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Lyophilised Oxalobacter formigenes - OxThera AB

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Drug Profile

Lyophilised Oxalobacter formigenes - OxThera AB

Alternative Names: IxOC 3; Lyophylised Oxalobacter formigenes; OC 3; OC5; Oxabact; Oxabact OC5 - Oxalobacter formigenes HC-1; Oxalobacter

Latest Information Update: 22 Feb 2023

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

Highest Development Phases

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

Most Recent Events

  • 22 Feb 2023 Phase III clinical development is still ongoing in Primary hyperoxaluria (In children, In adolescents, In adults, In the elderly) in United Kingdom, USA, Belgium, Tunisia and France (PO) (OxThera AB pipeline, February 2023)
  • 03 Sep 2021 OxThera terminates a phase III ePHex-OLE extension study in Primary hyperoxaluria (In adolescents, In children, In the elderly, In adults) in Belgium, Germany, Spain and United Kingdom as the parent trial OC5-DB-02 did not achieve primary endpoint (PO) (NCT03938272)
  • 11 Jun 2021 Efficacy and adverse events data from a phase III OC5-DB-02 trial in Primary hyperoxaluria released by OxThera

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