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A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients With Known or Suspected Focal Liver Lesions and Severe Renal Impairment

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Trial Profile

A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients With Known or Suspected Focal Liver Lesions and Severe Renal Impairment

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Mar 2025

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At a glance

  • Drugs CMC 001 (Primary) ; Alanine; Colecalciferol; Manganese chloride
  • Indications Liver disorders; Renal impairment
  • Focus Diagnostic use; Registrational
  • Acronyms SPARKLE
  • Sponsors Ascelia Pharma

Most Recent Events

  • 18 Mar 2025 According to an Ascelia Pharma media release, today announced that the company has received final minutes from the meeting with the FDA, providing positive guidance for the Orviglance NDA to progress with the submission mid-2025 as planned to obtain regulatory approval.
  • 09 Feb 2024 According to an Ascelia Pharma media release, company starts image reading phase and re-confirms Phase 3 SPARKLE results by May 2024.
  • 18 Aug 2023 According to an Ascelia Pharma media release, the company reported the need for a re-evaluation of the collected images from this study. Clarification that the images were not read and scored properly. Preparations for the re-evaluation are already underway, and we will communicate the timeline and financial implications for this mid-September.

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