Recombinant lipase - Mayoly-Spindler/AzurRx BioPharma

Drug Profile

Recombinant lipase - Mayoly-Spindler/AzurRx BioPharma

Alternative Names: MS-1819; MS1819-SD

Latest Information Update: 22 Oct 2018

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At a glance

  • Originator Mayoly-Spindler
  • Developer AzurRx BioPharma; Mayoly-Spindler
  • Class Anti-inflammatories; Carboxylic ester hydrolases; Pancreatic enzymes; Recombinant proteins
  • Mechanism of Action Lipase replacements; Triglyceride modulators
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase II Exocrine pancreatic insufficiency; Pancreatitis

Most Recent Events

  • 16 Oct 2018 The US FDA approves an IND application in Exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF)
  • 16 Oct 2018 AzurRx BioPharma plans a phase IIb trial for Exocrine pancreatic insufficiency in USA and Europe in the fourth quarter of 2018
  • 24 Sep 2018 Interim efficacy and adverse events data from a phase IIa trial in Exocrine pancreatic insufficiency released by AzurRx BioPharma and Mayoly Spindler
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