Larazotide, also called AT-1001 or INN-202, is a peptide studied as a tight-junction regulator, mainly in coeliac disease. Published human randomized trials have tested it for gluten-challenge settings and persistent symptoms despite a gluten-free diet. No FDA-approved larazotide indication is verified in the sources reviewed here. Chia does not offer larazotide; this guide is education-only.
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See if you qualify →What it is
Larazotide is a peptide also described in the literature as larazotide acetate, AT-1001, and INN-202. It has been studied as a nondietary therapy for coeliac disease and as a compound related to intestinal barrier function, but the retrieved sources focus on research settings rather than routine care claims 9, 11, 12.
Names: larazotide, larazotide acetate, AT-1001, and INN-202
The same compound family may appear under several names: larazotide, larazotide acetate, AT-1001, and INN-202. Reviews of nondietary therapies for coeliac disease discuss larazotide/AT-1001 in the context of barrier and zonulin-related pathways 9, 11, 12.
What class is it?
Larazotide is best described as a tight-junction regulator peptide. In plain English, tight junctions are the seals between cells lining the gut; researchers study them because changes in these seals may affect intestinal permeability and immune exposure 8, 11.
| Name a reader may see | What it refers to | Best context |
|---|---|---|
| Larazotide | Common compound name | General search and patient education |
| Larazotide acetate | Salt/form name used in several coeliac disease trials | Clinical-trial literature |
| AT-1001 | Earlier research name | Mechanism and early proof-of-concept studies |
| INN-202 | Identifier used in some discussions of the compound | Compound identification |
Mechanism of action
Larazotide’s proposed mechanism centers on tight junctions, intestinal epithelial barrier function, intestinal permeability, and zonulin-related pathways. Reviews describe AT-1001 as a zonulin inhibitor or barrier-targeted approach, while the human trials test clinical and biomarker endpoints rather than proving every step of the pathway in patients 9, 11.
Tight junctions, intestinal barrier function, and zonulin-related pathways
The gut lining is not just a wall. It is a living border that decides what passes from the intestine into the body. Tight junctions are part of that border. Zonulin-related pathways have been studied because they may influence how open or closed those junctions are 8, 11.
In coeliac disease research, larazotide acetate has been studied during gluten challenge and in people with persistent symptoms despite a gluten-free diet. Those trials connect the mechanism to real patient settings, but they do not prove that every person with gut symptoms has the same barrier problem 2, 4, 5.
What the mechanism does and does not prove in humans
A mechanism can explain why a compound is worth studying. It does not, by itself, prove benefit, safety, or the right patient group. That is why the randomized trials matter more than mechanistic labels like “gut barrier peptide” or “zonulin inhibitor” 2, 9.
Preclinical work has also explored zonulin or tight-junction targeting in inflammatory models, including animal or lab-based research. These studies are useful for biology, but animal or cell findings should not be treated as proven human benefits for larazotide 8, 10.
Evidence
Larazotide’s evidence grade is A for quantity and study design because the supplied PubMed set includes 5 larazotide-specific randomized controlled trial records. That grade does not mean the compound works, and it does not mean it is safe for unsupervised use.
Why larazotide is graded A for evidence quantity and study design
The retrieved PubMed set includes multiple randomized controlled trials of larazotide acetate or AT-1001 in coeliac disease, including proof-of-concept safety and pharmacology work, gluten-challenge studies, and a trial in persistent symptoms despite a gluten-free diet 2, 3, 4, 5.
A separate randomized controlled trial studied larazotide in children with post-COVID multisystem inflammatory syndrome and reported on viral spike antigen clearance and recovery-related outcomes. That is a different patient group, so it should not be used to infer benefit for routine gut symptoms or weight management 1.
What has larazotide been studied for?
The strongest human research cluster is coeliac disease. Trials have evaluated larazotide acetate during gluten challenge and in people with persistent symptoms despite a gluten-free diet 2, 4, 5. Reviews also place larazotide among nondietary therapies investigated for coeliac disease, not as a replacement for diagnosis or dietary care 9, 12.
Readers sometimes find larazotide while searching for “gut barrier,” “leaky gut,” peptides, or metabolic health. The retrieved evidence does not support treating larazotide as a weight-loss medication or a GLP-1 medication. For GLP-1 education, Chia has separate resources and offers clinician-reviewed options such as semaglutide injection and tirzepatide tablets or injection for eligible patients.
Coeliac disease and gluten challenge studies
Two randomized placebo-controlled studies evaluated larazotide acetate in patients with coeliac disease undergoing gluten challenge. These studies are important because gluten challenge is a controlled research setting, not a do-it-yourself test or diet experiment 4, 5.
Persistent symptoms despite a gluten-free diet
A randomized controlled trial evaluated larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet. That patient group is specific: people with coeliac disease who still had symptoms even while following dietary treatment 2.
Post-COVID multisystem inflammatory syndrome research
A 2025 randomized controlled trial studied larazotide in children with post-COVID multisystem inflammatory syndrome, focusing on viral spike antigen clearance and recovery. Because this is pediatric, post-infectious, and immune-related research, it calls for specialist interpretation and does not translate into general self-use 1.
Preclinical and early translational research in inflammatory conditions
Animal and translational studies have explored barrier-related strategies in inflammatory settings, including zonulin and intestinal epithelial barrier research and larazotide-releasing materials in colitis models. These are not proof of human benefit; they are early research signals 8, 10.
What studies exist
| Year | Design | Study | Journal | Record |
|---|---|---|---|---|
| 2025 | Randomised controlled trial | Viral spike antigen clearance and augmented recovery in children with post-COVID multisystem inflammatory syndrome treated with larazotide | Science translational medicine | PMID 40737433 |
| 2015 | Randomised controlled trial | Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial | Gastroenterology | PMID 25683116 |
| 2007 | Randomised controlled trial | The safety, tolerance, pharmacokinetic and pharmacodynamic effects of single doses of AT-1001 in coeliac disease subjects: a proof of concept study | Alimentary pharmacology & therapeutics | PMID 17697209 |
| 2013 | Randomised controlled trial | Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study | Alimentary pharmacology & therapeutics | PMID 23163616 |
| 2012 | Randomised controlled trial | A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge | The American journal of gastroenterology | PMID 22825365 |
| 2013 | Randomised controlled trial | A controlled trial of gluten-free diet in patients with irritable bowel syndrome-diarrhea: effects on bowel frequency and intestinal function | Gastroenterology | PMID 23357715 |
| 2023 | Primary study | Targeting endothelial tight junctions to predict and protect thoracic aortic aneurysm and dissection | European heart journal | PMID 36638776 |
| 2020 | Primary study | Targeting zonulin and intestinal epithelial barrier function to prevent onset of arthritis | Nature communications | PMID 32332732 |
| 2019 | Review / secondary | Nondietary Therapies for Celiac Disease | Gastroenterology clinics of North America | PMID 30711207 |
| 2025 | Primary study | Antibacterial hyaluronic acid hydrogel with sustained release of larazotide as effective colitis treatment | Journal of controlled release : official journal of the Controlled Release Society | PMID 40915363 |
| 2021 | Review / secondary | The Therapeutic use of the Zonulin Inhibitor AT-1001 (Larazotide) for a Variety of Acute and Chronic Inflammatory Diseases | Current medicinal chemistry | PMID 33397225 |
| 2019 | Review / secondary | Evolving Therapy for Celiac Disease | Frontiers in pediatrics | PMID 31157194 |
| Registration | Phase | Status | Enrolment | Title |
|---|---|---|---|---|
| NCT00362856 | PHASE2 | COMPLETED | 80 | Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects |
| NCT01730482 | PHASE1 | COMPLETED | 6 | A Study to Assess the Absorption, Metabolism and Excretion of Migalastat Hydrochloride (AT1001-014) |
| NCT01476163 | N/A | AVAILABLE | — | Physician Initiated Expanded Access Request for Migalastat in Individual Patients With Fabry Disease |
| NCT01853852 | PHASE1 | COMPLETED | 14 | A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A |
| NCT00925301 | PHASE3 | COMPLETED | 67 | Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease |
| NCT00492960 | PHASE2 | COMPLETED | 171 | Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease |
| NCT03569007 | PHASE3 | TERMINATED | 307 | Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms |
| NCT01218659 | PHASE3 | COMPLETED | 68 | Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease |
This table is retrieved from PubMed and ClinicalTrials.gov rather than assembled by hand, so it shows what is indexed — including the absences. Last retrieved 2026-09-11.
