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Human fecal microbiota, MBiotix HBI
Human fecal microbiota, MBiotix HBI is a Microbiota therapeutic / Fecal microbiota transplant (FMT) Small molecule drug developed by Medical University of Warsaw. It is currently in Phase 3 development for Recurrent Clostridioides difficile infection, Primary or secondary prevention of C. difficile infection. Also known as: MBiotix HBI.
MBiotix HBI is a human fecal microbiota transplant that restores a healthy gut microbiome composition to treat microbiota-associated diseases.
MBiotix HBI is a human fecal microbiota transplant that restores a healthy gut microbiome composition to treat microbiota-associated diseases. Used for Recurrent Clostridioides difficile infection, Primary or secondary prevention of C. difficile infection.
At a glance
| Generic name | Human fecal microbiota, MBiotix HBI |
|---|---|
| Also known as | MBiotix HBI |
| Sponsor | Medical University of Warsaw |
| Drug class | Microbiota therapeutic / Fecal microbiota transplant (FMT) |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
This biotherapeutic product contains a standardized preparation of human fecal microbiota designed to restore microbial diversity and function in the patient's intestinal tract. By reintroducing beneficial bacteria and restoring eubiotic conditions, it aims to treat conditions associated with dysbiosis, particularly recurrent Clostridioides difficile infection and potentially other gastrointestinal and metabolic disorders.
Approved indications
- Recurrent Clostridioides difficile infection
- Primary or secondary prevention of C. difficile infection
Common side effects
- Gastrointestinal symptoms (abdominal pain, diarrhea, constipation)
- Nausea
- Fever
- Infection or sepsis (rare)
Key clinical trials
- Fecal Microbiota Transplantation in Children With Autism Spectrum Disorder and Gastrointestinal Symptoms (NA)
- The Impact of Fecal Microbiota Transplantation as an Immunomodulation on the Risk Reduction of COVID-19 Disease Progression With Escalating Cytokine Storm and Inflammatory Parameters (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Human fecal microbiota, MBiotix HBI CI brief — competitive landscape report
- Human fecal microbiota, MBiotix HBI updates RSS · CI watch RSS
- Medical University of Warsaw portfolio CI
Frequently asked questions about Human fecal microbiota, MBiotix HBI
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Related
- Drug class: All Microbiota therapeutic / Fecal microbiota transplant (FMT) drugs
- Manufacturer: Medical University of Warsaw — full pipeline
- Therapeutic area: All drugs in Gastroenterology / Infectious Disease
- Indication: Drugs for Recurrent Clostridioides difficile infection
- Indication: Drugs for Primary or secondary prevention of C. difficile infection
- Also known as: MBiotix HBI
- Compare: Human fecal microbiota, MBiotix HBI vs similar drugs
- Pricing: Human fecal microbiota, MBiotix HBI cost, discount & access