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PeptideLegally CompoundedClinical Trials

Larazotide

About

About Larazotide

Larazotide acetate (AT-1001) is a tight junction regulator peptide that reduces intestinal permeability ('leaky gut') and has been studied in celiac disease and non-celiac gluten sensitivity. It acts locally in the gut without significant systemic absorption, giving it a highly targeted safety profile. Clinical trials in celiac disease show reduction in gluten-induced symptoms and gut permeability markers. Compounded versions are available for off-label gut health applications.

Science

Mechanism of Action

Competitively inhibits zonulin's activation of tight junction proteins (occludin, claudins), preventing paracellular permeability increases and blocking translocation of antigens and inflammatory molecules across the intestinal epithelium.

Dosing

Typical Protocol

0.5–1 mg oral capsule 3x daily before meals.

⚠ Protocol information is for educational purposes only. Dosing must be determined by a licensed physician based on individual health status and goals.

Regulatory

Legal Status in 2026

Legally Compounded

This compound is legal to prescribe and dispense through a licensed 503A or 503B compounding pharmacy with a valid prescription. It is not FDA-approved as a finished drug product, but compounding is explicitly permitted under federal law. Quality and sterility standards vary by pharmacy — look for PCAB-accredited compounders.

Evidence

Evidence Tier

Clinical Trials

Evidence from randomized controlled trials (RCTs) or large observational studies in humans. This is the gold standard — effects have been measured in controlled conditions and results are peer-reviewed and reproducible.

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