Recombinant lipase - Mayoly-Spindler/AzurRx BioPharma

Drug Profile

Recombinant lipase - Mayoly-Spindler/AzurRx BioPharma

Alternative Names: MS-1819; MS1819-SD

Latest Information Update: 14 Feb 2018

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At a glance

  • Originator Mayoly-Spindler
  • Developer AzurRx BioPharma; Mayoly-Spindler
  • Class Carboxylic ester hydrolases
  • 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.

  • New Molecular Entity No

Highest Development Phases

  • Phase II Exocrine pancreatic insufficiency; Pancreatitis

Most Recent Events

  • 18 Jan 2018 Phase-II clinical trials in Exocrine pancreatic insufficiency in France (PO)
  • 18 Jan 2018 The Agence Nationale de Sécurité du Médicament et des Produits de Santé approves IND application for a phase IIa trial for Exocrine pancreatic insufficiency in France
  • 20 Oct 2017 AzurRx BioPharma submits Investigational Medicinal Product Dossier to European Medicines Agency for Exocrine pancreatic insufficiency
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