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A bioequivalence clinical study of Renazorb compared to Fosrenol to enable comparison of phosphate binding effectiveness of Renazorb against this approved drug in healthy volunteers

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Trial Profile

A bioequivalence clinical study of Renazorb compared to Fosrenol to enable comparison of phosphate binding effectiveness of Renazorb against this approved drug in healthy volunteers

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 01 Jul 2025

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At a glance

  • Drugs Lanthanum carbonate (Primary)
  • Indications Hyperphosphataemia
  • Focus Registrational; Therapeutic Use

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.
  • 02 Feb 2022 According to an Unicycive Therapeutics media release, data from this trial will be presented at the National Kidney Foundation (NKF) Spring Clinical Meeting
  • 08 Dec 2021 New trial record

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