Larazotide Acetate
Peptide ·Exploratory record · not publication-reviewed ·Updated July 13, 2026
Larazotide acetate is an oral octapeptide zonulin-pathway antagonist investigated as an adjunct for celiac disease symptoms despite a gluten-free diet. It is not FDA-approved, and its phase 3 celiac disease program was discontinued after interim analysis did not support trial continuation. Earlier phase 2 signals make it biologically interesting, but it is not an approved leaky-gut or gluten-exposure treatment.
Exploratory record, not a reviewed medical publication.
See the editorial and medical-review policies for the publication gate.
This safety record covers a controlled, investigational, or otherwise out-of-scope substance. It remains available for reference, but it is not part of NutriStack's public supplement publication set.
What the research says.
A quick, data-only summary. The full evidence, dosing, and sources are below.
Larazotide Acetate is a peptide most often used for investigated for persistent celiac symptoms, designed to reduce tight-junction permeability, oral local gut peptide. NutriStack rates the overall evidence as emerging. A typical adult dose is Clinical trials commonly studied 0.5 mg three times daily before meals; no approved dose exists, commonly taken as investigational oral capsule only in clinical research. This profile indexes 3 sources.
The bottom line
Evidence rating emerging. Most-documented uses: investigated for persistent celiac symptoms, designed to reduce tight-junction permeability, oral local gut peptide. 3 sources indexed (2013–2022), with 0 interaction records on file.
How it works, mechanistically.
Core mechanism
Larazotide is designed to act locally in the gut lumen to reduce zonulin-mediated tight-junction opening and intestinal permeability after gluten exposure. The intended effect is barrier modulation rather than immune tolerance or gluten digestion. It does not permit gluten ingestion in celiac disease and does not replace a strict gluten-free diet.1,2
Dosing & protocol.
Trials administered larazotide before meals to act locally in the intestinal lumen. It is not a dietary supplement and should not be used to permit gluten exposure.1
What it actually costs.
Real-world pricing across three quality tiers. Assumes Investigational Oral Larazotide Capsule.
Research-market pricing is not a dosing recommendation; human use is not FDA-approved unless specifically stated. Updated 2026-06-04.
Full safety detail.
Side effects
- Nausea
- Abdominal discomfort
- Headache
- Diarrhea or constipation
- Failure to control celiac inflammation if used instead of gluten avoidance
Contraindications
Sources, by evidence tier.
Numbered references. Citations throughout the page link here.
Randomized controlled trials
2- 1Larazotide Acetate for Persistent Symptoms of Celiac Disease Despite a Gluten-Free Diet: A Randomized Controlled TrialLeffler DA et al. · Gastroenterology · 2015
0.5 mg dose improved symptom endpoint
- 2Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled studyKelly CP et al. · Alimentary Pharmacology and Therapeutics · 2013
Studied as adjunct during controlled challenge
Reference material
1- 39 Meters Biopharma Announces Interim Analysis of Phase 3 Study of Larazotide for Celiac Disease Does Not Support Trial Continuation9 Meters Biopharma · Company Press Release · 2022
CedLara phase 3 did not continue after interim analysis
Common questions.
Quick answers about Larazotide Acetate, drawn from the data on this page.
What is Larazotide Acetate?
Larazotide acetate is an oral octapeptide zonulin-pathway antagonist investigated as an adjunct for celiac disease symptoms despite a gluten-free diet. It is not FDA-approved, and its phase 3 celiac disease program was discontinued after interim analysis did not support trial continuation. Earlier phase 2 signals make it biologically interesting, but it is not an approved leaky-gut or gluten-exposure treatment.
What is Larazotide Acetate used for?
Commonly cited benefits of Larazotide Acetate include: Investigated for persistent celiac symptoms; Designed to reduce tight-junction permeability; Oral local gut peptide; Not FDA-approved. NutriStack rates the overall evidence as emerging.
What is a typical dose of Larazotide Acetate?
A typical adult dose of Larazotide Acetate is Clinical trials commonly studied 0.5 mg three times daily before meals; no approved dose exists. The commonly recommended form is Investigational oral capsule only in clinical research. These are general ranges, not personalized advice; confirm the right dose with a clinician.
What are the side effects of Larazotide Acetate?
Reported side effects include nausea, abdominal discomfort, headache, diarrhea or constipation, failure to control celiac inflammation if used instead of gluten avoidance. This is educational information; check with a healthcare professional before use.
How strong is the evidence for Larazotide Acetate?
NutriStack rates this as Emerging, meaning early RCT signal, mechanistic data, or limited human evidence. Full tier criteria are at https://nutristackapp.com/methodology/evidence-tiers.
Use this with your stack
Larazotide Acetate in NutriStack.
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