Unicycive: FDA to Review Lead Drug Candidate for Hyperphosphatemia

Dow Jones11-11

By Colin Kellaher

Unicycive Therapeutics said the Food and Drug Administration accepted its application seeking approval of its lead drug candidate as a treatment for an electrolyte disorder related to kidney disease.

Unicycive, which is seeking an FDA green light for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis, Monday said the agency set a target action date of June 28, 2025 for the application.

The Los Altos, Calif., clinical-stage biotechnology company said oxylanthanum carbonate, if approved, would lower the pill burden in terms of the number and size per dose for patients with hyperphosphatemia, a condition involving too much phosphate in the blood that occurs in nearly all patients with end-stage renal disease.

Unicycive said it was preparing to commercialize and launch the drug in the second half of 2025.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

November 11, 2024 07:31 ET (12:31 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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