HealthBiome has announced that it has achieved significant regulatory milestones in both the United States and South Korea for its proprietary postbiotic ingredient HB05P.
The company has completed the New Dietary Ingredient Notification (NDIN) process with the US Food and Drug Administration (FDA) for the high-dose formulation, marking the second FDA NDI acknowledgement following the low-dose approval received in December 2024 as the world's first NDI for Akkermansia muciniphila strain.
Concurrently, on December 24, 2025, the Korean Ministry of Food and Drug Safety (MFDS) granted functional ingredient approval for HB05P with the authorised health claim "May help to maintain muscle strength, which can be affected by ageing."
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.
This dual regulatory achievement establishes HealthBiome as the only company worldwide to receive both FDA NDI acknowledgement 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, demonstrating consistent regulatory acceptance across major markets.
HB05P 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 utilises a proprietary pasteurisation process to create a heat-killed bacterial formulation that maintains functionality while significantly improving safety and stability compared to live probiotic products.
With the global population aged 60 and older projected to double to 2.1 billion by 2050, maintaining muscle health during ageing has become increasingly important for quality of life and independence.
HB05P addresses this growing need through a novel postbiotic approach targeting the gut-muscle axis, distinguished by dual regulatory recognition and robust clinical evidence in the healthy ageing nutrition market.
"Achieving regulatory approvals from both the US FDA and Korean MFDS represents a major achievement for HealthBiome 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."
"We are now positioned for commercial launches in both markets beginning in 2026."
The clinical evidence supporting muscle health improvement
The HB05P formulation has demonstrated statistically significant improvements in muscle strength through rigorous human clinical trials.
The formulation also exhibited an excellent safety profile with no significant adverse events.
In a 12-week randomised, double-blind, placebo-controlled study conducted in 80 Korean adults aged 60-80, the HB05P group showed the following improvements:
- Statistically significant increases in muscle strength compared with the placebo group, with p-values of 0.007-0.008 for primary endpoints
- Favourable changes in key biomarkers, including increased IGF-1 and prealbumin, with decreased myostatin levels.