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13C,15N-Urea
13C,15N-Urea is a Diagnostic agent Small molecule drug developed by Robert Bok, MD, PhD. It is currently in Phase 1 development.
Labeled urea is hydrolyzed by H. pylori urease enzyme in the stomach, releasing isotope-labeled CO2 that can be detected in breath samples.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | 13C,15N-Urea |
|---|---|
| Sponsor | Robert Bok, MD, PhD |
| Drug class | Diagnostic agent |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
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.
Approved indications
Common side effects
Key clinical trials
- Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer (PHASE2)
- Hyperpolarized 13C MRI as a Biomarker in Advanced Solid Tumors (PHASE1, PHASE2)
- Pilot Study of (MR) Imaging with Pyruvate (13C) to Detect High Grade Prostate Cancer (EARLY_PHASE1)
- Nitric Oxide Flux and Ureagenesis in Argininosuccinate Synthetase Deficiency (ASSD)(Citrullinemia I) (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- 13C,15N-Urea CI brief — competitive landscape report
- 13C,15N-Urea updates RSS · CI watch RSS
- Robert Bok, MD, PhD portfolio CI
Frequently asked questions about 13C,15N-Urea
What is 13C,15N-Urea?
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Related
- Drug class: All Diagnostic agent drugs
- Manufacturer: Robert Bok, MD, PhD — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing