HealthBiome Achieves Dual Regulatory Approval for Akkermansia-Based Muscle Health Ingredient
Key Insights
HealthBiome (search) has become the first company worldwide to receive both FDA NDI acknowledgment for Akkermansia muciniphila-based dietary supplements at two dosage levels and Korean MFDS functional ingredient approval with a specific muscle health claim.
The company's postbiotic ingredient HB05P (search), derived from Akkermansia muciniphila isolated from Korean mothers' breast milk, received approval for a high-dose formulation of 3.0×10¹⁰ cells/day from both regulatory authorities.
Korea's health functional food market, valued at over $4 billion annually with 8-10% yearly growth, represents a significant commercial opportunity for the approved ingredient targeting the aging (search) population's muscle health needs.
HealthBiome (search) Inc., a pioneering strict anaerobic microbiome company, has achieved unprecedented regulatory success with dual approvals for its proprietary postbiotic ingredient HB05P (search) in both the United States and South Korea. The company successfully completed the New Dietary Ingredient Notification (NDIN) process with the U.S. Food and Drug Administration (FDA) for its high-dose formulation (3.0×10¹⁰ cells/day, NDI1438), marking the second FDA NDI acknowledgment following the low-dose approval (1.0×10¹⁰ cells/day, NDI1363) received in December 2024.
Concurrently, on December 24, 2025, the Korean Ministry of Food and Drug Safety (search) (MFDS) granted functional ingredient approval (Approval No. 2025-71) for HB05P (search) with the authorized health claim "May help to maintain muscle strength which can be affected by aging (search)."
First-in-Class Regulatory Achievement
This dual regulatory achievement establishes HealthBiome (search) as the only company worldwide to receive both FDA NDI acknowledgment for two dosage levels of Akkermansia muciniphila-based dietary supplements and Korean MFDS functional ingredient approval with a specific muscle health claim. Notably, both regulatory authorities approved the same high-dose formulation (3.0×10¹⁰ cells/day), demonstrating consistent regulatory acceptance across major markets.
The FDA acknowledgment represents the world's first NDI for Akkermansia muciniphila strain, positioning HealthBiome (search) at the forefront of postbiotic innovation in the dietary supplement sector.
Novel Postbiotic Approach
HB05P (search) is a postbiotic ingredient derived from Akkermansia muciniphila HB05, a beneficial bacterial strain originally isolated from the breast milk of healthy Korean mothers. The ingredient utilizes a proprietary pasteurization process to create a heat-killed bacterial formulation that maintains functionality while significantly improving safety and stability compared to live probiotic products.
The formulation targets the gut-muscle axis through a novel postbiotic approach, addressing the growing need for muscle health maintenance in aging (search) populations. With the global population aged 60 and older projected to double to 2.1 billion by 2050, maintaining muscle health during aging has become increasingly important for quality of life and independence.
Clinical Evidence and Market Potential
The HB05P (search) formulation has demonstrated statistically significant improvements in muscle strength through rigorous human clinical trials. In a 12-week randomized, double-blind, placebo-controlled study conducted in 80 Korean adults aged 60-80, the HB05P group showed improvements in muscle health parameters. The formulation also exhibited an excellent safety profile with no significant adverse events.
Korea's health functional food market, valued at more than $4 billion annually and growing at 8-10% per year, represents a significant commercial opportunity for science-backed functional ingredients.
Commercial Launch Timeline
"Achieving regulatory approvals from both the US FDA and Korean MFDS represents a major achievement for HealthBiome (search) and validates our scientific approach and product quality on an international scale," said Byoung-Chan Kim, CEO of HealthBiome. "The Korean MFDS approval is particularly significant as it includes a specific functional claim for muscle health, while the FDA acknowledgement enables our entry into the world's largest dietary supplement market."
Kim added, "We are now positioned for commercial launches in both markets beginning in 2026."
The dual regulatory success positions HealthBiome (search) for market entry in two major regions, with the company preparing for commercial launches in both the United States and South Korea throughout 2026.