Y-27632 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials sponsored by industry developer Aurion Biotech are evaluating therapeutic candidates for ophthalmic conditions, including corneal edema, corneal endothelial dysfunction, Fuchs endothelial corneal dysfunction, and pseudophakic bullous keratopathy. Spanning early to late clinical development, these studies include a completed Phase 1/2 trial assessing preliminary safety and efficacy alongside a Phase 3 study currently recruiting patients.

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 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Y-27632 selectively inhibits Rho-associated protein kinases 1 and 2 (ROCK1 and ROCK2), blocking ROCK-dependent phosphorylation of downstream cytoskeletal regulators and suppressing actomyosin contractility. By inhibiting ROCK signaling, this compound promotes corneal endothelial cell proliferation, migration, and adhesion, providing a mechanistic basis for treating corneal endothelial dysfunction and corneal edema evaluated in clinical trials.

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>).