In clinical trials
Digestive & weight
Larazotide acetate
Also called AT-1001
Larazotide acetate is an investigational peptide studied for celiac disease. Its Phase 3 trial was stopped for futility and it is not approved.
- Reviewed by
- William Maish, MD MBA MPH, Clinical Product Lead
- Published
- October 5, 2026
- Last updated
- October 5, 2026
Key takeaway
Larazotide acetate is an investigational oral peptide that was studied as an add-on to the gluten-free diet for celiac disease, intended to tighten the junctions between intestinal cells. Its pivotal Phase 3 trial was stopped for futility, and pooled trial data did not show an effect on a key measure of intestinal permeability. As of 2026, it is not approved and its lead program has been halted.
At a glance
| FDA status | Investigational peptide, not approved by the FDA |
| Studied for | Oral add-on to the gluten-free diet for celiac disease |
| Phase 3 result | Trial (CeDLara) stopped for futility and did not meet its endpoint |
| Pooled data | No effect on the intestinal permeability measure |
| Evidence strength | Low research |
What is larazotide acetate?
Larazotide acetate is an experimental peptide of eight amino acids, taken by mouth, studied as an adjunct to the gluten-free diet in celiac disease, an autoimmune reaction to gluten that damages the small intestine. It was most recently developed by 9 Meters Biopharma under the code AT-1001. It is investigational, is not approved, and its lead development program has been discontinued.
How does it work?
Larazotide was designed to act as a "tight-junction regulator." The intestinal lining has junctions between cells that control what passes through; in celiac disease these are thought to loosen, letting gluten fragments cross and trigger inflammation.
Larazotide was proposed to counter the hormone zonulin1 and promote closure of these junctions, reducing the leakage. This is the proposed mechanism; as the trials below show, it did not translate into a confirmed clinical benefit.
Is it FDA-approved?
No. Larazotide acetate is investigational and not approved. Its pivotal Phase 3 trial was discontinued, and there is no active late-stage program.
What does the research show?
The decisive evidence is negative, as the two main human analyses show:
| Evidence | Design | Result |
| Phase 3 CeDLara trial | Interim analysis in 2022 against a primary endpoint of reducing celiac symptom severity | Stopped for futility2 after the analysis indicated it would not meet that endpoint |
| Meta-analysis3 indexed on PubMed | 4 randomized trials | No significant effect on the lactulose-to-mannitol permeability ratio, a biological measure of gut leakiness, with only inconsistent symptom signals in gluten-challenge subgroups |
A mechanistic review1 describes the intended tight-junction pathway. Overall, the human evidence does not support a benefit.
More for digestive & weight
Sources: a meta-analysis of larazotide trials (Hoilat et al., Clinics and Research in Hepatology and Gastroenterology, 2022, DOI: 10.1016/j.clinre.2021.1017823) and a mechanistic review (Slifer et al., American Journal of Physiology: Gastrointestinal and Liver Physiology, 2021, DOI: 10.1152/ajpgi.00386.20201), both indexed on PubMed; and reporting on the Phase 3 discontinuation. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.