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Reloxaliase - Allena Pharmaceuticals

Drug Profile

Reloxaliase - Allena Pharmaceuticals

Alternative Names: ALLN 177; Oxalate decarboxylase - Allena Pharmaceuticals

Latest Information Update: 18 Nov 2019

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At a glance

  • Originator Allena Pharmaceuticals
  • Class Enzymes; Recombinant proteins
  • Mechanism of Action Oxalate decarboxylase replacements; Oxalate inhibitors
  • Orphan Drug Status

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

    Yes - Primary hyperoxaluria; Hyperoxaluria
  • New Molecular Entity No

Highest Development Phases

  • Phase III Hyperoxaluria
  • Phase II Primary hyperoxaluria

Most Recent Events

  • 04 Dec 2019 Allena Pharmaceuticals announces its intention to discuss the registrational path, including expedited options with the US FDA for reloxaliase for Hyperoxaluria with chronic kidney disease in the first quarter of 2020
  • 07 Nov 2019 Positive top-line efficacy and adverse events data from the phase III URIROX-1 trial in Hyperoxaluria and additional efficacy data from the phase II Study 206 in Primary hyperoxaluria or Hyperoxaluria released by Allena Pharmaceuticals
  • 05 Jun 2019 Interim adverse events and efficacy data from a phase II basket trial in Hyperoxaluria and primary Hperoxaluria released by Allena Pharmaceuticals (NCT03391804)
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