Larazotide

Research Papers and Clinical Trials

Larazotide acetate (also known as AT-1001) has been studied across multiple conditions, with most research focusing on intestinal barrier function and inflammatory conditions.

Celiac Disease Research

The primary therapeutic target for larazotide has been celiac disease, where it aims to protect intestinal barrier function. A Phase 2 safety and tolerability study in celiac disease patients was completed (NCT00362856), though a subsequent Phase 3 efficacy and safety trial was terminated (NCT03569007). Recent narrative reviews have examined larazotide alongside other interventions for celiac disease management, though specific efficacy data from these reviews is not detailed in the available evidence.

Intestinal Barrier Protection

Laboratory studies have demonstrated larazotide's protective effects on intestinal barriers. One 2025 study published in Biomedicines showed that larazotide acetate protects intestinal mucosal barriers from anoxia/reoxygenation injury through multiple cellular mechanisms, though the specific study design and sample sizes are not provided in the available evidence.

Emerging Applications

Recent research has explored larazotide in several new therapeutic areas:

• Long COVID: A Phase 2 trial is currently active but not recruiting participants to evaluate AT1001 for long COVID treatment (NCT05747534)
• Pediatric inflammatory conditions: A 2025 study in Science Translational Medicine reported that larazotide treatment helped clear viral spike antigens and improved recovery in children with post-COVID multisystem inflammatory syndrome
• Liver disease: Research published in Pediatrics and Neonatology examined preventive effects of larazotide acetate on non-alcoholic fatty liver disease in mouse models
• Colitis: A 2025 study in the Journal of Controlled Release investigated an antibacterial hyaluronic acid hydrogel with sustained larazotide release for colitis treatment

Study Limitations

The available evidence shows a mix of completed, terminated, and ongoing trials, with limited details about sample sizes, specific outcomes, or methodological approaches. The terminated Phase 3 celiac disease trial suggests potential challenges in demonstrating clinical efficacy, though the reasons for termination are not specified in the available evidence.

This summary is based on limited evidence and does not constitute medical advice. Patients should consult healthcare providers for treatment decisions.