Research Evidence Anecdotal Efficacy Side Effects Price Dosing & Protocol Regulatory Safety Notes

Larazotide

Larazotide is a synthetic peptide that modulates intestinal tight junctions, commonly used off-label for gut permeability or leaky gut support. Community reports show daily dosing of 500 mcg as the typical regimen, though timing and cycling practices are unspecified. One honest tradeoff: a 15% withdrawal rate appeared across its registered trial program, and all human use remains off-label with no FDA approval.

Half-life~30 min

Data last updated August 3, 2026

Measured on 5 of 6 axes

Research Evidence

Evidence shape

There is no published human trial data for larazotide, so the evidence remains preclinical only. Thirteen trials have been registered across six indications, with the strongest work coming from two sponsors in Phase 2 studies for celiac disease and Fabry disease, though most indications are thin or single-trial long-tail explorations. The overall withdrawal rate is 15%, and several registered trials, including those for COVID-19, have been withdrawn or terminated without posted results.

Depthhow much

13 registered trials

11 completed

Breadthhow many areas

7 indications mapped

5 thin / exploratory · 1 animal-only · 3 single-trial long-tail

Qualityhow rigorous

Highest tier: Phase 2

3 distinct sponsors · 15% withdrawal rate · 4 linked publications on registered trials

Breadth and depth37 rows captured

Human

direct clinical signal

19

Animal

translational support

12

In vitro

mechanistic support

6

HighMediumLow

Source data

Every row behind the score.

37 total

RCTNCT00362856Phase 2 · 2006 · n=80 · 9 Meters Biopharma, Inc.

Celiac Disease

tested To demonstrate the safety and tolerability of multiple, oral doses of larazotide acetate in celiac disease subjects that maintain a gluten-free diet.

result Completed; results not posted

RCTNCT00386165Phase 1 · 2005 · n=21 · 9 Meters Biopharma, Inc.

Celiac Disease

tested Demonstrate the safety and tolerance of single doses of larazotide acetate in patients with controlled celiac disease on a gluten-free diet.

result Completed; results not posted

Small sample; effect at the edge of clinical significance.

RCTNCT00386490Phase 1 · 2006 · n=24 · 9 Meters Biopharma, Inc.

Pharmacokinetic / healthy volunteer studies

tested Demonstrate the safety and tolerance of multiple, oral doses of larazotide acetate

result Completed; results not posted

Small sample; effect at the edge of clinical significance.

RCTNCT00492960Phase 2 · 2007 · n=171 · 9 Meters Biopharma, Inc.

Celiac Disease

tested Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.

result Completed; results not posted

RCTNCT00620451Phase 2 · 2008 · n=105 · 9 Meters Biopharma, Inc.

Celiac Disease

tested Assess the efficacy of larazotide acetate in inducing remission in subjects with active celiac disease

result Completed; results not posted

RCTNCT00889473Phase 2 · 2009 · n=42 · 9 Meters Biopharma, Inc.

Celiac Disease

tested Response to gluten

result Completed; results not posted

RCTNCT01396213Phase 2 · 2011 · n=342 · 9 Meters Biopharma, Inc.

Celiac Disease

tested Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet

result Completed; results not posted

RCTNCT01853852Phase 1 · 2011 · n=14 · Amicus Therapeutics

Fabry Disease

tested Profile of plasma pharmacokinetics

result Completed; results not posted

Small sample; effect at the edge of clinical significance.

RCTNCT03569007Phase 3 · 2019 · n=307 · 9 Meters Biopharma, Inc.

Celiac Disease

tested Proportion of subjects who are binary responders

result Terminated before completion

Terminated: Trial terminated by Sponsor

RCTNCT05022303Phase 2 · 2021 · n=12 · Massachusetts General Hospital

Covid19

tested Evaluate the efficacy and safety of AT1001 versus placebo on mitigating symptoms of MIS-C

result Terminated before completion

Terminated: Decline in MISC cases

RCTNCT05747534Phase 2 · 2023 · n=107 · Massachusetts General Hospital

Long COVID

tested Adverse Event Profiling and Time to Symptom Resolution

result Completed; results not posted

RCTPMID 17697209n=21

Treatment studies

tested intestinal permeability (fractional excretion of lactulose/mannitol)

result Placebo group had a 70% increase in intestinal permeability after gluten, while AT-1001 (12 mg) showed no increase; GI symptoms were lower (P=0.018).

Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.

RCTPMID 22825365n=86

Treatment studies

tested gastrointestinal symptom severity

result In 86 patients, larazotide (0.25–8 mg TID) did not significantly change LAMA ratio, but lower doses limited gluten‑induced symptom worsening versus placebo.

Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.

RCTPMID 23163616n=184

Treatment studies

tested gluten‑induced symptoms (GSRS) and anti‑tissue transglutaminase IgA levels

result Larazotide 1 mg TID reduced GSRS symptom score (P=0.002) and lowered anti‑tTG IgA ratio to 5.78 vs 19.0 placebo (P≤0.010).

Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.

RCTPMID 40737433n=12

Treatment studies

tested faster resolution of gastrointestinal symptoms, faster clearance of spike antigen, and faster return to usual activities

result Children treated with larazotide displayed faster resolution of GI symptoms, faster clearance of spike antigen, and quicker return to usual activities compared with placebo.

Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.

OpenNCT01730469Phase 1 · 2011 · n=32 · Amicus Therapeutics

Fabry Disease

tested Number of subjects with adverse events to assess safety and tolerability

result Completed; results not posted

Non-randomised; effect size cannot be separated from placebo.

OpenNCT01730482Phase 1 · 2011 · n=6 · Amicus Therapeutics

Fabry Disease

tested Recovery of total radioactivity in urine

result Completed; results not posted

Non-randomised; effect size cannot be separated from placebo.

StudPMID 26770266

Treatment studies

tested Indication: celiac disease

Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.

CasePMID 34032635n=1

Treatment studies

tested plasma SARS-CoV-2 spike antigen levels, inflammatory markers, and clinical status

result Larazotide treatment coincided with a decrease in plasma SARS‑CoV‑2 spike antigen levels and inflammatory markers, and clinical improvement beyond standard therapy.

Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.

AnimalDOI 10.64898/2025.12.22.695858