NDATOPICALCREAM
Approved
Jul 1970
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
EFUDEX (fluorouracil) by Pfizer is nucleic acid synthesis inhibitors [moa]. First approved in 1970.
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EFUDEX (fluorouracil) is a topical cream nucleoside metabolic inhibitor that blocks nucleic acid synthesis to treat actinic keratosis and other skin cancers. Applied directly to affected skin areas, it disrupts rapidly dividing cell populations characteristic of malignant and pre-malignant lesions. The drug has been a dermatology standard since 1970, though its safety profile reflects systemic absorption and metabolic effects.
$0.021BPart D
LOE ApproachingProduct approaching loss of exclusivity with minimal Part D claims; brand team likely focused on competitive differentiation and potential generic transition planning.
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.