Larazotide dosage and evidence
Written by Aaron CuhaReviewed Sep 2026
The short answer
Larazotide is a gut barrier peptide for celiac disease that is still being tested. It reached a large final-stage study, but the company stopped that study and never published a result.
Evidence grade for Larazotide: Moderate. The rule: at least one finished study in people, and at least 100 people who took it. The sum on this page: 2 completed trials, 526 people given it. A grade counts how much has been done to people, not whether it works.
- People given it
- 526
- Human studies
- 2
- Found nothing
- 1
Dose
No human dose established
Amounts that were given in studies sit in Human evidence on this page. None of them is a personal dose.
2 completed trials, 526 people given it
No first-hand reports gathered yet. That is a gap in what we have collected, not a finding that nothing has been reported.
Goal pages: Gut health
In plain English
In plain English, from Aaron
This is how I would explain it to a friend. The evidence, with the numbers, is further down the page.
Larazotide is a pill for celiac disease. It is meant to tighten a leaky gut lining so gluten cannot slip through. It was tested a lot, but it was never approved. The company stopped its last big study and never published a result.
What people take it for
- Celiac symptoms that go on even on a gluten-free diet.
- Protection when gluten sneaks into food.
- Leaky gut in general, outside celiac disease.
What studies in people showed
In 342 adults with celiac disease who still had symptoms on a gluten-free diet, only the lowest dose, 0.5 mg, beat a dummy pill. The higher doses did not. When more drug does not do more, that one good result is harder to trust. In 184 people who ate gluten on purpose, the 1 mg dose made symptoms milder. It also blunted a rise in a celiac antibody. But the gut lining was no less leaky than on the dummy, and that was the whole idea of the drug. The large final study signed up 307 people. The company stopped it, and no result was ever published.
What people report
Reports, not study results
The good
- Milder symptoms during a gluten challenge on the 1 mg dose, in one study.
The bad
- Only the lowest dose beat the dummy in the biggest published study.
- It did not make the gut lining less leaky, which is what it was built to do.
- The final big study was stopped with no result.
Where these come from: These come from the studies on this page. We have not collected user reports on this one yet.
My bottom line
Nobody knows if this works, because the study that would have told us was stopped. If you have celiac disease, in my opinion a strict gluten-free diet and your doctor are still the plan.
An opinion, not a finding. I am a coach, not a doctor.
What it has been measured to do
Measured in people
Goals Larazotide has been tested for in people, biggest studies first. We count only what the studies on this page say, so the real numbers may be higher.
- Gut and digestion184 people · 1 study · 1 found nothing
35 of the 36 indexed goals have no study of any kind behind Larazotide
No study in people, animals or cells on this page reports a result for these. That does not prove Larazotide does nothing for them. It does mean anything you have heard about Larazotide and one of these did not come from a study cited here.
Show full evidence
What is Larazotide?
Larazotide is a gut barrier peptide for celiac disease that is still being tested. It reached a large final-stage study, but the company stopped that study and never published a result.
Larazotide acetate is a peptide taken by mouth. It is meant to tighten the gut lining by blocking zonulin, a signal that loosens it. The aim is to cut the leaky gut response to gluten in celiac disease.
In 342 adults who still had symptoms on a gluten-free diet, only the lowest dose, 0.5 mg, beat the dummy pill. In 184 people with celiac disease who ate gluten on purpose, the 1 mg dose made symptoms milder, but the gut lining was no less leaky than on the dummy. It went on to a large final-stage study with 307 people, but the company stopped that study and published no result. It is not approved. It is still one of the most tested gut barrier peptides.
How does Larazotide work?
It blocks zonulin signaling. That tightens the seals between gut lining cells, called tight junctions, and keeps pieces of gluten from slipping through.
The evidence, in charts
Fig. 1a · how many people
526people, across 2 studies in people cited here
| Study | People | Share |
|---|---|---|
| Gastroenterology 2015 | 342 | 65% |
| Alimentary Pharmacology and Therapeutics 2013 | 184 | 35% |
One study holds 65% of these people, so the total rests more on one study than its size suggests. Counts are the number of people each study on this page says it signed up. That includes studies that only watched people and gave nobody the compound. 1 more study in people gives no headcount and is not counted here. Studies still signing people up are left out, and only studies cited on this page are counted.
Fig. 1b · evidence mix
All 3 sources here are studies in people.
- Study in people · done in people3100%
Counted from the list of sources on this page. It counts only what we cite, so there may be more studies out there. A review counts once, however many studies it sums up.
