Larazotide
Larazotide Acetate (AT-1001)
Also known as: AT-1001
An investigational gut-barrier peptide for celiac disease that reached Phase 3 but was terminated by the sponsor without a published result.
Overview
Larazotide acetate is an orally active peptide that tightens the intestinal barrier by acting as a zonulin antagonist, aiming to reduce the leaky-gut response to gluten in celiac disease. It advanced to Phase 3, but the pivotal trial was terminated by the sponsor without a published result, and it is not approved. It remains one of the most clinically studied gut-barrier peptides.
Mechanism of action
Antagonizes zonulin signaling to strengthen intestinal tight junctions and limit passage of gluten fragments across the gut lining.
Key studies & citations
- Human2013
Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study
184 patients on a gluten challenge: 1 mg larazotide limited gluten-induced symptoms and blunted the rise in anti-tTG antibodies, but intestinal permeability (LAMA ratio) did not differ from placebo.
Alimentary Pharmacology and Therapeutics - Human2015
Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial
Phase 2b in 342 adults: the 0.5 mg dose met the primary symptom endpoint versus placebo; higher doses did not.
Gastroenterology - Human2022
A Phase 3 study of larazotide acetate for the relief of persistent symptoms in patients with celiac disease on a gluten-free diet (NCT03569007)
The pivotal Phase 3 (307 enrolled, sponsor 9 Meters Biopharma) is listed as terminated by the sponsor; no efficacy result was published.
ClinicalTrials.gov
Frequently asked questions
Is larazotide approved for celiac disease?
No. Despite reaching Phase 3, its main trial was terminated by the sponsor without a published result, and it is not approved.