Gut HealthEstablishedHuman trials

Larazotide

Larazotide Acetate (AT-1001)

Overview

Larazotide acetate is a synthetic 8-amino-acid peptide derived from Zonula Occludens Toxin that acts as a tight junction regulator reducing intestinal permeability. It has completed Phase 2 clinical trials for celiac disease demonstrating significant reductions in intestinal permeability and symptoms. Larazotide is notable as a targeted pharmacological approach to intestinal barrier function — addressing the leaky gut mechanism that underlies multiple inflammatory and autoimmune conditions beyond celiac disease.

Mechanism of Action

Larazotide acts as a competitive antagonist of zonulin — an endogenous protein that regulates tight junction permeability in the intestinal epithelium. Zonulin triggers the disassembly of tight junction proteins (claudins occludin ZO-1) increasing intestinal permeability and allowing luminal antigens to cross the epithelial barrier and trigger immune activation. By blocking the zonulin receptor on epithelial cells larazotide prevents tight junction disruption maintaining the intestinal barrier integrity. This mechanism is particularly relevant in celiac disease where gliadin triggers zonulin release causing the intestinal permeability that allows gluten peptides to trigger the immune response. Clinical trials have demonstrated reductions in intestinal permeability markers and symptom improvements even during gluten exposure.

Dosage Information

Typical Dose

0.5-2 mg three times daily (Phase 2 trial doses)

Frequency

Three times daily before meals

Administration

Oral capsule

Notes

Phase 2 trials completed for celiac disease. Not yet FDA approved. Research use as a tight junction stabilizer for leaky gut applications. Oral bioavailability is intentionally limited — local gut action is the therapeutic target.

Where does Larazotide sit?

See how this peptide compares across all 111 peptides in our database.

Evidence Score

0.70

Clinical trials
1.0035%
Literature
0.7430%
Community
0.0020%
Completeness
0.8815%
1 RCTs18 reviews

Compound Data

Larazotide structure

Molecular Formula

C32H55N9O10

Molecular Weight

725.80 g/mol

IUPAC Name

2-[[(2S)-1-[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[2-[(2-aminoacetyl)amino]acetyl]amino]-3-methylbutanoyl]amino]-4-methylpentanoyl]amino]-3-methylbutanoyl]amino]-5-oxopentanoyl]pyrrolidine-2-carbonyl]amino]acetic acid

PubChem CID

9810532

Potential Side Effects

Generally well tolerated in clinical trialsHeadache (uncommon)Nausea (uncommon)Upper respiratory tract infection (uncommon in trials)

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Quick Facts

Administration
Oral capsule
Typical Dose
0.5-2 mg three times daily (Phase 2 trial doses)
Frequency
Three times daily before meals
References
0 curated + 49 from PubMed
Clinical Trials
28 registered
Evidence Score
0.7 / 100