MCS-2 is the only oral botanical new drug to complete global Phase III trials for benign prostatic hyperplasia, with four trials conducted at 27 centers across 19 U.S. states and 12 major Taiwanese hospitals. These studies involved over 200 urologists in the U.S. and more than 70 in Taiwan, including two pivotal and two open-label extension trials.

The drug has met FDA guidelines from Phase I through Phase III and undergone over ten international toxicology studies. Across all trials, MCS-2 demonstrated excellent safety with no serious adverse events, supporting its suitability for long-term use in BPH/LUTS patients.

Jyong Biotech’s core technology enhances bioavailability and allows development of oral, injectable and bladder instillation formulations. These innovations are protected by patents across the Americas, Asia and Europe, overcoming existing patent barriers set by major pharmaceutical companies.

BPH/LUTS affects hundreds of millions of men worldwide, and current therapies often lead to side effects and resistance. With an extensive physician network and robust clinical data, Jyong Biotech is positioning MCS-2 for future regulatory filings and global commercialization, though it remains investigational in all jurisdictions.