Unicycive Therapeutics, Inc. (Nasdaq: UNCY) has 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.
If approved, OLC, a next-generation lanthanum-based phosphate binding agent, could significantly alleviate the treatment burden for patients. Unicycive is preparing for a commercial launch in the second half of 2025, contingent upon FDA approval.
Addressing Treatment Burden in CKD Patients
Shalabh Gupta, MD, Chief Executive Officer of Unicycive, stated, “CKD patients on dialysis with hyperphosphatemia 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 pursuing FDA approval for OLC via the 505(b)(2) regulatory pathway. The NDA submission is supported by data from three clinical studies: a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis. Additional preclinical studies and chemistry, manufacturing, and controls (CMC) data are also included. 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.
Clinical Trial Data
Data from a Phase 1 dose escalation study, published in Clinical and Translational Science, demonstrated that OLC was well-tolerated at escalating doses (500 mg, 1,000 mg, 1,500 mg, or 2,000 mg administered three times a day). The study, which included 32 healthy participants, showed dose-dependent decreases in urinary phosphorus excretion from baseline during treatment, indicating reduced phosphate absorption. There were no serious adverse events, severe or life-threatening adverse events, deaths, or adverse events leading to discontinuation.
A bioequivalence study published in Clinical Therapeutics established pharmacodynamic bioequivalence of OLC to lanthanum carbonate (Fosrenol®). The study randomized 80 participants, with 75 receiving all doses, and found that OLC was well-tolerated and demonstrated bioequivalence to lanthanum carbonate. The least squares mean (LSM) change in urinary phosphate excretion from baseline to the evaluation period was similar for both OLC (-320.4 mg/day [90% CI: -349.7, -291.0]) and lanthanum carbonate (-324.0 mg/day [90% CI: -353.3, -294.7]), with a between-group LSM difference of 3.6 [90% CI: -37.8, 45.1] mg/day.
Market Opportunity and Unmet Needs
The global market opportunity for treating hyperphosphatemia is expected to exceed $2.28 billion, with North America accounting for over $1 billion. Despite the availability of several FDA-cleared medications, 75% of U.S. dialysis patients fail to achieve target phosphorus levels recommended by medical guidelines. A 2022 survey of nephrologists indicated that the greatest unmet need in hyperphosphatemia treatment is a lower pill burden and better patient compliance.
About Hyperphosphatemia
Hyperphosphatemia is a serious condition prevalent in nearly all patients with End Stage Renal Disease (ESRD). Untreated hyperphosphatemia can lead to secondary hyperparathyroidism (SHPT), renal osteodystrophy, cardiovascular disease, and increased mortality in CKD patients on dialysis. Approximately 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.
