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July 1, 2026

US FDA rejects approval of Unicycive’s kidney disease therapy

The US Food and Drug Administration (FDA) has declined to approve Unicycive Therapeutics’ resubmitted new drug application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.

US FDA rejects approval of Unicycive’s kidney disease therapy