Larazotide
Tested in peopleIt has been tested in people, but it is not an approved medicine. The studies are usually small.
Also called AT-1001 / Larazotide acetate / INN-202
Studied for tightening the gut lining in celiac disease. Reached late-stage human trials but missed its main goal.
Can a doctor prescribe this?
No. Pharmacies are not on record as being allowed to make this into a medicine.
The FDA has not approved this as a medicine.
Investigational. Not approved and not on the compounding list.
Official status: Not on the 503A bulks list. Checked 2026-08-04.
Lab suppliers we list: 2
Doses used in research
Taken word for word from the studies and trials listed on this page. This is not a recommendation and not a dose for anyone to take.
In human trials
See source wording
by mouth
Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD SymptomsPHASE3 · NCT03569007
“Larazotide 0.25 mg.”
See source wording
by mouth
A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac DiseasePHASE2 · NCT01396213
“Larazotide Acetate 0.5 mg.”
See source wording
by mouth · for 6 weeks
Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac DiseasePHASE2 · NCT00492960
“900 mg gluten.”
See source wording
by mouth
Safety and Tolerability Study of Larazotide Acetate in Celiac Disease SubjectsPHASE2 · NCT00362856
“placebo TID + gluten 800 mg TID administered orally in capsules.”
See source wording
by mouth · for 6 weeks
Study of the Efficacy of Larazotide Acetate to Treat Celiac DiseasePHASE2 · NCT00889473
“Gluten 900 mg.”
See source wording
by mouth
Safety Study of Larazotide Acetate to Treat Celiac Disease.PHASE1 · NCT00386165
“larazotide acetate 4 mg capsules.”
See source wording
by mouth
Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac DiseasePHASE2 · NCT00620451
“Larazotide acetate 4 mg.”
See source wording
by mouth · for 21 days
AT1001 for the Treatment of Long COVIDPHASE2 · NCT05747534
“Subjects will receive 250 or 500 µg of Larazotide Acetate orally four times a day (QID) for 21 days.”
See source wording
by mouth · for 10 days
Safety of Larazotide Acetate in Healthy VolunteersPHASE1 · NCT00386490
“Larazotide acetate 0.25 mg.”
In animal studies
See source wording
rats · another route · for 7 days
Ameliorative Effects of Larazotide Acetate on Intestinal Permeability and Bacterial Translocation in Acute Pancreatitis Model in Rats.Digestive diseases and sciences · 2024
“The AP model was created by administering 250 mg/100 g bm L-Arginine intraperitoneally 2 times with an hour interval.”
See source wording
rats · another route · for 3 days
Effects of larazotide acetate, a tight junction regulator, on the liver and intestinal damage in acute liver failure in rats.Human & experimental toxicology · 2021
“Materials and methods The thioacetamide (TAA) group received intraperitoneal (ip) injections of 300 mg/kg TAA for 3 days.”
- Viral spike antigen clearance and augmented recovery in children with post-COVID multisystem inflammatory syndrome treated with larazotide.
Study in people
Science translational medicine · 2025
- Preventive effects of Larazotide acetate (AT-1001) on non-alcoholic fatty liver diseases (NAFLD) in a mouse model.
Animal study, rats or mice
Pediatrics and neonatology · 2026
- Antibacterial hyaluronic acid hydrogel with sustained release of larazotide as effective colitis treatment.
Animal study, rats or mice
Journal of controlled release : official journal of the Controlled Release Society · 2025
- Ameliorative Effects of Larazotide Acetate on Intestinal Permeability and Bacterial Translocation in Acute Pancreatitis Model in Rats.
Animal study, rats or mice
Digestive diseases and sciences · 2024
- Sex-dependent Lupus <i>Blautia (Ruminococcus) gnavus</i> strain induction of zonulin-mediated intestinal permeability and autoimmunity.
Animal study, rats or mice
Frontiers in immunology · 2022
- Larazotide acetate: a pharmacological peptide approach to tight junction regulation.
Animal study, rats or mice
American journal of physiology. Gastrointestinal and liver physiology · 2021
- Effects of larazotide acetate, a tight junction regulator, on the liver and intestinal damage in acute liver failure in rats.
Animal study, rats or mice
Human & experimental toxicology · 2021
- Potassium-Competitive Acid Blocker Increases Ileal Permeability and Exacerbates Ileal Inflammation under Stress Conditions in a Mouse Model of Eosinophilic Enteritis.
Lab dish study
Digestion · 2026
- Bromelain and ficin proteolytic effects on gliadin cytotoxicity and expression of genes involved in cell-tight junctions in Caco-2 cells.
Lab dish study
Amino acids · 2023
- Bromelain and Ficin proteolytic effects on gliadin cytotoxicity and expression of genes involved in cell-tight junctions in Caco-2 cells
Lab dish study
Journal not recorded · 2023
- The PAR2 Antagonist Larazotide Can Mitigate Acute Histamine-Stimulated Epithelial Barrier Disruption in Keratinocytes: A Potential Adjunct Treatment for Atopic Dermatitis.
JID innovations : skin science from molecules to population health · 2025
- Larazotide Acetate Protects the Intestinal Mucosal Barrier from Anoxia/Reoxygenation Injury via Various Cellular Mechanisms.
Biomedicines · 2025
- Integrated Role of Microbial, Fungal, and Plant-Derived Interventions in the Management of Celiac Disease: A Narrative Review.
Review of earlier work
Cureus · 2026
- Coeliac disease and the intestinal barrier: mechanisms of disruption and strategies for restoration.
Review of earlier work
Gut · 2026
- Elucidating the Significance of Zonulin in the Pathogenesis of Chronic Inflammatory Disorders: Emphasis on Intestinal Barrier Function and Tight Junction Regulation.
Review of earlier work
Current medicinal chemistry · 2025
- New Therapeutic Challenges in Pediatric Gastroenterology: A Narrative Review.
Review of earlier work
Healthcare (Basel, Switzerland) · 2025
- Is There a Future Without Gluten Restrictions for Celiac Patients? Update on Current Treatments.
Review of earlier work
Nutrients · 2025
- Zonulin as a Potential Therapeutic Target in Microbiota-Gut-Brain Axis Disorders: Encouraging Results and Emerging Questions.
Review of earlier work
International journal of molecular sciences · 2023
- Larazotide acetate for treatment of celiac disease: A systematic review and meta-analysis of randomized controlled trials.
Review of earlier work
Clinics and research in hepatology and gastroenterology · 2022
- Current pharmacological approaches and potential future therapies for Celiac disease.
Review of earlier work
European journal of pharmacology · 2021
- The Therapeutic use of the Zonulin Inhibitor AT-1001 (Larazotide) for a Variety of Acute and Chronic Inflammatory Diseases.
Review of earlier work
Current medicinal chemistry · 2021
- Larazotide Acetate for Treatment of Celiac Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Review of earlier work
Journal not recorded · 2020