ADRUCIL

Pre-Launch

fluorouracil

Pfizer

ANDAINJECTIONINJECTABLE

Lifecycle

Pre-Launch

Clinical Trials

Data completeness

3/8 — Basic

ADRUCIL (fluorouracil) by Pfizer is (dna) and to a lesser extent inhibits the formation of ribonucleic acid (rna); these affect rapidly growing cells and may lead to cell death. Approved for rectum () adenocarcinoma of the breast () gastric adenocarcinoma () pancreatic adenocarcinoma () 1.

Drug data last refreshed 1mo ago

Mechanism of Action

(DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA); these affect rapidly growing cells and may lead to cell death. Fluorouracil is converted to three main active metabolites: 5-fluoro-2′-deoxyuridine-5′-monophosphate (FdUMP), 5-fluorouridine-5′triphosphate (FUTP) and…

Indications (1)

Rectum () Adenocarcinoma of the Breast () Gastric Adenocarcinoma () Pancreatic Adenocarcinoma () 1

Clinical Trials (20)

NCT07490301Phase 2/3Not Yet Recruiting

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

NCT07554456Phase 2/3Not Yet Recruiting

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

NCT07042685Phase 2Recruiting

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)

NCT06501989Phase 2Withdrawn

Study of 5-fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer

Started Sep 2025

Metastatic Colorectal Cancer

NCT07398807Phase 1Recruiting

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.