Oxylanthanum Carbonate (OLC)-Probable approval date June 28, 2025.

Unicycive Therapeutics announced that the U.S. FDA has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), which is used to treat hyperphosphatemia in patients with chronic kidney disease on dialysis.

The US FDA is reviewing the NDA with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. This indicates that the FDA is evaluating the application, and a decision on whether to approve OLC is anticipated around that time.


Unicycive Therapeutics claims in their press release that OLC is protected by a strong global patent portfolio, which includes an issued patent on the composition of matter that provides exclusivity until 2031 and the potential for a patent term extension until 2035 following OLC approval. 


Oxylanthanum carbonate is undergoing FDA approval through the 505(b)(2) regulatory pathway. This pathway allows the manufacturer to reference data from a previously approved drug, Fosrenol (lanthanum carbonate), for certain aspects of the application, such as safety and efficacy. 


However, oxylanthanum carbonate must still prove its own safety, efficacy, and pharmacodynamic equivalence to Fosrenol.



Oxylanthanum carbonate and lanthanum carbonate are both phosphate binders used to treat hyperphosphatemia. However, oxylanthanum carbonate utilises a novel nanoparticle technology to deliver lanthanum, the active ingredient. This leads to a smaller tablet size and reduced drug volume than lanthanum carbonate, making it easier to swallow.


Unicycive reported a net loss of $36.7 million for 2024. OLC approval appears to be crucial for the company. Based on projections of a five to seven percent share in the U.S. phosphate-binder market, analysts expect steady-state annual revenue near USD 125 million from OLC.




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