
Company Overview - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney diseases [5] - The company's lead investigational treatment is oxylanthanum carbonate, aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis [5] - The second investigational drug, UNI-494, is intended for treating conditions related to acute kidney injury and has received orphan drug designation from the FDA for preventing Delayed Graft Function in kidney transplant patients [5] Intellectual Property - The U.S. Patent and Trademark Office has issued U.S. Patent 12,377,082 for UNI-494, ensuring intellectual property protection until 2040 [1] - This patent complements an earlier method of use patent for UNI-494 in treating Acute Kidney Injury [1] - The patent portfolio for UNI-494 supports potential partnership opportunities and future development efforts [2] Product Development - UNI-494 is a novel nicotinamide ester derivative that acts as a selective ATP-sensitive mitochondrial potassium channel activator, addressing mitochondrial dysfunction in kidney diseases [3] - The drug has completed a Phase 1 dose-ranging safety study in healthy volunteers [3] - The company is currently focused on seeking FDA approval for its lead product, oxylanthanum carbonate [2] Acute Kidney Injury Context - Acute kidney injury (AKI) is characterized by a sudden loss of kidney function, with primary causes including sepsis, ischemia, and drug-induced nephrotoxicity [4] - AKI affects 20-200 per million in the community, 7-18% of hospitalized patients, and approximately 50% of ICU patients [4] - An estimated 2 million people die from AKI globally each year, with survivors at increased risk for chronic kidney disease and end-stage renal disease [4]