Drug intelligence / Profile preview

fecal microbiota transplant

Development stage
Unknown
Lead developer
OpenBiome
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
Colonic, Rectal, Nasoenteric, Nasogastric, Oral
01

Overview

OpenBiome was a non-profit public stool bank that provided standardized, screened human fecal microbiota preparations for fecal microbiota transplantation (FMT). [13, 15] These preparations, formulated as oral capsules (e.g., FMP30, G3) and suspensions for rectal administration (via enema or colonoscopy), were designed to treat diseases linked to gut dysbiosis by restoring a healthy microbial community. [0, 2, 4] The primary mechanism involves repopulating the recipient's gut with a diverse microbiota from a healthy donor, which can outcompete pathogens like *Clostridioides difficile*, restore normal metabolic functions such as secondary bile acid production, and modulate the host's immune response. [11, 17] While it was most established as a therapy for recurrent *C. difficile* infection, OpenBiome's products were also investigated in clinical trials for inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), and hepatic encephalopathy. [10, 6, 7, 3] OpenBiome ceased shipping its FMT preparations at the end of 2024 following the U.S. FDA's approval of manufactured live biotherapeutic products for CDI. [10]

Brand names
OpenBiome
Other names
FMTFecal Microbiota Transplantation

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