peptide wiki

Larazotide

aka Larazotide acetate · AT-1001 · INN-202 · GGVLVQPG

Healing & Recovery research-only

Mechanism

Synthetic eight-amino-acid peptide that acts as a zonulin antagonist and tight-junction regulator, helping restore and maintain intestinal epithelial barrier function (reducing paracellular 'leaky gut' permeability). It was developed (as larazotide acetate, AT-1001 / INN-202) primarily for celiac disease as an adjunct to a gluten-free diet. It is not FDA-approved: a Phase 3 trial (CeDLara) in celiac disease was discontinued for futility, and the compound remains investigational with no approved human indication. The acetate salt form carries CAS 881851-50-9.

Studied uses

Identification

CAS number258818-34-7
Molecular formulaC32H55N9O10
SequenceGGVLVQPG
Typical dose0.25-0.5 mg taken orally three times daily before meals (clinical-trial dosing); acts locally in the gut lumen with minimal systemic absorption
Half-lifeMinimal systemic exposure; acts locally in the gastrointestinal tract rather than via sustained plasma levels

Safety

Not FDA-approved for any indication; clinical development for celiac disease did not demonstrate efficacy in Phase 3. Reported trial adverse effects were generally mild and gastrointestinal. Not a WADA-prohibited substance.

Vendors selling Larazotide

No vendor listings on file yet.

Research

Coeliac disease and the intestinal barrier: mechanisms of disruption and strategies for restoration
Damianos JA, Bledsoe A, Camilleri M, Murray JA. · Gut (2026) · review

Coeliac disease is characterised by immune-mediated damage to the small intestine in response to dietary gluten in genetically predisposed individuals. Increased intestinal permeability is a central component to its pathophysiology.

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Potassium-Competitive Acid Blocker Increases Ileal Permeability and Exacerbates Ileal Inflammation under Stress Conditions in a Mouse Model of Eosinophilic Enteritis
Yamamoto K, Tanaka F, Nishida Y, Maruyama H, Ominami M, Nadatani Y, Otani K, Fukunaga S, Hosomi S, Fujiwara Y. · Digestion (2026) · animal

Introduction Potassium-competitive acid blockers (P-CABs) have been empirically administered to treat non-esophageal eosinophilic gastrointestinal diseases, although their efficacy remains unproven.

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Beyond gluten-free diet: Novel therapeutic frontiers in celiac disease armamentarium
Mundhra SK, Kochhar RK. · World journal of gastrointestinal pharmacology and therapeutics (2026) · review

Celiac disease is a chronic, immune-mediated enteropathy triggered by dietary gluten ingestion in a genetically susceptible individual.

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Integrated Role of Microbial, Fungal, and Plant-Derived Interventions in the Management of Celiac Disease: A Narrative Review
Kubala K, Pietrucha T, Goldyn M, Grabinska M, Halik P, Jusiak J. · Cureus (2026) · review

Celiac disease (CeD) is a chronic autoimmune enteropathy triggered by gluten ingestion in genetically susceptible individuals carrying human leukocyte antigen (HLA)-DQ2 or HLA-DQ8 haplotypes.

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Preventive effects of Larazotide acetate (AT-1001) on non-alcoholic fatty liver diseases (NAFLD) in a mouse model
Huang YC, Chiang Chiau JS, Cheng ML, Lee HC, Chan WT, Chang SW, Chen YC, Yeung CY, Jiang CB. · Pediatrics and neonatology (2026) · animal
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Upcoming Treatments in Celiac Disease: From Luminal Enzymes to Oral Immune Tolerance
Taavela J, Elli L, Bouma G, Tye-Din JA, Schuppan D, Lundin KEA, Schumann M. · United European gastroenterology journal (2026) · review

Celiac disease (CeD) is a chronic autoimmune enteropathy triggered by dietary gluten in genetically predisposed individuals. Currently, a gluten-free diet (GFD) is the only available treatment, being effective in improving mucosal health and symptoms.

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A Study of Migalastat in Pediatric Subjects (2 to <12 Yrs) With Fabry Disease and Amenable GLA Variants
· ClinicalTrials.gov (2026) · rct

An open-label study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of migalastat treatment in pediatric subjects 2 to \< 12 years of age with Fabry disease and with amenable GLA variants.

