Larazotide: Patient Information & Safety Notes
Also known as AT-1001
Other names: at-1001
Larazotide acetate is a synthetic 8-amino-acid peptide that acts as a tight junction regulator, reducing intestinal permeability ("leaky gut"). It has been studied in Phase 2 and Phase 3 clinical trials for celiac disease but has not received FDA approval.
In plain language
What Larazotide Acetate is used for
- Investigated in clinical trials for celiac disease and intestinal permeability
Taking this medicine
How it is administered
- Oral capsule
Read before you decide
Risks and precautions
Risks and warnings
- Nausea, headaches, abdominal discomfort, mild cramping (reported in clinical trials)
- Clinical benefit not established — Phase 3 trial did not meet its primary endpoint
Who should not take it
- Safety not established in severe renal or hepatic impairment
- Pregnancy or breastfeeding (insufficient safety data)
Common questions
Patient questions
Is larazotide approved for celiac disease?
No. Larazotide acetate has been studied in clinical trials for celiac disease but has not been FDA-approved. A Phase 3 trial did not meet its primary endpoint. Individuals with celiac disease should follow a gluten-free diet and work with a gastroenterologist for evidence-based management.
Is larazotide the same as a gluten blocker?
No. Larazotide does not block gluten digestion. It was studied as a tight junction modulator intended to reduce intestinal permeability associated with celiac disease. It is not an approved treatment and should not replace gluten avoidance.
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This information is educational — not medical advice.
This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.