urea-13c
Trade name: PyloPlus
Small moleculeapproved
Approved
Sep 17, 1996
Clinical trial activity
3 trials · 5 clinical orgs · 5 marketing orgs
Phase 1
1
Phase 2
1
Phase 3
0
Phase 4
1
Earliest trial started Jul 31, 2012 (NCT01623154)
Timeline
1990s
- Sep 17, 1996
Otsuka — Earliest FDA Approval
- Sep 17, 1996
Otsuka — NDA Secondary Org
- Sep 17, 1996
Otsuka — NDA Organization
- Feb 4, 1999
Dxs Devices — NDA Secondary Org
- Dec 17, 1999
Metabolic Solutions Inc. — NDA Secondary Org
2000s
- Dec 17, 2002
Exalenz Bioscience LTD. — Marketing Organization
- Dec 17, 2002
Meridien Research — NDA Secondary Org
2010s
- Jan 1, 2016
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
Mechanism of action
- Bacterial ureaseOTHER
Bacterial urease other
Combination products
idkit:hp
with citric acid
Approval history
- approvedSep 17, 1996
Chemistry & pharmacology
Loading structure…
SMILES
N[13C](N)=O- Mol. weight
- 61.05 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL2096648 ↗
Also known as
- (13c)urea
- (13c)urea
- 13c-urea
- 13c-urea
- 13c-urea
- 13c-urea
- 13c-urea
- carbon 13 urea
- carbon 13 urea
- carbon-13 urea
- carbon-13 urea
- helikit
- pylobactell
- urea (13c)
- urea (13c)
- urea (13c)
- urea 13 c
- urea 13 c
- urea-13c
- urea-13c
- urea-13c
- urea c 13
- urea c 13
- urea c 13
- urea c-13
- urea c-13
- urea c-13
- urea c-13
- urea c-13
- urea, c-13
- urea, c-13
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03900910 | N/A | Apr 1, 2018 | Government of Taiwan, National Taiwan University |
| NCT02670889 | Phase 1/Phase 2 (Phase 2) | Nov 1, 2016 | Children's National Medical Center, University of Pennsylvania |
| NCT01623154 | Phase 4 | Jul 31, 2012 | Otsuka |
Showing 3 of 3 trials
Page 1 / 1
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Children's National Medical Center | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Government of Taiwan | Government | 1 | 0 | 1 | 2018 |
| National Taiwan University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Otsuka | For profit | 1 | 1 | 1 | 2012 |
| University of Pennsylvania | Academic/Hospital | 1 | 0 | 1 | 2016 |
5 organizations
Page 1 / 1
Marketing (6)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Dxs Devices | For profit | NDA2 | Feb 4, 1999 |
| Exalenz Bioscience LTD. | For profit | MKTG | Dec 17, 2002 |
| Meridien Research | For profit | NDA2 | Dec 17, 2002 |
| Metabolic Solutions Inc. | For profit | NDA2 | Dec 17, 1999 |
| Otsuka | For profit | NDA2 | Sep 17, 1996 |
| Otsuka | For profit | NDA | Sep 17, 1996 |