LOS ALTOS, Calif. — January 29, 2026 — Leads & Copy — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company focused on kidney disease therapies, announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC). OLC is the company’s investigational oral phosphate binder for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.
The FDA has designated the OLC resubmission as a Class II complete response, entailing a six-month review period from the resubmission date. A Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026, has been set.
According to Shalabh Gupta, M.D., Chief Executive Officer of Unicycive, the company is pleased with the FDA’s prompt acceptance of the NDA resubmission for OLC. He added that Unicycive is advancing commercial preparation activities in anticipation of a potential launch of OLC later this year, to provide a treatment option to patients with CKD on dialysis who continue to struggle with hyperphosphatemia.
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. It also includes multiple preclinical studies and chemistry, manufacturing and controls (CMC) data. The FDA did not express any concerns regarding OLC’s preclinical, clinical, or safety data included in the original NDA submission.
The Company ended 2025 with an unaudited position of $41.3 million in cash, cash equivalents, and short-term investments, which permits continued advancement of OLC commercial launch activities and a cash runway into 2027.
OLC is an investigational oral phosphate binder using proprietary nanoparticle technology. This technology is designed to deliver high phosphate binding potency, potentially reducing the number and size of pills patients need to take to treat hyperphosphatemia in CKD patients on dialysis. Its potential best-in-class profile may offer patient adherence benefits over current treatment options by requiring a lower pill burden.
Unicycive is pursuing FDA approval of OLC via the 505(b)(2) regulatory pathway. OLC is protected by a 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 affecting nearly all patients with End Stage Renal Disease (ESRD). Over 450,000 individuals in the U.S. require medication to manage their phosphate levels annually. Uncontrolled hyperphosphatemia is linked to increased death and hospitalization for CKD patients on dialysis. Treatment aims to lower serum phosphate levels by restricting dietary phosphorus intake and using daily oral phosphate binding drugs with each meal to facilitate fecal elimination of dietary phosphate.
Unicycive Therapeutics is focused on developing treatments for kidney diseases. Its lead treatment, OLC, is a phosphate binding agent for hyperphosphatemia in CKD patients on dialysis. Unicycive’s second treatment, UNI-494, is intended for conditions related to acute kidney injury and has been granted orphan drug designation (ODD) by the FDA for preventing Delayed Graft Function (DGF) in kidney transplant patients. UNI-494 has completed a Phase 1 dose-ranging safety study in healthy volunteers.
Source: Unicycive Therapeutics, Inc.
