{
  "slug": "recombinant-collagen",
  "name": "Recombinant Collagen (rhCollagen)",
  "alternate_names": [
    "rhCollagen",
    "Recombinant human collagen",
    "Recombinant humanized collagen",
    "Yeast/E. coli-expressed collagen"
  ],
  "mechanism": [
    "Bioengineered human-sequence collagen or functional collagen fragment expressed in microbial hosts (Pichia pastoris, E. coli, S. cerevisiae) — research-context structural protein, not a metabolized small molecule",
    "Extracellular matrix (ECM) scaffold / tissue-repair substrate in wound-dressing and tissue-engineering research",
    "Integrin-mediated cell adhesion in fibroblast/keratinocyte models (preclinical)",
    "Collagen-peptide-derived dipeptide signaling (Pro-Hyp · Hyp-Gly) is documented for ORAL animal-source hydrolyzed collagen — analog/research-context only, NOT demonstrated for recombinant collagen"
  ],
  "target": [
    "Dermal extracellular matrix (preclinical)",
    "Connective tissue scaffold",
    "COL3A1 (recombinant type III expression studies)",
    "COL1A1 (recombinant type I expression studies)"
  ],
  "use_case": [
    "tissue-repair / wound-dressing biomaterial (research-context · preclinical + device pathway)",
    "skin / connective-tissue support (research-context · analog evidence from animal-source collagen only)",
    "recombinant production-platform substrate (technical context)"
  ],
  "body_system": [
    "SKIN",
    "MUSCULO",
    "CELL"
  ],
  "evidence_tier": "C",
  "evidence_anchor_pmid_count": 3,
  "dosage_range": "No established oral recombinant-collagen dose — zero recombinant-specific human oral RCTs. For reference only, animal-source hydrolyzed collagen (analog) oral RCTs used 2.5-10 g/day; topical/biomaterial recombinant collagen (hydrogel, microneedle, dressing) is used per medical-device specification, not as an oral dose.",
  "safety_notes": "Recombinant human-sequence collagen avoids animal-pathogen (BSE/TSE) risk and is theorized to have lower immunogenicity than animal-source collagen, though no head-to-head oral immunogenicity RCT exists. FDA GRN 1171 (a recombinant collagen polypeptide that received a no-questions response) is a strain/product-specific oral-food GRAS backing and does not auto-extend to other expression systems or collagen types. Expression host (E. coli / Pichia pastoris) should be disclosed. Recombinant-collagen-specific oral-safety data are minimal; animal-source collagen peptides have a good oral tolerability record (occasional mild GI upset).",
  "regulatory": {
    "fda": "GRN 1171 (recombinant collagen polypeptide; FDA no-questions response). Animal-source collagen sold as DSHEA dietary supplement; structure/function claims permitted with 30-day notification.",
    "efsa": "No EFSA authorized health claim (0 authorized · 5 collagen/joint/skin claims rejected). Recombinant collagen may trigger Novel Food (Reg 2015/2283) assessment; collagen health claims prohibited in the EU.",
    "anvisa": "Animal-source hydrolyzed collagen (colágeno hidrolisado) widely sold under RDC 243/2018; recombinant-collagen-specific pathway not yet defined. IN 28/2018 alegação funcional not authorized for collagen."
  },
  "authorized_claims": [],
  "ingredient_hub_url": "https://asxan.ai/ingredients/recombinant-collagen/",
  "related_goal_slugs": [
    "skin-beauty"
  ],
  "related_lifestyle_slugs": [
    "senior-60-plus"
  ],
  "last_evidence_review": "2026-06-13",
  "schema_version": "nc-public-v0.2",
  "api_version": "nc-public-v0.3",
  "_meta": {
    "last_evidence_review": "2026-06-13",
    "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",
        "rnd_pipeline_compounds",
        "supplier_specific_grade_specifications",
        "unpublished_endpoint_data"
      ],
      "rationale": "asxan.ai surfaces the educational, evidence-tier-disclosed slice. Formula composition, clinical-protocol internals, and RnD pipeline data are intentionally outside this public surface."
    }
  }
}