Larazotide: Benefits, Dosage & FDA Status
Larazotide Acetate (AT-1001)
An 8-amino-acid oral peptide that tightens intestinal tight junctions by antagonizing zonulin signaling. The most-studied 'leaky gut' peptide with celiac trial data.
FDA Status
Not FDA-approved — Phase 3 completed for celiac disease (results mixed)
Typical Dose
0.5 mg three times daily before meals (oral)
Evidence Grade
B+Multiple clinical studies + widespread clinical use
Half-Life
Acts locally in the GI lumen
Routes of Administration
oral
First Synthesized
2007
Clinics Indexed
33 providers have offered Larazotide in our tracked directory.
Mechanism of Action
Zonulin antagonist that maintains intestinal tight-junction integrity, reducing paracellular passage of antigens.
Key Reported Benefits
- ✓Tight-junction restoration
- ✓Intestinal permeability reduction
- ✓Celiac symptom reduction
Benefits listed reflect commonly reported effects from clinical trials and practitioner use. Individual response varies. Evidence-grade B+ indicates multiple clinical studies + widespread clinical use.
Reported Side Effects
- •Mild GI upset
- •Headache
Contraindications
- ⚠Pregnancy
Commonly Stacked With
Larazotide vs Other Peptides
Regulatory & Safety Context
FDA status: Not FDA-approved — Phase 3 completed for celiac disease (results mixed)
This page is for educational purposes only and does not constitute medical advice. Peptide use outside of an FDA-approved indication should be discussed with a licensed medical professional. Source quality, cold-chain storage, and injection hygiene all materially affect safety outcomes.
See state-by-state legality: US peptide legality by state →
References
Selected primary literature on Larazotide. Full PubMed records linked. Additional citations are available on request.
Last reviewed: 2026-04-30
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