Recombinant lipase - Mayoly-Spindler/AzurRx BioPharma

Drug Profile

Recombinant lipase - Mayoly-Spindler/AzurRx BioPharma

Alternative Names: MS-1819; MS1819-SD

Latest Information Update: 05 Jul 2018

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At a glance

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

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

  • New Molecular Entity No

Highest Development Phases

  • Phase II Exocrine pancreatic insufficiency; Pancreatitis

Most Recent Events

  • 29 Jun 2018 AzurRx BioPharma completes a phase IIa trial of recombinant lipase (MS 1819 SD) in exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis in Australia, New Zealand and France (NCT03481803)
  • 29 Jun 2018 AzurRx BioPharma plans a phase II trial for Exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis in the second half of 2018
  • 08 May 2018 AzurRx BioPharma intends to file an IND application with the US FDA for Exocrine pancreatic insufficiency in the later half of 2018
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