HealthBiome Achieves Dual Regulatory Milestones: FDA NDI Acknowledgment and Korean MFDS Approval for HB05P Muscle Health Ingredient

Akkermansia muciniphila postbiotic receives both U.S. FDA dietary supplement clearance and Korean functional ingredient approval with muscle health claim, positioning HealthBiome for dual-market launch in 2026

DAEJEON, South Korea, Jan. 6, 2026 /PRNewswire/ -- HealthBiome Inc., a pioneering strict anaerobic microbiome company, announced today that it has achieved significant regulatory milestones in both the United States and South Korea for its proprietary postbiotic ingredient HB05P.

The company has successfully completed the New Dietary Ingredient Notification (NDIN) process with the U.S. Food and Drug Administration (FDA) for the 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 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 (Approval No. 2025-71) for HB05P with the authorized health claim "May help to maintain muscle strength which can be affected by aging."

This dual regulatory achievement establishes HealthBiome 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.

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 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.

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. 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 aging nutrition market.

"Achieving regulatory approvals from both the U.S. 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 acknowledgment enables our entry into the world's largest dietary supplement market. We are now positioned for commercial launches in both markets beginning in 2026."

Clinical Evidence Supporting Muscle Health Improvement

The HB05P formulation (3.0×10¹⁰ cells/day) 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:

• Statistically significant increases in muscle strength over placebo group with p-values of 0.007-0.008 for primary endpoints
• Favorable changes in key biomarkers including increased IGF-1 and prealbumin, with decreased myostatin levels
• Excellent safety profile with no significant adverse events

FDA NDI Notification Process

The FDA NDI notification process requires manufacturers to submit comprehensive scientific data including ingredient composition, manufacturing methods, dosage information, and safety test results to demonstrate safety prior to market introduction. The FDA reviews submitted materials and communicates approval decisions to manufacturers within 75 days of submission.

Both HB05P formulations utilize pasteurization technology to create postbiotic-based products that maintain the functional benefits of live probiotics while dramatically improving safety, stability, and ease of storage and consumption. Following thorough review of manufacturing processes, safety data, and toxicology verification materials, the FDA granted NDIN acknowledgment letters for both dosages.

Korean MFDS Functional Ingredient Approval

The Korean Ministry of Food and Drug Safety's functional ingredient approval (Approval No. 2025-71) issued on December 24, 2025, authorizes HB05P with the following specifications:

• Ingredient Name: Pasteurized Akkermansia muciniphila HB05 (HB05P) powder
• Functional Claim: "May help to maintain muscle strength which can be affected by aging"
• Daily Intake: 3.0×10¹⁰ cells/day

This approval represents the first Akkermansia muciniphila-based ingredient to receive Korean functional health food approval with a muscle health claim. The Korean regulatory pathway required comprehensive safety and efficacy documentation, including clinical trial data demonstrating improvements in muscle strength in elderly populations. Korea's health functional food market, valued at over $4 billion USD annually and growing at 8-10% per year, represents a significant commercial opportunity for science-backed functional ingredients.

About Akkermansia muciniphila

Akkermansia muciniphila is one of the beneficial bacteria found in the human gut, playing an important role in supporting intestinal health and metabolic wellness. Present in over 75% of healthy adults and comprising 1-4% of the gut microbiome, this species has attracted significant scientific and commercial interest.

About HealthBiome

Founded in 2017 as a researcher-initiated startup from the Korea Research Institute of Bioscience and Biotechnology (KRIBB), HealthBiome Inc. is headquartered in Daejeon with a GMP manufacturing facility in Jeonju, South Korea. The company specializes in drug development and dietary supplements based on strict anaerobic human commensal microbiome.

HealthBiome's product pipeline includes HB05P for muscle health improvement, and HB03 for colorectal cancer applications. The company is pursuing a dual-pathway strategy, developing products as dietary supplements and pharmaceutical products to address critical unmet needs in aging populations.

For more information:

Website: www.healthbiome.co.kr
Email: [email protected]

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Media Contact:

Jay Lee
Chief Business Officer
HealthBiome Inc.
Phone: +82-70-4348-1647
Email: [email protected]

SOURCE HealthBiome, Inc.