Last reviewed · How we verify
MBK-01 — Competitive Intelligence Brief
phase 3
Live biotherapeutic product
Immunology / Gastroenterology
Biologic
Live · refreshed every 30 min
Target snapshot
MBK-01 (MBK-01) — Mikrobiomik Healthcare Company S.L.. MBK-01 is a microbiome-based therapeutic that modulates the composition and function of the gut microbiota to restore immune homeostasis and reduce inflammation.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| MBK-01 TARGET | MBK-01 | Mikrobiomik Healthcare Company S.L. | phase 3 | Live biotherapeutic product | ||
| Lactobacillus casei variety rhamnosus granules | Lactobacillus casei variety rhamnosus granules | Seoul National University Hospital | marketed | Probiotic / Live biotherapeutic product | ||
| lactobacillus LB | lactobacillus LB | Hospital General de Mexico | marketed | Live biotherapeutic product / Probiotic | ||
| Lactobacillus Crispatus M247 | Lactobacillus Crispatus M247 | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | marketed | Live biotherapeutic product | ||
| E. coli Nissle suspension | E. coli Nissle suspension | University of Hohenheim | marketed | Live biotherapeutic product (probiotic) | ||
| INF108F probiotic | INF108F probiotic | Massachusetts General Hospital | marketed | Live biotherapeutic product (probiotic) | ||
| EcN-Suspension | EcN-Suspension | Ardeypharm GmbH | phase 3 | Live biotherapeutic product |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Live biotherapeutic product class)
- Ardeypharm GmbH · 1 drug in this class
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS · 1 drug in this class
- Infant Bacterial Therapeutics · 1 drug in this class
- Mikrobiomik Healthcare Company S.L. · 1 drug in this class
- OxThera · 1 drug in this class
- Rebiotix Inc. · 1 drug in this class
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- MBK-01 CI watch — RSS
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- Whole Live biotherapeutic product class — RSS
Cite this brief
Drug Landscape (2026). MBK-01 — Competitive Intelligence Brief. https://druglandscape.com/ci/mbk-01. Accessed 2026-05-13.
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