{"id":"13c-15n-urea","_chembl":null,"modality":"Small molecule","_dailymed":null,"mechanism":{"target":"Helicobacter pylori urease","explanation":"When H. pylori is present in the stomach, its urease enzyme breaks down the isotope-labeled urea into ammonia and carbon dioxide. The labeled CO2 is absorbed into the bloodstream and exhaled, where it can be detected and measured to confirm active H. pylori infection.","oneSentence":"Labeled urea is hydrolyzed by H. pylori urease enzyme in the stomach, releasing isotope-labeled CO2 that can be detected in breath samples."},"_scrapedAt":"2026-03-28T05:47:58.130Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779123334,"model":"claude-sonnet-4-5-20250929"},"competitors":[{"name":"14C-Urea","brand":"Pytest","company":null,"rationale":"Alternative isotope-labeled urea for H. pylori breath testing"},{"name":"Stool antigen test","brand":null,"company":null,"rationale":"Non-invasive alternative for H. pylori detection"}],"description":"13C,15N-Urea is a stable isotope-labeled form of urea used as a diagnostic agent. It contains carbon-13 and nitrogen-15 isotopes, enabling detection of Helicobacter pylori infection through breath testing. The compound is administered orally and metabolized by bacterial urease if H. pylori is present.","indications":{"approved":[{"status":"investigational","condition":"Helicobacter pylori infection diagnosis","patientPopulation":"Adult and pediatric patients requiring H. pylori testing"}]},"trialDetails":[{"nctId":"NCT06391034","phase":"PHASE2","title":"Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer","status":"RECRUITING","sponsor":"Robert Bok, MD, PhD","startDate":"2024-09-24","conditions":"Prostate Cancer","enrollment":161},{"nctId":"NCT05599048","phase":"PHASE1, PHASE2","title":"Hyperpolarized 13C MRI as a Biomarker in Advanced Solid Tumors","status":"RECRUITING","sponsor":"Robert Bok, MD, PhD","startDate":"2022-12-15","conditions":"Advanced Solid Tumor","enrollment":65},{"nctId":"NCT02526368","phase":"EARLY_PHASE1","title":"Pilot Study of (MR) Imaging with Pyruvate (13C) to Detect High Grade Prostate Cancer","status":"RECRUITING","sponsor":"Ivan de Kouchkovsky, MD","startDate":"2016-03-22","conditions":"Prostate Cancer, Localized Prostate Carcinoma","enrollment":80},{"nctId":"NCT01610089","phase":"NA","title":"Nitric Oxide Flux and Ureagenesis in Argininosuccinate Synthetase Deficiency (ASSD)(Citrullinemia I)","status":"COMPLETED","sponsor":"Baylor College of Medicine","startDate":"2012-12","conditions":"Citrullinemia","enrollment":6}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_1","status":"active","brandName":"13C,15N-Urea","genericName":"13C,15N-Urea","companyName":"Robert Bok, MD, PhD","companyId":"robert-bok-md-phd","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}