Unicycive resubmits NDA for oxylanthanum carbonate after June 2026 CRL

Unicycive Therapeutics announced on September 29, 2026 that it has resubmitted its New Drug Application for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis. The resubmission was announced from Mountain View, California, for the treatment of hyperphosphatemia in CKD patients on dialysis.¹

Unicycive expects the FDA to accept the NDA within 30 days and to assign a new PDUFA date six months from the resubmission date.¹ The filing incorporates chemistry, manufacturing and controls data from a new third-party drug product manufacturing vendor.¹ That vendor's facility was last inspected by the FDA in March 2024 and received a "No Action Indicated" classification, the agency's top rating for cGMP compliance.¹ The new vendor's CMC package uses specifications similar to the original vendor's and has already manufactured OLC drug product with completed 12-month stability data.¹ The company also said it supplied added in-vitro data comparing the two vendors, following earlier FDA input on the matter.

The move follows a Complete Response Letter Unicycive received in June 2026, which cited the same third-party manufacturing deficiencies flagged in an earlier CRL from June 2025, tied to the FDA not having reinspected the original vendor.¹ The agency raised no concerns about clinical efficacy or safety data and did not request additional data.¹ As of September 29, 2026, the original vendor's facility inspection has been assigned by the FDA but has not yet taken place.¹ Unicycive said it intends to retain both manufacturing vendors to preserve supply chain redundancy.¹

The NDA is supported by a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study in CKD patients on dialysis, in addition to preclinical and CMC data.¹ As of June 30, 2026, the company reported $61.4 million in unaudited cash, cash equivalents and marketable securities, with a runway extending into the second half of 2027.¹

Separately, the filing noted that on September 28, 2026, Unicycive appointed Meredith S. Manning as an independent director effective October 1, 2026, where she will serve on the Audit, Compensation, and Nominating and Corporate Governance Committees and chair the latter.¹