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Larazotide acetate

Larazotide acetate is an oral peptide investigated as an intestinal tight-junction regulator, chiefly as an adjunct to a gluten-free diet in celiac disease.

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At a glance

Evidence stage
Early human
Regulatory status
Investigational; the celiac phase 3 program was discontinued after a 2022 interim sample-size assessment did not support continuing the trial.
Research context
Larazotide acetate is an oral peptide investigated as an intestinal tight-junction regulator, chiefly as an adjunct to a gluten-free diet in celiac disease.

What this is

  • Larazotide acetate is an oral peptide investigated as an intestinal tight-junction regulator, chiefly as an adjunct to a gluten-free diet in celiac disease.

What this isn't

  • A recommendation to use, prepare, combine, or administer a product
  • Evidence that a related molecule or a differently formulated product has the same effects

Key terms

Larazotide acetate is an oral peptide investigated as an intestinal tight-junction regulator, chiefly as an adjunct to a gluten-free diet in celiac disease.

Larazotide is intended to limit inappropriate opening of the junctions between intestinal epithelial cells, potentially reducing exposure of the underlying immune system to gluten fragments. The phase 2 report describes this barrier-focused rationale. It is not a gluten-digesting enzyme, and symptom improvement would not establish that gluten exposure has become safe.

Evidence limits

How to read the evidence

The phase 3 decision was based on an interim assessment of feasibility and required sample size, not proof that every proposed mechanism is false. Conversely, the phase 2 symptom result is insufficient to establish mucosal protection or a replacement for a gluten-free diet. The code AT-1001 should be checked against the actual molecule because similar development codes have been used elsewhere.

Sources appraised 2026-10-28. Educational information; not medical advice. Study findings apply to the populations, preparations and outcomes described.

External sources and citations

  1. Larazotide for persistent celiac symptoms: randomized trial. 2015
  2. 9 Meters: phase 3 larazotide interim analysis does not support continuation. 2022

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