FDA Accepts Oxylanthanum Carbonate NDA Resubmission for Hyperphosphatemia in CKD, Dialysis

The US Food and Drug Administration (FDA) has accepted Unicycive Therapeutics’ NDA for oxylanthanum carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.1

As described in a January 29, 2026, release from the Company, the Agency has deemed the OLC resubmission to be a Class II complete response which has a 6-month review period from the date of resubmission and set a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2026.1

“We are pleased that the agency has promptly accepted the resubmission of our NDA for OLC,” Shalabh Gupta, MD, Chief Executive Officer of Unicycive, said in a statement.1 “We are advancing our commercial preparation activities in anticipation of a potential launch of OLC later this year, to help provide an important treatment option to patients with CKD on dialysis who continue to struggle with hyperphosphatemia.”

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.1

In April 2025, Unicycive announced patient-reported outcomes data from its phase 2 study of oxylanthanum carbonate for hyperphosphatemia in patients with CKD on dialysis as well as findings from a survey on top barriers to phosphate binder adherence among patients undergoing dialysis. The data were presented during poster sessions at the National Kidney Foundation (NKF) Spring Clinical Meetings and highlighted patients’ satisfaction with oxylanthanum carbonate compared to their prior phosphate lowering therapy as well as patient perspectives on the barriers phosphate binder pill size and count pose to consistent medication use.2

Later, in June 2025, the FDA issued a Complete Response Letter to Unicycive Therapeutics’ NDA for OLC, citing deficiencies previously identified at a third-party manufacturing vendor unrelated to OLC. Of note, no other concerns were stated, including pre-clinical, clinical, or safety data.3

As part of its overall manufacturing strategy, the Company had previously identified a back-up third-party manufacturing vendor to build redundancy into its supply chain. According to Unicycive, the second vendor has a long history of successful FDA and international regulatory inspections and has already produced OLC drug product, which could also be used to support the resolution of the CMC issues identified in the CRL.3

The resubmission of the NDA is supported by data from 3 clinical studies, including a phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers and a tolerability study of OLC in CKD patients on dialysis, as well as multiple preclinical studies and chemistry, manufacturing and controls (CMC) data.1

A decision on its approval is expected on June 27, 2026, nearly a year after the 2025 CRL.1

References

1. Unicycive Therapeutics. Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission. January 29, 2026. Accessed January 29, 2026. https://www.globenewswire.com/news-release/2026/01/29/3228435/0/en/Unicycive-Therapeutics-Announces-FDA-Acceptance-of-Oxylanthanum-Carbonate-OLC-New-Drug-Application-NDA-Resubmission.html

2. Brooks A. FDA Issues CRL to Oxylanthanum Carbonate for Hyperphosphatemia in CKD, Dialysis. HCPLive. June 30, 2025. Accessed January 29, 2026. https://www.hcplive.com/view/fda-issues-crl-oxylanthanum-carbonate-hyperphosphatemia-ckd-dialysis

3. Brooks A. Oxylanthanum Carbonate May Offer Desirable Alternative to Current Phosphate Binders. HCPLive. April 10, 2025. Accessed January 29, 2026. https://www.hcplive.com/view/oxylanthanum-carbonate-may-offer-desirable-alternative-current-phosphate-binders