Larazotide
Status
No approved product. No FDA-approved labeling exists. Larazotide completed phase 3 development for coeliac disease without meeting its endpoint; no approval elsewhere is listed in this entry's sources.
What it is
An oral peptide studied in celiac disease trials for gut barrier function.
What published research measured
An eight-amino-acid peptide that acts locally in the gut lumen to tighten intestinal epithelial tight junctions, developed as an adjunct for coeliac disease in patients who remain symptomatic on a gluten-free diet. It is one of the few compounds in this library to have completed a phase 3 trial, and the honest result is that the trial did not succeed — the CedLara study was halted after an interim analysis found it unlikely to meet its primary endpoint, following phase 2 results that had been positive at the lowest dose tested. It is not absorbed systemically by design, which gives it a favourable safety profile. Use for non-coeliac intestinal permeability, the reason it usually appears outside gastroenterology, has no supporting trial evidence.
Source
Phase 2 coeliac disease trials · CedLara phase 3 trial halted at interim analysis
Sources
No linked primary source is on file for this entry yet.
Educational use only, never medical advice. No doses.