Unicycive Therapeutics announces issuance of patent for UNI-494 to treat CKD.

Unicycive Therapeutics announced the issuance of a US patent for UNI-494, a treatment for Chronic Kidney Disease (CKD). This patent follows an earlier method of use patent for treating Acute Kidney Injury with the same drug. The company is focused on seeking FDA approval for its lead product, oxylanthanum carbonate, but sees the patent as part of a broader intellectual property portfolio for UNI-494 that could support potential partnerships and future development.

Unicycive Therapeutics (Nasdaq: UNCY) has secured a new U.S. patent (12,377,082) for UNI-494, extending intellectual property protection until 2040 for treating Chronic Kidney Disease (CKD). This patent complements an existing patent for UNI-494's use in treating Acute Kidney Injury (AKI). The company, focused on seeking FDA approval for its lead product oxylanthanum carbonate, sees the patent as part of a broader intellectual property portfolio for UNI-494 that could support potential partnerships and future development [1].

UNI-494, a novel nicotinamide ester derivative and selective ATP-sensitive mitochondrial potassium channel activator, has a novel mechanism of action that restores mitochondrial function. This mechanism may be beneficial for the treatment of several diseases, including kidney disease. The drug has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers [2].

The patent issuance for UNI-494 to treat CKD follows the issuance of an earlier method of use patent for treating AKI with the same drug. This demonstrates Unicycive's commitment to developing innovative treatments for kidney diseases, which are significant global health challenges. Acute kidney injury (AKI) is defined as a sudden loss of kidney function, often associated with sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. It is estimated to occur in 20-200 per million population in the community, with 7-18% of patients in the hospital and approximately 50% of patients admitted to the intensive care unit. Importantly, AKI is associated with morbidity and mortality, with an estimated 2 million people dying of AKI worldwide every year [3].

The patent issuance for UNI-494 to treat CKD further strengthens Unicycive's intellectual property portfolio and enhances its position in the market. The company's strategic focus on kidney diseases aligns with the growing need for effective treatments in this area. While the company remains focused on seeking FDA approval for its lead product, the new patent for UNI-494 opens up potential partnership opportunities and future development efforts [1].

References:
[1] https://www.stocktitan.net/news/UNCY/unicycive-therapeutics-granted-new-u-s-patent-for-uni-494-to-treat-ic0kyaqi6zmf.html
[2] https://uk.finance.yahoo.com/news/unicycive-therapeutics-granted-u-patent-110500549.html
[3] https://www.globenewswire.com/news-release/2025/08/18/3134912/0/en/Unicycive-Therapeutics-Granted-New-U-S-Patent-for-UNI-494-to-Treat-Chronic-Kidney-Disease.html