← Back to feed Unicycive receives CRL for oxylanthanum carbonate Sponsor Unicycive Therapeutics
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Drug oxylanthanum carbonate
Indication Hyperphosphatemia in adults with chronic kidney disease on dialysis More on Unicycive Therapeutics ↗ Google News FDA issued a Complete Response Letter to Unicycive Therapeutics for the resubmitted NDA of oxylanthanum carbonate (OLC) in hyperphosphatemia. FDA cited the same third-party manufacturing deficiencies flagged in the June 2025 CRL and confirmed no clinical efficacy or safety concerns were raised; the agency's inspection of the third-party vendor had not been conducted as part of this review cycle.
Read original at ir.unicycive.com ↗ Background Drug-class context · Wikipedia Oxylanthanum carbonate (OLC) is an investigational oral phosphate binder based on lanthanum carbonate nanoparticle technology, designed to reduce pill burden in dialysis-dependent chronic kidney disease patients who require phosphate control. The current U.S. hyperphosphatemia treatment landscape is dominated by sevelamer (Renvela) and lanthanum carbonate (Fosrenol), both of which require multiple large pills per meal. Unicycive positions OLC on a differentiated pill-count / tolerability profile. The June 30, 2026 CRL is the SECOND consecutive review-cycle CRL — FDA issued the same third-party manufacturing citation in June 2025, triggering the December 2025 Class 2 resubmission that carried a PDUFA target action date of June 29, 2026. Per Unicycive's June 30 disclosure, FDA has not yet inspected the third-party manufacturing site as part of the current review cycle.
Source: Wikipedia · CC BY-SA
Topic hyperphosphatemia
