Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
FB-401
- Development stage
- Discontinued
- Lead developer
- Forte Biosciences
- Modality
- Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics
- Administration
- Topical
01
Overview
FB-401 is Forte Biosciences' investigational **topical live biotherapeutic** for atopic dermatitis, developed under an exclusive license from the NIH/DHHS covering dermatologic use of gram-negative bacterial consortia. The product has been described as a preparation of **three strains of *Roseomonas mucosa*** intended to modulate cutaneous dysbiosis associated with atopic dermatitis, with the therapeutic concept centered on restoration of a healthier skin microbiome and suppression of pathogenic *Staphylococcus aureus* overgrowth rather than direct receptor pharmacology. FB-401 was studied in adults and children with mild-to-moderate atopic dermatitis, including a randomized placebo-controlled Phase 2 trial using topical administration three times weekly, but the program failed to show superiority to placebo on the primary endpoint and Forte subsequently discontinued its development for atopic dermatitis.
- Other names
- Roseomonas mucosatopical live biotherapeuticlive therapeutic product of 3 strains of Roseomonas mucosa
Beyond the preview
Go deeper on FB-401.
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 FB-401.