Core Insights - Unicycive Therapeutics announced preclinical data showing that the combination of oxylanthanum carbonate (OLC) and tenapanor significantly reduces urinary phosphate excretion compared to either drug alone [1][2][6] Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead candidate being oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients [10] - The company is seeking FDA approval for OLC through the 505(b)(2) regulatory pathway, with a New Drug Application (NDA) under review and a target action date set for June 28, 2025 [10][7] Product Details - OLC is a next-generation phosphate binder utilizing proprietary nanoparticle technology, designed to improve patient adherence due to a lower pill burden compared to existing treatments [5] - The global market for hyperphosphatemia treatment is projected to exceed 1 billion [5] Clinical Findings - The combination therapy of OLC and tenapanor resulted in a 41.3% reduction in urinary phosphate excretion, while OLC alone showed a 17.7% reduction and tenapanor alone led to a 12.5% reduction [6] - The study indicates that OLC could be particularly beneficial for patients who are unresponsive or intolerant to current phosphate binders [3] Market Need - Approximately 75% of patients on maintenance dialysis do not meet serum phosphate targets, highlighting the need for new treatment approaches [3] - The greatest unmet need identified by nephrologists is a lower pill burden and improved patient compliance in the treatment of hyperphosphatemia [5]
Unicycive Therapeutics Announces the Publication of Preclinical Data on Synergies Between Oxylanthanum Carbonate and Tenapanor in American Society of Nephrology Journal Kidney360