Larazotide (AT-1001, dosed as larazotide acetate) is a synthetic eight-amino-acid peptide derived from a fragment of the Vibrio cholerae zonula occludens toxin.
Amounts reported for Larazotide are listed under Reported protocols, each with its source and study kind. No amount ladder is inferred from them. This is educational source context, not a protocol or recommendation.
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Human study rows are described per source under Reported protocols; they belong to their trial populations and are not a general amount.
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What published studies and recent community write-ups report about amounts, timing and course length. 5 clinical and 1 community-reported rows, each linked to its source. These are descriptions of what others report, not instructions, and nothing here is medical advice.
| Context | Dose | Frequency | Route | Course | Source |
|---|---|---|---|---|---|
| Clinical5 rows | |||||
| Phase 2b trial for persistent symptoms on a gluten-free diet342 adults with celiac disease on a gluten-free diet for at least 12 months who still had symptoms (NCT01396213) | 0.5, 1 or 2 mg | Three times daily, 15 minutes before meals | Oral capsules of enteric-coated beads | 12 weeks of treatment, preceded by a 4-week placebo run-in and followed by a 4-week placebo run-outNot applicable | Gastroenterology (PubMed Central)2015 |
| Only the lowest dose met the primary endpoint, a lower celiac symptom score than placebo, with 26% fewer symptomatic days and less headache and tiredness; the 1 and 2 mg doses were no different from placebo on any endpoint. Safety matched placebo. This inverted dose-response, better at lower doses, runs through the whole larazotide programme and is why the phase 3 trial tested 0.25 and 0.5 mg. Several authors were Alba Therapeutics employees. | |||||
| Gluten-challenge trial over six weeks184 patients with celiac disease on a gluten-free diet, given 2.7 g of gluten a day | 1, 4 or 8 mg | Three times daily | Oral | 6 weeksNot applicable | Alimentary Pharmacology and Therapeutics (PubMed)2013 |
| The 1 mg dose limited gluten-induced symptoms on the Gastrointestinal Symptom Rating Scale (p = 0.002), and all three doses blunted the rise in anti-tissue transglutaminase antibodies (a 19-fold rise on placebo against 3.9- to 7.7-fold on the drug), but urinary lactulose-mannitol ratios, the intended marker of intestinal permeability, did not differ from placebo. Adverse events were similar to placebo. | |||||
| Dose-ranging gluten-challenge trial over two weeks86 patients with diet-controlled celiac disease, with or without a 2.4 g per day gluten challenge | 0.25, 1, 4 or 8 mg | Three times daily | Oral | 14 daysNot applicable | American Journal of Gastroenterology (PubMed)2012 |
| Permeability measurements proved too variable in outpatients to show any drug effect, but some of the lower doses appeared to prevent the worsening of gastrointestinal symptoms that gluten produced, while the highest dose did not. The drug was well tolerated with headache and urinary tract infection the most common complaints. The study confirmed that 2.4 g of gluten a day reproducibly provokes symptoms, which shaped later trials. | |||||
| Phase 3 CeDLara trial (terminated)307 adults with biopsy-confirmed celiac disease on a gluten-free diet for at least 6 months with persistent symptoms, at 160 US sites | 0.25 mg or 0.5 mg | Three times daily | Oral capsules of enteric-coated beads | 12 weeksNot applicable | ClinicalTrials.gov2019 |
| The primary endpoint was the proportion of patients whose abdominal symptom score fell by a set margin. The registry records that the sponsor, 9 Meters Biopharma, terminated the trial in July 2022 with 307 participants enrolled, and no results have been posted, which leaves larazotide without a positive pivotal trial after some 15 years of development. | |||||
| Multisystem inflammatory syndrome in children (case series and phase 2a trial)4 children aged 3-17 in an open-label case series, then 12 hospitalised children with a median age of 5.7 years in a randomised, double-blind, placebo-controlled phase 2a trial | 10 mcg/kg per dose, to a maximum of 500 mcg | Four times daily | Oral, as an adjunct to steroids and intravenous immunoglobulin | 21 days, with 24 weeks of safety follow-up in the trialNot applicable | Science Translational Medicine (PubMed)2025 |
| The rationale is that zonulin-driven gut leakiness lets SARS-CoV-2 spike protein into the blood; treated children cleared spike antigen faster, resolved gastrointestinal symptoms sooner and returned to usual activities earlier, with no larazotide-related adverse events in either report. The per-kilogram dose comes from the 2022 case series by the same Massachusetts General Hospital group, whose senior author co-founded Alba Therapeutics. Twelve patients cannot establish efficacy. | |||||
| Community-reported1 row | |||||
| Vendor capsule format | 500 mcg per capsule, 60 capsules per bottle; no dose stated | Not stated | Oral | Not statedNot stated | Community resource2026 |
| A vendor claim. The 500 mcg strength equals the 0.5 mg dose that met the phase 2b endpoint, but the trial product was enteric-coated beads designed to release the peptide in the intestine, and the vendor page does not say whether its capsules are enteric-coated; it lists five published papers and describes the compound as tight-junction and gut-barrier research material. The certificate for lot LZ01 confirms identity by mass spectrometry with purity by HPLC but does not report a measured content. | |||||
The phase 2b trial began with four weeks of single-blind placebo while patients recorded symptoms, which showed large day-to-day variability and a trend toward improvement on placebo alone before any drug was given.
