urea, C-14

Trade name: pytest

Small moleculeapprovedImaging agent

Approved

May 9, 1997

Urea C-14 is a urea molecule radiolabelled with a radioactive carbon-14. Urea C-14 Breath Test is indicated for use in the detection of gastric urease as an aid in the diagnosis of H.pylori infection in the human stomach. The test utilizes a liquid scintillation counter for the measurement of CO in breath samples. To detect H.pylori, urea labeled with C is swallowed by the patient. If gastric urease from H.pylori is present, urea is split to form CO and NH at the interface between the gastric epithelium and lumen and CO is absorbed into the blood and exhaled in the breath. Antibiotics, proton pump inhibitors, sucralfate, and bismuth preparations are known to suppress H.pylori. Ingestion of antibiotics or bismuth within 4 weeks and proton pump inhibitors or sucralfate within 2 weeks prior to performing the test may give false negative results. — NCATS

Clinical trial activity

1 trials · 3 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
1

Earliest trial started Nov 6, 2024 (NCT07224048)

Timeline

1990s

  1. May 9, 1997

    Avent — Earliest FDA Approval

  2. May 9, 1997

    Avent — NDA Secondary Org

  3. May 9, 1997

    Avent — NDA Organization

Indications

Mechanism of action

  • Unspecified targetOTHER

    Diagnostic agent

  • contrast mediumRadiopaque

    contrast medium radiopaque

Approval history

  • approvedPriority reviewMay 9, 1997

Chemistry & pharmacology

Loading structure…

SMILES

N[14C](N)=O
Mol. weight
62.0478 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 14c-urea
  • 14c-urea
  • 14c-urea
  • carbon 14 urea
  • carbon 14 urea
  • carbon 14 urea
  • carbon-14 urea
  • carbon-14 urea
  • carbon-14 urea
  • pytest
  • pytest
  • pytest
  • pytest kit
  • pytest kit
  • urea (14c)
  • urea (14c)
  • urea (14c)
  • urea (14c)
  • urea 14 c
  • urea 14 c
  • urea-14c
  • urea-14c
  • urea-14c
  • urea c 14
  • urea c 14
  • urea c 14
  • urea c 14
  • urea c 14
  • urea c 14
  • urea c-14
  • urea c-14
  • urea, c-14
  • urea, c-14
  • urea, c-14
  • urea, c-14

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07224048Phase 4Nov 6, 2024NRG Oncology, Phathom Pharmaceuticals, Inc., University of Miami
Showing 1 of 1 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NRG OncologyAcademic/Hospital1012024
Phathom Pharmaceuticals, Inc.For profit1012024
University of MiamiAcademic/Hospital1112024
3 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
AventFor profitNDA2May 9, 1997
AventFor profitNDAMay 9, 1997