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Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate New Drug Application Resubmission and PDUFA Date of March 25, 2027

UNCY
  • Unicycive Therapeutics announced the FDA accepted its resubmitted New Drug Application for oxylanthum carbonate (OLC) on October 21, 2026.
  • The resubmission includes Chemistry, Manufacturing, & Controls data from a new third-party drug product manufacturing vendor.
  • The FDA designated the resubmission as Class II with a six-month review period & set a PDUFA target action date of March 25, 2027.
  • The original New Drug Application received a Complete Response Letter in June 2026 citing deficiencies at the previous manufacturing vendor.
  • The new vendor's facility received a "No Action Indicated" status following an FDA inspection in March 2024.
  • Unicycive does not know if the FDA will conduct a pre-approval inspection of the new vendor & plans to seek a shorter timeline if the original vendor is found compliant with cGMP.
  • The NDA is supported by data from three clinical studies, multiple preclinical studies, & CMC data without FDA concerns regarding safety.
  • OLC is an investigational oral phosphate binder utilizing nanoparticle technology to reduce pill burden for CKD patients on dialysis.
  • The company seeks approval via the 505(b)(2) pathway with patent exclusivity until 2031 & potential extension until 2035.
  • Unicycive's second candidate, UNI-494, has received orphan drug designation for preventing Delayed Graft Function in kidney transplant patients.