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.
- 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
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
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