GastrointestinalIn Clinical Trials

Larazotide

Oral

Overview

A synthetic octapeptide derived from Vibrio cholerae zonula occludens toxin that acts as a tight junction regulator. Larazotide acetate modulates intestinal permeability by preventing zonulin-mediated opening of tight junctions between enterocytes.

Mechanism of Action

By reducing paracellular permeability, it aims to prevent gluten peptide translocation across the intestinal barrier in celiac disease, reducing the immune-mediated inflammatory response triggered by gluten exposure..

Research Summary & Key Findings

Phase 2b trial showed significant reduction in celiac disease symptoms and improved lactulose-to-mannitol ratio (a marker of intestinal permeability) in patients on a gluten-free diet exposed to gluten challenge (Leffler et al., Gastroenterology, 2015). Phase 3 trials ongoing as adjunctive therapy for celiac disease. If approved, would be the first pharmacological treatment for celiac disease beyond dietary gluten avoidance.

Clinical Status

In Clinical Trials

Larazotide is currently undergoing clinical trials. It is not yet FDA-approved and is available only through clinical research settings or investigational protocols.

Administration Routes

Oral

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol.