Peptide LibraryLarazotide dosage in published studies and labels
These are the doses used for Larazotide in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.
Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.
Last checked against primary sources:
Studied regimens and sources
Larazotide has no approved dosage; there is no larazotide label on DailyMed. Human dosing comes from celiac disease trials of doses taken by mouth three times daily: a phase 2b trial of 0.5, 1 and 2 mg met its primary endpoint only at 0.5 mg, a gluten-challenge study tested 0.25 to 8 mg, and a phase 3 trial of 0.25 and 0.5 mg was terminated by its sponsor with no results posted.
| Human dosing established | Yes |
|---|---|
| Studied dose range | 0.25–8 mg three times daily studied in trials |
| Route | Oral |
| Frequency | Three times daily |
| Duration studied | 14 days to 12 weeks in the published trials |
| Evidence level | Clinical Trial Evidence |
| Last reviewed | 2026-11-07 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| Phase 2b, persistent symptoms despite a gluten-free diet — Gastroenterology 2015 (NCT01396213)Clinical trial · Randomised, double-blind, placebo-controlled trial | Adults with celiac disease on a gluten-free diet for at least 12 months with ongoing symptoms (n=342) | 0.5 mg, 1 mg or 2 mg, or placebo | Oral | Three times daily | 12 weeks | Primary endpoint (gastrointestinal symptom score) met with 0.5 mg; 1 mg and 2 mg were no different from placebo on any endpoint; safety comparable with placebo | Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial. Gastroenterology. 2015. |
| Gluten-challenge dose-ranging study — Am J Gastroenterol 2012Clinical trial · Randomised, double-blind, placebo-controlled dose-ranging study | Adults with diet-controlled celiac disease (n=86) | 0.25, 1, 4 or 8 mg, or placebo, with or without 2.4 g/day gluten | Oral | Three times daily | 14 days | No significant effect on the primary permeability measure (lactulose/mannitol ratio), which was highly variable; some lower doses, not the highest, appeared to limit gluten-induced symptom worsening | A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge. Am J Gastroenterol. 2012. |
| Phase 3 symptom-relief trial (NCT03569007)Clinical trial · Randomised, double-blind, placebo-controlled phase 3 trial | Adults with biopsy-confirmed celiac disease on a gluten-free diet for at least 6 months with persistent symptoms (307 enrolled) | 0.25 mg or 0.5 mg capsules, or placebo | Oral | Three times daily | 12 weeks to the primary endpoint | Terminated by the sponsor; no results posted on ClinicalTrials.gov | NCT03569007 — Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms |
Where sources disagree
- Larazotide acetate was given by mouth in celiac disease trials (in the phase 3 trial as enteric-coated beads in gelatin capsules), not as an injection. In the phase 2b trial only the lowest dose separated from placebo; higher doses did not.
- The only phase 3 trial was terminated by its sponsor without posted results, so no dose has been confirmed in phase 3.