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InvestigationalClinical / approved drugOralEvidence 2/5

Larazotide

Also known as: Larazotide acetate, AT-1001

An oral, gut-restricted peptide that antagonizes zonulin signaling to limit gluten-driven intestinal tight-junction permeability in celiac disease.

This page is a structured profile. Narrative evidence, dosing context and FAQs live on the research guide — not duplicated here as a second full article.

Illustrative oral database profile for Larazotide
Illustrative profileOral
Database profileInvestigational
LarazotideClinical / approved drug
Drug class
Tight-junction regulator / zonulin antagonist
Primary targets
Zonulin / tight junctions
Dose reference
Investigational; 0.5 mg orally three times daily in trials
Half-life
Minimal systemic absorption (gut-restricted)
Developer / origin
Alba Therapeutics / 9 Meters Biopharma
Reference year
2005
Evidence score
2/5 - Investigational — failed pivotal trial
Evidence 2/5

Investigational — failed pivotal trial

Larazotide showed positive phase 2 symptom data at the low 0.5 mg dose, but the pivotal phase 3 CeDLara trial was discontinued for futility in 2022 and it is not approved.

Mostly animal, ex vivo, cell, or indirect evidence.

Evidence basis

  • Phase 2b trial in 342 adults met its primary endpoint only at the 0.5 mg dose
  • Gluten-challenge trials showed reduced gluten-induced symptoms at low doses
  • Phase 3 CeDLara halted for futility (2022)
  • Tolerability comparable to placebo; no regulatory approval

How to read this entry

Dose references and half-life values are pulled from trial protocols, labels, reviews, or published summaries where available. They are context for research and comparison, not a personal dosing recommendation.

Status matters: approved drugs have regulated indications; investigational compounds are still being studied; research-only peptides do not have established human dosing, safety, or efficacy for consumer use.

Larazotide guides

Read the matching guide or adjacent research pages for more context.

Peptide calculators

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