What the studies show
Tolerability across the phase 2 programme was broadly similar to placebo; larazotide is not absorbed to any meaningful extent and acts in the gut lumen. Safety was never the obstacle.
A few small or poorly-controlled human studies. Enough to be interesting; not enough to count on. Most of what gets called “clinically proven” online lives here.
In context
Larazotide is a synthetic eight-amino-acid peptide taken by mouth to tighten the junctions between intestinal cells, developed as the first drug for persistent symptoms in coeliac disease despite a gluten-free diet. Its 342-person phase 2b trial met its primary endpoint at the lowest of three doses while the two higher doses did no better than placebo. The phase 3 trial, CeDLara, was stopped in 2022 after an interim analysis showed it was unlikely to succeed. It is not approved anywhere.
Larazotide is investigational (phase 3 discontinued). Legal status differs by country — see the regulation section or the jurisdiction pages.
Questions
Is Larazotide proven to cause safety?
What studies are behind the grade?
Is Larazotide approved for this?
Other outcomes for Larazotide
- CCoeliac symptoms on a gluten-free diet1 phase 2b RCT (n=342, 12 wk)
- CDose–response1 phase 2b RCT (n=342)
- AConfirmation in phase 31 phase 3 RCT stopped at interim analysis
Written and maintained by LYO Research — how pages are written and checked. Reviewed 29 October 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →