AKK PROBIO® Akkermansia muciniphila CGMCC No.20955 (Live & Pasteurized, FDA NDI #1468)

AKK PROBIO® is a branded Akkermansia muciniphila ingredient developed by Thankcome Biological Science and Technology (Suzhou) Co., Ltd. in Jiangsu, China. The strain is deposited as CGMCC No.20955 and, according to the developer, was isolated from the gut microbiota of a healthy human donor and then selected from more than 200 human-derived Akkermansia candidates on the basis of survival under gastrointestinal conditions, mucin-degradation capacity, short-chain fatty acid production, safety and industrial scalability.

Akkermansia muciniphila is a mucin-degrading resident of the human gut that lives in the mucus layer and uses intestinal mucin as its carbon and nitrogen source. Its abundance is consistently lower in people with obesity and metabolic disease, which is why it has become one of the most closely watched next-generation probiotic species. AKK PROBIO® is supplied to brands and contract manufacturers as a B2B raw material, in both live and heat-inactivated form, backed by 18 strain-specific invention patents.

AKK PROBIO® is offered as a live probiotic (viable cells) and as a heat-inactivated, pasteurized postbiotic. The choice is not cosmetic: it changes regulatory status, processing tolerance and label positioning, so it should be settled early in a project.

The live form supports viable-cell positioning and, in the human trial, produced the broader set of significant outcomes. The pasteurized form is the more robust option for heat processing, ambient storage and beverage or functional food development, and it is the only form covered by the US NDI notification. For pet health and food applications, the pasteurized form is normally the practical starting point.

AKK PROBIO® holds self-affirmed GRAS status under 21 CFR 170.30 for both the live and the pasteurized form, with a use level of up to 7.0 x 10^10 AFU (Active Fluorescent Units) per serving. Self-affirmed GRAS is a manufacturer-held safety conclusion — it is not an FDA approval, an FDA certification or an FDA GRAS determination, and it should not be described as such on packaging or in marketing.

For dietary supplement use, the developer has completed FDA New Dietary Ingredient Notification #1468, which covers the pasteurized postbiotic form only, at 170 mg per day equivalent to 3.4 x 10^10 TFU (Total Fluorescent Units) per day. The live form does not have NDI status. An NDI notification is a pre-market notification pathway for ingredients not marketed before 15 October 1994; it is not a drug approval and does not constitute FDA endorsement. Note also that the two unit systems are not interchangeable: AFU applies in the GRAS serving context, TFU in the pasteurized-form NDI context.

Outside the United States the position is different. There is currently no EU novel food authorisation or EFSA opinion covering this strain. The existing EU authorisation of pasteurised Akkermansia muciniphila under Regulation (EU) 2022/168 is applicant and strain specific and does not automatically extend to CGMCC No.20955. Registration and claim status in mainland China, Hong Kong and other Asian markets must be reviewed case by case before a launch is planned.

The developer cites 13 peer-reviewed publications and 7 clinical studies specific to this strain. The anchor study is a randomised, double-blind, placebo-controlled trial in 130 overweight adults over 8 weeks, published as "Akkermansia muciniphila PROBIO ameliorates overweight via gut microbiota modulation: a randomized controlled trial" in Food Science and Human Wellness, 2025 (DOI 10.26599/FSHW.2025.9250659).

The trial ran three arms — placebo, live AKK PROBIO® at approximately 1 x 10^10 CFU/day, and the pasteurized postbiotic — and reported a body weight change of −0.63 kg in the active groups against a gain in the placebo group (P<0.001 as published). Waist circumference and waist–hip ratio fell significantly with the live form, as did total cholesterol, triglycerides and LDL-cholesterol. Both forms significantly improved HAMA-14 anxiety, HDRS-17 depression and PSQI sleep-quality scores, and serotonin and dopamine rose significantly in the live group. The authors attributed the limited BMI and fat-mass separation to the short 8-week intervention.

Preclinical work spans gut barrier integrity and DSS-induced colitis (Foods, 2025), gut microbiota–SCFA signalling (Probiotics and Antimicrobial Proteins, 2026), immune modulation via the NF-κB/MAPK pathway (Anaerobe, 2026), uric acid and gouty arthritis models (Food Science & Nutrition, 2024), PCOS and reproductive endpoints (Frontiers of Medicine, 2025), and neuroinflammation in an APP/PS1 Alzheimer model (Alzheimer's Research & Therapy, 2026). Safety documentation includes strain characterisation and preliminary safety evaluation (Foods, 2024) plus genotoxicity and subchronic toxicity work (Toxicology Reports, 2024).

Buyers should keep the hierarchy straight when writing copy: one human RCT, with everything else in animal or in vitro models. Animal mechanism data supports technical evaluation and formulation rationale, not consumer-facing health claims.

Documented use levels are up to 7.0 x 10^10 AFU per serving under the self-affirmed GRAS conclusion, and 170 mg/day (3.4 x 10^10 TFU/day) for the pasteurized form under NDI #1468. The human trial used approximately 1 x 10^10 CFU/day of the live form. Certificates of analysis, specification sheets, stability and shelf-life data, the GRAS conclusion summary and NDI documentation are available for technical review on request.

Typical applications are capsules, tablets, sachets and gummies in dietary supplements; functional foods and beverages, where the pasteurized form is the better starting point for processing and storage; sports nutrition; and companion-animal gut health. The ingredient is produced in Thankcome's own facilities in Suzhou. ACC Biotech can arrange samples, documentation, pricing and MOQ guidance.

AKK PROBIO® was a finalist for Ingredient of the Year (Microbiome Modulation) at the 2026 NutraIngredients USA Awards, won a Gold Medal and Special Award at the 2025 iCAN International Innovation Competition in Canada, and took an Ingredient Idol award at SupplySide Global 2025. The developer also describes it as the first gut-derived Akkermansia muciniphila to complete an FDA NDI notification — a supplier claim that buyers may wish to verify independently.

These statements have not been evaluated by the Food and Drug Administration. This ingredient is not intended to diagnose, treat, cure or prevent any disease. The information on this page is provided for B2B ingredient sourcing and technical review.