Larazotide Acetate
Also known as: AT-1001
Larazotide acetate is an investigational oral tight-junction peptide studied as an adjunct to a gluten-free diet for celiac disease. Its Phase III program stopped for futility, and pooled permeability findings did not establish benefit.
Quick Facts
Identity and development
Larazotide is an eight-amino-acid peptide developed as AT-1001, most recently by 9MetersBiopharma. It was studied alongside, rather than instead of, a gluten-free diet for celiac disease, the gluten-triggered autoimmune injury of the small intestine. The lead program was discontinued; it is not an approved medicine.
Proposed tight-junction mechanism
The hypothesis targeted intestinal junctions that regulate passage between cells. Celiac-related loosening may let gluten fragments cross and trigger inflammation. Larazotide was intended to oppose zonulin signaling and promote tighter junction closure.
This plausible mechanism did not yield confirmed clinical efficacy. A mechanistic review explains the pathway without overturning the later negative trial findings.
Sources: [1]
Approval and human outcomes
There is no FDA approval or active late-stage program in the described record.
| Evidence | Result |
|---|---|
| Ce DLara Phase III interim analysis, 2022 | Stopped for futility after the analysis indicated failure to meet the primary celiac-symptom-severity endpoint. |
| Meta-analysis of four randomized trials | No significant effect on lactulose-to-mannitol permeability ratio; symptom signals were inconsistent in gluten-challenge subgroups. |
The overall human evidence does not establish benefit, and the investigational peptide is not a substitute for the gluten-free diet.
References and further reading
This reference draws on Superpower’s Peptide Library and the research linked below. Peptide Dossier’s editorial team adapted and integrated the material on .
- 10.1152/ajpgi.00386.2020Proposed tight-junction mechanismCited in: Proposed tight-junction mechanism
- beyondceliac.orgApproval and human outcomesCited in: Approval and human outcomes
- 10.1016/j.clinre.2021.101782Approval and human outcomesCited in: Approval and human outcomes
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Disclaimer: This article is for informational and educational purposes only. It is not intended as medical advice. The information presented is based on published research and should not be used as a substitute for professional medical guidance. Always consult a qualified healthcare provider before starting any peptide protocol. Some peptides discussed may not be approved for human use by the FDA or equivalent regulatory bodies.