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.)
Related peptides
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.