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Lyophilised Oxalobacter formigenes - OxThera AB

Drug Profile

Lyophilised Oxalobacter formigenes - OxThera AB

Alternative Names: IxOC 3; Lyophylised Oxalobacter formigenes; OC 3; OC5; Oxabact; Oxalobacter

Latest Information Update: 15 Nov 2019

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At a glance

  • Originator Ixion Biotechnology
  • Developer OxThera
  • Class Bacteria; Probiotics
  • Mechanism of Action Bacteria replacements
  • Orphan Drug Status

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

    Yes - Short bowel syndrome; Primary hyperoxaluria
  • New Molecular Entity No

Highest Development Phases

  • Phase III Primary hyperoxaluria
  • No development reported Short bowel syndrome

Most Recent Events

  • 07 Nov 2019 Efficacy and adverse events data from a phase II trial in Primary hyperoxaluria released by OxThera
  • 23 Aug 2019 The European Medicines Agency approves Paediatric Investigation Plan for Primary hyperoxaluria
  • 23 Aug 2019 The Paediatric Committee of EMA recommends approval of Paediatric Investigational Plan (PIP) for Oxalobacter formigenes for Primary hyperoxaluria in European Union
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