Unicycive Therapeutics Resubmits NDA for Oxylanthanum Carbonate Phosphate Binder to FDA

Biotechnology company Unicycive Therapeutics, Inc. (UNCY) announced Tuesday the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), an investigational oral phosphate binder intended to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.

The company expects the U.S. Food and Drug Administration (FDA) to accept the NDA within 30 days, with a new Prescription Drug User Fee Act (PDUFA) target action date set for six months from the resubmission date.

The resubmission includes chemistry, manufacturing, and controls (CMC) data from a new third‑party drug product manufacturing vendor. That vendor’s facility was last inspected by the FDA in March 2024 and received a “No Action Indicated” classification, the highest inspection rating indicating acceptable current Good Manufacturing Practice (cGMP) compliance.

The new vendor’s CMC package contains technical specifications comparable to those of the original manufacturer, and the vendor has already produced OLC drug product and completed 12‑month stability studies.

Additionally, Unicycive has provided further in‑vitro bridging data between the two vendors, as recommended by the FDA during prior discussions.

In June 2026, the company received a Complete Response Letter (CRL) concerning its first OLC NDA resubmission. That CRL cited the same third‑party manufacturing deficiencies identified in an earlier CRL issued in June 2025 for the initial NDA submission.

The NDA is supported by data from three clinical studies—a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis—along with multiple preclinical studies and CMC data.

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