Oral peptide designed to close the junctions between intestinal cells and block gluten from entering in celiac disease. Its phase 3 was halted in 2022 for lack of efficacy.
FDA (US): Not approved (phase 3 CedLara discontinued in 2022 after an unfavorable interim analysis).
EMA (EU): Not approved.
Dose
There is no established dose in humans. In the phase 2b trial, the only effective dose was 0.5 mg orally three times a day (Gastroenterology 2015).
Safety
In trials its safety was comparable to placebo. It does not replace a gluten-free diet. Use only in clinical trials or research, under medical supervision; buying it is not recommended.
Effect by goal · level of evidence
Persistent celiac symptoms despite a gluten-free diet
improvesLow-moderateRCT (AA)in people
−26% days with symptoms
12-week trial in 342 adults: only the 0.5 mg dose reduced symptoms vs placebo (26% fewer days with symptoms); the 1 and 2 mg doses did not differ from placebo. The subsequent phase 3 was stopped for lack of efficacy.
In celiac disease, gluten increases intestinal permeability through the zonulin pathway. Larazotide acts locally in the intestine to keep the tight junctions between cells closed. The aim is to reduce the passage of gluten fragments that trigger the immune reaction.
What the evidence says
In people
Persistent celiac disease symptoms despite a gluten-free diet. 12-week trial in 342 adults: only the 0.5 mg dose reduced symptoms compared with placebo (26% fewer days with symptoms); the 1 and 2 mg doses did not differ from placebo. The later phase 3 trial was stopped for lack of efficacy. PubMed 25683116