Gut · Inflammation · Immune

Larazotide

Also known as: Larazotide acetate, AT-1001, INN-202

A tight-junction-modulating octapeptide investigated for celiac disease, with a Phase 3 program that did not meet its primary endpoint.

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Evidence strength

Strength of human clinical evidence — A (strongest) to D (mostly preclinical). This reflects research maturity, not safety or suitability.

CMixed or Limited Human Evidence

Vial Theory provides educational research summaries only. Content is not medical advice, diagnosis, treatment, dosing guidance, or individualized suitability screening. Regulatory status can change over time and varies by jurisdiction.

Key Takeaways

  • ›Larazotide is an oral, gut-acting peptide developed to tighten intestinal junctions in celiac disease.
  • ›Earlier Phase 2 trials were encouraging, but the pivotal Phase 3 trial did not meet its primary endpoint (2022).
  • ›Reported safety was generally mild, consistent with minimal absorption into the body.
  • ›It is not approved, and broad 'leaky gut' claims exceed the celiac-focused evidence.
  • ›Speak with a licensed healthcare professional before making any health-related decisions.

What It Is

Larazotide acetate is a synthetic eight-amino-acid peptide derived structurally from a region of the Vibrio cholerae zonula occludens toxin. It was developed as a tight-junction modulator intended to reduce paracellular permeability in the small intestinal epithelium. The compound was originally licensed by Alba Therapeutics and subsequently developed by 9 Meters Biopharma.

Mechanistically, larazotide is described as antagonizing the zonulin pathway and stabilizing intercellular tight junctions in the gut epithelium. It is administered orally and is not significantly systemically absorbed, which underlies its development hypothesis: a luminally active peptide that modifies intestinal barrier function locally rather than acting systemically.

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Disclaimer: This content is for educational and research purposes only and is not medical advice. Always consult a licensed healthcare professional before making health-related decisions.