Unicycive Therapeutics is awaiting FDA approval for OLC to treat hyperphosphatemia in CKD patients.

From GlobeNewswire: 2025-03-31 07:00:00

Unicycive Therapeutics, Inc. announced that the FDA is reviewing the New Drug Application for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in CKD patients on dialysis, with a target action date of June 28, 2025. They are preparing for a potential commercial launch of OLC in late 2025.

With a focus on kidney disease therapies, Unicycive aims to address the unmet needs of CKD patients on dialysis. OLC, if approved, could offer a new option for patients with hyperphosphatemia, a condition that affects 75% of CKD patients on dialysis in the U.S. Unicycive is actively preparing for the commercial launch of OLC, emphasizing its high potency and low pill burden.

Key milestones for Unicycive include the NDA acceptance by the FDA for OLC, with a PDUFA target action date of June 28, 2025. Additionally, the company’s partner in South Korea submitted an NDA for OLC and expects a decision by June 2026. Unicycive is focused on building a robust commercial infrastructure and raising awareness about OLC through various publications and presentations.

Financially, Unicycive reported a decrease in licensing revenues and an increase in research and development expenses for the year ended December 31, 2024. The company’s net loss attributable to common stockholders was $37.8 million for the same period, with cash and cash equivalents totaling $26.1 million as of December 31, 2024.

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Their lead drug candidate, OLC, is a phosphate binding agent designed for hyperphosphatemia in CKD patients on dialysis. With positive trial results, Unicycive is awaiting FDA approval, targeting a launch in late 2025. They also have a second asset, UNI-494, in clinical development for acute kidney injury.



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