Larazotide Reference

Plain English

What it is

Larazotide is an experimental peptide taken by mouth. It is meant to help tighten the tiny junctions between the cells that line the gut. It is not approved by the FDA for any use and has only been tested in clinical trials.

What people use it for

It was studied in people with celiac disease who still had gut symptoms even while eating a strict gluten-free diet. The idea was to use it on top of the gluten-free diet, not in place of it.

What the science shows

An earlier mid-stage (Phase 2) trial found that the lowest amount eased symptoms better than a gluten-free diet alone. But the larger, later Phase 3 trial called CeDLara was stopped early in 2022 because an outside review found it was not working well enough to keep going.

The catch

Larazotide is investigational and not an approved medicine, so it is not something a person can rely on as proven. It is not a replacement for a gluten-free diet or for celiac care guided by a doctor.

Reference summary

Peer-reviewed Phase 2b data (Leffler 2015) showed symptom improvement in celiac patients with persistent symptoms on a gluten-free diet, but the subsequent Phase 3 CeDLara trial was stopped early for futility in 2022. pepSmart presents larazotide only as trial-context educational content.

Regulatory and posture

Categories

Immune, Recovery

Aliases

Larazotide acetate, AT-1001, INN-202

Evidence posture

human - Human Phase 2 data exist, but the Phase 3 CeDLara celiac trial was discontinued in 2022 for futility; larazotide remains investigational with no approved product.

Regulatory status

Investigational. Larazotide acetate is a tight-junction regulator studied as an oral add-on to gluten-free diet in celiac disease. The Phase 3 CeDLara trial was discontinued in 2022 after an interim futility analysis; no FDA-approved drug label currently exists.

Content review status

investigational verified

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• Protocol builder overview - Public overview of the Pro protocol builder.