Unicycive Therapeutics, Inc.

Unicycive is a clinical-stage biotechnology company founded in 2016, focused on identifying, developing, and commercializing innovative therapies for significant unmet medical needs, initially concentrating on kidney disease. The company aims to create an efficient drug development platform to accelerate therapies from discovery to commercialization. Unicycive's current business model involves licensing technologies and drugs for development, regulatory approval, and commercialization in global markets. The initial focus is on developing and approving drugs in the U.S., followed by partnering with global biopharmaceutical companies for other regions. Currently, Unicycive has two development programs focused on kidney disease. The first is oxylanthanum carbonate, a next-generation phosphate binder for treating hyperphosphatemia in chronic kidney disease patients undergoing dialysis. This therapy was initially developed by Spectrum Pharmaceuticals and licensed to Unicycive in 2018, following a Phase 1 clinical trial conducted by Spectrum in 2012. The second program is UNI-494, a novel drug candidate for treating acute kidney injury. UNI-494 was licensed from Sphaera Pharma, which conceived and performed initial characterization of potential pro-drug linkers. Unicycive completed IND-enabling preclinical studies and a Phase I clinical study in healthy volunteers with UNI-494 in 2024. As the company grows, it intends to identify medical conditions both within and outside of kidney disease.