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MBK-01
MBK-01 is a microbiome-based therapeutic that modulates the composition and function of the gut microbiota to restore immune homeostasis and reduce inflammation.
MBK-01 is a microbiome-based therapeutic that modulates the composition and function of the gut microbiota to restore immune homeostasis and reduce inflammation. Used for Inflammatory bowel disease or related gastrointestinal inflammatory conditions (specific indication not publicly confirmed).
At a glance
| Generic name | MBK-01 |
|---|---|
| Also known as | Fecal microbiota transfer, Fecal Microbiota Transplantation, Intestinal Microbiota Transplantation |
| Sponsor | Mikrobiomik Healthcare Company S.L. |
| Drug class | Live biotherapeutic product |
| Modality | Biologic |
| Therapeutic area | Immunology / Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
As a live biotherapeutic product, MBK-01 likely contains selected bacterial strains designed to restore dysbiotic microbiota composition. By rebalancing the microbial ecosystem, it aims to enhance barrier function, reduce pathogenic bacterial overgrowth, and promote anti-inflammatory immune responses through microbial metabolite production and immune cell education.
Approved indications
- Inflammatory bowel disease or related gastrointestinal inflammatory conditions (specific indication not publicly confirmed)
Common side effects
- Gastrointestinal symptoms (abdominal discomfort, diarrhea, constipation)
- Nausea
- Fever or systemic inflammatory response
Key clinical trials
- Clinical Trial With MBK-01, Intestinal Microbiota Capsules, for the Treatment of Patients With Recurrent Diverticulitis (PHASE2)
- Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin (PHASE3)
- Evaluate the Efficacy, Safety and Tolerability of Fecal Microbiota Transfer for the Treatment of Patients With Nonalcoholic Steatohepatitis (PHASE2)
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:
- MBK-01 CI brief — competitive landscape report
- MBK-01 updates RSS · CI watch RSS
- Mikrobiomik Healthcare Company S.L. portfolio CI