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JUN 29 2026
CRL

Unicycive Therapeutics — oxylanthanum carbonate $UNCY

for hyperphosphatemia in adults with chronic kidney disease on dialysis

NDA · Standard Review

About

Hyperphosphatemia is a condition where phosphate builds up in the blood, usually because damaged kidneys can no longer filter it out; many people feel no symptoms, but others develop calcium deposits in soft tissue, and low blood calcium can cause muscle spasms. Oxylanthanum carbonate is an oral phosphate binder: it travels through the gut, binds phosphate from food, and carries it out in the stool instead of letting it reach the bloodstream. Because dialysis removes phosphate only between meals, this drug may help keep levels lower and could reduce the calcium deposits and spasms that come with the disorder.

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

PDUFA history

  • → JUN 29 2026 shifted to JUN 30 2026 (CRL issued 2026-06-30, one day after PDUFA target. Same third-party manufacturing deficiencies as the June 2025 CRL; FDA raised no clinical efficacy or safety concerns and requested no additional data. FDA had not yet inspected the third-party manufacturing vendor as part of this review cycle.; announced JUN 30 2026)