Leading Human Microbiome Companies

Published: November 2025

The term microbiome refers to the specific clusters of commensals, symbiotic and pathogenic microorganisms that reside in various sites on and within the human body. This ecological community of microorganisms, including their metagenomes (collection of their genes / genomes, proteins and metabolites) and surrounding environment, is collectively referred to as the microbiome.

The human microbiome is involved in various functions that are essential to lead a healthy life. Majority of microorganisms benefit humans by supplementing them with traits that they would otherwise not possess. These include metabolism of complex carbohydrates, renewal of gut epithelial cells and prevention of growth of pathogens.

However, it is important to mention that several microorganisms are associated with pathogenic characteristics or have the capability of translating into a disease-causing microbe. Some noteworthy examples of pathogenic microorganisms include bacterial species of the genera Staphylococcus, Streptococcus, Enterococcus, Klebsiella, Enterobacter and Neisseria.

Roots Analysis has conducted an exhaustive study on Human Microbiome Market featuring the current market landscape and future opportunity for the companies engaged in human microbiome therapeutics, over a span of next 10 years.

Leading Human Microbiome Companies

AOBiome Therapeutics
Exeliom Biosciences
Notitia Biotechnologies
Rise Therapeutics
Osel

The figure below highlights the leading human microbiome companies:

leading-players-to-watch-human-microbiome-market

Interested in exploring all ~55 human microbiome drug developers, along with their 215 therapeutics and recent initiatives?

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Discover Below the Details on Leading Human Microbiome Companies

Let us dive deep into the details of the leading human microbiome companies. It is essential to note that the selection of top players can differ substantially according to the defined criteria.

1. AOBiome Therapeutics

Company Overview

AOBiome Therapeutics is a clinical-stage biotechnology company focused on developing microbiome-based therapeutics for inflammatory skin conditions. The company harnesses a proprietary strain of Ammonia Oxidizing Bacteria (AOB) to restore immune functionality and modulate inflammatory responses, targeting diseases like atopic dermatitis, acne, and rosacea. It is worth highlighting, B244, the company’s leading product candidate, delivers beneficial metabolites that support skin health by reducing inflammation and enhancing the skin barrier. The company is advancing multiple clinical trials globally and holds key patents protecting its innovative microbiome platform.

List of Human Microbiome Therapeutics, with Phase of Development and Target Indications

B244
- Phase II / III for Acne Vulgaris (Dermatological Disorders)
- Phase II for Atopic Dermatitis (Dermatological Disorders)
- Phase II for Migraine (Neurological Disorders)
- Phase II for Rosacea (Dermatological Disorders)
- Phase II for Hypertension (Cardiovascular Disorders)
- Phase I / II for Allergic Rhinitis (Inflammatory Disorders)

Recent Developments

In May 2025, AOBiome Therapeutics revealed new mechanistic insights through metabolomic analysis of B244, identifying numerous skin-beneficial metabolites including ceramides, retinoids, tocopherol, and niacinamide, which have the potential to improve atopic dermatitis and other inflammatory skin diseases.

To know more about the recent initiatives of AOBiome Therapeutics and other human microbiome companies, access full report.

2. Exeliom Biosciences

Company Overview

Exeliom Biosciences is a biopharmaceutical company founded in 2016 and headquartered in France, integrates cutting-edge microbiome science with drug development to address significant unmet medical needs. Further, the company specializes in microbiome-based immunotherapies aimed at treating diseases, such as inflammatory bowel diseases, cancer, and infectious diseases. In addition to this, the company is advancing multiple clinical trials in Crohn’s disease, immuno-oncology, and recurrent Clostridium difficile infection. It is worth noting that its lead candidate, EXL01, is an oral biotherapeutic based on a single strain of Faecalibacterium prausnitzii, which modulates immune responses to enhance treatment efficacy.

List of Human Microbiome Therapeutics, with Phase of Development and Target Indications

EXL01
- Phase II / III for Clostridium difficile Infection (Infectious Diseases)
- Phase II for Crohn’s Disease (Inflammatory Disorders)
- Phase II for Hepatocellular Carcinoma (Oncological Disorders)
- Phase II for Renal Cell Cancer (Oncological Disorders)
- Phase II for Gastric Cancer (Oncological Disorders)
- Phase I / II for Non-Small Cell Lung Cancer (Oncological Disorders)

Recent Developments

In April 2025, Exeliom Biosciences successfully enrolled its first patient in the MAINTAIN POP clinical trial, a study assessing the safety and efficacy of EXL01, a live biotherapeutic drug based on Faecalibacterium prausnitzii.

To know more about the recent initiatives of Exeliom Biosciences and other human microbiome companies, access full report.

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3. Notitia Biotechnologies

Company Overview

Notitia Biotechnologies is a next-generation microbiome company focused on unlocking the gut microbiome’s data to develop innovative products and therapies for both patients and the general public. The company’s proprietary Foundation Guild™ platform targets key beneficial bacterial groups critical for maintaining a healthy gut ecosystem. Notitia aims to maximize healthspan by protecting and restoring the Foundation Guild™, supporting immune function, metabolic health, and resistance to disease. Their pipeline includes botanical drugs and live biotherapeutics, with clinical programs addressing conditions such as COVID-19, multiple sclerosis, and metabolic disorders.

