JUN 29 2026
Unicycive Therapeutics — oxylanthanum carbonate $UNCY
for hyperphosphatemia in adults with chronic kidney disease on dialysis
About
Hyperphosphatemia is a condition where too much phosphate builds up in the blood, which can lead to harmful calcium deposits in soft tissues and muscle spasms. Oxylanthanum carbonate is an oral medicine that binds to phosphate in the digestive tract. By trapping dietary phosphate before it enters the bloodstream, this drug may help lower phosphate levels in patients on dialysis.
Pivotal trial
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
Drug Watch — recent news on oxylanthanum carbonate
- Oxylanthanum Carbonate Second CRL Deepens Delay for Patients With Chronic Kidney Disease - The American Journal of Managed Care
- Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA) - Yahoo Finance
- Manufacturing Deficiencies Behind FDA's Oxylanthanum Carbonate Rejection - PharmTech.com
- FDA Accepts Oxylanthanum Carbonate NDA Resubmission for Hyperphosphatemia in CKD, Dialysis - HCPLive
- UPDATE - Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission - Yahoo Finance
Sponsor Watch — recent news on Unicycive Therapeutics
- Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)
- Unicycive Therapeutics Announces First Quarter 2026 Financial Results and Provides Business Update
- Unicycive Therapeutics Announces Full Year 2025 Financial Results and Provides Business Update
- UPDATE - Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission
- Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission
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)