Unicycive Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025.
Addressing Hyperphosphatemia in CKD Patients
Hyperphosphatemia is a common and serious condition affecting nearly all patients with end-stage renal disease (ESRD). If untreated, it can lead to secondary hyperparathyroidism (SHPT), renal osteodystrophy, and cardiovascular disease, significantly increasing mortality risk for dialysis patients. Current treatments often involve dietary restrictions and multiple daily doses of phosphate-binding drugs, creating a substantial pill burden for patients.
Oxylanthanum Carbonate (OLC): A Potential New Treatment Option
Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent developed using proprietary nanoparticle technology. Unicycive is seeking approval via the 505(b)(2) regulatory pathway. The NDA submission is supported by data from three clinical studies, including a Phase 1 study in healthy volunteers, a bioequivalence study, and a tolerability study in CKD patients on dialysis, along with preclinical and CMC data. OLC is protected by a strong global patent portfolio, including composition of matter patents with exclusivity until 2031, potentially extendable to 2035.
Clinical and Commercial Implications
Shalabh Gupta, MD, Chief Executive Officer of Unicycive, stated that OLC could offer meaningful patient adherence benefits over existing treatments by reducing the number and size of pills required per dose, and by offering pills that are swallowed rather than chewed. Nephrologists have identified lower pill burden and improved patient compliance as significant unmet needs in hyperphosphatemia treatment. The global market for hyperphosphatemia treatments is projected to exceed $2.5 billion, with the U.S. accounting for over $1 billion. Despite available medications, a significant percentage (75%) of U.S. dialysis patients do not achieve target phosphorus levels.
Unicycive is preparing to commercialize and launch OLC in the second half of 2025, pending FDA approval. The FDA also granted a waiver for the NDA application PDUFA fees, saving Unicycive approximately $4 million.
