established chemotherapy backbone.
Launch
Early-stage launch with generic competition at 30% intensity; commercial team will focus on rapid market penetration and physician adoption in oncology.
Mechanism of Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Class:
Nucleoside Metabolic Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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 Apr 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.