What is the role of Larazotide (larazotide acetate) in the treatment of celiac disease?

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Last updated: July 6, 2025View editorial policy

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From the Research

Larazotide acetate is a potential adjunct therapy to a gluten-free diet for the treatment of celiac disease, with the most promising results observed at a dose of 0.5 mg. The medication works by regulating tight junctions in the intestinal epithelium, preventing the opening of tight junctions between intestinal cells, which helps reduce the passage of gluten peptides and other harmful substances through the intestinal barrier 1. This mechanism may help reduce intestinal inflammation and symptoms in celiac patients who experience continued symptoms despite following a strict gluten-free diet. Some key points to consider about larazotide acetate include:

  • It is not yet FDA-approved, but has shown promise in clinical trials as a potential adjunct therapy to a gluten-free diet 1, 2.
  • The most promising results have been observed at lower doses, particularly 0.5 mg 1.
  • While larazotide does not allow celiac patients to freely consume gluten, it may help manage symptoms from inadvertent gluten exposure and reduce intestinal permeability 1, 2.
  • The medication appears to have a favorable safety profile with minimal side effects reported in trials 1, 2.
  • Patients should understand that even if larazotide becomes commercially available, maintaining a strict gluten-free diet would remain the cornerstone of celiac disease management 3. It's also worth noting that larazotide acetate is one of several potential therapeutic options being developed for the treatment of celiac disease, and it may have a complementary role to gluten withdrawal, mainly to prevent inadvertent gluten contamination 3. Overall, larazotide acetate shows promise as a potential adjunct therapy to a gluten-free diet for the treatment of celiac disease, and further research is needed to fully understand its efficacy and safety.

References

Research

Therapeutic options for coeliac disease: What else beyond gluten-free diet?

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 2020

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