Drugs / DE-127
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | myopia 27 | 2024-02-28 | “has filed an application for manufacturing and marketing approval in Japan for the product STN1012700 / DE-127” santen.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT03329638 | Oct 2017 → Sep 2019 | myopia | Santen Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-12-27 | Santen Gmbh | Regulatory RYJUSEA🄬 Mini ophthalmic solution 0.025% (atropine sulfate ophthalmic solution), Japan’s first ophthalmic solution for slowing myopia progression, receives approval for manufacturing and marketing santen.com ↗ |
| 2024-02-28 | Santen Gmbh | Regulatory Eyedrops for slowing the progression of myopia: Santen files application for manufacturing and marketing approval STN1012700 / DE-127 (atropine sulfate hydrate ophthalmic solution) in Japan santen.com ↗
Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced today that it has filed an application for manufacturing and marketing approval in Japan for the product STN1012700 / DE-127 (generic name: atropine sulfate hydrate ophthalmic solution) (hereinafter DE-127), a product designed to slow the progress of myopia. |
All press releases naming this drug 4 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DE-127 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03329638 ↗ |