Oxylanthanum Carbonate (OLC)

May 12, 2026: Unicycive Therapeutics, Inc. (NASDAQ: UNCY) reported Q1 2026 results and reiterated that the FDA review of its resubmitted NDA for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis, remains on track with a PDUFA target action date of June 29, 2026. The company said FDA accepted the NDA resubmission in January 2026; the December 2025 resubmission reflected progress by a third-party drug-product manufacturing vendor. Unicycive stated the NDA is supported by three clinical studies (Phase 1, bioequivalence, and tolerability in CKD on dialysis), plus preclinical and CMC data, and that FDA did not raise concerns about preclinical, clinical, or safety data in the original submission.

Unicycive is continuing commercial readiness activities for a potential OLC launch later in 2026, including access/reimbursement support via its UniSource reimbursement hub.

Program update: UNI-494 (acute kidney injury-related conditions) has FDA orphan drug designation for prevention of delayed graft function in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers.