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Human trialsRepair AT-1001, INN-202

Larazotide acetate

The most rigorously tested 'leaky gut' peptide — and it failed its phase 3.

Class
Octapeptide tight-junction regulator
Molar mass
~724 g/mol
Half-life
Minimal systemic absorption
Human PK
Published
Regulatory
Not approved — phase 3 discontinued
Sport
Not listed

What it is claimed to help

These are the uses attached to Larazotide acetate in research, clinical practice, or marketing. Listing a claim is not endorsing it — tap any of them to see every other compound carrying the same claim.

What the human evidence actually is

Grade: Human trials

Randomised controlled human trials exist. Not necessarily approved, and not necessarily positive.

Extensive and instructive. Phase 2 trials in celiac disease showed symptom benefit and drove enormous interest. The phase 3 CeDLara trial was stopped for futility in 2022 after an interim analysis. This is the clearest example on the site of a peptide with promising early human data that did not survive a proper trial.

How it is supposed to work

Zonulin antagonist that tightens intestinal epithelial tight junctions, acting locally in the gut lumen with almost no systemic absorption.

Safety

Well tolerated across trials — the problem was efficacy, not safety.

Storage and handling

Lyophilised peptide is generally stored at 2–8 °C, or below −20 °C for long-term storage. Reconstituted in bacteriostatic water (0.9% benzyl alcohol) a solution is typically treated as usable for about 28 days refrigerated, versus roughly 24 hours for plain sterile water, which has no preservative. Add the water slowly down the vial wall and swirl — never shake, which shears peptide chains and foams the solution.

The arithmetic is the dangerous part

Whatever number a protocol or a prescriber gave you, converting it into syringe units is where a misplaced decimal becomes a tenfold error. Our calculators do that conversion and nothing else — they never invent a dose.

Open the calculators

Sources

  1. Leffler DA et al. Larazotide phase 2b, Gastroenterology 2015
  2. 9 Meters Biopharma CeDLara phase 3 discontinuation announcement, 2022

Verified against primary sources on 27 August 2026. Regulatory status in this field changes several times a year. See How We Rate Evidence.

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