Unicycive Resubmits NDA for Oxylanthanum Carbonate to FDA

Reuters2025-12-29

Unicycive Resubmits NDA for Oxylanthanum Carbonate to FDA

Unicycive Therapeutics Inc. has resubmitted its New Drug Application (NDA) for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis, to the U.S. Food and Drug Administration (FDA). The resubmission follows significant progress by Unicycive's third-party manufacturing vendor in addressing FDA-cited deficiencies and demonstrating inspection readiness. The FDA previously identified a single deficiency related to the manufacturing vendor's compliance status. No additional issues were raised during a recent Type A meeting with the FDA. The company expects a new Prescription Drug User Fee Act (PDUFA) date in the first half of 2026, with review expected to be completed within six months of NDA acceptance.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Unicycive Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9616401-en) on December 29, 2025, and is solely responsible for the information contained therein.

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