Drugs / Sepetaprost
last change Aug 2025 re-read 9 days ago

Sepetaprost

also known as ONO-9054 · STN1012600 · DE-126 · Sepetoprost

Small molecule targets PTGER3, PTGFR via activation

Developed for
open-angle glaucoma · ocular hypertension
Investigated by
Santen Pharmaceutical Co., Ltd. · Ono Pharma USA Inc · Santen Inc. · Ono Pharmaceutical Co., Ltd.

Trials 8

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT05905653 May → Jun 2023 — Santen Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1 NCT01670266 Aug 2012 → May 2013 ocular hypertension, open-angle glaucoma Ono Pharma USA Inc Completed No outcome recorded
Phase 1 NCT01508988 Jan → Apr 2012 — Ono Pharma USA Inc Completed No outcome recorded
Phase 23 trials · 1 met primary
Phase 2 NCT04742283 Dec 2020 → Dec 2021 ocular hypertension, open-angle glaucoma Santen Inc. Completed Met primary
Phase 2 NCT03216902 Jul 2017 → Feb 2018 open-angle glaucoma Santen Inc. Completed No outcome recorded
Phase 2 NCT02083289 May → Dec 2014 ocular hypertension, open-angle glaucoma Ono Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT05495061 Aug 2022 → Apr 2023 ocular hypertension, open-angle glaucoma Santen Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 3 NCT05503901 Aug 2022 → Jan 2024 open-angle glaucoma Santen Pharmaceutical Co., Ltd. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2025-08-25 Santen Gmbh Regulatory Santen Obtains Manufacturing and Marketing Approval in Japan for SETANEO® 0.002% Ophthalmic Solution, a Bicyclic Prostaglandin Derivative that Acts on FP and EP3 Receptors, for Treatment of Glaucoma and Ocular Hypertension santen.com ↗
Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced today that it has obtained manufacturing and marketing approval in Japan for SETANEO® ophthalmic solution 0.002% (generic name: sepetaprost; development code: STN1012600; hereinafter the product) for the treatment of glaucoma and ocular hypertension.
2024-09-26 Santen Gmbh Regulatory Santen applies for manufacturing and marketing approval in Japan for STN1012600 ophthalmic solution (sepetaprost ophthalmic solution), a treatment for glaucoma and ocular hypertension with a novel mechanism of action for lowering intraocular pressure santen.com ↗
Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced today that it has filed an application for manufacturing and marketing approval of STN1012600 (generic name: sepetaprost) in Japan.

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as Sepetaprost “Sepetaprost is a novel investigative prodrug, the active form of which is a dual agonist targeting both prostaglandin F receptors and prostaglandin E receptor 3.” PMID 40043909 ↗ Mar 2025
Known as DE-126 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03216902 ↗
Known as ONO-9054 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02083289 ↗
2

NCT01670266 ↗

NCT01508988 ↗

Known as Sepetoprost “ONO-9054 (Sepetoprost), the prodrug of ONO-AG-367” PMID 26720443 ↗ Dec 2015
Known as STN1012600 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05503901 ↗
2

NCT05495061 ↗

NCT05905653 ↗

Action Activate “novel EP3 and FP receptor agonist ONO-9054” PMID 26720443 ↗ Dec 2015
2

“Prostanoid EP3 receptor agonist” CHEMBL4297633 ↗

“Prostanoid FP receptor agonist” CHEMBL4297633 ↗

Modality Small molecule — CHEMBL4297633 ↗
Route Other “Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18” NCT01670266 ↗
Target PTGER3 “Prostanoid EP3 receptor agonist” CHEMBL4297633 ↗
Target PTGFR “Prostanoid FP receptor agonist” CHEMBL4297633 ↗