Larazotide

Larazotide Acetate (AT-1001)

Evidence & Status

  • Moderate Evidence
  • Moderate

At a Glance

A synthetic octapeptide under investigation, including celiac-disease and Long-COVID research contexts.

Plain English

Larazotide remains investigational; trial status does not establish a treatment recommendation.

Overview

A synthetic octapeptide investigated in celiac disease. It is investigational and has no FDA-approved indication.

Research Summary

NCT01396213 is a completed Phase 2B celiac-disease study. NCT03569007 is a Phase 3 trial terminated by the sponsor on July 21, 2022; it is not described as a completed negative Phase 3 study. NCT05747534 is a recruiting Phase 2 Long-COVID/PASC protocol and supports protocol/status only, not efficacy or established treatment.

Research Areas

  • Intestinal barrier function
  • Tight junction modulation
  • Celiac disease
  • Non-celiac gluten sensitivity
  • Leaky gut
  • Inflammatory bowel disease

Safety & Risks

Serious Risks

  • Long-term safety data are limited.
  • No FDA-approved indication.

Reported Side Effects

  • Headache
  • Nausea
  • Diarrhea (mild; generally well-tolerated in trials)
United States
Investigational only; not approved
United Kingdom
Investigational only
Australia
Investigational only
Canada
Investigational only

Citations & Sources