Reported dosing ranges
Larazotide dosing should not be copied from research papers or online peptide listings. In the retrieved PubMed records provided for this article, the citation data confirms human trials and study contexts, but it does not provide a reliable numeric dosing range to report.
| Study context | What the retrieved source confirms | Numeric dose range available from supplied record? | How to interpret it |
|---|---|---|---|
| Proof-of-concept coeliac disease study | Single doses of AT-1001 were evaluated for safety, tolerance, pharmacokinetics, and pharmacodynamics 3. | No numeric range in the supplied PubMed citation data | Research context only; not dosing guidance |
| Coeliac disease gluten challenge | Larazotide acetate was studied in randomized placebo-controlled gluten-challenge trials 4, 5. | No numeric range in the supplied PubMed citation data | Research context only; do not perform a gluten challenge without clinician guidance |
| Persistent symptoms despite gluten-free diet | Larazotide acetate was studied in a randomized controlled trial for persistent celiac symptoms despite a gluten-free diet 2. | No numeric range in the supplied PubMed citation data | Research context only; not a personal dosing plan |
| Post-COVID multisystem inflammatory syndrome in children | Larazotide was studied in a pediatric randomized controlled trial focused on viral spike antigen clearance and recovery 1. | No numeric range in the supplied PubMed citation data | Specialist pediatric context only |
Because the supplied evidence set does not give numeric dosing details, we will not invent them. This is the safer and more useful answer: if a source does not show the dose clearly, a patient-facing guide should not turn guesses into instructions.
Legal status
Our regulatory log holds no confirmed federal action for Larazotide. That means we have not found one with a primary source — not that none exists.
This section is generated from a dated log of federal actions rather than written by hand, and it is re-checked daily against the Federal Register and FDA sources. Last checked 2026-09-11. See the full legal-status tracker for every compound we follow.
Safety
Larazotide safety has been assessed in randomized coeliac disease studies, including a proof-of-concept study focused on safety, tolerance, pharmacokinetics, and pharmacodynamics. But the retrieved records do not establish long-term safety for unsupervised use, broad gut-health use, or use from research-chemical sources 3, 2.
What randomized trials can tell us about tolerability
Randomized trials can identify common short-term adverse events in the studied group and setting. For larazotide, the supplied records confirm safety and tolerability evaluation in coeliac disease subjects, plus randomized studies in gluten challenge and persistent symptoms despite a gluten-free diet 3, 4, 5, 2.
That is helpful, but it has limits. A trial in coeliac disease does not answer every safety question for children, pregnancy, immune disease, complex gastrointestinal illness, or people using multiple medications. The pediatric post-COVID inflammatory trial is also a distinct medical setting and should not be generalized 1.
What remains uncertain about long-term safety
Long-term safety remains uncertain when a compound is used outside the exact populations and protocols studied. Reviews discuss larazotide as one of several evolving nondietary approaches for coeliac disease, which means the field is still being defined rather than settled 9, 12.
Supply quality is also a safety issue. “Research use only” material is not made for people. Identity, impurity, sterility, strength, and storage can be uncertain, and those risks are separate from the compound’s biology.
Interactions
Larazotide interaction data are limited in the retrieved sources. The supplied PubMed records confirm human trials and reviews, but they do not provide dedicated drug-drug, supplement, pregnancy, or broad contraindication studies.
Drug, supplement, and condition questions to discuss
People with coeliac disease, inflammatory bowel symptoms, autoimmune disease, post-infectious illness, pregnancy, or pediatric concerns should involve a clinician before considering any barrier-targeted therapy. The available trial contexts are specific and do not cover every real-world medical situation 1, 2, 4.
If you take immune-modulating drugs, steroids, biologics, anticoagulants, diabetes medications, or multiple supplements, a clinician should review the full list. No interaction studies in the retrieved evidence set means “not studied,” not “known to be safe.”
