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Unicycive Therapeutics Announces the Publication of Oxylanthanum Carbonate Pivotal Trial Data in Clinical Journal of the American Society of Nephrology
GlobeNewswire News Room· 2025-07-24 12:00
LOS ALTOS, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the publication of pivotal trial data describing the safety and tolerability of oxylanthanum carbonate (OLC) in chronic kidney disease (CKD) patients on dialysis in the Clinical Journal of the American Society of Nephrology. The publication, entitled “A Phase 2 Clinical Tr ...
Unicycive Presents New Patient-Level Data Underscoring Challenges Faced with Current Phosphate Binders and Highlighting the Potential of Oxylanthanum Carbonate to Address Barriers to Adherence for Patients with Hyperphosphatemia on Dialysis
Globenewswire· 2025-04-10 12:00
– Patient-reported outcomes from Phase 2 trial of oxylanthanum carbonate (OLC) demonstrate high patient satisfaction with OLC compared to their prior phosphate lowering therapy – – Findings from a patient survey conducted in partnership with the National Kidney Foundation (NKF) showed excessive number and large size of phosphate binder pills to be top barriers to consistent medication use – – Results to be presented in poster sessions at the NKF Spring Clinical Meetings – LOS ALTOS, Calif., April 10, 2025 ( ...
Unicycive to Highlight Patient Reported Outcomes Data at Upcoming Medical Meetings Showing Oxylanthanum Carbonate Reduced Pill Burden and Improved Adherence in Treatment of Hyperphosphatemia
Newsfilter· 2025-03-13 11:00
Core Insights - Unicycive Therapeutics is presenting patient-reported outcomes data from its pivotal UNI-OLC-201 clinical study on oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis [1][2] - The New Drug Application (NDA) for OLC has been accepted by the FDA, with a target action date set for June 28, 2025 [2][9] - Hyperphosphatemia remains uncontrolled in 75% of U.S. dialysis patients, highlighting a significant unmet need for more effective treatments [3][7] Company Overview - Unicycive Therapeutics is focused on developing novel treatments for kidney diseases, with OLC as its lead drug candidate [9] - OLC utilizes proprietary nanoparticle technology to reduce pill burden, potentially improving patient adherence [2][5] - The company has a strong global patent portfolio for OLC, with exclusivity until 2031 and potential extension until 2035 [7][9] Market Opportunity - The market for treating hyperphosphatemia is projected to exceed $2.28 billion, with North America accounting for over $1 billion [7] - Despite existing phosphate binders, 75% of dialysis patients do not achieve target phosphorus levels, indicating a substantial market gap [7][8] Clinical Study Insights - OLC has shown the potential to reduce pill burden by half, which is a key factor in improving adherence among dialysis patients [6][8] - The upcoming medical meetings will feature abstracts related to the pivotal clinical study, emphasizing the importance of addressing pill burden in treatment [4][6]