An 8-amino-acid synthetic peptide researched as an oral adjunct for celiac disease and intestinal-barrier ('leaky gut') dysfunction.
Not approved anywhere. It reached the most advanced stage of any celiac-disease drug candidate, then failed.
Also known as: Larazotide acetate, AT-1001, INN-202
Acts as a zonulin antagonist, blocking zonulin-induced opening of intestinal tight junctions. Promotes rearrangement of tight-junction proteins and actin, tightening the epithelial barrier and reducing paracellular permeability to antigens such as gliadin.
Larazotide was designed to reduce gut permeability in celiac patients who remain symptomatic on a gluten-free diet. It looked promising in a phase 2b trial of 342 adults, meeting its primary endpoint at the low dose. But the pivotal phase 3 CeDLara trial, begun in 2019, was discontinued in 2022 after an interim analysis concluded the effect size was too small to reach significance without an impractically large sample — a clear negative outcome. Early phase 2 success did not replicate. The mechanism remains scientifically plausible; the failure is attributed to modest effect size and endpoint sensitivity.
We report both positive and negative trial results. For exact study protocols, read the sources — we cite them rather than repackage them.
Bars reflect the strength & volume of research evidence for each use — not a guarantee of results.
Generally well tolerated in trials, with adverse events broadly comparable to placebo. Because it is minimally absorbed and acts locally in the gut, systemic exposure is low. The programme was stopped for lack of efficacy, not safety.
Not a stacking compound. In celiac research it is discussed alongside gluten-degrading enzyme and immune-tolerance approaches rather than combined with other peptides.
Mechanistic context only — we don't publish combinations, amounts or protocols.
Unlike the broad anti-inflammatory positioning of KPV or BPC-157, larazotide has a narrow, specific mechanism — sealing intestinal tight junctions — and, unusually for this list, actually completed rigorous late-stage human trials, which it failed.
No. Its phase 3 trial was halted in 2022 for insufficient efficacy.
A common misconception is that early success guarantees approval. The larger phase 3 could not reproduce a statistically meaningful effect.
No. It was studied only as an adjunct to a gluten-free diet, never a replacement.
No reviews yet. If you've used Larazotide, be the first to share what it helped with and any side effects.
⚠️ Educational research information only — not medical advice. Many peptides are sold strictly for laboratory research and are not approved treatments. The evidence scores reflect research interest and strength, not efficacy or safety for any individual. Always consult a qualified professional.