The research, led by Dr. Fouad T. Chebib, revealed that udenafil lowers blood urea nitrogen levels—a critical marker for kidney function—and mitigates cardiac hypertrophy. These findings align with earlier tests showing that the drug effectively targets the cyclic guanosine monophosphate signaling pathway, offering a distinct therapeutic mechanism compared to existing vasopressin V2 receptor antagonists.

Mezzion Pharma Chairman and CEO Dong Hyun Park noted that the company’s extensive two-decade safety profile for udenafil provides a robust foundation for upcoming human studies. With the FDA acknowledging the strength of the nonclinical data package, the company is now finalizing protocols for a Phase 2b study. This trial aims to monitor disease progression, kidney volume, and safety in adults, potentially offering a new treatment pathway for a genetic condition that currently affects up to 1 in 1,000 people globally.