Microbiome Disease Pipeline Insight 2025: 180+ Pipeline Drugs, Live Biotherapeutics, and Microbiota-Based Therapeutics Driving Innovation | DelveInsight

DelveInsight's "Microbiome Disease - Pipeline Insight, 2025" covers over 180+ therapies in development targeting microbiome-associated diseases across diverse therapeutic areas, including gastrointestinal, metabolic, dermatological, neurological, and immunological disorders. As scientific understanding of host-microbiome interactions deepens, the field is witnessing accelerated clinical translation of microbiota-modulating interventions.

The pipeline encompasses a diverse range of modalities, including live biotherapeutic products (LBPs), fecal microbiota transplants (FMT), engineered bacterial consortia, small molecules, and prebiotic/probiotic combinations. Key therapeutic targets include gut dysbiosis, inflammatory pathways, and microbial metabolite signaling that play a role in conditions such as inflammatory bowel disease (IBD), Clostridioides difficile infection (CDI), metabolic syndrome, and neurodegenerative disorders.

Immuno-modulation through the microbiome is also a central theme, with companies investigating microbiota-derived therapies for autoimmune diseases, oncology, and even mental health disorders. Several late-stage programs in CDI and ulcerative colitis are progressing toward regulatory milestones, while earlier-stage efforts are expanding into obesity, autism spectrum disorders, and rare metabolic diseases.

With a diverse range of approaches, from engineered next-generation probiotics to rationally designed consortia and microbial metabolite mimetics, the microbiome therapeutic space is rapidly evolving. These advances are expected to unlock novel treatment paradigms, reshape standards of care, and broaden therapeutic options for patients with conditions previously lacking effective interventions.

Interested in learning more about the current treatment landscape and the key drivers shaping the microbiome disease pipeline? Click here: https://www.delveinsight.com/report-store/microbiome-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Microbiome Disease Pipeline Report
• DelveInsight's Microbiome Disease Pipeline analysis depicts a robust space with 140+ active players working to develop 180+ pipeline drugs for Microbiome Disease treatment.
• The leading Microbiome Disease companies include MaaT Pharma, Qu Biologics, Biomica Ltd., Seres Therapeutics, Micro Viable Therapeutics, Metagen Therapeutics, Inc., Microbiotica, Enterome, Azitra, Vedanta Biosciences, Inc., and others are evaluating their lead assets to improve the Microbiome Disease treatment landscape.
• Key Microbiome Disease pipeline therapies in various stages of development include MaaT 013, QBKPN, BMC128, SER-155, MVT-201, and others.
• In January 2025, Immuron Limited announced the submission of a Clinical Study Report to the FDA for Phase 2 trials of Travelan®, aimed at mitigating travelers' diarrhea. The study showed significant immunological and microbiome responses, suggesting benefits in reducing and clearing pathological ETEC bacteria and improving gut health.
• In June 2024, Nestlé Health Science agreed to acquire Seres' VOWST commercialization rights - a notable commercial milestone for oral microbiome therapeutics.
• In April 2023, the FDA approved VOWSTTM (SER-109) from Seres and Nestlé to treat recurrent CDI, following the ECOSPOR trials. It is the first FDA-approved oral fecal microbiota product, containing bacterial spores purified from screened human donor feces.

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Microbiome Disease Overview
Microbiome-related diseases arise from imbalances or disruptions in the human microbiome-the diverse community of microorganisms living in and on the body, especially in the gut. A healthy microbiome plays a crucial role in digestion, immune regulation, and protecting against harmful pathogens. When this balance is disturbed (a condition called dysbiosis), it can contribute to a wide range of diseases, including inflammatory bowel disease (IBD), obesity, diabetes, allergies, neurological disorders, and even some cancers. Research into the microbiome is expanding rapidly, with growing interest in therapies like probiotics, prebiotics, fecal microbiota transplantation (FMT), and microbiome-targeted drugs to restore microbial balance and improve health outcomes.

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Microbiome Disease Treatment Analysis: Drug Profile
MaaT013: MaaT Pharma
MaaT013 is a high-richness, high-diversity Microbiome Ecosystem TherapyTM designed to restore the balance between the gut microbiome and the immune system. It contains ButycoreTM, a consortium of bacterial genera known for producing immuno-regulatory metabolites that help modulate immune function and enhance tolerance. The therapy aims to reduce steroid-resistant, gastrointestinal-predominant acute Graft-versus-Host Disease (aGvHD) by improving immune responsiveness. MaaT013 has received Orphan Drug Designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). It is intended for acute hospital use as an off-the-shelf, multi-donor-derived therapy. The drug is currently in Phase III clinical development for the treatment of Graft-versus-Host Disease (GvHD).

QBKPN: Qu Biologics
QBKPN SSI is a first-in-class immune modulator developed to enhance the lungs' innate immunity and barrier function. The therapy is being evaluated in clinical trials for its potential to restore immune balance, prevent severe respiratory infections (including COVID-19 and its variants), and reduce all-cause mortality. Designed to strengthen the body's first line of defense against infections and immune-related diseases such as cancer, QBKPN SSI is positioned as a novel treatment approach for immunodeficiency disorders. The drug is currently in Phase II clinical development.

BMC128: Biomica Ltd.
BMC128 is a rationally-designed microbial consortium developed using PRISM, a proprietary high-resolution microbiome analysis platform powered by Evogene's MicroBoost AI technology. As a Live Bacterial Product (LBP), BMC128 consists of four unique bacterial strains, naturally found in the human gut, with the ability to enhance immune responses and support anti-tumor activity through multiple biological mechanisms. Rationally-designed consortia like BMC128 aim to restore microbial diversity and functionality using individually selected, cultured bacteria. Currently, the drug is in Phase I clinical development for the treatment of colorectal cancer.

Learn more about the novel and emerging Microbiome Disease pipeline therapies @ https://www.delveinsight.com/report-store/microbiome-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Microbiome Disease Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intravenous
• Subcutaneous
• Oral
• Intramuscular

By Molecule Type
• Monoclonal antibody
• Small molecule
• Peptide

Scope of the Microbiome Disease Pipeline Report
• Coverage: Global
• Key Microbiome Disease Companies: MaaT Pharma, Qu Biologics, Biomica Ltd., Seres Therapeutics, Micro Viable Therapeutics, Metagen Therapeutics, Inc, Microbiotica, Enterome, Azitra, Vedanta Biosciences, Inc., and others.
• Key Microbiome Disease Pipeline Therapies: MaaT 013, QBKPN, BMC128, SER-155, MVT-201, and others.

Dive deep into rich insights for drugs used for Microbiome Disease treatment; visit @ https://www.delveinsight.com/report-store/microbiome-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Microbiome Disease Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Microbiome Disease Pipeline Therapeutics
6. Microbiome Disease Pipeline: Late-Stage Products (Phase III)
7. Microbiome Disease Pipeline: Late-Stage Products (Phase III)
8. Microbiome Disease Pipeline: Mid-Stage Products (Phase II)
9. Microbiome Disease Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
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Healthcare Consulting
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About DelveInsight
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This release was published on openPR.