Larazotide
A synthetic peptide that regulates intestinal tight junctions, in clinical trials for celiac disease and studied for leaky gut conditions.
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This information is for educational purposes. Peptide therapy should be guided by a licensed healthcare provider. Connect with a Noho clinician
What is Larazotide?
Larazotide acetate is a synthetic peptide derived from Vibrio cholerae zonula occludens toxin (ZOT). Unlike ZOT which opens tight junctions, larazotide acts as a tight junction regulator that prevents pathological opening of intestinal tight junctions. It has undergone multiple Phase 2 and Phase 3 clinical trials for celiac disease and is also being studied for MIS-C (multisystem inflammatory syndrome in children) and other barrier-dysfunction conditions.
Why People Talk About It
Celiac disease symptom management
ModerateIntestinal permeability reduction
ModerateLeaky gut support
EmergingGluten exposure protection
ModerateHow It Works
Larazotide acts like a gatekeeper for the spaces between cells in your gut lining. It helps keep these gates properly closed, preventing unwanted substances from leaking through the intestinal barrier into your bloodstream.
Common Questions
Safety Information
Common Side Effects
Cautions
- • Not yet FDA-approved
- • Not a replacement for gluten-free diet
- • Clinical trial data is promising but approval pending
What We Don't Know
Long-term effects of chronic tight junction modulation are being studied. Post-marketing safety data is not yet available.
Published Research
34 studiesViral spike antigen clearance and augmented recovery in children with post-COVID multisystem inflammatory syndrome treated with larazotide
A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge
The safety, tolerance, pharmacokinetic and pharmacodynamic effects of single doses of AT-1001 in coeliac disease subjects: a proof of concept study
Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study
Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial
The Therapeutic use of the Zonulin Inhibitor AT-1001 (Larazotide) for a Variety of Acute and Chronic Inflammatory Diseases
The potential utility of tight junction regulation in celiac disease: focus on larazotide acetate
Larazotide acetate: a pharmacological peptide approach to tight junction regulation
The PAR2 Antagonist Larazotide Can Mitigate Acute Histamine-Stimulated Epithelial Barrier Disruption in Keratinocytes: A Potential Adjunct Treatment for Atopic Dermatitis
Antibacterial hyaluronic acid hydrogel with sustained release of larazotide as effective colitis treatment
Larazotide Acetate Protects the Intestinal Mucosal Barrier from Anoxia/Reoxygenation Injury via Various Cellular Mechanisms
Ameliorative Effects of Larazotide Acetate on Intestinal Permeability and Bacterial Translocation in Acute Pancreatitis Model in Rats
Zonulin Antagonist, Larazotide (AT1001), As an Adjuvant Treatment for Multisystem Inflammatory Syndrome in Children: A Case Series
Tight junction regulation in celiac disease: role of larazotide acetate
Peptide Derivatives of the Zonulin Inhibitor Larazotide (AT1001) as Potential Anti SARS-CoV-2: Molecular Modelling, Synthesis and Bioactivity Evaluation
Larazotide acetate induces recovery of ischemia-injured porcine jejunum via repair of tight junctions
In vivo assessment of a delayed release formulation of larazotide acetate indicated for celiac disease using a porcine model
Effects of larazotide acetate, a tight junction regulator, on the liver and intestinal damage in acute liver failure in rats
In silico Analysis Revealed Potential Anti-SARS-CoV-2 Main Protease Activity by the Zonulin Inhibitor Larazotide Acetate
The α3β4 nAChR partial agonist AT-1001 attenuates stress-induced reinstatement of nicotine seeking in a rat model of relapse and induces minimal withdrawal in dependent rats
[Larazotide as an option in case of failure of a gluten-free diet]
AT-1001 Is a Partial Agonist with High Affinity and Selectivity at Human and Rat α3β4 Nicotinic Cholinergic Receptors
Functional characterization of AT-1001, an α3β4 nicotinic acetylcholine receptor ligand, at human α3β4 and α4β2 nAChR
High affinity α3β4 nicotinic acetylcholine receptor ligands AT-1001 and AT-1012 attenuate cocaine-induced conditioned place preference and behavioral sensitization in mice
AT-1001: a high-affinity α3β4 nAChR ligand with novel nicotine-suppressive pharmacology
Pharmacological stress is required for the anti-alcohol effect of the α3β4* nAChR partial agonist AT-1001
Commentary: larazotide acetate - an exciting new development for coeliac patients?
Commentary: larazotide acetate - an exciting new development for coeliac patients? Authors' reply
Larazotide acetate promotes tight junction assembly in epithelial cells
Larazotide acetate for treatment of celiac disease: A systematic review and meta-analysis of randomized controlled trials
Larazotide acetate regulates epithelial tight junctions in vitro and in vivo
Reducing small intestinal permeability attenuates colitis in the IL10 gene-deficient mouse.
Targeting zonulin and intestinal epithelial barrier function to prevent onset of arthritis.
Multisystem inflammatory syndrome in children is driven by zonulin-dependent loss of gut mucosal barrier.
Always consult a qualified clinician
This information is for educational purposes. Peptide therapy should be guided by a licensed healthcare provider. Connect with a Noho clinician
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Quick Facts
- Class
- Tight Junction Regulator
- Evidence
- Moderate
- Safety
- Well-Studied
- Updated
- Mar 2026
- Citations
- 34PubMed
Also known as
Tags
Related Goals
Evidence Score
Clinical Trials
View Clinical TrialsLinks to ClinicalTrials.gov for reference. Listing does not imply endorsement.
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