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Lactobacillus reuteri - BioGaia/Infant Bacterial Therapeutics

Drug Profile

Lactobacillus reuteri - BioGaia/Infant Bacterial Therapeutics

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: 22 Aug 2019

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At a glance

  • Originator BioGaia; Infant Bacterial Therapeutics
  • 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 III Acute enterocolitis
  • Phase II Constipation; Type 2 diabetes mellitus

Most Recent Events

  • 04 Jul 2019 Phase-III clinical trials in Acute enterocolitis (In neonates, Prevention) in USA (PO), after July 2019 (NCT03978000)
  • 04 Jul 2019 Phase-III clinical trials in Acute enterocolitis (Prevention, In neonates) in France, Hungary and Spain (PO) (EudraCT2018-000754-22)
  • 01 Jul 2019 US FDA approves IND application for Lactobacillus reuteri in Acute enterocolitis, before July 2019
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