Unicycive Therapeutics Receives FDA Acceptance Of Its NDA Resubmission For Oxylanthanum Carbonate For Treatment Of Hyperphosphatemia In Patients With Chronic Kidney Disease On Dialysis

Unicycive Therapeutics has announced that the FDA has accepted its resubmission of the New Drug Application (NDA) for oxylanthanum carbonate (OLC), an oral phosphate binder for treating hyperphosphatemia in chronic kidney disease patients on dialysis. The NDA was resubmitted after a Complete Response Letter in June 2026, and the FDA has assigned a six-month review period with a target action date of March 25, 2027. The resubmission includes data from a new third-party manufacturing vendor, which received a 'No Action Indicated' status from the FDA during its last inspection in March 2024.