The company's lead investigational therapy, oxylanthanum carbonate (OLC), is an oral phosphate binder designed to manage hyperphosphatemia in patients with chronic kidney disease (CKD) undergoing dialysis. OLC utilizes proprietary nanoparticle technology to enhance phosphate binding potency, aiming to reduce pill burden and improve patient adherence. 

In June 2025, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Unicycive's New Drug Application (NDA) for OLC. The CRL cited deficiencies at a third-party manufacturing vendor unrelated to OLC itself, with no concerns regarding the drug's preclinical, clinical, or safety data. Unicycive has identified an alternative manufacturing vendor with a history of successful regulatory inspections and plans to request a Type A meeting with the FDA to discuss next steps. 

Beyond OLC, Unicycive is developing UNI-494, a novel compound intended for the treatment of conditions related to acute kidney injury. UNI-494 has received orphan drug designation from the FDA for the prevention of delayed graft function in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. 

As of June 2025, Unicycive reported an unaudited cash balance of approximately $20.7 million, with a projected cash runway extending into the second half of 2026.