Unicycive(US:UNCY) GlobeNewswire News Roomยท2025-07-24 12:00Core Insights - Unicycive Therapeutics has published pivotal trial data on oxylanthanum carbonate (OLC) for chronic kidney disease (CKD) patients on dialysis, demonstrating its safety and tolerability [1][2] - The Phase 2 clinical trial showed that OLC effectively controlled serum phosphate levels in over 90% of patients with a low pill burden [2][8] - The company is seeking FDA approval for OLC through the 505(b)(2) regulatory pathway, with a strong patent portfolio supporting its market position [7][11] Company Overview - Unicycive Therapeutics is focused on developing innovative treatments for kidney diseases, with OLC as its lead investigational product aimed at treating hyperphosphatemia in CKD patients on dialysis [11] - The company is also developing UNI-494 for acute kidney injury, which has received Orphan Drug designation from the FDA [11] Clinical Trial Findings - The Phase 2 trial involved 86 patients, with only 59% achieving target serum phosphate levels at screening [2] - OLC was well tolerated, with the most common treatment-related adverse events being gastrointestinal issues, affecting 9% of patients with diarrhea and 6% with vomiting [8] - Two-thirds of patients required three or fewer OLC tablets per day to achieve effective phosphate control [8] Market Need - There is a significant unmet need in managing hyperphosphatemia among CKD patients on dialysis, with over 450,000 individuals in the U.S. requiring medication for phosphate control annually [8][9] - OLC's unique profile may transform the standard of care for these patients by reducing pill burden and improving treatment adherence [5][6]