Unicycive Resubmits NDA for Oxylanthanum Carbonate

MOUNTAIN VIEW, Calif., Sept. 29, 2026 /CourierPR/ -- Unicycive Therapeutics, Inc. has resubmitted its New Drug Application (NDA) for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The resubmission includes CMC data from a new third-party drug product manufacturing vendor, which was last inspected by the FDA in March 2024 and received a “No Action Indicated” status, the highest FDA inspection classification indicating that the facility is in an acceptable state of current Good Manufacturing Practices (cGMP) compliance.

The NDA resubmission package includes 12 months of OLC drug product stability data from the new manufacturing vendor. Unicycive anticipates the FDA will accept the NDA within 30 days of resubmission, with a new assigned PDUFA (Premarket Approval Application) date expected to be six months from the resubmission date. As of June 30, 2026, the company's unaudited cash, cash equivalents, and marketable securities totaled $61.4 million, providing a runway into the second half of 2027.

Unicycive received a Complete Response Letter (CRL) from the FDA in June 2026, citing the same third-party manufacturing deficiencies identified in a previous CRL issued in June 2025. The FDA did not raise concerns regarding clinical efficacy or safety data and did not request additional data from the company. The original third-party manufacturing vendor has received written notification from the FDA that its facility inspection has been assigned, but the inspection has not yet occurred as of September 29, 2026. If the original vendor is inspected in the near term and deemed cGMP-compliant, the company plans to seek FDA alignment on a shorter approval timeline for the OLC NDA resubmission.

OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with CKD on dialysis. It is protected by a strong global patent portfolio, including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually, there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels. Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

Unicycive's lead investigational treatment, OLC, is being developed via the 505(b)(2) regulatory pathway. 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.