Oxylanthanum Carbonate (OLC)

June 30, 2026: Unicycive Therapeutics, Inc. (NASDAQ: UNCY) received an FDA Complete Response Letter (CRL) for the resubmitted NDA for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA did not raise concerns about OLC’s clinical efficacy or safety and did not request additional clinical data.

The CRL cites the same third-party manufacturing deficiencies referenced in the prior CRL (June 2025). Unicycive says the FDA inspection of the third-party manufacturing vendor did not occur during the resubmission review. The company noted it had a Type A meeting with FDA in September 2025 regarding the vendor’s remediation progress and inspection readiness, and states FDA did not raise additional issues at that meeting.

Unicycive also said labeling discussions are ongoing; the latest FDA communication was received June 29, 2026 regarding carton and container labeling. The company plans to work toward a successful vendor inspection and an expedited NDA resubmission.