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World’s First Regulatory Approval for Akkermansia in Respiratory Health
The company has received approval from South Korea’s Ministry of Food and Drug Safety for its heat-killed strain of Akkermansia muciniphila (EB-AMDK19) as an individually recognized functional ingredient for improving respiratory health, particularly in relation to cough. This marks the first global case in which Akkermansia has been officially recognized for functionality, validating its potential to help normalize immune responses and improve respiratory conditions such as asthma.
Enterobiome has focused research on hard-to-culture gut microbes including Akkermansia muciniphila and Faecalibacterium prausnitzii, both beneficial bacteria residing in the intestinal mucosa. These strains are notoriously difficult to commercialize due to oxygen sensitivity, but Enterobiome holds patented high-yield cultivation methods in Korea, the United States, Europe, China, and Japan.
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Commercialization with Dong-A Pharmaceutical and Amazon
Sales channels are already secured. The supplement will be launched in South Korea through Dong-A Pharmaceutical early next year, while a global rollout will begin in the United States next month via Amazon. The company expects about 8 billion won ($60 million) in first-year revenue from the respiratory health supplement alone, supported by pre-orders.
According to Global Market Insights, the global asthma therapeutics market is projected to grow from $25.7 billion in 2024 to $37.8 billion by 2032. Enterobiome noted that post-COVID-19, demand for preventive respiratory health supplements is on the rise, particularly among aging populations.
To facilitate the U.S. entry, Enterobiome secured self-affirmed GRAS (Generally Recognized as Safe) status earlier this year, a prerequisite for novel food ingredients in the market.
Beyond respiratory health, the company plans to pursue additional indications including weight management and hair health, with regulatory filings underway. Enterobiome is also advancing its clinical pipeline, having recently received IND approval from the MFDS for a live Akkermansia-based atopic dermatitis treatment. The therapy has shown efficacy comparable to steroids, with added preventive and durable effects.
CEO Jae-gu Seo said, “Since our founding in 2018, we have built a strong technology base. Now, it is time to translate that into tangible outcomes. With innovative microbiome-derived materials, we aim to contribute not only to gut health but also to immune, respiratory, and skin health.”
