Drugs / STN1013800
STN1013800
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | isolated blepharochalasis | 2024-12-26 | “filed an application in Japan for manufacturing and marketing approval of STN1013800 (generic name: oxymetazoline hydrochloride) for the treatment of acquired blepharoptosis.” santen.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06911216 | Mar → Apr 2025 | ptosis | Santen Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06514612 | Dec 2024 → Aug 2026 overdue | blepharophimosis | Santen SAS | Recruiting | No outcome recorded |
| Phase 3 | NCT06683651 | Oct 2024 → Jun 2026 overdue | ptosis | Santen Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-01-08 | RVL Pharmaceuticals, Inc. | Regulatory RVL Pharmaceuticals Announces Santen Obtains Manufacturing and Marketing Approval in Japan for UPNEEQ® Mini Ophthalmic Solution 0.1% rvlpharma.com ↗
This milestone expands access in Japan to the first approved non-invasive treatment for blepharoptosis, where treatment options have primarily been limited to surgical procedures. |
| 2025-12-22 | Santen Gmbh | Regulatory Santen Obtains Manufacturing and Marketing Approval in Japan for UPNEEQ® Mini Ophthalmic Solution 0.1%, a Treatment for Acquired Blepharoptosis santen.com ↗ |
| 2024-12-26 | Santen Gmbh | Regulatory Santen Applies for Manufacturing and Marketing Approval in Japan for STN1013800 (oxymetazoline hydrochloride), Eye Drops for Treatment of Acquired Blepharoptosis santen.com ↗
Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced today that it has filed an application in Japan for manufacturing and marketing approval of STN1013800 (generic name: oxymetazoline hydrochloride) for the treatment of acquired blepharoptosis. |
All press releases naming this drug 3 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | STN1013800 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06683651 ↗ |
| Known as | Oxymetazoline HCl | “LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) in the Treatment of Acquired Blepharoptosis.” NCT06514612 ↗ |
| Known as | Oxymetazoline Hydrochloride | “STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers” NCT06514612 ↗ |
| Route | Other | “ocular administration of STN1013800 to both eyes” NCT06911216 ↗ |