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# Unicycive Therapeutics NDA for Oxylanthanum
- URL: https://www.fdaweb.com/unicycive-therapeutics-nda-for-oxylanthanum/
- Published: 2024-11-11T12:00:00.000Z
- Updated: 2026-09-14T14:46:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158160

FDA has accepted for review an Unicycive Therapeutics 505 (b) (2) NDA for oxylanthanum carbonate (OLC) and its use in treating hyperphosphatemia patients with chronic kidney disease (CKD) on dialysis. The agency has set a 6/28/2025 user fee review action target date.

Unicycive says OLC is designed to address the burdensome treatment regimen that typical CKD patients have to endure, such as taking up to 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,” the company says.

The submission is based on 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), multiple preclinical studies, and chemistry, manufacturing and controls data, according to the company.

Oxylanthanum carbonate is described as a next-generation lanthanum-based phosphate binding agent that utilizes the company’s proprietary nanoparticle technology