Peptide Profile
AT1001 · Larazotide acetate
Larazotide acetate (AT-1001) is a synthetic octapeptide zonulin antagonist that reduces intestinal permeability by blocking zonulin-mediated disassembly of intestinal epithelial tight junctions, studied as an adjunctive treatment…
Educational research information — not medical advice. Review primary sources and consult a qualified professional before any decision.
Educational research tools — not medical advice.
Synthetic octapeptide that prevents zonulin-mediated tight junction opening; maintains intestinal epithelial barrier integrity
Larazotide acetate (AT-1001) is a synthetic octapeptide zonulin antagonist that reduces intestinal permeability by blocking zonulin-mediated disassembly of intestinal epithelial tight junctions, studied as an adjunctive treatment to reduce symptom burden in celiac disease patients during inadvertent or deliberate gluten exposure. By inhibiting zonulin receptor signaling, larazotide prevents the disruption of tight junction proteins — including occludin and claudins — that would otherwise permit immunogenic gluten peptides to traverse the epithelial barrier and trigger the CD4+ T-cell-mediated mucosal injury characteristic of active celiac disease. A Phase 2 randomized, double-blind trial published in The American Journal of Gastroenterology demonstrated that larazotide acetate reduced activation of celiac disease during gluten challenge; however, the Phase 3 trial published in Gastroenterology, designed to evaluate larazotide for persistent symptoms in celiac disease patients already following a gluten-free diet, did not meet its primary endpoint. Larazotide has not received FDA approval; no NDA has been filed following the Phase 3 outcome, and it remains an investigational compound with no approved indication.
Population research notes
These signals reflect research interest areas, not treatment indications.
Larazotide acts locally in the gut and is essentially not absorbed into the bloodstream, so a systemic plasma half-life doesn't apply.
based on 3 studies · 2 RCTs · most recent 2026
Tight junction regulator (AT-1001) for celiac disease. Phase 3 ILIT-1 (NCT02633956) failed primary endpoint 2019. No NDA filed. Additional Phase 3 planned by ImmunoGenX. Investigational.
Regulatory status reflects publicly available information and may change. This is not legal or medical advice.
3 sources cited · 1 strong · 2 moderate
2 RCTs · 1 Cohort
Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial
Gastroenterology · 2015
In a 12-week phase 2 multicenter randomized controlled trial, larazotide acetate 0.5 mg three times daily significantly reduced celiac disease gastrointestinal symptoms compared with placebo in adults with celiac disease on a gluten-free diet, with 26% fewer symptomatic days and improvements in abdominal pain and non-gastrointestinal symptoms including fatigue.
Potassium-Competitive Acid Blocker Increases Ileal Permeability and Exacerbates Ileal Inflammation under Stress Conditions in a Mouse Model of Eosinophilic Enteritis.
Digestion · 2026
# Summary Research found that potassium-competitive acid blockers (P-CABs) increased intestinal permeability and worsened eosinophilic enteritis inflammation in mice exposed to psychological stress, while larazotide acetate (a zonulin inhibitor) demonstrated potential therapeutic benefit by reducing permeability and improving inflammation in this setting. This study demonstrated that the detrimental effects of P-CABs on the intestinal barrier appear to be stress-dependent and may be reversible through zonulin inhibition.
A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge
American Journal of Gastroenterology · 2012
Research in a dose-ranging randomized controlled trial found that lower doses of larazotide acetate appeared to limit gluten-induced worsening of gastrointestinal symptoms in patients with celiac disease during a 14-day gluten challenge, supporting intestinal tight junction regulation as a therapeutic target for gluten sensitivity.
Research-use compound with limited human data. Evidence strength varies — see the Evidence section.
No established clinical contraindications. This is an investigational compound with limited human data and has not been evaluated by the FDA for safety in this context. Consult a qualified clinician.
Consult a qualified healthcare professional before making any health decisions. This information is educational only and does not constitute medical advice.
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VSLarazotide
Larazotide acetate (AT-1001) is a synthetic octapeptide zonulin antagonist that reduces intestinal permeability by blocking zonulin-mediated disassembly of intestinal epithelial tight junctions, studied as an adjunctive treatment to reduce symptom burden in celiac disease patients during inadvertent or deliberate gluten exposure. By inhibiting zonulin receptor signaling, larazotide prevents the disruption of tight junction proteins — including occludin and claudins — that would otherwise permit immunogenic gluten peptides to traverse the epithelial barrier and trigger the CD4+ T-cell-mediated mucosal injury characteristic of active celiac disease.
tight junction restoration, intestinal barrier repair, leaky gut prevention.
Research on Larazotide primarily documents effects related to tight junction restoration and intestinal barrier repair and leaky gut prevention. These are areas covered in preclinical and clinical literature — individual response varies and effects depend on context of use.
For Larazotide, its FDA status is investigational (not FDA-approved), and it is designated for research use only. Regulatory status reflects publicly available information and may change. This is not legal or medical advice.
5 providers in the directory currently offer Larazotide.
Larazotide is tracked across 3 research vendors on PeptideBase, with per-mg prices ranging $9.00–$9.99. This reflects research-use vendor pricing, not clinical or prescription costs.
In a 12-week phase 2 multicenter randomized controlled trial, larazotide acetate 0.5 mg three times daily significantly reduced celiac disease gastrointestinal symptoms compared with placebo in adults with celiac disease on a gluten-free diet, with 26% fewer symptomatic days and improvements in abdominal pain and non-gastrointestinal symptoms including fatigue.
Larazotide is featured in the following research stacks on PeptideBase: KPV + Larazotide: Gut Barrier & Anti-Inflammatory.
Price per mg varies by quantity, vendor type, and formulation. Research use only.
Data verified July 2026 · Larazotide price intelligence
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