US-Cleared
Self-affirmed GRAS for both live and pasteurized forms, plus completed FDA NDI Notification #1468 for the pasteurized form.
Akkermansia muciniphila · CGMCC No.20955
The Akkermansia You Can Build On
US-cleared · 7 clinical studies & 13 peer-reviewed publications, anchored by a landmark 8-week RCT (P < 0.001) · live & pasteurized.
AKK PROBIO® (Akkermansia muciniphila, CGMCC No.20955) is the Akkermansia ingredient formulators can build on: self-affirmed GRAS for both forms, completed FDA NDI Notification #1468 for the pasteurized form, a deep clinical base, and both live and pasteurized forms.
For R&D
For Regulatory
For QA
For Brand Owners
For Distributors
200+strains screened
18invention patents
13peer-reviewed publications
7clinical studies
GRASself-affirmed, live + pasteurized
FDA NDI#1468, pasteurized form
B2B ingredient positioning
A rare combination for formulators and brand owners
Akkermansia muciniphila is one of the most researched next-generation probiotics, but for a brand, the hard part is launching it. AKK PROBIO® reduces that evaluation burden with self-affirmed GRAS for both forms, completed FDA NDI Notification #1468 for the pasteurized form, 7 clinical studies, 13 peer-reviewed publications, and both live and pasteurized forms.
Three brand pillars
Built for technical review, not retail hype
Clinically Studied
13 peer-reviewed publications and 7 clinical studies, anchored by a landmark 8-week double-blind, placebo-controlled RCT.
Dual-Form
Live probiotic and pasteurized postbiotic forms help teams match the ingredient to supplements, foods, beverages, and other formats.
Regulatory & Safety
Self-affirmed GRAS + FDA NDI #1468
AKK PROBIO® holds self-affirmed GRAS under 21 CFR §170.30 for live and pasteurized forms, and has completed FDA New Dietary Ingredient Notification #1468 for the pasteurized form.
Applications
Live and pasteurized forms for multiple B2B formats
Dietary supplements
Capsules, powders, and gummies, with live or pasteurized positioning.
Food & beverage
Pasteurized form for processing tolerance and shelf-stable formulation.
Sports nutrition
Fits body-composition, metabolic, and recovery-oriented concepts.
Pet health
A documented, safety-evaluated ingredient route for companion-animal gut health.
Science & Evidence
13 publications and 7 clinical studies on the AKK PROBIO strain
Human, safety, and preclinical research support a stronger technical conversation with R&D, QA, and regulatory teams.
Review the evidenceAwards & recognition
Recognized by the industry
- 2026 NutraIngredients USA AwardsFinalist — Ingredient of the Year (Microbiome Modulation)
- 2025 iCAN International Innovation CompetitionGold Medal & Special Award (Canada)
- 2025 Ingredient Idol AwardFeatured at Natural Products Expo West 2025
Evaluating Akkermansia for your next formulation?
Request a sample, or talk to our technical team about your application.