FDA Accepts Unicycive's NDA for Oxylanthanum Carbonate to Treat Hyperphosphatemia in CKD Patients on Dialysis
Key Insights
The FDA has accepted Unicycive Therapeutics' NDA for Oxylanthanum Carbonate (OLC) with a PDUFA target action date of June 28, 2025.
OLC aims to reduce the high pill burden for hyperphosphatemia (search) patients with chronic kidney disease (search) (CKD) on dialysis.
Unicycive is seeking approval via the 505(b)(2) regulatory pathway, supported by data from three clinical studies and preclinical data.
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 (search) in patients with chronic kidney disease (search) (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 (search) is a serious condition affecting nearly all patients with End Stage Renal Disease (ESRD). Untreated, it can lead to secondary hyperparathyroidism (SHPT), renal osteodystrophy, and cardiovascular disease, significantly increasing mortality risk for dialysis patients. Current treatments often involve multiple pills daily, creating a substantial burden for patients.
Oxylanthanum Carbonate: A Potential Solution
Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent that utilizes proprietary nanoparticle technology. Unicycive is developing OLC to reduce the pill burden associated with existing treatments. According to a 2022 survey of nephrologists, a lower pill burden and better patient compliance are the greatest unmet needs in hyperphosphatemia (search) treatment with phosphate binders.
Shalabh Gupta, MD, Chief Executive Officer of Unicycive, stated, "CKD patients on dialysis with hyperphosphatemia (search) are often saddled with an onerous treatment regimen that includes having to take as many as 12 pills per day. OLC may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of the number and size of pills per dose, and the pills are swallowed instead of chewed for added convenience."
Regulatory Pathway and Clinical Data
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package includes data from a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study in CKD patients on dialysis, as well as multiple preclinical studies and chemistry, manufacturing, and controls (CMC) data. OLC is protected by a strong global patent portfolio, including issued patents on composition of matter with exclusivity until 2031, and potential for patent term extension until 2035.
Market Opportunity
The global market for treating hyperphosphatemia (search) is expected to exceed $2.5 billion, with the United States accounting for over $1 billion. Despite available medications, 75% of U.S. dialysis patients fail to achieve target phosphorus levels, highlighting the need for improved treatment options.