omidenepag
Trade name: Omlonti
Small moleculeapproved
Approved
Sep 22, 2022
Clinical trial activity
13 trials · 1 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
11
Phase 3
8
Phase 4
0
Earliest trial started Jul 1, 2012 (NCT01654484)
Timeline
2010s
- Jan 1, 2012
Santen Inc. — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2013
Santen Inc. — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2016
Santen Inc. — Earliest Phase 3 Sponsor(trial)
2020s
- Sep 22, 2022
Santen Inc. — Earliest FDA Approval
- Sep 22, 2022
Santen Inc. — Marketing Organization
- Sep 22, 2022
Santen Inc. — NDA Secondary Org
- Sep 22, 2022
Santen Inc. — NDA Organization
Indications
Mechanism of action
- Prostanoid EP2 receptorAGONIST
PTGER2 agonist
Approval history
- approvedSep 22, 2022
Chemistry & pharmacology
Loading structure…
SMILES
O=C(O)CNc1cccc(CN(Cc2ccc(-n3cccn3)cc2)S(=O)(=O)c2cccnc2)n1- Mol. weight
- 478.53 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Availability
- Discontinued
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4297666 ↗
- ChEMBLCHEMBL3707245 ↗
Also known as
- de-117
- de-117
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06666855 | Phase 3 | Nov 30, 2024 | Santen Inc. |
| NCT03858894 | Phase 2 | Jan 28, 2019 | Santen Inc. |
| NCT03697811 | Phase 3 | Sep 27, 2018 | Santen Inc. |
| NCT03691649 | Phase 3 | Sep 13, 2018 | Santen Inc. |
| NCT03691662 | Phase 3 | Sep 13, 2018 | Santen Inc. |
| NCT02981446 | Phase 3 | Nov 1, 2016 | Santen Inc. |
| NCT02822742 | Phase 3 | Jul 1, 2016 | Santen Inc. |
| NCT02822729 | Phase 3 | Jul 1, 2016 | Santen Inc. |
| NCT02650063 | Phase 1 | Dec 1, 2015 | Santen Inc. |
| NCT02623738 | Phase 2/Phase 3 (Phase 3) | Nov 1, 2015 | Santen Inc. |
| NCT02179008 | Phase 2 | Jun 1, 2014 | Santen Inc. |
| NCT01868126 | Phase 2 | May 1, 2013 | Santen Inc. |
| NCT01654484 | Phase 1/Phase 2 (Phase 2) | Jul 1, 2012 | Santen Inc. |
Showing 13 of 13 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Santen Inc. | For profit | 13 | 13 | 3 | 2012 |
1 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Santen Inc. | For profit | MKTG | Sep 22, 2022 |
| Santen Inc. | For profit | NDA2 | Sep 22, 2022 |
| Santen Inc. | For profit | NDA | Sep 22, 2022 |