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Frequently Asked Questions
What is larazotide acetate?
Larazotide acetate is a locally acting, nonsystemic oral octapeptide designed to stabilize intestinal tight junctions and reduce paracellular permeability ('leaky gut'). It was developed primarily as an adjunct to a gluten-free diet in celiac disease.
Is larazotide FDA-approved?
No. The Phase III CeDLara trial in celiac disease was discontinued in 2022 because larazotide did not separate from placebo on the primary endpoint. Larazotide is not FDA-approved for any indication and has no commercially available pharmaceutical product in the US.
What does the human evidence actually show?
The strongest reproducible signal was symptom improvement at 0.5 mg three times daily in celiac patients on a gluten-free diet (Leffler et al., Gastroenterology 2015). Phase III did not confirm this signal. Evidence for non-celiac 'leaky gut' indications is preliminary and largely based on mechanistic and animal data.
Is larazotide safe?
Across Phase IIb/III trials, larazotide had a safety profile similar to placebo. Because it is nonsystemic and acts locally in the gut lumen, adverse effects have been minimal and primarily gastrointestinal.
Can I get larazotide acetate?
Limited compounded forms have appeared through some specialty pharmacies, but availability is inconsistent and clinical use is investigational. There is no FDA-approved commercial product.
Is it the same as zonulin antagonists sold OTC?
No. OTC 'zonulin' supplements have no demonstrated mechanistic equivalence to larazotide and are not the same molecule. Larazotide is a defined synthetic octapeptide studied in controlled trials.
Who would consider larazotide?
It has been studied as an adjunct in celiac patients with persistent symptoms despite a strict gluten-free diet. Given Phase III failure, most clinicians do not actively prescribe larazotide, and patients pursuing it should do so only under a clinician familiar with the current evidence.
How do I find a doctor familiar with larazotide?
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