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Manganese chloride tetrahydrate - Ascelia Pharma

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Drug Profile

Manganese chloride tetrahydrate - Ascelia Pharma

Alternative Names: CMC-001; Mangoral; Orviglance

Latest Information Update: 16 Aug 2023

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At a glance

  • Originator CMC Contrast
  • Developer Ascelia Pharma
  • Class Contrast media; Heavy metals
  • Mechanism of Action Magnetic resonance imaging enhancers
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Liver disorders
  • New Molecular Entity No

Highest Development Phases

  • Phase III Liver disorders

Most Recent Events

  • 09 Aug 2023 Ascelia Pharma plans to discuss with the FDA regarding the significant intra-reader variability observed in image scoring in the phase III SPARKLE trial
  • 21 Jun 2023 Safety and efficacy data from a open-label trial in hepatically impaired participants was presented at the European Association for the Study of the Liver Congress, 2023 (EASL-2023)
  • 27 Feb 2023 Ascelia Pharma completes a phase III SPARKLE trial in Liver disorders (Diagnosis) in the US, Argentina, Colombia, Germany, Italy, Mexico, Poland, Russia, Sweden and Turkey (PO) (NCT04119843)

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