Unicycive Provides Update on New Drug Application for Oxylanthanum Carbonate to Treat Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

Core Viewpoint - The FDA has identified deficiencies in cGMP compliance at a third-party manufacturing vendor for Unicycive Therapeutics' New Drug Application (NDA) for oxylanthanum carbonate (OLC), with a final decision expected by June 28, 2025 [1][2]. Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead investigational treatment being oxylanthanum carbonate (OLC) [6]. - OLC is an oral phosphate binder designed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, utilizing proprietary nanoparticle technology to enhance phosphate binding potency [3][4]. Product Details - OLC aims to reduce the pill burden for patients, potentially improving adherence compared to existing treatments [3]. - The NDA submission for OLC is based on data from three clinical studies and multiple preclinical studies, with a strong global patent portfolio protecting the product until at least 2031, with potential extensions until 2035 [4]. Market Context - Hyperphosphatemia is a critical condition affecting nearly all patients with End Stage Renal Disease (ESRD), with over 450,000 individuals in the U.S. requiring medication annually to manage phosphate levels [5]. - Effective treatment of hyperphosphatemia is essential to reduce associated risks of increased mortality and hospitalization in CKD patients on dialysis [5].