Core Viewpoint - Unicycive Therapeutics has published positive data from its oxylanthanum carbonate (OLC) bioequivalence study, demonstrating its pharmacodynamic equivalence to lanthanum carbonate (LC), which is crucial for the company's New Drug Application (NDA) currently under FDA review [1][2][3]. Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead candidate OLC aimed at treating hyperphosphatemia in chronic kidney disease patients [1][8]. - The company is preparing for the commercial launch of OLC in 2025, following the NDA review by the FDA [3][8]. Study Details - The bioequivalence study involved 80 healthy participants, with 75 completing the trial. OLC was administered as 1000 mg swallowable tablets three times a day, while LC was given as 1000 mg chewable tablets in a two-way crossover design [3]. - The primary pharmacodynamic variable measured was the least squares mean (LSM) change in urinary phosphate excretion, showing similar results for both OLC (–320.4 mg/day) and LC (–324.0 mg/day) [3]. Market Opportunity - The global market for treating hyperphosphatemia is projected to exceed 1 billion [5]. - Despite existing FDA-cleared medications, 75% of U.S. dialysis patients do not meet target phosphorus levels, indicating a significant unmet need in the market [5]. Product Advantages - OLC utilizes proprietary nanoparticle technology and has a lower pill burden compared to existing treatments, which may enhance patient adherence [5]. - The product is protected by a strong global patent portfolio, with exclusivity until 2031 and potential extension until 2035 [5][8].
Unicycive Therapeutics Announces Publication of Oxylanthanum Carbonate (OLC) Positive Bioequivalence Data in Clinical Therapeutics