Sold as Meretek Ubt, Breathtek Ubt For H-Pylori, Pylori-Chek Breath Test, Helicosol. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 3 applications for Urea C-13 (sold as Meretek Ubt, Breathtek Ubt For H-Pylori, Pylori-Chek Breath Test and others), first approved Sep 17, 1996, with 1 new use approved and 0 published complete response letters.
| European Implementation Study on Simultaneous Screening for Gastric and Colorectal CancersHelicobacter Pylori Infection, Colorectal Cancer · University of Latvia | — | Not yet recruiting | Oct 14, 2026 |
| Pylori Duo for Adjunctive Treatment and Prevention of Recurrence of Helicobacter Pylori InfectionHelicobacter Pylori Infection, Dyspepsia · Gala Servicios Clinicos S.L. | Not applicable | Not yet recruiting | Jul 27, 2026 |
| Helicobacter Pylori Infection Status and Pathological Features for Predicting Gastric Cancer Biological Behavior and Prognosis: A Real-World Observational StudyHelicobacter Pylori, Early Gastric Cancer · Chinese PLA General Hospital | — | Recruiting | Jul 24, 2026 |
| Psychoemotional Status and Functional Gastrointestinal DisordersFunctional Dyspepsia, Irritable Bowel Syndrome · Center of New Medical Technologies | — | Not yet recruiting | Apr 20, 2026 |
| Intrafamilial Helicobacter Pylori Infection in Hong KongH.Pylori Infection · Chinese University of Hong Kong | Not applicable | Not yet recruiting | May 22, 2024 |
| Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5Follicular Lymphoma · The Lymphoma Academic Research Organisation | Phase 3 | Active, not recruiting | Feb 28, 2024 |
| Validation of a Molecular Test for Risk-stratification of Patients With High-risk Intestinal Metaplasia (GCEP2 Study)Stomach Neoplasm · National University Hospital, Singapore | — | Active, not recruiting | Mar 23, 2023 |
| PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation StudyHelicobacter Pylori Infection, Post-Treatment · ARJ Medical, Inc. | Phase 3 | Recruiting | Jan 12, 2023 |
| Sep 17, 1996 | Meretek Ubt, Breathtek Ubt For H-PyloriNDA 20586 · New molecular entity | Otsuka America | 4 | Discontinued |
| Feb 4, 1999 | Pylori-Chek Breath TestNDA 20900 · New formulation or manufacturer | Dxs Devices | 0 | Discontinued |
| Dec 17, 1999 | HelicosolNDA 21092 · New formulation or manufacturer | Metabolic Solutions | 1 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
