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A Double Blind, Dose-Ranging, Phase 1 Study In Healthy Volunteers to Assess Safety and the Phosphate Binding Capacity of Lanthanum Dioxycarbonate (SPI-014, Renazorb)

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Trial Profile

A Double Blind, Dose-Ranging, Phase 1 Study In Healthy Volunteers to Assess Safety and the Phosphate Binding Capacity of Lanthanum Dioxycarbonate (SPI-014, Renazorb)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Jul 2025

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At a glance

  • Drugs Lanthanum carbonate (Primary)
  • Indications Hyperphosphataemia
  • Focus Therapeutic Use
  • Sponsors Spectrum Pharmaceuticals

Most Recent Events

  • 10 Jun 2025 According to a Unicycive Therapeutics media release, The FDA communicated to the Company that it had identified deficiencies in cGMP compliance at a third-party manufacturing vendor after an FDA inspection, any label discussions between the FDA and the Company are precluded. The Company has responded to all FDA information requests and expects a final decision from the FDA by the PDUFA action date of June 28, 2025.
  • 07 May 2025 According to Unicycive Therapeutics media release, the company is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission is based on data from three clinical studies including a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis, multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data.
  • 07 Jan 2025 According to Unicycive Therapeutics media release, data from this study was published in the peer-reviewed journal, Clinical and Translational Science.

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