Ripasudil hydrochloride dihydrate Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 490

Clinical Trials

Numerous clinical trials ranging from Phase 1 to Phase 4 evaluate ripasudil hydrochloride dihydrate for various ophthalmic conditions, including Fuchs' endothelial corneal dystrophy, primary open-angle glaucoma, ocular hypertension, corneal edema following cataract surgery, and retinopathy of prematurity. Conducted by academic and pharmaceutical sponsors such as Kowa Research Institute, Kyushu University, Stanford University, and Aerie Pharmaceuticals, these studies display varied recruitment statuses, including completed, actively recruiting, and active but not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05275972	RECRUITING	Fuchs; Fuchs Dystrophy; Fuchs' Endothelial Dystrophy	Stanford University	2023-01-23	PHASE3
NCT05289661	ACTIVE_NOT_RECRUITING	Fuchs	Stanford University	2022-07-15	PHASE3
NCT05636579	RECRUITING	Corneal Edema; Corneal Endothelial Dystrophy; Endothelial Dysfunction; Fuchs Dystrophy; Fuchs' Endothelial Dystrophy; Bullous Keratopathy; Pseudophakic Bullous Keratopathy; Corneal Edema Pseudophakic	Asociación para Evitar la Ceguera en México	2022-11-08	PHASE1
NCT06048380	RECRUITING	Fuchs' Endothelial Dystrophy; Cataract	Singapore Eye Research Institute	2025-03-01	PHASE3
NCT05795699	COMPLETED	Fuchs Endothelial Corneal Dystrophy	Kowa Research Institute, Inc.	2023-03-30	PHASE3
NCT03813056	UNKNOWN	Fuchs Endothelial Dystrophy	Michael D. Straiko, MD	2019-03-25	PHASE2
NCT05826353	COMPLETED	Fuchs Endothelial Corneal Dystrophy	Kowa Research Institute, Inc.	2023-05-11	PHASE3
NCT05528172	COMPLETED	Corneal Edema After Cataract Surgery	Kowa Research Institute, Inc.	2022-08-04	PHASE3
NCT04621136	COMPLETED	Retinopathy of Prematurity	Kyushu University	2020-11-01	PHASE1; PHASE2
NCT03249337	RECRUITING	Fuchs' Endothelial Dystrophy	Marian Macsai, MD	2017-12-06	PHASE4
NCT04620135	COMPLETED	Primary Open Angle Glaucoma; Ocular Hypertension	Aerie Pharmaceuticals	2020-11-30	PHASE3
NCT04621136	Completed	Retinopathy of Prematurity	Kyushu University	2020-11-01	Phase 1\|Phase 2
NCT03575130	UNKNOWN	Fuchs' Endothelial Dystrophy; Fuchs Dystrophy; Corneal Endothelial Dystrophy; Corneal Endothelial Cell Loss; Cornea Guttata	University of Erlangen-Nürnberg Medical School	2018-06-05	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-17)

Check the Ripasudil hydrochloride dihydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ripasudil hydrochloride dihydrate selectively inhibits Rho-associated protein kinase 1 (ROCK1) and ROCK2 with IC50 values of 51 nM and 19 nM, respectively, preventing the phosphorylation of downstream cytoskeletal target proteins involved in cell contraction and adhesion. This targeted enzyme inhibition alters trabecular meshwork cellular behavior and enhances corneal endothelial dynamics, providing therapeutic efficacy in clinical conditions such as primary open-angle glaucoma, ocular hypertension, and corneal endothelial dystrophies.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).