Larazotide
A zonulin antagonist — the most clinically advanced "leaky gut" candidate, with positive Phase 2b data in celiac disease but a failed Phase 3 trial readout in 2022.
A synthetic 8-amino-acid peptide antagonist of zonulin that stabilizes tight junctions between intestinal epithelial cells, developed by Alba Therapeutics / 9 Meters Biopharma specifically for the non-celiac-enteropathy "leaky gut" pathophysiology.
Mechanism of action
Blocks zonulin-mediated disassembly of intestinal tight junctions, maintaining epithelial barrier integrity. Prevents paracellular passage of gluten-derived peptides and other luminal antigens that would otherwise trigger mucosal inflammation. Administered orally and acts within the intestinal lumen.
Primary uses
- Celiac disease (investigational adjunct to gluten-free diet)
- Environmental enteric dysfunction research
- Community off-label use for "leaky gut" / increased intestinal permeability
Typical dosing
Clinical trial dose was 0.5 mg three times daily before meals. Community use mirrors this.
Regulatory status
Phase 3 CeDLara trial (9 Meters Biopharma) missed its primary endpoint in celiac disease in June 2022. Company later declared bankruptcy. IP and follow-on development reportedly continuing under new sponsors as of 2026.
References
- [clinical-trial] Leffler DA, et al. "Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial." Gastroenterology, 2015;148:1311-1319.
- [clinical-trial] 9 Meters Biopharma. "CeDLara Phase 3 trial topline results." June 2022. (Primary endpoint not met.)
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Guides & tools
This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.