Calmangafodipir - PledPharma

Drug Profile

Calmangafodipir - PledPharma

Alternative Names: Aladote; PledOx; PP-095; PP-100-01; SP-04 - Solasia Pharma

Latest Information Update: 29 Oct 2018

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At a glance

  • Originator PledPharma
  • Developer PledPharma; Solasia Pharma
  • Class Acetates; Chemoprotectants; Ethylenediamines; Hepatoprotectants; Pyridines; Small molecules
  • Mechanism of Action Antioxidants; Iron chelating agents
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Chemotherapy-induced damage
  • Phase I/II Liver failure

Most Recent Events

  • 23 Oct 2018 The European Medicines Agency approves waiver application for the paediatric investigation plan for calmangafodipir (PledOx®)
  • 22 Aug 2018 PledPharma completes enrolment in its phase I/II trial for Liver failure (Adjunctive treatment, In Adolescents, In Adults, Prevention) in United Kingdom (IV) (NCT03177395)
  • 29 Jun 2018 PledPharma plans a phase II trial for Liver failure (Adjunctive treatment, Prevention) (IV) (PledPharma website, June 2018)
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