The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
JUL 29 2026
UPCOMING · 56 DAYS TO PDUFA

Unicycive Therapeutics oxylanthanum carbonate $UNCY

for hyperphosphatemia in adults with chronic kidney disease on dialysis

NDA · Standard Review

Accepted JAN 29 2026.

About

Hyperphosphatemia is a condition where excess phosphate builds up in the blood, often causing calcium imbalances that may lead to muscle spasms or soft tissue calcification. Oxylanthanum carbonate is an oral medication that binds to dietary phosphate in the digestive tract, preventing its absorption into the bloodstream. By trapping phosphate before it enters circulation, the drug could help maintain healthier mineral balance for people on dialysis who struggle with this complication.

Pivotal trial

NCT06218290 Phase 2 completed NCT06218290

The goal of this clinical study is to test the tolerability of oxylanthanum carbonate (OLC) in patients with chronic kidney disease on hemodialysis and have hyperphosphatemia (too much phosphorus in their blood). The main question it aims to answer is whether patients taking OLC for hyperphosphatemia are able to tolerate the drug

Source: ClinicalTrials.gov