# Larazotide

An oral peptide meant to tighten the seals between gut-lining cells. It was the leading drug candidate for celiac disease until 2022, and is now marketed online for leaky gut.

Also called: AT-1001, INN-202
Source page: https://peplogue.com/peptides/larazotide/
Reviewed: 2026-10-12. Not medical advice.

## How it works

- Where it acts: Thought to tighten the junctions between gut-lining cells.
- What it changes: Less leakage of gluten fragments through the gut wall in lab studies.
- What people notice: Its phase 3 trial in celiac disease stopped for lack of benefit. It was well tolerated.

## What the evidence shows

- **Celiac symptoms despite a gluten-free diet**: Failed. In phase 2, only the lowest of three doses beat placebo. The phase 3 trial stopped in June 2022 after an interim look showed it would need far more patients to have a chance of success.
- **Leaky gut**: Lab only. Not a recognized diagnosis, and not tested in a trial.

## Side effects and risks

- common: Side effects matched placebo in the trials.

Who should avoid it: Relying on it in place of a gluten-free diet.

## How it has been given in studies

Capsules of 0.25 mg to 2 mg three times a day, 15 minutes before meals.

## Legal status

- United States: undefined. Not approved anywhere.
- European Union: undefined. Not approved anywhere.
- Spain: undefined. No larazotide medicine in CIMA; it is not approved anywhere. Not authorised in Spain and not lawful to sell to the public.
- Germany: undefined. Not approved anywhere, so no lawful medicine in Germany. Selling it breaches the AMG (§ 21, § 96).
- France: undefined. Not approved anywhere; no French authorisation. Any online offer is an unapproved medicine.
- Italy: undefined. No Italian authorisation found. Not lawful to sell to the public as a medicine. Research-grade vials online are unverified products.
- Netherlands: undefined. Not approved anywhere, so no Dutch authorisation. Selling it as a medicine is illegal per IGJ.
- United Kingdom: undefined. Not approved anywhere.
- Canada: undefined. Not approved anywhere.
- Australia: undefined. Not approved anywhere.

## Questions people ask

**Does larazotide work for celiac disease?**

In phase 2, only the lowest of three doses beat placebo. The phase 3 trial stopped in June 2022 after an interim look showed it would need far more patients to have a chance of success.

**Does larazotide help leaky gut?**

Leaky gut is not a recognized diagnosis, and larazotide has not been tested for it in a trial.

**Is larazotide approved?**

No, it is not approved anywhere, and it should not be relied on in place of a gluten-free diet.

**Is larazotide safe?**

Side effects matched placebo in the trials.

## Sources

- Leffler et al. 2015: larazotide in celiac disease, phase 2b: https://pmc.ncbi.nlm.nih.gov/articles/PMC4446229/
- 9 Meters Biopharma: phase 3 trial discontinued (21 Jun 2022): https://www.sec.gov/Archives/edgar/data/0001551986/000155198622000046/ex-991pressreleasedated621.htm