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Urea C-14 is a diagnostic agent used for the detection of urease associated with Helicobacter pylori in the human stomach and initial diagnosis or post-treatment monitoring of Helicobacter pylori infection in adults. Urea 14C is a urea molecule radiolabelled with a radioactive carbon-14.
- Mechanism
- Curator reviewed
The urease enzyme is not present in mammalian cells, so the presence of urease in the stomach is evidence that bacteria are present. The presence of urease is not specific for H. pylori, but other bacteria are not usually found in the stomach. To detect H. pylori, urea labeled with 14C is swallowed by the patient. If gastric urease from H. pylori is present, urea is split to form CO2 and NH3 at the interface between the gastric epithelium and lumen and 14CO2 is absorbed into the blood and exhaled in the breath. Following ingestion of the capsule by a patient with H. pylori, 14CO2 excretion in the breath peaks between 10 and 15 minutes and declines thereafter with a biological half-life of about 15 minutes. Therefore, the detection of isotope-labelled carbon dioxide in exhaled breath indicates that urease is present in the stomach, and hence that H. pylori bacteria are present.
- Primary indication
- 14C-urea is intended for use in the detection of gastric urease as an aid in the diagnosis of Helicobacter pylori (H. pylori) infection in the human stomach.Curator reviewed · 1 structured indication
- Formula / weight
- CH4N2O · 62.048 g/mol (avg)
- First approval
- United States, 1997
- Also known as
- 14C-urea · Carbon 14 urea · Carbon-14 urea · Urea (14C) · Urea 14 C
- Code names
- Urea C-14
- Brand names
- Pytest
Resolves to
XSQUKJJJFZCRTK-NJFSPNSNSA-NSMILESN[14C](N)=OWhat you can answer from here — as of September 23, 2026
Which other approved drugs treat the same conditions as Urea C-14, and which companies have late-stage candidates in those indications?