{
  "slug": "akkermansia",
  "name": "Akkermansia muciniphila (next-generation probiotic)",
  "alternate_names": [
    "A. muciniphila",
    "Akkermansia",
    "Pasteurized Akkermansia muciniphila",
    "AKK",
    "Next-generation probiotic"
  ],
  "mechanism": [
    "Mucin-degrading gut commensal that stimulates host mucus turnover and strengthens the intestinal mucus layer / gut barrier (research context)",
    "Amuc_1100 outer-membrane protein activates TLR2 signaling to improve gut-barrier integrity (preclinical · pasteurized form retains activity)",
    "Improvement of metabolic markers (insulin sensitivity, lipid profile) in early human and animal studies (research context)",
    "Modulation of GLP-1 and gut-hormone / energy-metabolism pathways (preclinical / early human)",
    "Anti-inflammatory modulation of the gut-immune axis (preclinical)"
  ],
  "target": [
    "Intestinal mucus layer / gut barrier",
    "TLR2 (Amuc_1100)",
    "Insulin sensitivity / metabolic markers",
    "GLP-1 / gut-hormone signaling"
  ],
  "use_case": [
    "gut-barrier / digestive health (research-context · early human)",
    "metabolic health — insulin sensitivity & lipid markers (research-context · single small RCT + preclinical)",
    "weight / cardiometabolic support (research-context · emerging, not confirmed)"
  ],
  "body_system": [
    "GUT",
    "IMMUNE"
  ],
  "evidence_tier": "C",
  "evidence_anchor_pmid_count": 1,
  "dosage_range": "Educational reference, not a dosing recommendation. The pivotal exploratory human study (Depommier 2019) used ~10^10 cells/day of pasteurized A. muciniphila for 3 months; EU novel-food authorization caps use at <=3.4x10^10 cells/day in adults. Confirmatory efficacy trials are limited.",
  "safety_notes": "Pasteurized A. muciniphila was well tolerated in the small exploratory human study and judged safe by EFSA for adults at <=3.4x10^10 cells/day. Human efficacy evidence is early (one small proof-of-concept RCT plus preclinical work) — benefits are emerging, not established (evidence grade C). Not assessed for pregnant/lactating women or children (excluded from EU authorization). Live vs pasteurized forms differ; caution in immunocompromised individuals. Educational, not medical advice.",
  "regulatory": {
    "fda": "Lawful US dietary ingredient: pasteurized A. muciniphila strains have completed FDA NDI notification (HealthBiome HB05P low-dose acknowledged Dec 2024; AKK PROBIO NDI 2026) and a strain holds self-affirmed GRAS (2024) for live and pasteurized forms. Structure/function claims only; NO FDA-authorized health claim.",
    "efsa": "Pasteurized A. muciniphila is an authorized EU novel food (Commission Implementing Regulation (EU) 2022/168; EFSA 2021 positive safety opinion, A-mansia Biotech) for food supplements (Dir 2002/46/EC) and FSMP at <=3.4x10^10 cells/day in adults (excl. pregnant/lactating). NO authorized Reg 432/2012 health claim.",
    "anvisa": "No ANVISA record of A. muciniphila on the permitted probiotic-strain or dietary-supplement (RDC 243/2018) list; as a next-generation strain it is not an established listed ingredient and has no confirmed Brazilian market-access path. No Anexo V functional claim.",
    "cn": "Not approved as a China novel food ingredient; only an Akkermansia muciniphila fermented-lysate cosmetic notification is pending (June 2025), with no food/supplement approval — not lawfully marketable as a food/supplement ingredient in China."
  },
  "regulatory_markets": [
    {
      "market": "US",
      "status": "DSHEA",
      "tier": "permitted"
    },
    {
      "market": "EU",
      "status": "Novel Food",
      "tier": "permitted"
    }
  ],
  "authorized_claims": [],
  "ingredient_hub_url": "https://asxan.ai/ingredients/akkermansia/",
  "related_goal_slugs": [
    "gut-digestion",
    "weight-management"
  ],
  "related_lifestyle_slugs": [
    "weight-management",
    "glp-1-companion"
  ],
  "last_evidence_review": "2026-06-22",
  "schema_version": "nc-public-v0.2",
  "api_version": "nc-public-v0.3",
  "_meta": {
    "last_evidence_review": "2026-06-22",
    "ip_axes_disclosed": {
      "public_axes": [
        "mechanism",
        "target",
        "use_case",
        "body_system",
        "evidence_tier",
        "dosage_range",
        "safety_notes",
        "regulatory",
        "authorized_claims"
      ],
      "ip_axes_not_exposed": [
        "proprietary_formula_ratios",
        "clinical_protocol_internals",
        "proprietary_research_compounds",
        "supplier_specific_grade_specifications",
        "unpublished_endpoint_data"
      ],
      "rationale": "asxan.ai surfaces the educational, evidence-tier-disclosed slice. Formula composition and clinical-protocol internals are intentionally outside this public surface."
    }
  }
}