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MBK-01 — Competitive Intelligence Brief

MBK-01 (MBK-01) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Live biotherapeutic product. Area: Immunology / Gastroenterology.

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)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / 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)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Live biotherapeutic product class)

  1. Ardeypharm GmbH · 1 drug in this class
  2. Fondazione Policlinico Universitario Agostino Gemelli IRCCS · 1 drug in this class
  3. Infant Bacterial Therapeutics · 1 drug in this class
  4. Mikrobiomik Healthcare Company S.L. · 1 drug in this class
  5. OxThera · 1 drug in this class
  6. Rebiotix Inc. · 1 drug in this class

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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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