www.fdanews.com/articles/210728-unicycives-ckd-drug-renazorb-demonstrates-bioequivalence-to-fosrenol
Unicycive’s CKD Drug Renazorb Demonstrates Bioequivalence to Fosrenol
January 6, 2023
Unicycive Therapeutics’ investigational phosphate-reducing drug Renazorb has demonstrated bioequivalence to Shire’s Fosrenol (lanthanum carbonate) in a study of healthy volunteers.
The phosphate-binding drug candidate uses proprietary nanoparticle technology to reduce phosphate levels in dialysis patients.
Despite the availability of FDA-cleared medications, 75 percent of dialysis patients fail to meet recommended phosphorus levels, the company said.
Unicycive plans on filing a new drug application for Renazorb in mid-2023.