Drug intelligence / Profile preview

bifidobacterium longum subsp. infantis m-63

Development stage
Phase 4
Lead developer
Morinaga Milk Industry
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
01

Overview

Bifidobacterium longum subsp. infantis M-63 is a probiotic strain of human-residential bifidobacteria (HRB) developed by the Japanese dairy manufacturer Morinaga Milk Industry Co., Ltd. [1, 2] The active ingredient is the live bacterial strain itself, which is classified as a biologic. [4] This strain is particularly noted for its unique and superior capacity to utilize human milk oligosaccharides (HMOs), the complex sugars abundant in breast milk, allowing it to effectively colonize the infant gut. [2, 4] By promoting a Bifidobacterium-predominant gut microbiota, M-63 supports infant gut health, enhances immune function by increasing fecal IgA, and improves gastrointestinal well-being. [13, 19] It has achieved Generally Recognized as Safe (GRAS) status from the US FDA for use in infant formula and foods (2022) and has been approved as a New Food Ingredient in China for infant and toddler foods (2024). [1, 4] While primarily used for infant health, it has also been clinically studied as part of multi-strain formulations for conditions such as allergic rhinitis and irritable bowel syndrome. [3, 7]

Other names
B. infantis M-63Bifidobacterium infantis M-63

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