Clinical studies evaluating Y-27632-based therapies have advanced from Phase 1 through Phase 3 trials. These clinical evaluations focus on addressing corneal endothelial disorders, including corneal edema, Fuchs endothelial corneal dysfunction, and pseudophakic bullous keratopathy. The trials aim to establish the therapeutic utility of Rho-kinase inhibition in supporting corneal cell recovery and restoring tissue function.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07368959 | RECRUITING | Corneal Edema; Corneal Endothelial Dysfunction; Fuchs Endothelial Corneal Dysfunction; Pseudophakic Bullous Keratopathy (PBK) |
Aurion Biotech |
2026-02-19 | PHASE3 |
| NCT06041256 | COMPLETED | Corneal Edema; Corneal Endothelial Dysfunction |
Aurion Biotech |
2023-10-18 | PHASE1; PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-05-22)
Check the
Y-27632 Dihydrochloride
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
- Y-27632 Dihydrochloride Mechanism of Action: ROCK Inhibition in Pluripotent Stem Cell Research
- Y-27632 Dihydrochloride: Selectivity & Specificity
- Y-27632 Dihydrochloride Working Concentration | Cell Culture | Treatment
- Y-27632 Dihydrochloride Solubility in DMSO
- Y-27632 Dihydrochloride Stock Solution
- Y-27632 Dihydrochloride Storage
- Y-27632 Dihydrochloride Stability
- Y-27632 Dihydrochloride VS KD025 (Belumosudil) | Netarsudil (AR-13324) 2HCl
- Y-27632 Dihydrochloride Molecular Weight
- Y-27632 Dihydrochloride SMILES
- Y-27632 Dihydrochloride CAS Number
- Y-27632 Dihydrochloride Chemical Structure (2D and 3D)
- Y-27632 Dihydrochloride IC50 for Cell-based and Cell-free Assays
- Y-27632 Dihydrochloride Sigma (Y0503)? Try a better option.
- Y-27632 Dihydrochloride MedChemExpress (HY-10583)? Try a better option.
- Y-27632 Dihydrochloride Tocris (1254)? Try a better option.
- Y-27632 Dihydrochloride STEM CELL (72307)? Try a better option.
- Y-27632 Dihydrochloride Cayman (10005583)? Try a better option.
- Y-27632 Dihydrochloride SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.