Identity
Larazotide acetate is an investigational tight-junction regulator studied in celiac disease.
Selected study only; not a complete clinical review.
Peptide library
Larazotide acetate
Your guide to this compound.
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Evidence in perspective
Only the lowest tested dose improved the primary symptom endpoint in the selected study. The continuing gluten-free diet and non-monotonic dose response matter; it is not evidence that patients can safely reintroduce gluten.
About this assessment
Existing source snapshot critically reassessed.
Based on the selected source scope described in this profile, often an indexed abstract. Full methods and clinician sign-off remain pending; no systematic-review claim.
Editorial assessment · 2026-09-07
Who was studied
342 adults with persistent symptoms despite a gluten-free diet.
What the sources found
The lowest tested dose improved the primary symptom endpoint; higher doses did not. The gluten-free diet continued.
Regulatory scope
Current authorization for the exact product and jurisdiction was not independently checked in this snapshot. A clinical trial is not marketing authorization.
What remains unknown
Selected indexed primary-study abstract reviewed. Full methods, bias, all safety outcomes, product stability, current jurisdictional authorization and a comprehensive literature search remain outstanding. This is not a complete clinical review.
How it works
Larazotide acetate is an investigational tight-junction regulator studied in celiac disease.
The study-specific findings below distinguish biological activity from demonstrated treatment benefit.
Human trials
This catalog identifies human research. A trial can be early, small or negative; its existence does not establish approval or benefit for every proposed use. Check the study population and outcomes.
Reported adverse effects
- Reported safety was comparable with placebo in this study, not proof of long-term safety.
Selected study only; not a complete clinical review.
Contraindications
- A complete contraindication and interaction review remains outstanding.
Human trials
This catalog identifies human research. A trial can be early, small or negative; its existence does not establish approval or benefit for every proposed use. Check the study population and outcomes.
Sources used for this snapshot
Claim-by-claim evidence
Benefits
The lowest tested dose improved the primary symptom endpoint; higher doses did not. The gluten-free diet continued.
Selected study only; not a complete clinical review.
Adverseeffects
Reported safety was comparable with placebo in this study, not proof of long-term safety.
Selected study only; not a complete clinical review.
References
Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial. 2015.
PMID: 25683116
Catalog review date: Sep 7, 2026. This date alone does not establish independent clinical review.