At a glance
| Aliases | AT-1001; INN-202 |
|---|---|
| Studied route | Oral |
| Primary development area | Celiac disease adjunct therapy |
| Pivotal history | Celiac program discontinued in 2022 |
| Approval | No FDA-approved medicine identified |
Overview
Also known as AT-1001 or INN-202, larazotide was developed to influence epithelial tight junctions, the structures that help control movement between intestinal cells. A randomized phase 2 study enrolled adults with persistent celiac symptoms despite a gluten-free diet. Only the lowest studied group met the primary symptom endpoint, while higher groups did not. The subsequent phase 3 celiac program did not deliver an approval and was discontinued in 2022. Other investigational interest does not reverse that evidence history or validate broad claims about treating an undefined 'leaky gut' syndrome.
How it works
Larazotide is intended to regulate tight-junction behavior and reduce excessive paracellular permeability. Development research links its activity to pathways involved in gliadin-associated barrier disruption rather than directly digesting gluten or eliminating celiac autoimmunity. The mechanism is biologically plausible but does not establish that treated patients can safely abandon dietary avoidance, nor that all gastrointestinal symptoms arise from the same barrier defect.
The question studied in celiac disease
The phase 2 trial studied persistent symptoms in adults already following a gluten-free diet for at least a year. Participants continued that diet. It was an adjunct-treatment study, not a demonstration that larazotide could replace dietary management.
Supporting sources [1]
Mixed dose-group results
Among 342 randomized adults, the lowest studied group improved the prespecified gastrointestinal symptom score compared with placebo. The two higher groups did not differ from placebo. This nonuniform result limits a simple claim of proven efficacy across exposures.
Supporting sources [1]
What happened to phase 3
A 2022 SEC filing reports the decision to discontinue further development of larazotide in celiac disease. The later-stage program therefore cannot be cited as successful confirmation of the earlier symptom findings.
Supporting sources [2]
What early tolerability can establish
Adverse-event findings in the phase 2 study were broadly comparable with placebo. That supports the tolerability assessment of that study, but does not establish long-term safety in all populations or safety of unverified products sold for unrelated indications.
Supporting sources [1]
Does it permit gluten consumption?
The evidence does not establish protection from celiac injury during unrestricted gluten exposure. Symptom improvement, intestinal permeability and mucosal disease control are distinct endpoints. A quieter digestive tract would not by itself prove that celiac inflammation is controlled.
Reading this profile
Jurisdiction: Investigational; pivotal celiac program discontinued; no FDA marketing approval identified.. Molecular class: Oral tight-junction regulatory octapeptide.
This profile was written with AI-assisted research and checked against the linked sources. It has not been represented as a clinician’s review. Evidence summaries describe the cited studies and products; they do not establish that a separately purchased preparation is equivalent.
Sources & references
Follow the original material. Product labels define specific formulations and uses; trial registration describes a study and does not by itself establish benefit.
- Larazotide acetate for persistent celiac symptoms: randomized controlled trial ↗Original research · Checked 2026-10-27
- 9 Meters Biopharma SEC filing: discontinuation of larazotide celiac development ↗Manufacturer / sponsor · Checked 2026-10-27
- ClinicalTrials.gov: larazotide phase 3 celiac study ↗Clinical trial source · Checked 2026-10-27