Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.
FDA status
Investigational
Investigational. No FDA-approved larazotide product. A phase 3 celiac study was stopped for futility.
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Evidence tier
Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 3/5. 106 PubMed citations indexed.
Larazotide acetate is a synthetic octapeptide derived from the Vibrio cholerae zonula occludens toxin (ZOT) sequence that acts as a tight junction regulator by competitively blocking zonulin receptors
What the literature studies
Immune Research
Evidence tier
Human RCT
Compounding record
Status not verified
Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.
Regulatory source not verified; no checked date is assigned.
The Phase 3 CeDLara celiac disease trial was discontinued in 2022-2023 due to futility (insufficient effect size to power the study)
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Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.