Lactobacillus reuteri - BioGaia

Drug Profile

Lactobacillus reuteri - BioGaia

Alternative Names: Apylori Probiotic Capsules; BioGaia ProTectis; IBP 9414; Lactobacillus reuteri ATCC 55730; Lactobacillus reuteri DSM 17938; Lactobacillus reuteri Protectis; NEC therapy - BioGaia

Latest Information Update: 06 Sep 2018

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At a glance

  • Originator BioGaia; Infant Bacterial Therapeutics
  • Developer BioGaia
  • 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 - Acute enterocolitis
  • New Molecular Entity No

Highest Development Phases

  • Marketed Gastrointestinal disorders
  • Phase II Acute enterocolitis; Constipation; Type 2 diabetes mellitus
  • Clinical Phase Unknown Colic

Most Recent Events

  • 26 Jun 2018 BioGaia plans the phase III "The Connection Study" trial for Acute enterocolitis (Prevention, In neonates) in North America and Europe in the second half of 2018
  • 11 Dec 2017 Adverse events data from a phase II trial in Acute enterocolitis released by Infant Bacterial Therapeutics
  • 24 Nov 2017 BioGaia intends to seek marketing approval for Lactobacillus reuteri for Acute enterocolitis in USA and Europe by 2020
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