List of Human Microbiome Therapeutics, with Phase of Development and Target Indications
The section provides information on the different drugs being developed by Notitia Biotechnologies, along with details on the phase of development and target indication.

NM108 / NBT-NM108
- Phase II for Colon Cancer (Oncological Disorders)
- Phase II for COVID-19 (Infectious Diseases)
- Phase II for Prader-Willi Syndrome (Metabolic Disorders)
- Phase I / II for Multiple Sclerosis (Autoimmune Disorders)
- Phase I for Parkinson's Disease (Neurological Disorders)
- Phase I for Early/End-stage Diabetic Kidney Disease (Rena Disorders)
BM306
- Phase I for Multiple Sclerosis (Autoimmune Disorders)

Recent Developments

In October 2024, Notitia Biotechnologies announced the publication of a pivotal study in Cell, identifying a Core Microbiome Signature, composed of two key bacterial groups - the Foundation Guild and Pathobiont Guild that serve as crucial indicators of gut health.

To know more about the recent initiatives of Notitia Biotechnologies and other human microbiome companies, access full report.

4. Rise Therapeutics

Company Overview

Rise Therapeutics is a biotechnology company focuses on transforming treatment paradigms by harnessing the interplay between microbiota and immunity. The company focuses on developing innovative, microbiome-based immunotherapies for autoimmune diseases, inflammatory disorders, and cancer. Rise Therapeutics is advancing multiple product candidates through early clinical development, leveraging synthetic biology to enhance immune regulation and improve patient outcomes. It is worth highlighting that the firm has a proprietary oral delivery platform, TriPartite X (TPX), to create targeted biologics that modulate immune responses via the gut microbiome.

List of Human Microbiome Therapeutics, with Phase of Development and Target Indications
The section provides information on the different drugs being developed by Rise Therapeutics, along with details on the phase of development and target indication.

R-2487
- Phase I for Rheumatoid Arthritis (Autoimmune Disorders)
- Phase I for Sjogren's Syndrome (Autoimmune Disorders)
R-3750
- Phase I for Ulcerative Colitis (Gastrointestinal Disorders)
- Phase I for Chronic Obstructive Pulmonary Disease (Respiratory Disorders)
- Preclinical for Crohn's Disease (Inflammatory Disorders)
R-5780
- Phase I for Solid Tumors (Oncological Disorders)
- Phase I for Type 1 Diabetes (Autoimmune Disorders)

Recent Developments

In January 2025, Rise Therapeutics announced the completion of dose escalation study for R-2487 and R-3750 clinical trials.

To know more about the recent initiatives of Rise Therapeutics and other human microbiome companies, access full report.

5. Osel

Company Overview

Osel is a pioneering biotechnology company dedicated to developing live biotherapeutic products (LBPs) that restore health by modulating the human microbiome. It is worth noting that Osel was among the first companies authorized by the FDA to test live bacterial therapeutics, focusing primarily on women’s health, including recurrent urinary tract infections and bacterial vaginosis. The company employs a proprietary approach to identify and leverage beneficial microbes to treat microbiome disruptions, with a product pipeline demonstrating promising clinical potential. Osel continues advancing clinical trials targeting both gynecological and gastrointestinal microbiome-related conditions.

List of Human Microbiome Therapeutics, with Phase of Development and Target Indications
The section provides information on the different drugs being developed by Osel, along with details on the phase of development and target indication.

LACTIN-V / CTV-05 / Lactobacillus crispatus CTV-05
- Phase II for Bacterial Vaginosis (Infectious Diseases)
LACTIN-V / CTV-05
- Phase II / III for Urinary Tract Infection (Infectious Diseases)
- Phase I for Preterm Labor (Reproductive Disorders)
- Phase I for Human Papilloma Virus Infection (Infectious Diseases)
CBM588 / MIYAIRI 588 / Cdactin-O
- Phase I for Hematopoietic and Lymphoid Cell Neoplasm (Oncological Disorders)
- Phase I for Renal Cell Carcinoma (Oncological Disorders)
MucoCept
- Preclinical for HIV Infection (Infectious Diseases)
Gassericin K7 Bacteriocin
- Preclinical for Cervical Cancer (Oncological Disorders)

Recent Developments

In early 2024, Osel filed a new Investigational New Drug (IND) application for CBM588 for oncology indications and initiated a Phase 1 dose-escalation trial in advanced kidney cancer at the City of Hope Comprehensive Cancer Center. This study, which uses a new live cell encapsulation formulation of CBM588, is currently enrolling patients.

To know more about the recent initiatives of Osel and other human microbiome companies, access full report.

What About Other Human Microbiome Companies Around the World?

The above article features the leading human microbiome companies selected from a pool of around 55 drug developers, developing over 215 human microbiome therapeutics, that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.

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