Why supplement or research-chemical use can add risk
A peptide sold online may come with a label, but that label is not the same as a diagnosis, medication review, prescription decision, or pharmacy quality process. This matters most when symptoms could signal coeliac disease, inflammatory bowel disease, infection, medication side effects, or another condition that needs testing.
How to obtain it legally
Larazotide access questions should start with a licensed clinician, not a peptide marketplace. A legitimate clinical process usually includes medical history, symptom review, diagnosis review, medication and supplement review, risk screening, and a decision about whether any prescription pathway is appropriate.
Start with a licensed clinician rather than a peptide marketplace
If you are asking about larazotide because of gluten reactions, chronic diarrhea, bloating, fatigue, or suspected coeliac disease, the first step is proper medical evaluation. Do not start or stop a gluten-free diet, or perform a gluten challenge, without a clinician’s guidance because testing and interpretation can be affected.
What a legitimate clinical process usually includes
- A clinician reviews your diagnosis, symptoms, labs, and current medications.
- The clinician explains what has and has not been shown in human trials.
- Any prescription decision is individualized and is never guaranteed.
- A licensed pharmacy process is different from a research-chemical vendor, which is not a substitute for medical care.
- For related gut-barrier and peptide education, readers can compare larazotide with Chia’s article on KPV peptide.
Why Chia does not offer larazotide
Chia does not offer larazotide. We are stating that plainly because this page is meant to be a reliable reference, not a sales page. Chia does offer other clinician-reviewed treatments in our live catalog, such as low-dose naltrexone tablets and glutathione injection or nasal spray, but those are separate treatments with separate evidence questions.
At Chia, treatment starts with a 100% online health questionnaire and review by a licensed US provider. Prescriptions are only issued where clinically appropriate and are not guaranteed. Chia medications are compounded by state-licensed US 503A pharmacies and shipped to the patient’s door; compounded drugs are not FDA-approved. If you want to discuss your goals with a Chia provider, you can start with the eligibility quiz.
How does larazotide compare with other gut-barrier or peptide topics?
Larazotide is different from many peptides discussed online because its retrieved evidence set includes several human randomized controlled trials, mainly in coeliac disease. Many peptide topics have less human evidence, different mechanisms, or only preclinical data.
| Topic | Main pathway or category | Human evidence in this article’s retrieved set | Chia offering status |
|---|---|---|---|
| Larazotide / AT-1001 | Tight-junction and intestinal barrier research | Multiple randomized controlled trial records in coeliac disease and one pediatric post-COVID inflammatory trial 1, 2, 3, 4, 5 | Not offered by Chia |
| KPV | Peptide discussed for inflammatory pathways | Separate topic; see Chia’s KPV peptide guide | Education-only unless listed in Chia’s live catalog |
| Low-dose naltrexone | Immune and inflammation-related clinical topic | Separate topic and evidence base | Chia offers tablets from $59/mo via clinician review |
| Glutathione | Antioxidant and cellular redox topic | Separate topic and evidence base | Chia offers injection and nasal spray forms |
Larazotide vs other peptides discussed online
The key difference is evidence type. Larazotide has randomized human trial records in the supplied PubMed set. Other peptide topics may have mostly animal, cell, or small human studies, so it is important not to treat all peptides as having the same level of support.
When to look for condition-specific clinical care instead
If your main concern is possible coeliac disease, blood in stool, weight loss without trying, anemia, severe diarrhea, persistent vomiting, pregnancy, or a sick child, look for condition-specific medical care. A peptide article cannot replace testing, diagnosis, or urgent evaluation.
The sources provided for this article do not include a confirmed reason for discontinuation or a complete development history. What can be said from the retrieved evidence is that larazotide was studied in multiple randomized trials, mainly in coeliac disease, and the evidence should be interpreted by study context rather than by online claims.
Do not use a research-chemical marketplace as a substitute for medical care. If you are asking about larazotide, start with a licensed clinician who can review your diagnosis, symptoms, medication list, and whether any prescription pathway is appropriate.
