Unicycive Therapeutics announced that the U.S. Food and Drug Administration has formally accepted the company’s resubmitted New Drug Application for oxylanthanum carbonate, an oral phosphate binder intended for patients with chronic kidney disease on dialysis.
FDA sets six-month review clock
The agency classified the filing as a Class II submission, triggering a six-month review period that culminates in a PDUFA target action date of March 25, 2027. The acceptance follows a Complete Response Letter issued in June 2026 that required additional Chemistry, Manufacturing and Controls data.
“We are pleased that the FDA has accepted the resubmission of our NDA for OLC and assigned a PDUFA date,” said Shalabh Gupta, M.D., chief executive officer of Unicycive.
The new vendor’s facility underwent an FDA inspection in March 2024 and received a “No Action Indicated” rating, indicating compliance with current Good Manufacturing Practice at that time. The company hopes the updated manufacturing information will satisfy the agency’s earlier concerns.
Regulators have not yet indicated whether they will conduct a pre-approval inspection of the new supplier. Unicycive also noted that if the original manufacturing site is inspected and found compliant, the company would seek alignment on a shorter approval timeline.
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The resubmission addresses deficiencies noted in the second Complete Response Letter, which cited issues at the original third-party manufacturer that the FDA could not re-inspect during the prior review cycle. The timing of any future inspection remains at the agency’s discretion.
The NDA is supported by data from three clinical studies: a Phase 1 trial in healthy volunteers, a bioequivalence study in the same population, and a tolerability study involving chronic kidney disease patients on dialysis.
In the original filing, the FDA did not raise concerns about the preclinical or clinical safety data for oxylanthanum carbonate, suggesting that the primary obstacles were manufacturing-related.
For patients, the key benefit of OLC could be a reduced pill burden. The nanoparticle technology delivers high phosphate-binding potency, potentially allowing fewer tablets per day compared with existing binders, which may improve adherence and quality of life.
Oxylanthanum carbonate is being pursued under the 505(b)(2) pathway, which permits reliance on existing data for certain aspects of the application. The product is protected by a global patent portfolio that includes composition-of-matter claims with exclusivity through 2031 and the possibility of extension to 2035.
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Hyperphosphatemia affects nearly all patients with end-stage renal disease, and more than 450,000 U.S. individuals require medication each year to control phosphate levels. Uncontrolled elevations are linked to higher mortality and increased hospitalizations among dialysis patients.
Pipeline expansion and regulatory context
Company officials highlighted that the development program also includes a second investigational product, designated UNI-494, aimed at conditions linked to acute kidney injury.
UNI-494 has been granted orphan drug designation by the FDA for the prevention of delayed graft function in kidney transplant patients, and a Phase 1 dose-ranging safety study in healthy volunteers has been completed.
OLC is Unicycive’s lead investigational treatment, while the company continues to develop additional kidney-related therapies.