Fig. 2 · evidence over time
The studies cover 3 different years, 2013 to 2022, counted from the list of sources on this page.
Fig. 3 · legal status at a glance
US
Not approved
UK
Not approved
AU
Not approved
CA
Not approved
Not approved in any of the four countries shown. This is what the law says, not a verdict on the science. See Legal status below for the full text and any notes.
Fig. 4 · how much does what
Nobody has tested different amounts in people
This chart would show how the effect changes as the amount goes up. For this compound, nobody has measured that in people. So we leave it empty. We will not borrow an animal chart and pretend it works the same in people.
Fig. 5 · what the molecule is
- Kind of compound
- Peptide
- Molecule weight
- ~732 Da
- Half-life
- Stated in words, not a numbersee the exact wording below
- Chain length
- None on file
No amino acid sequence is on file for Larazotide, so none is drawn rather than guessed from a name.
The studies we cite
- Study in people2013Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study
Larazotide reduced symptoms during a deliberate gluten challenge, but missed the thing it was designed to fix. A hundred and eighty-four people with coeliac disease ate gluten on purpose while taking the drug or a dummy. On 1 mg, symptoms were milder and the rise in a coeliac antibody was blunted. The leakiness of the gut lining, which is the whole idea behind the drug, was no different from the dummy. So the mechanism it was built on was not demonstrated.
184 patients on a gluten challenge: 1 mg larazotide limited gluten-induced symptoms and blunted the rise in anti-tTG antibodies, but intestinal permeability (LAMA ratio) did not differ from placebo.
- Study in people2015Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial
The smallest dose worked and the bigger doses did not, which is a pattern worth being suspicious of. Three hundred and forty-two adults with coeliac disease who still had symptoms on a gluten free diet took one of three doses or a dummy. Only the 0.5 mg group beat the dummy on the symptom measure the trial was built around. When more drug does not do more, the single positive result is harder to trust than it first looks.
Phase 2b in 342 adults: the 0.5 mg dose met the primary symptom endpoint versus placebo; higher doses did not.
- Study in people2022A Phase 3 study of larazotide acetate for the relief of persistent symptoms in patients with celiac disease on a gluten-free diet (NCT03569007)
The trial that was meant to settle it was abandoned. This was the late stage study of larazotide for people with coeliac disease still suffering on a gluten free diet. Three hundred and seven people had enrolled when the company stopped it. No result was ever published, so nobody knows what it would have shown. A stopped trial is not a failed drug and it is not a working one. It is a question left open, and no one is answering it.
The pivotal Phase 3 (307 enrolled, sponsor 9 Meters Biopharma) is listed as terminated by the sponsor; no efficacy result was published.
Where to buy Larazotide
1 seller lists Larazotide in our latest read. They are ranked by trust score, then by archive rating, then by certificate tier, then by the lowest price per milligram. Archive evidence is counted before source-backed. Each path is out of 4, and the two are not added. A higher price does not raise the score. The letter is the certificate chip. 0 of them have a published certificate that names Larazotide.
Some seller links may pay this site when you buy through them. A payment never changes a seller's tier or rank, and no seller has a say in any page.
| Seller | Trust score | Vial sizes | From, per mg | Certificate for Larazotide | Seller link |
|---|---|---|---|---|---|
| Core Power Peptides | 40 WeakSource-backed 1 of 4. Archive evidence 1 of 4.C | 5 mg | $16.0 | None found for Larazotide | View |
- LC Lab-confirmed: the issuing laboratory echoed this certificate back
- A Current certificate, independent laboratory named, laboratory not yet checked
- B Certificate published, but no laboratory link, older than a year, or the laboratory did not recognise the published lookup
- C No certificate could be read
Every listing and vial size for Larazotide · How the trust score is counted
Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.
Common questions
Has Larazotide been tested in people?
Yes. 526 people given it across 2 completed trials cited here, 1 of which found nothing. Larazotide is a gut barrier peptide for celiac disease that is still being tested. It reached a large final-stage study, but the company stopped that study and never published a result.
What is the Larazotide dosage?
No human dose established. Amounts that were given in studies sit in Human evidence on this page. None of them is a personal dose. 2 completed trials, 526 people given it
Is Larazotide FDA-approved?
Investigational; a final-stage study missed its main goal
Is larazotide approved for celiac disease?
No. It reached a large final-stage study, but the company stopped that study and never published a result. It is not approved.
Latest reading on Larazotide
Blog posts about Larazotide, newest first.