Drug intelligence / Profile preview

Bifidobacterium infantis Rosell-33

Development stage: Unknown
Lead developer: Lallemand Health Solutions
Modality: Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Administration: Oral

Overview

Bifidobacterium infantis Rosell-33 (also designated R0033) is a live probiotic bacterial strain developed by Lallemand Health Solutions. As a live biotherapeutic product (LBP), it is designed to colonize the infant gastrointestinal tract to restore healthy bifidobacterial populations, support gut mucosal integrity, and modulate immune system development. Clinically, it has been utilized for pediatric indications including the treatment of various forms of diarrhea, reduction of respiratory tract infections, and support of immune maturation and anaemia management in infants. The strain has received GRAS status from the FDA (GRAS notice 758) and is approved for use in infant food in multiple jurisdictions, including China. It is also under clinical investigation for its potential to improve immunity in HIV-exposed but uninfected (iHEU) infants.

Other names: Bifidobacterium longum subsp. infantis Rosell-33

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