Larazotide
Larazotide acetate · AT-1001 · AT1001
Snapshot
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Larazotide (AT-1001, larazotide acetate) is a synthetic peptide developed as a gut permeability regulator, acting as a zonulin pathway antagonist that limits tight junction opening7. Interest centers on reducing gluten-driven barrier disruption, so its studied uses are persistent symptoms in celiac disease despite a gluten-free diet and symptoms during gluten exposure1, 2. It has also been given as adjunctive therapy in post-COVID multisystem inflammatory syndrome in children5.
Human research is limited to about six small trials, mostly in celiac disease and post-COVID multisystem inflammatory syndrome in children. A 2015 randomized trial in adults with persistent symptoms despite a gluten-free diet found benefit at only one of the doses tested1. A meta-analysis found symptom improvement during gluten challenge but not on a gluten-free diet alone, with no difference in a permeability measure4. A 2025 randomized placebo-controlled trial in children with post-COVID inflammatory syndrome found faster symptom resolution and spike antigen clearance with adjunctive larazotide; no other trial has replicated it. Larazotide remains an investigational oral peptide, and a review notes that no medication is approved for celiac disease8.
Last updated October 17, 2026. Read how we make monographs.
In the full monograph
34 sources, 22 studies
- When to useThe situations practitioners use it for, each with the reason and the study behind it.
- SafetyWho should avoid it, who needs extra care, and the side effects reported in studies.
- Protocol notesThe doses used in studies, how and when they were taken, and how the forms on the market compare.
- How it worksWhat it is and how it works in the body, in plain terms.
- Published studiesThe studies behind each use, popular claims checked against them, and trials still under way.
- Word of mouthWhat patients and practitioners report online, kept separate from the clinical evidence.
- Clinical perspectiveA closing read of where the evidence is solid, where it is thin, and what has not been studied.
Sources
- 1Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial.pubmed.ncbi.nlm.nih.govLeffler, Kelly, Green et al. · Gastroenterology · 2015 · Pubmed
- 2Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study.pubmed.ncbi.nlm.nih.govKelly, Green, Murray et al. · Alimentary pharmacology & therapeutics · 2013 · Pubmed
- 3A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge.pubmed.ncbi.nlm.nih.govLeffler, Kelly, Abdallah et al. · The American journal of gastroenterology · 2012 · Pubmed
- 4Larazotide acetate for treatment of celiac disease: A systematic review and meta-analysis of randomized controlled trials.pubmed.ncbi.nlm.nih.govHoilat, Altowairqi, Ayas et al. · Clinics and research in hepatology and gastroenterology · 2022 · Pubmed
- 5Viral spike antigen clearance and augmented recovery in children with post-COVID multisystem inflammatory syndrome treated with larazotide.pubmed.ncbi.nlm.nih.govYonker, Kane, Swank et al. · Science translational medicine · 2025 · Pubmed
- 6Zonulin Antagonist, Larazotide (AT1001), As an Adjuvant Treatment for Multisystem Inflammatory Syndrome in Children: A Case Series.pubmed.ncbi.nlm.nih.govYonker, Swank, Gilboa et al. · Critical care explorations · 2022 · Pubmed
- 7Breaking Down Barriers: How Understanding Celiac Disease Pathogenesis Informed the Development of Novel Treatments.pubmed.ncbi.nlm.nih.govValitutti, Fasano · Digestive diseases and sciences · 2019 · Pubmed
- 8Current pharmacological approaches and potential future therapies for Celiac disease.pubmed.ncbi.nlm.nih.govKulkarni, Patel, Khanna et al. · European journal of pharmacology · 2021 · Pubmed