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A randomized, double-blind, placebo-controlled, multicenter phase III clinical study on the efficacy and safety of tenapanor in the treatment of hyperphosphatemia in patients with end-stage renal disease-hemodialysis (ESRD-HD)

Trial Profile

A randomized, double-blind, placebo-controlled, multicenter phase III clinical study on the efficacy and safety of tenapanor in the treatment of hyperphosphatemia in patients with end-stage renal disease-hemodialysis (ESRD-HD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Mar 2025

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At a glance

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

Most Recent Events

  • 26 Feb 2025 According to a Fosun Pharma media release,the company announced that it has received approval from the National Medical Products Administration (NMPA) for the New Drug Application (NDA) for Tenapanor Hydrochloride Tablets.
  • 29 Feb 2024 New trial record
  • 12 Jul 2023 According to a Fosun Pharma USA media release, based on results form this study the company has submitted the New Drug Application (NDA) for Tenapanor Hydrochloride Tablets (the New Drug) for the control of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on hemodialysis which was accepted for review by the National Medical Products Administration (NMPA).

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