NDAINTRAVENOUSSOLUTION
Approved
Feb 2026
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
FAVLYXA (fluorouracil) by Viatris is nucleic acid synthesis inhibitors [moa]. First approved in 2026.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FAVLYXA (fluorouracil) is a nucleoside metabolic inhibitor that disrupts nucleic acid synthesis, approved as an intravenous solution. It is indicated for oncology applications where it blocks tumor cell proliferation by interfering with DNA and RNA synthesis. This is a generic-equivalent formulation of a established chemotherapy backbone used across multiple cancer types.
Launch
Early-stage launch with moderate competitive pressure (30/100) suggests a mid-sized commercial team focused on market penetration and formulary positioning against established competitors.
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 Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, Fluorouracil and Irinotecan
Started Aug 2026
130 enrolled
Colorectal Cancer
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 Jun 2026
90 enrolled
Esophageal Squamous Cell Carcinoma
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
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
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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.