Capsules were taken three times a day, 15 minutes before meals, for 12 weeks while patients stayed on their gluten-free diet. Only the 0.5 mg group separated from placebo, with about a quarter fewer symptomatic days over the period.
All groups returned to placebo for four weeks of follow-up. The pooled analysis of the four randomised trials found larazotide helped symptoms mainly during deliberate gluten challenge and not in patients simply maintaining a gluten-free diet.
Plus 1 community resource (a dosing guide, forum thread or vendor write-up), reported above but not linked.
Larazotide (AT-1001, dosed as larazotide acetate) is a synthetic eight-amino-acid peptide derived from a fragment of the Vibrio cholerae zonula occludens toxin, developed by Alessio Fasano's group and Alba Therapeutics as the first tight-junction regulator for celiac disease. In phase 2 trials of 86 to 342 patients it reduced gluten-triggered symptoms at low doses of 0.5-1 mg three times daily but not at higher ones, and it never changed the lactulose-mannitol permeability test it was designed to improve; the phase 3 CeDLara trial of 0.25 and 0.5 mg three times daily was terminated by its sponsor, 9 Meters Biopharma, in July 2022 without published results. A 2025 phase 2a trial in 12 children with post-COVID multisystem inflammatory syndrome reported faster clearance of viral spike antigen with no drug-related adverse events. It is not approved anywhere and is sold online as 500 mcg capsules, a strength that matches the only dose that met a trial endpoint.
These themes describe recurring questions in published research. They are not claims of effectiveness or recommendations for use.
Innate defense, inflammatory signaling and barrier models.
Only the lowest dose met the primary endpoint, a lower celiac symptom score than placebo, with 26% fewer symptomatic days and less headache and tiredness; the 1 and 2 mg doses were no different from placebo on any.
The 1 mg dose limited gluten-induced symptoms on the Gastrointestinal Symptom Rating Scale (p = 0.002), and all three doses blunted the rise in anti-tissue transglutaminase antibodies (a 19-fold rise on placebo against.
Permeability measurements proved too variable in outpatients to show any drug effect, but some of the lower doses appeared to prevent the worsening of gastrointestinal symptoms that gluten produced, while the highest.
The primary endpoint was the proportion of patients whose abdominal symptom score fell by a set margin. The registry records that the sponsor, 9 Meters Biopharma, terminated the trial in July 2022 with 307 participants.
The rationale is that zonulin-driven gut leakiness lets SARS-CoV-2 spike protein into the blood; treated children cleared spike antigen faster, resolved gastrointestinal symptoms sooner and returned to usual activities.
Study models remain visible so laboratory and animal findings are not mistaken for established human outcomes.
5 protocol rows on this page come from human trials, trial registrations, regulator labels or reviews of human data. Approval status and populations are stated per row.
1 row record what blogs, vendor write-ups or forums describe for Larazotide. None has been verified against primary literature.
Sequence, synonyms and registry identifiers as recorded in PubChem, the National Library of Medicine's open chemistry database. Formula, mass and CAS number are summarized at the top of the page.
Gly-Gly-Val-Leu-Val-Gln-Pro-Gly
AT-1001, Larazotide acetate, AT-2347, Larazotide [USAN:INN], Glycylglycyl-L-valyl-L-leucyl-L-valyl-L-glutaminyl-L-prolylglycine, UNII ZN3R5560ZV
ORFLZNAGUTZRLQ-ZMBVWFSWSA-N
2-[[(2S)-1-[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[2-[(2-aminoacetyl)amino]acetyl]amino]-3-methylbutanoyl]amino]-4-methylpentanoyl]amino]-3-methylbutanoyl]amino]-5-oxopentanoyl]pyrrolidine-2-carbonyl]amino]acetic acid
8 curated references, each with its journal, year and study model, plus 1 community resource reported but not linked.