Investigational and not approved by the FDA. This page is educational information only. It is not medical advice and not a recommendation to use anything.

IndexedBuilt automatically from public databases on 2026-09-30. Not yet hand-reviewed by PLOBT.How this works →

Larazotide

Investigational

Tight junction regulator peptide

Also known as: AT-1001, larazotide acetate, Larazotida, AT-2347, AT 2347, larazotidum, larazotide-acetate

Evidence score

63/ 100

Moderate evidence

A real evidence base, with gaps

Regulatory standing. In clinical trials, not yet approved
Limited human data. Some human data exists, not conclusive
Registered human trials. 29 registered studies on ClinicalTrials.gov, most advanced Phase 3
1 cited source. Includes primary / regulatory sources

Computed with the same four public criteria as every profile. The human-evidence grade on an indexed profile is set automatically and may change when it is hand-reviewed. It is not a safety score, not a purity rating, and not medical advice, and not a claim that this compound treats, cures, or prevents any condition.

What it is

Larazotide, also known as AT-1001 or larazotide acetate, is a synthetic eight amino acid peptide studied mainly in celiac disease. It is thought to act locally in the gut by helping regulate tight junctions between intestinal cells, which may reduce the passage of gluten fragments across the intestinal lining.

What the evidence shows

Automatic summaryLimited human data

Larazotide is not FDA-approved for any use. It has been tested in about 29 registered human trials, reaching Phase 3, and some earlier trials suggested modest symptom effects in celiac disease, but results have been mixed and a Phase 3 program was reportedly stopped for lack of clear benefit, so effectiveness in humans is not established.

Key facts

Molecular formula

C32H55N9O10

Molecular weight

725.8 g/mol

Registered human trials

Live from ClinicalTrials.gov, refreshed daily.

29registered studies

Phase 3most advanced phase

22completed (sample)

1recruiting (sample)

AT1001 for the Treatment of Long COVID

Phase 2CompletedNCT05747534

Safety Study of Larazotide Acetate to Treat Celiac Disease.

Phase 1CompletedNCT00386165

Safety, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged >12 Years) With Fabry Disease

Phase 3CompletedNCT04049760

Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

Phase 2CompletedNCT00889473

Published literature

Live from Europe PMC. This is how much has been published, not how much is proven in humans.

45papers referencing Larazotide

Targeting zonulin and intestinal epithelial barrier function to prevent onset of arthritis.

Nat Commun2020

Multisystem inflammatory syndrome in children is driven by zonulin-dependent loss of gut mucosal barrier.

J Clin Invest2021

Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial.

Gastroenterology2015

Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study.

Aliment Pharmacol Ther2013

Sources

Risks, side effects and study doses are only published on hand-reviewed profiles. Want this one reviewed, or spotted something wrong? Tell us.