Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | OMLONTI | — | 2022-09-22 | fda.gov ↗ |
Trials 12 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02650063 | Dec 2015 → Feb 2016 | — | Santen Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01654484 | Jul → Nov 2012 | open-angle glaucoma | Santen Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03858894 | Jan → Jun 2019 | open-angle glaucoma | Santen Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02179008 | Jun 2014 → Jan 2015 | ocular hypertension, open-angle glaucoma | Santen Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01868126 | May → Aug 2013 | open-angle glaucoma | Santen Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02623738 | Dec 2015 → Feb 2017 | ocular hypertension, open-angle glaucoma | Santen Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT03691662 | Sep 2018 → Oct 2019 | glaucoma | Santen Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03697811 | Sep 2018 → Jan 2022 | open-angle glaucoma | Santen Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03691649 | Sep 2018 → Dec 2019 | glaucoma | Santen Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02981446 | Jan 2017 → Jan 2019 | open-angle glaucoma | Santen Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02822742 | Jul 2016 → Apr 2017 | open-angle glaucoma | Santen Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02822729 | Jul 2016 → Nov 2017 | ocular hypertension, open-angle glaucoma | Santen Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | omidenepag isopropyl | “Omidenepag isopropyl (OMDI) is the prodrug of omidenepag, a selective, non-prostaglandin, prostanoid EP2 receptor agonist, which has been shown to lower intraocular pressure...” PMID 32572719 ↗ Jun 20202“Omidenepag Isopropyl in Latanoprost Low/Nonresponders With Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 3, Nonrandomized, Two-Phase, Open-Label Study.” PMID 37853676 ↗ Oct 2023 “Twelve-month efficacy and safety of omidenepag isopropyl, a selective EP2 agonist, in open-angle glaucoma and ocular hypertension: the RENGE study.” PMID 34495425 ↗ Sep 2021 |
| Known as | DE-117 | “DE-117 ophthalmic solution” NCT02822729 ↗ |
| Known as | OMDI | “PURPOSE: To assess the long-term safety and efficacy of omidenepag isopropyl (OMDI) 0.002% (a first-in-class, selective, non-prostaglandin, prostanoid EP2 receptor agonist),...” PMID 34495425 ↗ Sep 20212“once-daily 0.002% omidenepag isopropyl (OMDI) in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) who do not respond or respond poorly to latanoprost.” PMID 37853676 ↗ Oct 2023 “Omidenepag isopropyl (OMDI) is the prodrug of omidenepag, a selective, non-prostaglandin, prostanoid EP2 receptor agonist” PMID 32572719 ↗ Jun 2020 |
| Known as | Omlonti | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297666 ↗ |
| Action | Activate | “a first-in-class, selective, non-prostaglandin, prostanoid EP2 receptor agonist” PMID 34495425 ↗ Sep 20211“Prostanoid EP2 receptor agonist” CHEMBL4297666 ↗ |
| Modality | Small molecule | — CHEMBL4297666 ↗ |
| Route | Topical | “One drop DE-117 Low Dose in each eye daily for 28 days” NCT01868126 ↗ |
| Target | PTGER2 | “Prostanoid EP2 receptor agonist” CHEMBL4297666 ↗ |