FDA has accepted Unicycive’s NDA resubmission for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in dialysis CKD patients.
Written By: Pharmacally Medical News Desk
Unicycive Therapeutics has received a key regulatory milestone for its investigational kidney disease therapy, oxylanthanum carbonate (OLC). The company announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for OLC, an oral phosphate binder intended to treat hyperphosphatemia in chronic kidney disease (CKD) patients undergoing dialysis.
The FDA classified the resubmission as a Class II complete response, which carries a six-month review timeline. The Agency has also assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026.
Shalabh Gupta, M.D., Chief Executive Officer of Unicycive, said the company is encouraged by the FDA’s prompt acceptance and is moving forward with commercial preparation activities. Unicycive expects that, if approved, OLC could potentially launch later in 2026, offering a new treatment option for dialysis patients who continue to face challenges in controlling phosphate levels.
The NDA submission is supported by data from three clinical studies, including a Phase 1 trial in healthy volunteers, a bioequivalence study, and a tolerability study in CKD patients on dialysis. In addition, the application includes multiple preclinical studies and comprehensive chemistry, manufacturing, and controls (CMC) information. Importantly, the FDA did not raise concerns regarding the preclinical, clinical, or safety data included in the original submission.
Oxylanthanum carbonate is designed using proprietary nanoparticle technology to provide strong phosphate binding potency while reducing pill burden. This could represent an important adherence advantage, as many dialysis patients currently require multiple large pills daily to manage hyperphosphatemia.
Unicycive is pursuing approval under the FDA’s 505(b)(2) regulatory pathway. The company noted that OLC is backed by a strong global patent portfolio, with composition of matter protection through 2031 and the possibility of extension until 2035.
Hyperphosphatemia remains a widespread and serious condition among patients with end-stage renal disease (ESRD), affecting nearly all individuals on dialysis. In the United States alone, more than 450,000 patients require medications to control elevated phosphate levels. Poorly managed hyperphosphatemia has been linked to higher rates of hospitalization and mortality, making effective phosphate control a critical component of dialysis care.
Unicycive ended 2025 with approximately $41.3 million in cash, cash equivalents, and short-term investments, providing the company with financial runway into 2027 as it continues to advance OLC toward a potential commercial launch.
References
UPDATE – Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission, 29 January 2026, https://ir.unicycive.com/news/detail/118/update—unicycive-therapeutics-announces-fda-acceptance-of
Unicycive Resubmits NDA for Oxylanthanum Carbonate for Hyperphosphatemia Management in Dialysis Patients, Pharmacally, 30 December 2026, https://pharmacally.com/unicycive-resubmits-nda-for-oxylanthanum-carbonate-for-hyperphosphatemia-management-in-dialysis-patients/