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Viral spike antigen clearance and augmented recovery in children with post-COVID multisystem inflammatory syndrome treated with larazotide
Yonker LM, Kane AS, Swank Z, Papadakis L, Kenyon V, Han S, Lima R, Guthrie LB, Alvarez-Carcamo B, Lahoud-Rahme M, Balaguru D, Carroll RW, Lok J, El Saleeby C, Walt DR, Fasano A. · Science translational medicine (2025) · rct

Multisystem inflammatory syndrome (MIS) is a severe disease that occurs weeks to months after acute infection with SARS-CoV-2, often occurring in children (MISC). Symptoms include high fever, rash, nausea, diarrhea, and abdominal pain.

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Larazotide Acetate Protects the Intestinal Mucosal Barrier from Anoxia/Reoxygenation Injury via Various Cellular Mechanisms
Kim J, Madan JP, Laumas S, Krishnan BR, Jin Y. · Biomedicines (2025) ·

Background/Objective : Larazotide acetate (LA) is a synthetic octapeptide under development as a therapeutic candidate for celiac disease, acting to reduce intestinal permeability and regulate tight junctions (TJs).

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Antibacterial hyaluronic acid hydrogel with sustained release of larazotide as effective colitis treatment
Yu F, Chen Y, Ouyang S, Tong B, Jiang Z, Wang J, Ding B, Mao K, Wu W, Xu H. · Journal of controlled release : official journal of the Controlled Release Society (2025) ·

Gut barrier loss exacerbated gut microbiota dysbiosis by permitting pathogenic blooms, while gut microbiota dysbiosis caused the development of gut mucosal wounds by reducing mucus and breaking down epithelial tight junction.

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The PAR2 Antagonist Larazotide Can Mitigate Acute Histamine-Stimulated Epithelial Barrier Disruption in Keratinocytes: A Potential Adjunct Treatment for Atopic Dermatitis
Glinka DM, MacGregor GG. · JID innovations : skin science from molecules to population health (2025) ·

Atopic dermatitis (AD) is a chronic inflammatory skin condition with evidence of defects in the barrier properties of the epidermis. Changes in the permeability properties of the tight junction have been reported in AD, and reversing this leaky tight junction may be a potential treatment for AD.

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Rethinking Celiac Disease Management: Treatment Approaches Beyond the Gluten-Free Diet
Kounatidis D, Pavlou A, Evangelopoulos A, Psaroudaki M, Kotsi E, Petrakou I, Paraskevopoulos P, Stamatopoulos V, Mylona E, Vallianou NG. · Biomedicines (2025) · review

Celiac disease (CeD) is a chronic, immune-mediated enteropathy triggered by dietary gluten in genetically susceptible individuals, with environmental and epigenetic factors also contributing to its pathogenesis.

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New Therapeutic Challenges in Pediatric Gastroenterology: A Narrative Review
Dipasquale V, Romano C. · Healthcare (Basel, Switzerland) (2025) · review

Pediatric gastroenterology is entering a pivotal phase marked by significant challenges and emerging opportunities in treating conditions like celiac disease (CeD), eosinophilic esophagitis (EoE), inflammatory bowel disease (IBD), and autoimmune hepatitis (AIH) pose significant clinical hurdles, but new therapeutic ave…

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Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
· ClinicalTrials.gov (2019) · rct

To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.

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Safety, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged >12 Years) With Fabry Disease
· ClinicalTrials.gov (2019) · rct

This is a long-term, Open-label Study to Evaluate the Safety, Pharmacodynamics, and Efficacy of Migalastat in Subjects \> 12 Years of Age With Fabry Disease and Amenable GLA Variants

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A Phase 1 Study To Evaluate the Safety of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers
· ClinicalTrials.gov (2014) · rct

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV migalastat HCl alone and to determine absolute bioavailability for oral migalastat HCl as compared to IV administered migalastat HCl in healthy volunteers.

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A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A/AT1001 in Healthy Japanese Subjects
· ClinicalTrials.gov (2011) · rct

GR181413A/AT1001 (migalastat hydrochloride) is a low molecular weight iminosugar, an analog of the terminal galactose group that is cleaved from the substrate GL-3. This compound was researched and developed as a drug for treatment of Fabry disease.

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A 24-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease
· ClinicalTrials.gov (2006) · rct

Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.

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A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Female Participants With Fabry Disease
· ClinicalTrials.gov (2006) · rct

Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.

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Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects
· ClinicalTrials.gov (2006) · rct

This study was run to determine the safety, tolerance, and efficacy of multiple doses of larazotide acetate in subjects with celiac disease following a gluten challenge.

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