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fecal microbiota, live-brpk
- Development stage
- Approved
- Lead developer
- Seres Therapeutics
- 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
Fecal microbiota, live-brpk (brand name VOWST; code name SER-109) is the first orally administered live biotherapeutic product approved by the FDA for the prevention of recurrent Clostridioides difficile infection (rCDI) in adults 18 and older, following antibacterial treatment for rCDI. [2, 5, 6, 8] Developed by Seres Therapeutics and now owned and commercialized by Nestlé Health Science, it was approved on April 26, 2023. [2, 3, 6, 9] The drug consists of purified Firmicutes bacterial spores derived from the fecal matter of qualified human donors. [1, 5, 13] Its mechanism of action involves restoring the diversity of the gut microbiota, which creates an environment that resists C. difficile spore germination and growth. [1, 5, 19] The treatment regimen consists of taking 4 capsules once daily for 3 consecutive days. [4, 8]
- Brand names
- VOWSTVOS
- Other names
- microbiota capsulefecal microbiotaencapsulated fecal microbiota transplantationcFMT
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