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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: 21 Nov 2025

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At a glance

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

Most Recent Events

  • 28 Oct 2025 According to Unicycive Therapeutics media release, following receipt of a Complete Response Letter (CRL) on June 30, 2025, company announced an update from its meeting with the US FDA that company plans to resubmit the NDA or OLC bye year end and which may extend the PDUFA date to first half of 2026.
  • 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

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