Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
MTC01 (Icahn School of Medicine at Mount Sinai)
- Development stage
- Unknown
- Lead developer
- Icahn School of Medicine
- 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
- Rectal
01
Overview
**MTC01** is an investigational, defined live biotherapeutic product composed of 15 obligate anaerobic bacterial strains isolated from a single healthy fecal microbiota transplant donor. It is being developed by Icahn School of Medicine at Mount Sinai as a standardized, in-vitro-manufactured alternative to donor-derived fecal microbiota transplantation for recurrent *Clostridioides difficile* infection. The product is intended to restore protective gut microbial functions through durable strain engraftment and microbiome ecological replacement. In a randomized phase 1b study, an endoscopically delivered MTC01 dose prevented recurrent infection at 8 weeks in 7 of 9 treated participants, with no treatment-related adverse events reported. ([preview-www.nature.com](https://preview-www.nature.com/articles/s41591-026-04442-2.pdf))
- Other names
- Microbiome Translational Center drug 01MTC 01MTC01MTC-01
Beyond the preview
Go deeper on MTC01 (Icahn School of Medicine at Mount Sinai).
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Indications & development
Full profile accessExplore development by indication, patient population, and geography.
- Indications
- Development status
- Countries
Licensing & deals
Full profile accessTrace asset ownership, licensing agreements, and commercial partnerships.
- Partners
- Deal terms
- Milestones
Patents & exclusivity
Full profile accessExplore the patent landscape and regulatory exclusivity around an asset.
- Patents
- Expiration dates
- Exclusivity
Competitive landscape
Full profile accessCompare development programs by target, modality, and indication.
- Competing assets
- Targets
- Development stage
Research & analysis
Full profile accessConnect source evidence and development news to your research questions.
- Publications
- News
- Analysis
Bring the full picture into focus.
See how Gosset can support your research on MTC01 (Icahn School of Medicine at Mount Sinai).