Drugs / Ripasudil
Ripasudil
also known as
Glanatec · K-115 · K-115-R · K-321 · RIPASUDIL HYDROCHLORIDE DIHYDRATE · Ripasudil hydrochloride hydrate
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05636579 | Nov 2022 → Dec 2025 overdue | Fuchs' endothelial dystrophy, bullous keratopathy | Asociación para Evitar la Ceguera en México | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04621136 | Nov 2020 → Nov 2022 | retinopathy of prematurity | Kyushu University | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT04250207 | Jun 2020 → Sep 2021 | Fuchs' endothelial dystrophy | Kowa Research Institute, Inc. | Completed | Met primary |
| Phase 2 | NCT03813056 | Mar 2019 → Feb 2025 | Fuchs' endothelial dystrophy | Michael D. Straiko, MD | Unknown | No outcome recorded |
| Phase 2 | NCT03575130 | Jun → Dec 2018 | Fuchs' endothelial dystrophy, congenital corneal opacities, cornea guttata, and corectopia | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT06048380 | Mar → Jul 2025 overdue | Fuchs' endothelial dystrophy, cataract | Singapore Eye Research Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT05826353 | May 2023 → Jan 2025 | Fuchs' endothelial dystrophy | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05795699 | Mar 2023 → May 2025 | Fuchs' endothelial dystrophy | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05275972 | Jan 2023 → Nov 2027 expected | Fuchs atrophia gyrata chorioideae et retinae, Fuchs' endothelial dystrophy | Stanford University | Recruiting | No outcome recorded |
| Phase 3 | NCT05528172 | Aug 2022 → Jun 2023 | corneal edema | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05289661 | Jul 2022 → Nov 2026 expected | Fuchs atrophia gyrata chorioideae et retinae | Stanford University | Active not recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT04620135 Comparator | Nov 2020 → Jul 2021 | ocular hypertension, open-angle glaucoma | Aerie Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT03249337 Comparator | Dec 2017 → Dec 2021 overdue | Fuchs' endothelial dystrophy | Marian Macsai, MD | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2019-09-02 | Kowa Research Institute, Inc. | Regulatory Rhoキナーゼ阻害剤「リパスジル塩酸塩水和物」 角膜内皮障害を適応症とした米国における第Ⅱ相臨床試験のIND申請のお知らせ【開発コード：K-321】 kowa.co.jp ↗
この たび 、米国第Ⅱ 相臨床試験（以下「本試験」）を開始す るため、 米国 FDA（Food and Drug Administration ：米国食品医薬品局） に対し、 IND 申請（ Investigational New Drug application ：治験許可申請）を 2019 年 8 月 30 日付（現地時間）で 行いましたのでお知らせいたします。 |
All press releases naming this drug 19 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ripasudil | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05275972 ↗ |
| Known as | Glanatec | “Other Name: Glanatec®” NCT04620135 ↗ |
| Known as | K-115 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3426621 ↗ |
| Known as | K-115-R | ChEMBL registry synonym — accepted as the source's own label CHEMBL3426621 ↗ |
| Known as | K-321 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04250207 ↗ |
| Known as | RIPASUDIL HYDROCHLORIDE DIHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3426621 ↗ |
| Known as | Ripasudil hydrochloride hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3426621 ↗ |
| Action | Inhibit | “a potent ROCK inhibitor” NCT03813056 ↗ |
| Modality | Small molecule | — CHEMBL3426621 ↗ |
| Route | Topical | “Glanatec eye drops will be administered 6x per day for 2-4 weeks” NCT03813056 ↗ |