Unicycive Therapeutics, Inc. Overview
Pro stress-test →Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Its lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. The company is approaching a critical regulatory milestone with an expected FDA decision on (June 29, 2026).
Strategic Profile
Pro stress-test →The company is optimistic about potential approval of OLC and focused on preparations for the subsequent launch of OLC, with an FDA PDUFA target action date of June 29, 2026. Unicycive's second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. As of March 30, 2026, cash, cash equivalents, and marketable securities totaled $54.9 million, with sufficient resources to fund planned operations into 2027.
Competitive Landscape
Pro stress-test →Unicycive competes in the phosphate binder market for dialysis patients. Key competitors include established nephrology companies such as Fresenius, DaVita, and manufacturers of existing phosphate binders (sevelamer, lanthanum carbonate). OLC's differentiation centers on improved adherence and pill burden reduction versus current standard-of-care agents. The market is characterized by stable demand but moderate competition from entrenched players and generic alternatives.
Industry Context
Unicycive Therapeutics, Inc. operates in Nephrology therapeutics and kidney disease treatments.
Key facts
Founded: 2011 · Headquarters: Los Altos, US · Employees: N/A · Revenue: $0M · Market cap: N/A