Larazotide is studied as a tight-junction regulator peptide. In plain terms, researchers are interested in whether it can affect the gut barrier, intestinal permeability, and zonulin-related pathways. A proposed mechanism does not prove benefit for every gut symptom.
Most published human trial records supplied for this article involve coeliac disease, including gluten-challenge studies and persistent symptoms despite a gluten-free diet. One randomized trial studied children with post-COVID multisystem inflammatory syndrome. These study settings are not the same as general wellness or weight loss use.
Yes. AT-1001 is an earlier research name used for larazotide or larazotide acetate in the literature. You may also see INN-202 in compound discussions.
No. Larazotide is not a GLP-1 medication. GLP-1 drugs act through incretin hormone pathways involved in appetite, glucose, and metabolic regulation; larazotide is discussed in gut-barrier and tight-junction research.
The retrieved evidence set does not support larazotide as a weight-loss medication. The main human research cluster is coeliac disease, not obesity or metabolic treatment.
No patient should use this article to replace a gluten-free diet or change coeliac disease care. The trials studied specific research settings, and coeliac disease management should be guided by a clinician.
References
- 1.PMID 40737433 [randomised controlled trial] Yonker LM, Kane AS, Swank Z, et al. Viral spike antigen clearance and augmented recovery in children with post-COVID multisystem inflammatory syndrome treated with larazotide. Science translational medicine. 2025.
- 2.PMID 25683116 [randomised controlled trial] Leffler DA, Kelly CP, Green PH, et al. Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial. Gastroenterology. 2015.
- 3.PMID 17697209 [randomised controlled trial] Paterson BM, Lammers KM, Arrieta MC, et al. The safety, tolerance, pharmacokinetic and pharmacodynamic effects of single doses of AT-1001 in coeliac disease subjects: a proof of concept study. Alimentary pharmacology & therapeutics. 2007.
- 4.PMID 23163616 [randomised controlled trial] Kelly CP, Green PH, Murray JA, et al. Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study. Alimentary pharmacology & therapeutics. 2013.
- 5.PMID 22825365 [randomised controlled trial] Leffler DA, Kelly CP, Abdallah HZ, et al. A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge. The American journal of gastroenterology. 2012.
- 6.PMID 23357715 [randomised controlled trial; query artifact, not a larazotide study] Vazquez-Roque MI, Camilleri M, Smyrk T, et al. A controlled trial of gluten-free diet in patients with irritable bowel syndrome-diarrhea: effects on bowel frequency and intestinal function. Gastroenterology. 2013.
- 7.PMID 36638776 [primary study] Yang X, Xu C, Yao F, et al. Targeting endothelial tight junctions to predict and protect thoracic aortic aneurysm and dissection. European heart journal. 2023.
- 8.PMID 32332732 [primary study] Tajik N, Frech M, Schulz O, et al. Targeting zonulin and intestinal epithelial barrier function to prevent onset of arthritis. Nature communications. 2020.
- 9.PMID 30711207 [review/secondary] Serena G, Kelly CP, Fasano A. Nondietary Therapies for Celiac Disease. Gastroenterology clinics of North America. 2019.
- 10.PMID 40915363 [primary study] Yu F, Chen Y, Ouyang S, et al. Antibacterial hyaluronic acid hydrogel with sustained release of larazotide as effective colitis treatment. Journal of controlled release : official journal of the Controlled Release Society. 2025.
- 11.PMID 33397225 [review/secondary] Troisi J, Venutolo G, Terracciano C, et al. The Therapeutic use of the Zonulin Inhibitor AT-1001 (Larazotide) for a Variety of Acute and Chronic Inflammatory Diseases. Current medicinal chemistry. 2021.
- 12.PMID 31157194 [review/secondary] Yoosuf S, Makharia GK. Evolving Therapy for Celiac Disease. Frontiers in pediatrics. 2019.
About this article
Chia Health Editorial Team — Evidence-reviewed health education
This article is for educational purposes only and is not a substitute for individualized medical advice. Talk to a licensed clinician before starting, stopping, or changing any prescription.
AI tools may assist with research and drafting. Chia's editorial team reviews source use, clarity, treatment information, and safety framing before publication. A clinician is named only after explicit sign-off. Read our editorial standards.
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