Company Overview - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead drug candidate being oxylanthanum carbonate (OLC) [1][10] - OLC is a next-generation phosphate binding agent aimed at treating hyperphosphatemia in patients with chronic kidney disease (CKD) [5][10] Clinical Study Findings - Data from a Phase 1 dose escalation study of OLC in healthy volunteers was published, demonstrating that OLC was well tolerated and effectively reduced phosphate absorption [2][3] - The study involved 32 participants and evaluated escalating doses of OLC (500 mg to 2000 mg) administered three times a day, with results showing dose-dependent decreases in urinary phosphorus excretion [3][5] Regulatory Status - Unicycive is currently seeking FDA approval for OLC through the 505(b)(2) regulatory pathway, with a New Drug Application (NDA) under review and a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025 [3][6][10] Market Opportunity - The global market for treating hyperphosphatemia is projected to exceed 1 billion [5] - Despite existing treatments, 75% of U.S. dialysis patients do not achieve recommended phosphorus levels, indicating a significant unmet need in the market [5][10] Patent Protection - OLC is supported by a strong global patent portfolio, including exclusivity on composition of matter until 2031, with potential extensions until 2035 [6][10]
Unicycive Therapeutics Announces Publication of Positive Oxylanthanum Carbonate (OLC) Dose Escalation Data in Clinical and Translational Science